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December, 2009 | | (12/29) New HIV/AIDS study findings recently were published by D.P. Kidder and co-researchers | In this recent article published in the Jaids - Journal of Acquired Immune Deficiency Syndromes, scientists in the United States conducted a study "To compare drug. alcohol, and sexual HIV transmission risk behaviors of homeless and housed people living with HIV/AIDS. Data were from 8075 respondents in a cross-sectional. multisite behavioral survey of adults recently reported to have HIV infection."
"At interview, 310 respondents (4%) were homeless. Compared with homeless respondents, housed respondents were more likely to be sexually active (past 12 months). However, sexually active homeless respondents had more sex partners (lifetime and past 12 months), greater sex exchange for money or drugs (lifetime and past 12 months). and greater unprotected vaginal or anal sex with an unknown serostatus partner. Homeless respondents were more likely to have possible alcohol abuse (lifetime), used drugs (last 12 months), and injected drugs (lifetime and past 12 months). After controlling for potential confounding variables, housing status remained a significant predictor of number of sex partners (past 12 months). sex exchange (lifetime and past 12 months), unprotected sex with unknown status partner. and all drug and alcohol use variables. Homeless people living with HIV/AIDS are more likely to have ever or recently engaged in substance use and HIV transmission risk behaviors,! " wrote D.P. Kidder and colleagues.
The researchers concluded: "Findings underscore the need to provide HIV prevention services to homeless persons and address their housing needs." Kidder and colleagues published their study in Jaids - Journal of Acquired Immune Deficiency Syndromes (Housing Status and HIV Risk Behaviors Among Homeless and Housed Persons With HIV. Jaids - Journal of Acquired Immune Deficiency Syndromes, 2008;49(4):451-455).
~News RX.com - 12/28/2008
| | | | (12/29) New hepatitis C virus quality of care study results reported from Johann Wolfgang Goethe University | Current study results from the report, 'Deterioration of health-related quality of life and fatigue in patients with chronic hepatitis C: Association with demographic factors, inflammatory activity, and degree of fibrosis,' have been published. "Health-related quality of life (HRQoL) is impaired in patients with chronic hepatitis C. We investigated HRQoL and fatigue in patients with chronic hepatitis C virus (HCV) infection in relation to the degree of fibrosis and inflammation, and controlled for the influence of relevant demographic and medical variables," scientists in Frankfurt, Germany report.
"We conducted a cross-sectional two-center study including 215 outpatients with chronic hepatitis C applying the Short-Form Health Survey (SF-36) and the Fatigue Impact Scale (FIS-D). The contribution to the variability of these psychometric scores was evaluated for the degree of fibrosis as well as viremia, gender, age, mode of transmission, genotype, and ALT. There was a strong negative association between the degree of liver fibrosis and the physical SF-36 summary score (p=0.016). This was independent of the covariate age, also significantly predicting physical HRQoL (p=0.001). The absolute FIS score was significantly increased in patients with advanced fibrosis (p=0.043). In females, mental SF-36 summary score (p=0.007) and fatigue (p=0.017) were significantly more impaired. Our study suggests a significant association of physical aspects of HRQoL and fatigue with the extent of fibrosis," wrote G. Teuber and colleagues, Johann Wolfgang Goethe University.
~HCV Advocate - 12/29/2008 | | | May, 2009 | | (05/23) HIV Policy: The Path Forward—A Joint Position Paper of the HIV Medicine Association of the Infectious Diseases Society of America and the American College of Physicians | Executive Summary: The American College of Physicians (ACP) and the Infectious Diseases Society of America (IDSA) have jointly published 3 policy statements on AIDS, the first in 1986 [1], the second in 1988 [2], and the third in 1994 [3]. In 2001, the IDSA created the HIV Medicine Association (HIVMA), and this updated policy paper is a collaboration between the ACP and the HIVMA of the IDSA. Since the last statement, many new developments call for the need to reexamine and update our policies relating to HIV infection. First, there have been major advances in treatment for HIV infection that have transformed HIV/AIDS from a terminal illness to a chronic disease for many of those who have access to potent therapies and expert medical care [4]. Second, there has been a profound expansion and intensification of the global HIV pandemic, particularly in sub‐Saharan Africa, coupled with significant US leadership and resources aimed at providing prevention and care services to affected populations in developing countries. Third, the concerns that were prevalent in the mid‐1990s regarding the possibility of HIV transmission in health care settings have ultimately proven to be unfounded as the result of the adoption of universal precautions in those settings ...(continued)
~Kaiser Network - 05/23/2009 | | | | (05/19) L.A. County Restores Funding for Vital AIDS Medical Services | After Innovative Online Grassroots Advocacy Led by AHF, L.A. County Commission on HIV Votes to Restore Over $1M in Funding that Provides Direct HIV/AIDS Medical Care—Including Lifesaving AIDS Drugs—to Some of L.A.’s Most Vulnerable Citizens. County Will Use Part of $2.5 Million in Additional Federal Ryan White CARE Act Funds to Avert Cuts; L.A. County’s Board of Supervisors to Vote Tuesday to Confirm Restoration of Funds ...(continued)
~AIDS Healthcare Foundation - 05/19/2009 | | | | (05/17) Gilead Initiates Phase II Clinical Trial of Integrase-Based, Single-Tablet, Once-Daily Regimen for the Treatment of HIV | FOSTER CITY, Calif.- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has begun enrolling patients in a Phase II clinical trial of its investigational integrase-based, single-tablet, once-daily regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection. GS 9350 is an investigational compound being developed as a pharmacoenhancing or “boosting” agent to increase blood levels and allow once-daily dosing for certain medicines, including Gilead’s investigational HIV integrase inhibitor, elvitegravir. The Phase II study is designed to evaluate the safety and efficacy of the regimen compared to once-daily Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). The study will enroll 75 HIV-1 infected, antiretroviral treatment-naïve adults across approximately 50 investigative sites in the United States ...(continued)
~Gilead Sciences - 05/17/2009 | | | | (05/17) Shortage of HIV/AIDS, TB, Malaria Drugs in Ugandan District Could Lead to Treatment Interruption, Drug Resistance | A shortage of HIV/AIDS, tuberculosis and malaria medications in Uganda's northern Gulu district could cause patients to interrupt treatment and lead to drug resistance, Paul Onek, Gulu director of health services, said recently, IRIN/PlusNews reports. According to IRIN/PlusNews, inadequate management of the country's drug supply regularly causes shortages ...(continued)
~Kaiser Network - 05/17/2009 | | | | (05/15) NYC’s Frieden Brings ‘Real World Experience Fighting AIDS’ to CDC | AIDS Healthcare Foundation (AHF), the largest non-profit HIV/AIDS organization in the US which currently provides medical care and services to more than 100,000 individuals in 21 countries worldwide in the US, Africa, Latin America/Caribbean and Asia, and which has been critical of President Obama’s silence on AIDS throughout his first hundred days, today lauded the President’s appointment of New York City Health Commissioner Dr. Thomas Frieden as head of the Centers for Disease Control ...(continued)
~AIDS Healthcare Foundation - 05/15/2009 | | | | (05/01) Disability & Benefits: Government Plans Updated for 2009 | Social Security and Medicare revise their benefits at the beginning of each year to update the programs for inflation. Some numbers are based on the Federal Poverty Level table which does not come out until April of each year. For 2009, they have applied an inflation factor of 5.8%. which is the highest in several years. Those of you who are collecting Social Security benefits, either disability, retirement or spouse & children benefits should have already received a letter announcing the amount of your benefit for 2009. There are other numbers that change as well due to this inflation adjustment. Below is a quick rundown of the numbers affecting people on or considering Social Security Disability or Retirement ...(continued)
~HCV advocate - May 2009 | | | | (05/01) Treatment of Acute and Early Hepatitis C | In the March 1, 2009 Clinical Infectious Diseases, G. Matthews and colleagues reported findings from the Australian Trial in Acute Hepatitis C (ATAHC), looking at the natural history and treatment of acute and early chronic HCV infection. The analysis included 103 participants – 76 HIV negative and 27 HIV positive – who had a first positive HCV antibody test within six months prior to enrollment and either clinical hepatitis diagnosed within the past year or documented HCV antibody seroconversion within the past two years ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) Nitazoxanide for Chronic Hepatitis C | Nitazoxanide (Alinia) is an anti-infective agent with activity against a variety of protozoa, bacteria, and viruses; nitazoxanide and its active metabolite, tizoxanide, have been shown to potently inhibit HCV replication in laboratory studies. In the March 2009 Gastroenterology, a research team led by J.-F. Rossignol from the Romark Institute described results from STEALTH-C1, a study of nitazoxanide prior to pegylated interferon/ribavirin in previously untreated genotype 4 chronic hepatitis C patients in Egypt. Forty participants were randomly assigned to receive the standard-of-care regimen of pegylated interferon alfa-2a (Pegasys) plus 1000-1200 mg/day weight-adjusted ribavirin for 48 weeks, 28 patients received 500 mg twice-daily nitazoxanide monotherapy for 12 weeks followed by a dual combination of nitazoxanide plus Pegasys (without ribavirin) for 36 more weeks, and 28 received nitazoxanide monotherapy for 12 weeks followed by a triple combination of nitazoxanide, Pegasys, and ribavirin for 36 weeks ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) Can-Fite BioPharma To Initiate Phase I/II Clinical Trial With CF102 For The Treatment Of Liver Cancer | Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange announced that, following the approval by the Israel Ministry of Health and Rabin MC Ethics Committee, a phase I/II clinical trial with CF102 for the treatment of liver cancer will now start enrolling patients. The trial will investigate the safety and efficacy of CF102 in patients with liver cancer. This ascending-dose trial will be conducted at the Rabin Medical Center and include up to 40 patients ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) Summaries For Patients: Re-treating Patients With Chronic Hepatitis C Who Have Not Responded to Peginterferon-2b | Hepatitis C is inflammation of the liver caused by the hepatitis C virus (HCV). This disease is transmitted primarily by blood-to-blood contact. Risk factors include body piercing, intravenous drug use, and needlestick accidents. Most people cannot get rid of HCV on their own. More than 80% keep the virus in their blood for longer than 6 months and get chronic hepatitis C ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) Biolex Therapeutics Commences Phase 2B Trial Of Locteron(R) In Chronic Hepatitis C | Biolex Therapeutics, Inc. announced the commencement of patient dosing in the SELECT-2 Phase 2b trial of its lead product candidate Locteron for the treatment of chronic hepatitis C. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the side effects associated with pegylated interferons, the current standard of care, including flu-like symptoms. The Company also announced that the preliminary results of the recently completed United States Phase 2a Locteron trial ("PLUS" trial) will be presented at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) April 24, 2009 in Copenhagen, Denmark ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) INFORM-1 Clinical Trial Amended To Further Explore Promising Direct Antiviral Regimen In HCV Patients | InterMune, Inc. (Nasdaq: ITMN) announced that the innovative clinical study of protease inhibitor ITMN-191 (R7227) in combination with nucleoside polymerase inhibitor R7128 (Roche/Pharmasset), referred to as the INFORM-1 study, has been successfully amended to include additional cohorts to explore the combination in treatment-experienced and null responder HCV patients. In addition, the amended protocol now includes the administration of twice-daily and higher-dose regimens of ITMN-191 in combination with R7128 in treatment-naive patients ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) ImQuest BioSciences Receives Phase I SBIR Grant To Develop A Novel Hepatitis C Virus Therapeutic Agent | ImQuest BioSciences and Arisyn Therapeutics jointly announced the successful acquisition of funding from the National Institutes of Health to support the development of novel small molecule therapeutics for the treatment of hepatitis C virus (HCV) infection. ImQuest scientists will investigate the therapeutic potential and mechanism of action of ATI-0810 (Formerly PG301029) and a series of related chemical compounds. PG301029 is a highly novel transcriptional inhibitor of HCV replication, yielding a significant reduction of viral RNA synthesis in infected cells, and laboratory studies have demonstrated the compound to be less toxic and more active than the FDA approved agent ribavirin. Preliminary in vivo toxicology studies indicate that the compound is well tolerated and has a pharmacokinetic profile appropriate for drug development. The ImQuest research team will be led by Principal Investigator Todd B. Parsley, Ph.D., Director of Hepatitis Virus Research. The funded studies will permit ImQuest to define other potent transcriptional inhibitors of HCV, investigate the mechanism of action of the active molecules and provide additional rationale for the development of a combination anti-HCV therapy using the lead molecules ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) Vitamin K may boost effects of cancer pill Nexavar | CHICAGO (Reuters) - Vitamin K may enhance the effects of the cancer drug Nexavar, which may allow patients to take lower, less-toxic doses, U.S. researchers said on Wednesday. They said combining vitamin K with the cancer pill Nexavar or sorafenib sold by Onyx Pharmaceuticals Inc and German drugmaker Bayer AG helped it kill liver and pancreatic cancer in human cell cultures. "K vitamins ... appear to enhance the effects of sorafenib, thus requiring lower, less-toxic doses," Dr. Brian Carr of Thomas Jefferson University in Philadelphia said in a statement ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) Tougher rules planned for N.L. MDs infected with HIV, hepatitis | Doctors in Newfoundland and Labrador who have particular infectious diseases may soon be limited in the procedures they can perform on patients. Physicians who contract HIV or hepatitis will also be required to notify the College of Physicians and Surgeons of Newfoundland and Labrador, if proposed changes are adopted ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) LVADs can cause false-positive HCV-antibody tests, diligent follow-up testing urged to preserve transplant eligibility | Paris, France - Someone awaiting heart transplantation who is fitted with a left ventricular assist device (LVAD) may be at increased risk of falsely testing positive for hepatitis C virus (HCV) antibody, according to a study that included only a handful of patients but highlights the importance of more definitive follow-up testing to confirm or, preferably, rule out HCV infection ...(continued)
~HCV Advocate - May 2009 | | | | (05/01) RNA Test To Detect HIV During Acute, Primary Phase Not Widely Used, New York Times Reports | The New York Times on Friday examined an HIV blood test, which seeks out bits of the virus' RNA and can identify infections during the acute or primary phase. Standard rapid tests, which detect HIV antibodies, can provide immediate results but are not likely to identify an infection that has occurred in the past month. The RNA tests, which can identify infections in one week to 10 days, are able to detect infections in the early stages, when HIV is replicating but the immune system has not mounted a response. According to the Times, although many health officials and HIV/AIDS experts see detecting newly infected HIV-positive people as an "important next step in controlling the spread of HIV," the RNA test, the "only one capable of detecting the newest infections, has not been widely adopted for this purpose' ...(continued)
~Kaiser Network - 05/01/2009 | | | | (05/01) Early HAART Initiation Improves Vaccine Response Among HIV-Positive Children, Study Says | HIV-positive infants who begin treatment with highly active antiretroviral therapy within the first year of life can develop normal immune responses to childhood vaccines, according to a study published online Monday in the Proceedings of the National Academy of Sciences, Reuters Health reports. Vaccines function by stimulating the production of antibodies for a particular disease, but HIV causes a decline in these antibody-producing cells and therefore reduces immunity. Prior to the new study, researchers were unsure whether the timing of HAART initiation could help preserve these cells and promote normal immune responses to vaccines among children ...(continued)
~Kaiser Network - 05/01/2009 | | | April, 2009 | | (04/30) Early Initiation of Antiretroviral Therapy Improves HIV Survival Rates, Study Says | The New York Times on Thursday examined a study that found asymptomatic HIV-positive people who delayed antiretroviral treatment until their disease reached an advanced stage faced higher mortality rates than those who initiated treatment earlier. According to the Times, current national guidelines recommend starting HIV-positive people on antiretroviral treatment when CD4+ T cell counts fall below 350; however, the recent study suggests that initiating treatment earlier could reduce the risk of death. The study, as well as a related editorial, appeared online in the New England Journal of Medicine earlier this month and both will appear in the April 30 edition of the journal. In addition, a separate study published online earlier this month in the journal Lancet developed similar conclusions about the benefits of earlier antiretroviral therapy initiation, the Times reports ...(continued)
~Kaiser Network - 04/30/2009 | | | | (04/29) Use of Certain Antibiotics in Topical Cream Could Prevent HIV Transmission, Study Says | A class of antibiotics known as aminoglycosides could be used to make a topical cream that would trigger production of a protein in humans to prevent HIV transmission, according to a study published Tuesday in PLoS Biology, the Orlando Sentinel reports ...(continued)
~Kaiser Network - 04/29/2009 | | | | (04/28) Debio 025 in Hepatitis C | LAUSANNE, Switzerland, April 28 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions, particularly in the field of oncology, presented results from a phase IIa study with Debio 025, a selective cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C (HCV) effect. Revealed at the 44th Annual Meeting of the European Association for the Study of the Liver, in Copenhagen, these findings showed potent antiviral activity.
The phase IIa study investigated the efficacy and safety of Debio 025 in combination with Peg interferon alpha 2a (peg-IFN alpha-2a) and ribavirin in previously null-responder genotype 1 HCV patients. Results demonstrated that Debio 025 at doses of 400 mg (with initial loading) and 800 mg daily for 29 days shows a statistically significant reduction of HCV RNA of respectively -1.96 log (-98.9%) and -2.38 log (-99.5%) when co-administered with Peg-IFN alpha-2a and ribavirin in previous null responders ...(continued)
~HCV Advocate - 04/28/2009 | | | | (04/27) Research from V.G. Valcour and co-authors yields new data on HIV/AIDS co-infection | According to recent research from the United States, "The extent to which highly active antiretroviral therapy (HAART) era cognitive disorders are due to active processes, incomplete clearance of reservoirs, or comorbidities is controversial. This study aimed to determine if immunologic and virologic factors influence cognition after first-time HAART in Thai individuals with HIV-associated dementia (HAD) and Thai individuals without HAD (non-HAD)." "Variables were captured longitudinally to determine factors predictive of degree of cognitive recovery after first-time HAART. Neuropsychological data were compared to those of 230 HIV-negative Thai controls. HIV RNA and CD4 lymphocyte counts were not predictive of HAD cross-sectionally or degree of cognitive improvement longitudinally. In contrast, baseline and longitudinal HIV DNA isolated from monocytes correlated to cognitive performance irrespective of plasma HIV RNA and CD4 lymphocyte counts pre-HAART (p < 0.001) and at 48 weeks post HAART (p < 0.001). Levels exceeding 3.5 log(10) copies HIV DNA/10(6) monocyte at baseline distinguished all HAD and non-HAD cases (p < 0.001). At 48 weeks, monocyte HIV DNA was below the level of detection of our assay (10 copies/10(6) cells) in 15/15 non-HAD compared to only 4/12 HAD cases, despite undetectable plasma HIV RNA in 26/27 cases. Baseline monocyte HIV DNA predicted 48-week cognitive performance on a composite sco! re, independently of concurrent monocyte HIV DNA and CD4 count (p < 0.001). Monocyte HIV DNA level correlates to cognitive performance before highly active antiretroviral therapy (HAART) and 48 weeks after HAART in this cohort and baseline monocyte HIV DNA may predict 48-week cognitive performance. These findings raise the possibility that short-term incomplete cognitive recovery with HAART may represent an active process related to this peripheral reservoir," wrote V.G. Valcour and colleagues. The researchers concluded: "Neurology (R) 2009; 72:992-998'." Valcour and colleagues published their study in Neurology (HIV DNA and cognition in a Thai longitudinal HAART initiation cohort The SEARCH 001 Cohort Study. Neurology, 2009;72(11):992-998).
~News RX - 04/27/2009 | | | | (04/27) New hepatitis B virus research reported from University of Texas | According to recent research from the United States, "Chronic hepatitis B virus ( HBV) and hepatitis C virus ( HCV) are established causes of HCC. HCC patients are often diagnosed late and receive palliative therapies, however, the survival of Asian American patients with HCC treated without transplantation has not been well studied." "We reviewed our institution's experience to determine predictors and rates of survival in Asian American HCC patients treated without transplantation. We identified Asian American patients with HCC referred to M. D. Anderson Cancer Center. Patients were tested for HBV and HCV. Survival curves were generated by Kaplan-Meier method. Multivariate Cox proportional hazards regression was used to test the relationship between prognostic factors and survival. Of 82 Asian American HCC patients, most had advanced disease ( 65%) and received treatment ( 68%); however, only 11% had surgical resection. 94% had positive anti-HBc and 61% had positive HBsAg. 20% had positive anti-HCV. There were no significant changes in the rates of HBV and HCV over time. Male gender, high alpha-fetoprotein levels, and stage IV disease were associated with shorter survival Overall median survival was 9.2 months ( 95% CI 6.5-11.9), and the survival of HCV and HBV patients was not statistically different.! The survival rate of Asian American patients with advanced HCC, for whom transplantation was not available, was low," wrote J.P. Hwang and colleagues, University of Texas.The researchers concluded: "Timely hepatitis screening and interventions by primary care physicians may be the most logical solution to reduce the burden of hepatitis-associated HCC among Asian Americans." Hwang and colleagues published their study in BMC Cancer (Survival and hepatitis status among Asian Americans with hepatocellular carcinoma treated without liver transplantation. BMC Cancer, 2009;9():46).
~News RX - 04/27/2009 | | | | (04/27) HIV handicaps itself to escape immune system pressure | People with the ability to stave off AIDS for years after initial infection by HIV have been called "long-term non-progressors" or "elite controllers." One component of this remarkable resistance comes from an individual's HLA genes. Long-term non-progressors tend to have HLA genes that help the immune system recognize and fight HIV more efficiently. A team of researchers from the Emory Vaccine Center studying HIV-infected people with particularly effective HLA genes has observed how the virus mutates and evolves in response to immune pressure. The observations, published in the Journal of Experimental Medicine, can provide guidance on what kinds of immune responses a successful HIV vaccine should generate. The team was led by Eric Hunter, PhD, professor of pathology and laboratory medicine at Emory University School of Medicine, Emory Vaccine Center, and Yerkes National Primate Research Center. Hunter is a Georgia Research Alliance Eminent Scholar. First author Hayley Crawford, a graduate student at Oxford University, England, performed much of the research while working in Hunter's laboratory. The Emory/Oxford team studied people in Zambia and South Africa with one form of the HLA gene that helps the immune system control HIV, called HLA-B*5703. HLA genes encode molecules that display fragments of viral proteins, known as epitopes, on the surface of infected cells. When white blood cells known as cytotoxic T lymphocytes (CTLs) spot certain combinations of HLA molecules and viral epitopes, they attack the infected cells. The authors show that a set of three mutations in HIV's Gag protein, which makes up the viral core, progressively slow viral replication. In cell culture, a triple-mutant virus replicates 20 times slower than normal. However, these same mutations effectively eliminate the ability of CTLs to detect the virus. so that in an infected person, once all three mutations are in place, viral abundance shoots upwards."In this situation, HIV resembles a thief picking a lock. Once all three mutations are in place, the lock is picked and the virus can thrive because the immune system can't fight against it," Hunter says. The team followed the mutations' fate after transmission by studying couples in which one person had infected the other. If the recipient lacked HLA-B*5703, the virus lost the mutations, because the three handicapping mutations were not useful in evading the new, different immune system. But unlucky recipients with HLA-B*5703 who got the triple-mutant virus from their partners quickly got sick. The results demonstrate the importance of CTLs, the white blood cells that attack viral infected cells, in controlling HIV infection. They also suggest that a successful vaccine will need to induce responses to many epitopes, or combinations of HLA molecule and viral protein. Keywords: HIV/AIDS, AIDS, Acquired Immunodeficiency Syndrome, Biotechnology, Experimental Medicine, HIV, Human Immunodeficiency Virus, Pathology, Vaccines, Virology, Emory University.
~News RX - 04/27/2009 | | | | (04/25) Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen | NUTLEY, N.J., BRISBANE, Calif., and PRINCETON, N.J. - Roche, InterMune, Inc. (Nasdaq: ITMN - News) and Pharmasset (Nasdaq: VRUS - News) today announced the first results from their innovative, interferon-free regimen of direct acting antiviral (DAA) combination therapy for the treatment of patients chronically infected with the hepatitis C virus (HCV)(1). The study combined two oral DAAs, R7227 (also known as ITMN-191) and R7128, for the first time in patients. There were no serious adverse events reported during the 14 days of dosing, and the reductions in levels of HCV RNA were significant ...(continued)
~Intermune - 04/25/2009 | | | | (04/23) Hepatitis B Injection Approved for Treating Acute Exposure | NEW YORK - Health Canada has approved the hepatitis B immune globulin (human) injection (HepaGam B) for treating acute exposure to hepatitis B virus (HBV). Specifically, the approval is for post-exposure prophylaxis (PEP) for acute exposure to blood containing hepatitis B surface antigen (HBsAg), perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure to persons with acute hepatitis B infection. The most common expected adverse drug reactions for intravenous immuneglobulins are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia, and moderate low back pain.
~HCV Advocate - May 2009 | | | | (04/23) Africa Should Manufacture Generic HIV/AIDS Drugs, UNAIDS Head Sidibe Says | Africa should produce its own generic antiretroviral drugs in order to fight HIV/AIDS and ensure that the global financial crisis does not hinder treatment access, UNAIDS Executive Director Michel Sidibe said on Wednesday in Addis Ababa, Ethiopia, Reuters reports. "We should facilitate a discussion around how we can build a business case for producing generic drugs in Africa so that it can increase coverage but can, at the same time, be a profitable business," he said, adding, "It's important politically, it's important economically, it's important for the integration of Africa in the global market" ...(continued)
~Kaiser Network - 04/23/2009 | | | | (04/23) New Jersey Legislature Examining Ways To Avoid HIV/AIDS Medication Copayments in State Budget | New Jersey lawmakers on Tuesday indicated that they are examining ways to avoid proposed co-payments for some people living with HIV/AIDS who receive medications though the state, NorthJersey.com reports. The copayments are part of Gov. Jon Corzine's (D) $29.8 billion spending proposal for the state's new fiscal year and would collect $1.36 million by creating co-payments for HIV/AIDS drugs based on a sliding scale determined by income (Reitmeyer, NorthJersey.com, 4/21). The copayments would affect 9,000 people living with HIV/AIDS who have obtained no-cost medicine from the state because they do not qualify for other assistance programs. Advocates said that the copayments will hurt patients who are already struggling because of the poor economy (Kaiser Daily HIV/AIDS Report, 3/26) ...(continued)
~Kaiser Network - 04/23/2009 | | | | (04/20) Pharmasset stops hepatitis B trial, shares drop | BANGALORE - Pharmasset Inc (VRUS.O) said it stopped a late-stage study of its experimental treatment for chronic hepatitis B [clevudine] due to several serious adverse events in patients receiving the drug, sending its shares down 17 percent. However, analysts said discontinuing the hepatitis B trial could be a "long-term gain," as it would let the company channel all its resources to its more watched-out hepatitis C pipeline. The company, which decided to stop the trial named QUASH after a discussion with its independent data monitoring committee and the U.S. Food and Drug Administration, said it would now focus its resources on its hepatitis C pipeline ...(continued)
~HCV Advocate - 04/20/2009 | | | | (04/14) NEW AIDS RESEARCH TRAINING GRANTS AWARDED FOR PROJECTS IN 15 COUNTRIES | The Fogarty International Center of the National Institutes of Health has awarded seven grants totaling almost $2.7 million to train HIV/AIDS researchers in 15 low- and middle-income countries. The funds are awarded under the center’s 20-year-old signature AIDS International Training and Research Program, which has trained nearly 2,000 foreign researchers, most of whom remain in their countries to battle the epidemic, train young scientists and move into government health leadership. "America has become the leader in advancing prevention and treatment of HIV/AIDS in developing countries," said Fogarty director Roger I. Glass, M.D., Ph.D. "Training local researchers benefits their own countries and helps U.S. scientists develop new understanding and methods for combating the disease" ...(continued)
~National Institutes of Health - 04/14/2009 | | | | (04/13) Studies from D.A. Mackellar and co-researchers yield new data on HIV/AIDS | According to recent research from the United States, "Among HIV-infected persons. we evaluated use of client partner notification (CPN) and health-department partner notification strategies to inform sex partners of possible HIV exposure, and prior exposure to partner counseling and referral services. We conducted a cross-sectional, observational study of 590 persons diagnosed with HIV in the prior 6 months at 51 HIV test, medical. and research providers in Chicago and Los Angeles in 2003 and 2004." "Logistic regression was used to identify independent correlates of using CPN to notify all locatable partners. Participants reported a total of 5091 sex partners in the 6 months preceding HIV diagnosis: 1253 (24.6%) partners were locatable and not known to be HIV-positive. Of 439 participants with <= 1 locatable partners. 332 (75.6%) reported notifying 696 (55.5%) partners by CPN (585, 84.1%), health-department partner notification (94, 13.5%). or other means (17, 2.4%): 208 (47.4%) used CPN to notify all locatable partners. Independent correlates of CPN included having fewer locatable partners and discussing the need to notify partners with an HIV medical-care provider (black and Hispanic participants only). Many participants reported that their HIV test or medical-care provider did not discuss the need to notify partners (48.8%, 33.7%, respectively) and did not offer health-department partner-notification service., (60.8%, 52.8%). Many locatable sex partners who migh! t benefit from being notified of potential HIV exposure are not notified," wrote D.A. Mackellar and colleagues.The researchers concluded: "In accordance with national policies, HIV test and medical-care providers should routinely provide partner counseling and referral services to HIV-infected client,, so that all locatable partners are notified and provided all Opportunity to learn their HIV status." Mackellar and colleagues published their study in Sexually Transmitted Diseases (Exposure to HIV Partner Counseling and Referral Services and Notification of Sexual Partners among Persons Recently Diagnosed with HIV. Sexually Transmitted Diseases, 2009;36(3):170-177).
~News RX - 04/13/2009 | | | | (04/13) Data from Kaohsiung Medical University, Department of Internal Medicine provide new insights into hepatitis C virus therapy | New research, 'Treatment of chronic hepatitis C in Asia: when East meets West,' is the subject of a report. "The issue of best treatment for chronic hepatitis C virus (HCV) infection is in constant flux, not only in Western countries but also in Asia. Currently, pegylated-interferon plus ribavirin is the standard of care," investigators in Kaohsiung, Taiwan report.
"Studies from Asia provide evidence to support the same broad treatment strategies for Asian patients as recommended in Western countries. Nevertheless, there is increasing evidence that Asians have a higher likelihood of achieving a sustained virological response (SVR) than their Caucasians counterparts when treated with the corresponding regimen. With the recommended 'standard dose and duration treatment regimens', SVR is achieved in Asia for around 70% of HCV genotype 1 (HCV-1) infected cases, approximately 90% of HCV-2/3, approximately 65% of HCV-4, and approximately 80% of HCV-6 patients. Difference of body weight in race might contribute the superior response in Asian patients. HCV genotype distribution in Asia also differs from North-America/Europe. HCV-6 and its variants, previously mistyped as HCV-1, needs accurate genotyping. Increasing data support the proposal that HCV genotype, baseline viral load and on-treatment virological response provide information for de! cision-making so that treatment can be individualized. Beyond the older recommendations, an abbreviated 24-week regimen could be suggested for HCV-1/4 patients with baseline viral loads <400 000 IU/mL and a rapid virological response (RVR, HCV RNA undetectable at week 4), and an abbreviated 12-16 weeks of pegylated-interferon with weight-based doses of ribavirin could be suggested for HCV-2/3 patients with a RVR. Such tailored treatment regimens can reduce the costs of treatment and incidence of adverse events without compromising efficacy. Hepatitis C virus (HCV) infection is one of the most important causes of cirrhosis worldwide, and particularly in some countries of Asia (notably Japan) where it is now more prevalent than chronic hepatitis B virus infection. Hepatitis C virus infection can also lead to hepatocellular carcinoma (HCC). It is estimated that there are more than 170 million people chronically infected with HCV, and 3 to 4 million persons are newly infect! ed each year. The risk for developing cirrhosis 20 years after! initial HCV infection among those chronically infected varies between studies, but is estimated at around 10%-15% for men and 1-5% for women. Once cirrhosis is established, the rate of developing HCC is at 1%-4% per year. Approximately 280 000 deaths per year are related to HCV infection. Hepatitis C virus-related end-stage liver disease and HCC have become the leading cause for liver transplantation worldwide. In the Asia-Pacific area, the estimated prevalence of antibodies to HCV (anti-HCV) range from 0.3% in New Zealand to 5.6% in Thailand. In Japan, Middle East, Vietnam and Taiwan, several HCV hyper-endemic areas have been reported with an anti-HCV prevalence rate of 12% to as high as 58%. In addition to the well-known endemic status of HBV infection in most countries of the Asia-Pacific region, HCV infection presents another critical scenario of public health issue in this region, as outlined in Guidelines by the Asia-Pacific Association for Study of the Liver (APASL)," wrote ! M.L. Yu and colleagues, Kaohsiung Medical University, Department of Internal Medicine.The researchers concluded: "Given the lack of an effective vaccine, optimal treatment of chronic HCV infection is now perceived as a 'must' in terms of public health strategies, as well as of the clinical setting for individual patients." Yu and colleagues published their study in the Journal of Gastroenterology and Hepatology (Treatment of chronic hepatitis C in Asia: when East meets West. Journal of Gastroenterology and Hepatology, 2009;24(3):336-45).
~News RX - 04/13/2009
| | | | (04/06) Studies conducted at University of Connecticut on HIV/AIDS recently published | "Selecting sex partners of the same HIV status or serosorting is a sexual risk reduction strategy used by many men who have sex with men. However, the effectiveness of serosorting for protection against HIV is potentially limited," investigators in the United States report. "We sought to examine how men perceive the protective benefits of factors related to serosorting including beliefs about engaging in serosorting, sexual communication, and perceptions of risk for HIV. Participants were 94 HIV negative seroconcordant (same HIV status) couples, 20 HIV serodiscordant (discrepant HIV status) couples, and 13 HIV positive seroconcordant (same HIV status) couples recruited from a large gay pride festival in the southeastern US. To account for nonindependence found in the couple-level data, we used multilevel modeling which includes dyad in the analysis. Findings demonstrated that participants in seroconcordant relationships were more likely to believe that serosorting reduces concerns for condom use. HIV negative participants in seroconcordant relationships viewed themselves at relatively low risk for HIV transmission even though monogamy within relationships and HIV testing were infrequent. Dyadic analyses demonstrated that partners have a substa! ntial effect on an individual's beliefs and number of unprotected sex partners," wrote L.A. Eaton and colleagues, University of Connecticut.The researchers concluded: "We conclude that relationship partners are an important source of influence and, thus, intervening with partners is necessary to reduce HIV transmission risks." Eaton and colleagues published their study in AIDS and Behavior (HIV Transmission Risk among HIV Seroconcordant and Serodiscordant Couples: Dyadic Processes of Partner Selection. AIDS and Behavior, 2009;13(2):185-195).
~News RX - 04/06/2009
| | | | (04/06) Human papillomavirus genotype distribution in New Mexico cervical cancers | DNA from human papilloma virus type 16 (HPV16) and HPV type 18 (HPV18) were found in the majority of invasive cervical cancers in New Mexico in the 1980s and 1990s, according to a population-based study published in the March 24 online issue of the Journal of the National Cancer Institute. The mean age of women diagnosed with HPV16- or HPV18-positive cancer was 5 years younger than that of women diagnosed with cancers associated with other HPV types, which may have implications for cancer screening in the future. Large population-based studies that examine HPV genotype distribution in the United States have been lacking. Such studies are necessary to assess the impact of HPV vaccines that aim to reduce the incidence of cervical cancer due to HPV16 and HPV18.In the current study, Cosette M. Wheeler, Ph.D., of the University of New Mexico Health Sciences Center in Albuquerque, and colleagues used the Surveillance, Epidemiology, and End Results registry to identify 1,213 cases of in situ cervical cancer diagnosed between 1985 and 1999 and 808 cases of invasive cervical cancer diagnosed between 1980 and 1999 in New Mexico. The investigators used DNA-based testing to identify the HPV genotype that was present in tumor samples. In addition, they tested 4,007 cervical Pap test specimens from women who did not have cancer for the presence of HPV DNA. HPV16 DNA was found in 53.2 percent of invasive cervical cancers, while HPV18 DNA was found in 13.1 percent, and HPV45 DNA in 6.1 percent. In the in situ cervical cancer samples, HPV16 DNA was detected in 56.3 percent of cases, HPV31 DNA in 12.6 percent, and HPV33 DNA in 8.0 percent. The median age at diagnosis of invasive cancer positive for HPV16 and HPV18 was 48.1 and 45.9 years, respectively. By contrast, the median age at diagnosis of invasive cancer positive for other HPV genotypes was 52.3 years. "To our knowledge, this is the largest study of this kind conducted in a U.S. population," the authors write. "This study of HPV genotypes in New Mexico provides important baseline data for evaluating the effectiveness of newly implemented HPV-based technologies, HPV vaccines, and HPV screening in the prevention of cervical cancer. Moreover, these data can guide the future application of these technologies to maximize the cost-effec¬tive, public health benefits of these interventions."
~News RX - 04/06/2009 | | | | (04/06) Data from Wuhan University, Center for Gene Diagnosis provide new insights into hepatitis B virus genetics | New research, 'Polymorphisms and plasma soluble levels of E-selectin in patients with chronic hepatitis B virus infection,' is the subject of a report. "Infections with hepatitis B virus (HBV) may lead to a distinct clinical outcome which is partially related to host genetic variability. Our aim was to investigate the relationships between the polymorphisms of the E-selectin gene and disease progression in a HBV-infected Chinese Han population, and also to determine the plasma soluble E-selectin (sE-selectin) levels in this population," investigators in Wuhan, People's Republic of China report. "Genomic DNA was extracted from the peripheral blood of 367 HBV carriers and 281 healthy controls. Two polymorphisms (PstI for A561C and HphI for G98T) of the E-selectin gene were analyzed by polymerase chain reaction-restriction fragment length polymorphism. Circulating sE-selectin levels were measured by specific enzyme-linked immunosorbent assay (ELISA). The frequency of the C allele (AC or CC) of the A561C polymorphism was significantly higher in patients with liver cirrhosis (LC) compared to controls (p=0.002). There was no difference in allele distribution of the G98T polymorphism. But in patients with LC, classified according to the Child-Pugh classification, the frequency of the T carrier (GT and TT) was significantly different between Child-Pugh class A and class B plus C (p=0.009). Levels of plasma soluble E-selectin (sE-selectin) were significantly increased in HBV carriers with chronic hepatitis (CH) and LC (mean±SD 68.94±34.09 and 43.39±18.00 ng/! mL) compared to controls (13.96±7.50 ng/mL) (p <0.01). In the LC subgroup, levels of sE-selectin were significantly decreased from Child-Pugh class A to class C (p <0.05). In each group, individuals with the C allele showed higher sE-selectin levels than those with the A allele (p <0.05). This is the first report describing the association between E-selectin polymorphisms and HBV-related chronic liver diseases," wrote S. Wu and colleagues, Wuhan University, Center for Gene Diagnosis. The researchers concluded: "Our data suggest that the A561C polymorphism of the E-selectin gene may be associated with disease progression in patients with chronic HBV infection and control the expression of plasma soluble levels, while the G98T polymorphism may be related to fibrotic severity in the Chinese population." Wu and colleagues published their study in Clinical Chemistry and Laboratory Medicine (Polymorphisms and plasma soluble levels of E-selectin in patients with chronic hepatitis B virus infection. Clinical Chemistry and Laboratory Medicine, 2009;47(2):159-64).
~News RX - 04/06/2009 | | | | (04/02) Earlier Antiretroviral Treatment Could Reduce Risk of Death in HIV-Positive People, Study Finds | A study published Wednesday in the New England Journal of Medicine suggests that starting HIV-positive people on antiretroviral treatment earlier than what current guidelines recommend could reduce the risk of death, the Wall Street Journal's "Health Blog" reports (Goldstein, "Health Blog," Wall Street Journal, 4/1). Researchers in two separate analyses examined the medical records of about 17,000 HIV-positive people (Waters, Bloomberg, 4/1). They looked at participants' CD4+ T cell count, starting with 8,000 participants in the first analysis. The researchers compared patients who began antiretroviral treatment within six months of receiving a CD4 count between 351 and 500 with those who delayed starting treatment until after their CD4 count was 350 or less. The patients that delayed treatment had a 69% higher risk of death during the follow-up period ...(continued)
~Kaiser Network - 04/02/2009 | | | | (04/01) New York Times Examines HIV/AIDS Treatment Access in Myanmar | The New York Times on Wednesday examined antiretroviral treatment access in Myanmar, which ranks among the lowest countries worldwide in international assistance per capita. Medecins Sans Frontieres runs 23 clinics in the country, and the clinics serve as the primary source of antiretrovirals for HIV-positive people in Myanmar, according to the Times. According to MSF, 240,000 people are living with HIV in Myanmar, and 76,000 are in urgent need of antiretroviral access. In addition, about 25,000 HIV-positive people die annually in the country ...(continued)
~Kaiser Network - 04/01/2009 | | | | (04/01) Albuferon Top-Line Results | Human Genome Sciences (HGS) issued a press release in March that their drug, albuferon (plus ribavirin), was not inferior to Pegasys (plus ribavirin). One of the criteria for FDA marketing approval is that an experimental drug must be shown to be as effective as the current standard of care. In the press release issued on March 9, 2009, HGS listed the top-line results of their Phase III clinical trial comparing HGS’s long acting interferon albuferon to Roche’s long acting interferon Pegasys. In the study both drugs were used to treat chronic HCV genotype 1 patients ...(continued)
~HCV Advocate - April 2009 | | | | (04/01) Hepatitis B: The Basics | Hepatitis is an inflammation of the liver. “Hepa” refers to the liver and “titis” means inflammation. Hepatitis can be caused by toxins, drugs, too much alcohol, or a variety of viruses. Viruses that infect the liver are called hepatitis viruses. Each virus is unique and is identified by a letter of the alphabet, in the order of its discovery. Hepatitis B infection can cause either a short-term (acute) infection or a long-term or lifelong (chronic) infection. When newborns are born to HBV-infected mothers, they face a 90 percent risk of developing a chronic HBV infection. But when adults are infected, only 5 percent develop chronic infection – most experience a brief, acute infection. Most people who experience acute hepatitis B do not feel sick or have much liver damage, but people who develop chronic HBV infection can develop serious liver damage after years or decades of infection ...(continued)
~HBV Advocate - April 2009 | | | | (04/01) HBV: How Frequently to Monitor Chronic Hepatitis B | The following tests are recommended when patients are diagnosed with chronic hepatitis B:
• A doctor should take a complete medical history, asking about any family history of liver disease or cancer, and conduct a
thorough physical examination.
• Every six months, for at least one year, patients’ ALT levels should be checked for signs of liver damage, and a complete blood count with platelets, liver (hepatic) panel, and prothrombin time tests should also be run. These all require a blood sample.
• The doctor should conduct a viral test for hepatitis B surface antigen (HBsAg) and antibodies, “e” (HBeAg) antigens and
antibodies, and the core antibody (HBcAb). This should be done every three to six months after the initial diagnosis, and
then at least annually. This requires a blood sample.
• HBV DNA, which shows viral load in the bloodstream, should be tested. This also requires a blood sample. The frequency
of the test depends on viral load and whether ALT levels are normal.
• An alpha fetoprotein (AFP) test will check for liver cancer. This test should be conducted every six to 12 months, and also
requires a blood sample.
• A baseline ultrasound on the liver to check for liver cancer or other damage is recommended. Additional ultrasounds may
be recommended annually or more frequently if liver damage is suspected or if a patient has been infected for many years ...(continued)
~HBV Advocate - April 2009 | | | | (04/01) How to Interpret Hepatitis B Antibody& Viral Tests | To determine if someone is infected with the hepatitis B virus (HBV), or to find out the status of an infection, a clinician will take a blood sample and send it to a laboratory. Technicians will analyze it for several hepatitis B viral components, which provide a roadmap to an infection ...(continued)
~HBV Advocate - April 2009 | | | | (04/01) How to Interpret (and Understand) Liver Tests | It is important for people chronically infected with the hepatitis B virus (HBV) to regularly monitor the health of their liver, usually through lab tests performed on a blood sample. The tests analyze a variety of enzymes and other substances, which provide a report card on the health of a liver ...(continued)
~HBV Advocate - April 2009 | | | | (04/01) What Is HBV DNA and How Is It Measured? | Hepatitis B virus DNA (HBV DNA) carries the genetic blueprint of the virus. How many HBV DNA particles or “units” are found in a blood sample indicates how rapidly the virus is reproducing in the liver ...(continued)
~HBV Advocate - 04/01/2009 | | | | (04/01) Which Hepatitis B Drug Treatment to Use First | Today, there are several antivirals and one interferon medication to treat people infected with the hepatitis B virus (HBV). number of treatment options available, it is important to carefully which drug to use first. For example, use the wrong antiviral individual
could end up “resistant” to other antiviral drugs ...(continued)
~HBV Advocate - April 2009 | | | March, 2009 | | (03/30) Studies from Karolinska University provide new data on HIV/AIDS | "Several mucosal innate immune proteins exhibit HIV inhibitory activity and their analogues are potential microbicide candidates. However, their clinical associations and in-vivo role in cervicovaginal host defense against HIV acquisition are poorly defined," scientists writing in the journal AIDS report. "Cervicovaginal secretions (CVSs) were collected from HIV uninfected Kenyan sex workers at enrolment into an HIV prevention trial. After trial completion, CVS from participants acquiring HIV (cases) and matched controls were assessed for levels of innate immune factors and HIV neutralizing capacity, by blinded investigators. Cross-sectional and prospective associations of innate immune factors were examined. CVS contained high levels of defensins (human neutrophil peptide-1-3 and human beta defensin-2-3), LL-37 and secretory leukocyte protease inhibitor. Regulated upon activation normal T-cell expressed and secreted levels were lower, and IFN alpha was undetectable. CVS from 20% of participants neutralized a clade A primary HIV isolate, and 12% neutralized both clade A and C isolates. HIV neutralization was correlated with human neutrophil peptide-1-3 (alpha-defensins) and LL-37 levels. However, a.-defensin and LL-37 levels were increased in participants with bacterial sexu! ally transmitted infections and were independently associated with increased HIV acquisition in multivariate analysis," wrote P. Levinson and colleagues, Karolinska University. The researchers concluded: "Despite significant HIV inhibitory activity, cervicovaginal levels of alpha-defensins and LL-37 were associated with increased HIV acquisition, perhaps due to their association with bacterial sexually transmitted infections." Levinson and colleagues published their study in AIDS (Levels of innate immune factors in genital fluids: association of alpha defensins and LL-37 with genital infections and increased HIV acquisition. AIDS, 2009;23(3):309-317).
~News RX - 03/30/2009 | | | | (03/30) Data from Duke University, Duke Clinical Research Institute provide new insights into hepatitis C virus therapy | New research, 'Review article: investigational agents for chronic hepatitis C,' is the subject of a report. "The need for effective treatment for chronic hepatitis C infection has driven the development of novel antiviral agents that target specific steps in the viral replication cycle. To evaluate the current literature concerning investigational agents for chronic hepatitis C virus infection," investigators in the United States report. "Resources used included PubMed, conference proceedings from the American and European Liver Associations' meetings 2005-2008 and the National Institute of Health's clinical trials website (http://www.clinicaltrials.gov). The focus was restricted to investigational agents that have progressed beyond preclinical development. Over 50 investigational agents for chronic hepatitis C infection are currently in clinical development. Specifically targeted anti-viral therapy for HCV (STAT-C) shows great promise with NS3/4a protease inhibitors now entering phase 3 programmes. New interferon-alpha and ribavirin formulations aim to optimize anti-viral efficacy yet limit toxicity. Other candidates include novel immunomodulators and therapeutic vaccines. A new era of therapy for chronic hepatitis C beckons, promising increased cure rates with shortened duration of therapy," wrote A.J. Thompson and colleagues, Duke University, Duke Clinical Research Institute.The researchers concluded: "However, the era will not be without challenges including viral resistance, drug toxicity and the need to optimize combination therapy in the face of a rapidly evolving therapeutic arsenal." Thompson and colleagues published their study in Alimentary Pharmacology & Therapeutics (Review article: investigational agents for chronic hepatitis C. Alimentary Pharmacology & Therapeutics, 2009;29(7):689-705).
~News RX - 03/30/2009 | | | | (03/25) American Journal of Public Health Publishes Supplement on HIV/AIDS | The April 2009 supplement of the American Journal of Public Health focuses on issues surrounding HIV/AIDS, diversity and other topics. It includes editorials, commentaries, essays and research articles (American Journal of Public Health supplement, April 2009). Click to title to view.
~Kaiser Network - 03/25/2009 | | | | (03/13) Hepatitis C Treatments in Current Clinical Development | Click title for more information about HCV drugs from HCV Advocate.
~HCV Advocate - 03/13/2009 | | | | (03/09) Researchers at University of Thessaloniki, Medical Department release new data on hepatitis B virus in children | Fresh data on hepatitis B virus are presented in the report 'Epidemiology, course and disease burden of chronic hepatitis B virus infection. HEPNET study for chronic hepatitis B: a multicentre Greek study.' "Hepatitis B virus infection (HBV) has been recognized as a major health problem worldwide. Greece belongs to the intermediate endemicity countries with a trend of decreasing prevalence of HBV infection during the last decade," scientists in Thessaloniki, Greece report. The researchers concluded: "Hepatitis B virus infection (HBV) has been recognized as a major health problem worldwide. Greece belongs to the intermediate endemicity countries with a trend of decreasing prevalence of HBV infection during the last decade. However, the recent massive immigration to our country may have led to alterations of HBV epidemiology. In this study, we evaluated the epidemiological features of HBV infection in a sample of 3480 patients followed up during the years 1997-2006. Immigrants mainly from Albania represented the 18.6% of the total study population and 56.6% of children. The majority of the patients had no family history of HBV infection (67.3%) or of acute hepatitis (95.4%), no known source of infection (64.6%), with intrafamilial spread accounting for 16.9% of the HBV transmission in adults and 33.9% in children. HBeAg(-) hepatitis B was the predominant form of hepatitis (92.1%) among the Greek patients in contrast to the immigrants where 16.6! % were HBeAg(+). Liver cirrhosis was diagnosed in 8.8% of the total population and 0.9% had hepatocellular carcinoma. A high proportion of children were HBeAg(+) (62%), 55% from immigrant families, 25.2% were infected in the perinatal period and had no evidence of disease complications. In conclusion our results showed (a) a changing pattern in the epidemiology of HBV infection in Greece due to the significant number of HBeAg(+) patients, especially among children and (b) a considerable number of patients although aware of their infection, present with advanced disease." Raptopoulou and colleagues published their study in the Journal of Viral Hepatitis (Epidemiology, course and disease burden of chronic hepatitis B virus infection. HEPNET study for chronic hepatitis B: a multicentre Greek study. Journal of Viral Hepatitis, 2009;16(3):195-202).
~News RX - 03/09/2009 | | | | (03/09) Scientists at University of Pittsburgh, Medical Department detail research in gene therapy | "Herpes simplex virus type 1 (HSV-1) represents an attractive vehicle for a variety of gene therapy applications. To render this virus safe for clinical use, its cytotoxic genes must be removed without losing its ability to express transgenes efficiently," scientists writing in the journal Biotechnology and Bioengineering report. "Our vectors are deleted for the essential immediate early genes ICP4 and ICP27. These genes are controlled by unique promoters having enhancer elements responsive to a viral structural protein VP16. The expression of these genes occurs prior to the activation of all other lytic functions and is thus required to initiate and complete the virus replication cycle. For large scale manufacture of clinical grade vectors, efficient cell lines must be generated that express the essential viral gene products in trans during vector propagation. Here we describe methods for engineering HSV-1 production cell lines that improve vector growth by altering the kinetics of complementing gene expression. We examined the ability of Vero cells independently transduced with ICP4 and ICP27 under transcriptional control of their respective promoters to Support the growth of a replication defective vector (JDTOZHE), deleted for ICP4, ICP27 and approximately 20 kb of internal elements that are not! required for virus growth in Vero cells. Vector yield on this cell line was 3 logs lower than wild-type virus grown on Vero cells. To understand the mechanism underlying poor vector yield, we examined the expression of ICP4 and ICP27 during Virus complementation. While ICP27 was expressed immediately on vector infection, the expression of ICP4 was considerably delayed by 8-10 h, suggesting that the ICP4 promoter was not adequately activated by VP16 delivered by the infectious vector particle. Use of the ICP0 promoter to express ICP4 from the cellular genome resulted in higher induction levels and faster kinetics of ICP4 expression and a 10-fold improvement in vector yield," wrote K.G. Grant and colleagues, University of Pittsburgh, Medical Department. The researchers concluded: "This study suggests that vector complementation is highly dependent on the kinetics of complementing gene expression and can lead to large differences in vector yield." Grant and colleagues published their study in Biotechnology and Bioengineering (Engineering Cell Lines for Production of Replication Defective HSV-1 Gene Therapy Vectors. Biotechnology and Bioengineering, 2009;102(4):1087-1097).
~News RX - 03/09/2009 | | | | (03/09) New HIV/AIDS study findings have been reported by D. Djokic and colleagues | "High HIV infection rates in the United States are increasingly due to heterosexual risk behaviors, with increased rates in blacks and women. A survey of HIV knowledge and attitudes about HIV testing was conducted in an inner-city public housing population that included a convenience sample of residents of South Side Chicago Housing Authority facilities," researchers in the United States report. "The questionnaire addressed knowledge about HIV transmission and disease, health care options, condom use, prior HIV testing, and preferred places for HIV testing and education. Five hundred residents, ages 13-50 years completed the survey, during the period from November 2002 until April 2003. Eighty-three percent of the respondents were female and 50% of those surveyed were from 18-30 years of age. Race/ethnicity was not questioned in order to improve response rate. A comparable sample conducted earlier showed that population was 99% black race. Most respondents were knowledgeable about HIV transmission risk factors, although misinformation about transmission, treatment and prevention existed. Knowledge that HIV therapy is available was high (71%), while 25% thought an HIV vaccine was available and 13% thought there was a cure for HIV. Two thirds of sexually active respondents reported condom use in the past year. Three quarters reported previous testing for HIV and 90% ! of those tested returned for results. Most respondents wanted to learn more about HIV risk factors, testing and treatment but preferred primary care clinics to specialized places for HIV testing," wrote D. Djokic and colleagues. The researchers concluded: "Targeted HIV education interventions in the public housing facilities or primary care clinics are warranted." Djokic and colleagues published their study in AIDS Patient Care and Stds (HIV Knowledge and Attitudes toward HIV Testing of South Side Chicago Housing Authority Residents. AIDS Patient Care and Stds, 2009;23(1):23-28).
~News RX - 03/09/2009 | | | | (03/07) HCV & Cell Death | A new report from the University of Alberta is helping scientists understand the relationship between the hepatitis C virus and what causes the damage to the liver cell. In the past it was believed that the hepatitis C virus indirectly caused damage to liver cells—that is, that the virus itself didn’t kill the liver cell, but that the body’s adaptive immune system would attack and kill the entire liver cell that was infected with hepatitis C. In a study published in the February edition of PLoS Pathogens, Michael Joyce and colleagues transplanted human liver cells into mice and infected the liver cells with the hepatitis C virus. What they found was that the virus directly damaged the liver cell which could eventually lead to the death of the liver cell. This is noteworthy because mice do not have an adaptive immune system and proves that the virus itself can cause cell inflammation and death.
~HCV Advocate - 03/07/2009 | | | | (03/07) HCV Treatment after Liver Transplantation | Hepatitis C is the number one reason for liver transplantation in the United States. Unfortunately, since the hepatitis C virus is in the blood the new liver will become re-infected. In addition, the disease process can be much faster due to many factors, such as the use of immunosuppressive drugs to prevent the body’s rejection of the new liver but which also increase the rate of HCV replication and disease progression. The faster disease progression can lead to decompensated cirrhosis and the possibility of the need for another liver transplant. HCV treatment is urgently needed in these cases to eliminate HCV, and thereby help slow down or stop disease progression. However, treatment success rates in people who are waiting for a transplant or have recently received a transplant are historically low. This article will summarize a report conducted by F.D. Gordon and colleagues published in Liver Transplantation that reviewed available data on HCV treatment in post liver transplant patients with conventional interferon (with and without ribavirin) and pegylated interferon (with and without ribavirin) ...(continued)
~HCV Advocate - 03/07/2009 | | | | (03/07) Extended Treatment for Genotype 1b | In an attempt to improve treatment response for hard-to-treat chronic hepatitis C patients, T. Ide and colleagues conducted a study in which 113 participants with HCV genotype 1b and high pre-treatment HCV viral load were randomly assigned to receive pegylated interferon plus ribavirin for the standard 48-week duration or extended therapy lasting 44 weeks after they achieved undetectable HCV RNA (total duration of 48 to 68 weeks). As reported in the January 2009 American Journal of Gastroenterology, the SVR rate was somewhat higher in the extended duration group (53% vs. 36%), but the difference did not reach statistical significance. Among 20 participants who first became HCV RNA negative between weeks 16 and 24, however, individuals in the extended duration group were significantly more likely to achieve SVR (78%) than those in the standard duration group (9%), although the numbers were small. "The extended treatment significantly increased the SVR rate in patients who were HCV RNA negative at 16-24 weeks," the researchers concluded.
~HCV Advocate - 03/07/2009 | | | | (03/07) Hepatocellular Carcinoma Risk | Two recent studies looked at risk factors for hepatocellular carcinoma (HCC) in people with hepatitis C. As reported in the January 2009 Gastroenterology, A. Lok and colleagues evaluated the incidence rate and risk factors for HCC in the HALT-C study, a trial comparing low-dose (90 mcg once-weekly) Pegasys maintenance therapy for 3.5 years versus no further treatment in 1,005 chronic hepatitis C patients with bridging fibrosis or cirrhosis who did not respond to standard therapy. During a median 4.6 years of follow-up (maximum 6.7 years), 48% developed HCC. The cumulative five-year HCC incidence rate was similar for participants in the maintenance therapy arm (5.4%) and those who received no further treatment (5.0%). People with cirrhosis were almost twice as likely to develop HCC as those with bridging fibrosis (7.0% vs. 4.1%). Eight patients (17%) whose serial biopsy specimens showed only fibrosis developed HCC ...(continued)
~HCV Advocate - 03/07/2009 | | | | (03/07) Biliary and Pancreatic Cancer | As reported in the January 2009 Hepatology, H. El-Serag and colleagues sought to determine whether—in addition to their established risk for HCC—people with chronic hepatitis also have a higher rate of "hepatopancreaticobiliary" malignancies, or cancers of the liver, pancreas, and biliary system (gall bladder and bile ducts). This retrospective cohort study included more than 718,000 patients who received care at U.S. Veterans Affairs health facilities. A total of 146,394 hepatitis C patients were matched with up to four uninfected control subjects. During 1.37 million person-years of follow-up (average 2.3 years per patient) ...(continued)
~HCV Advocate - 03/07/2009 | | | | (03/07) HCV Diagnosis in Coinfected People | The increasing recognition of likely sexual transmission of HCV among HIV positive individuals has led to calls for regular HCV screening, but people with compromised immunity may not produce enough antibodies to show up on a standard test. As described in the January 2, 2009 issue of AIDS, E. Thomson and colleagues compared the sensitivity of standard HCV antibody testing versus RT-PCR HCV RNA testing for diagnosing acute HCV infection in people with HIV. The researchers looked at stored plasma samples from 43 HIV positive individuals in the St. Mary's Acute Hepatitis C Cohort in London; they generally did not have advanced immune suppression (median CD4 cell count of 570) and about half were taking combination antiretroviral therapy ...(continued)
~HCV Advocate - 03/07/2009 | | | | (03/07) High hepatitis C viral load increases risk of death in HIV/HCV coinfected patients | A high level of hepatitis C virus (HCV) in the blood is associated with an increased risk of death in HIV/HCV coinfected individuals, according to data presented on February 10th at the Sixteenth Conference on Retroviruses and Opportunistic Infections in Montreal, Canada ...(continued)
~HCV Advocate - 03/07/2009 | | | | (03/07) FTC Clears ZymoGenetics-Bristol-Myers Deal For Hepatitis C Drug Development | Monday, ZymoGenetics Inc. (ZGEN: News ) announced that its collaboration with Bristol-Myers Squibb Co. (BMY: News ) for hepatitis C compound PEG-Interferon lambda has been cleared by the United States Federal Trade Commission and Department of Justice clearance under provisions of the Hart-Scott-Rodino Antitrust Improvements Act ...(continued)
~HCV Advocate - 03/07/2009 | | | | (03/07) Continuous antiretroviral therapy improves survival in HIV/hepatitis C co-infected patients with liver cirrhosis | Antiretroviral therapy - but not treatment for chronic hepatitis C virus (HCV) infection - was associated with significantly improved survival in HIV/HCV co-infected individuals with liver cirrhosis, researchers reported on February 10th at the Sixteenth Conference on Retroviruses and Opportunistic Infections (CROI) in Montreal, Canada ...(continued)
~HCV Advocate - 03/07/2009 | | | | (03/05) New methods for estimating the tuberculosis case detection rate in high-HIV prevalence countries: the example of Kenya | Using three approaches to estimate the tuberculosis CDR in a country where HIV infection is prevalent, we showed that expansion of the tuberculosis control programme in Kenya led to an increase of 23% in the CDR between 1996 and 2006. While the methods developed here can be applied in other countries with a high prevalence of HIV infection, they rely on precise data on trends in such prevalence in the general population and among tuberculosis patients ...(continued)
~World Health Organization - 03/05/2009 | | | | (03/05) Microbicide Containing Natural Compound Provides Protection in Monkeys Against Simian Version of HIV, Study Says | An experimental microbicide containing a naturally occurring compound provides protection in monkeys against the simian version of HIV by diminishing immune responses to the virus, according to a study published Wednesday in the journal Nature, the Los Angeles Times reports. HIV typically spreads in the body by entering CD4+ T cells, which the immune system sends out to attack the virus after exposure. The compound -- called glycerol monolaurate, or GML -- works by inhibiting immune signals that dispatch the T cells to attack the infection. It is those T cells that HIV infects and uses to proliferate throughout the body (Engel, Los Angeles Times, 3/5). GML occurs naturally in the human body and already is approved for use as an antimicrobial and anti-inflammatory ingredient in cosmetics and toiletries, as well as an emulsifier in foods. In addition, each dose of GML used in the study costs less than one cent. According to the researchers, the study's findings have promising implications for the development of effective microbicides to prevent HIV (AFP/Google.com, 3/4) ...(continued)
~Kaiser Network - 03/05/2009
| | | | (03/04) Researchers Create HIV Strain That Can Infect Monkeys, Study Says | Scientists have created a strain of HIV that is able to infect and multiply in monkeys, leading to the possibility that researchers would be able to test HIV/AIDS drugs and vaccines in monkeys before testing them in humans, according to a study published in the journal Proceedings of the National Academy of Sciences, Reuters UK reports. The strain of HIV -- called simian-tropic HIV-1, or stHIV-1 -- was developed by altering a single gene in the human version of the virus to allow it to infect a pig-tailed macaque, according to researchers. Once injected into the monkey, the stHIV-1 reproduced almost as much as it does in humans; however, the animal ultimately suppressed the virus and stayed healthy. Paul Bieniasz, a researcher on the team from New York's Rockefeller University, said, "If our research is taken further, we hope that one day, perhaps in the not-too-distant future, we'll be able to make vaccines that are intended for use in humans and the very same product will be able to be tested in animals before human trials" ...(continued)
~Kaiser Network - 03/04/2009 | | | | (03/04) HBV Polymerase Resistance Mutations May Be Antagonistic | Susceptibility of hepatitis B virus (HBV) previously resistant to lamivudine may be restored as resistance to adefovir develops, according to a report in the March Journal of Medical Virology. "Most bacterial- and HIV-resistance is cumulative; newly acquired resistance comes on top of existing resistance," Dr. Hans L. Zaaijer from Academic Medical Center, University of Amsterdam, told Reuters Health. "Fortunately, it seems that HBV sometimes is forced to choose between resistance mechanisms." Dr. Zaaijer and colleagues described the effect of lamivudine and adefovir combination in two patients who were resistant not only to lamivudine, but also to adefovir. They underwent serial monotherapy with lamivudine and then adefovir ...(continued)
~HCV Advocate - 03/04/2009 | | | | (03/03) MOLECULE PROVIDES CLUES ABOUT HOW INFECTION WITH HUMAN PAPILLOMAVIRUS MAY LEAD TO CANCER | New research shows for the first time that certain types of human papillomavirus (HPV), which cause cervical and some other types of cancer, can inhibit the production of a tiny single-stranded RNA called microRNA 34a, or miR-34a. Because previous research had demonstrated that microRNAs regulate important functions of the cell, the new finding provides insight into the mechanisms by which HPV contributes to the development of cancer and may lead to the development of treatments to counter HPV infection. Currently, such treatments do not exist. The study, appearing online March 3, 2009, and in the April print edition of the journal RNA, was led by researchers at the National Cancer Institute (NCI), part of the National Institutes of Health.
Besides causing cervical cancer, HPV is a major cause of penile, anal, and vaginal cancers. HPV inhibits natural tumor suppression by inactivating a cellular tumor suppressor protein called p53. The p53 protein regulates the expression of other genes that control the cell cycle, activates the repair of damaged DNA in cells, and, in cases of severe damage, initiates cell death. This protein also stimulates the expression of a group of microRNAs, including miR-34a.
MicroRNAs are short strands of RNA that regulate protein expression by binding to specific messenger RNA molecules and inhibiting them from their normal function, which is to direct the production of proteins. Dysregulation and abnormal expression of microRNA genes are common occurrences in many human cancers, but little is known about the role that microRNAs play in cancer development or the causes leading to their abnormal expression.
The research team, led by Zhi-Ming Zheng, M.D., Ph.D., at NCI's Center for Cancer Research, first compared microRNA levels in cervical cancer cells and normal cervical cells and found that levels of miR-34a were much lower in the cancer cells than the normal cells.
During the early stages of HPV infection, the virus produces a protein known as E6. To gain an understanding of the mechanism by which E6 protein inhibits the expression of miR-34a during HPV infection, the researchers used a method known as RNA interference, which makes it possible to turn specific genes off and to observe the subsequent effects on cell activity. The team found that interfering with the expression of E6 in HPV-infected cervical cancer cells grown in the laboratory led to increased expression of both p53 protein and miR-34a. Most miR-34a accumulated during the early stages of cell division. The researchers also observed that induced expression of miR-34a suppressed cell growth and promoted cell death, which suggests that this microRNA also plays a role in tumor suppression.
"This study is the first compelling evidence to show tumor viruses are involved in the regulation of microRNA expression," said Zheng. "Our data imply that, in addition to HPV, other tumor viruses may also contribute to the abnormal expression of cellular microRNAs in virus-associated cancers.
The Zheng team is working to identify miR-34a targets in HPV-infected cells in order to understand the mechanism by which decreased expression of a microRNA favors tumor formation. In addition, they are studying several other microRNAs that are normally involved in cell growth regulation, yet increase their expression levels during HPV infection.
~National Institutes of Health - 03/03/2009
| | | | (03/03) Vertex Pharmaceuticals Strengthens HCV Drug Development Portfolio, Adds Novel Polymerase Inhibitors to Shape New Combinations with Telaprevir | Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX), which is developing the hepatitis C virus (HCV) protease inhibitor telaprevir, will add two polymerase inhibitors to its HCV drug development portfolio through a definitive agreement to acquire privately-held ViroChem Pharma Inc. in a stock and cash transaction. With the addition of these compounds, Vertex will advance its strategy to pursue novel combinations of Specifically Targeted Antiviral Therapies for hepatitis C (STAT-Cs) for the treatment of HCV infection. Following completion of the transaction, Vertex will own worldwide rights to ViroChem's HCV drug development portfolio, including VCH-222 and VCH-759, which have demonstrated substantial reductions in plasma HCV RNA when dosed as single agents and have been well-tolerated in clinical studies to date. In particular, VCH-222 dosed as 750 mg twice daily resulted in a median 3.7 log10 decrease in HCV RNA at the end of dosing in a three-day viral kinetic study, representing the most substantial reduction in viral load reported to date with an investigational HCV polymerase inhibitor dosed as a single agent. Vertex expects to begin clinical evaluation of novel combination regimens of its HCV protease inhibitor telaprevir, currently in Phase 3 clinical development, in the second half of 2009. The transaction is subject to customary pre-closing conditions ...(continued)
~HCV Advocate - 03/03/2009 | | | | (03/02) Researchers at Wuhan University target allergies immunology | Investigators publish new data in the report 'Insufficient increment of CD4+CD25+ regulatory T cells after stimulation in vitro with allergen in allergic asthma.' According to a study from Wuhan, People's Republic of China, "Allergen exposure can lead to the development of allergic asthma, sensitized asymptomatic or nonallergic responses in different conditions. Regulatory T (T(reg)) cells are involved in controlling the immune response direction." "The aim of this study was to determine whether allergic asthmatics had defects in CD4+CD25+ T(reg) cells and CD4+IL (interleukin)-10+ T(reg) cells after specific allergen exposure. Peripheral-blood mononuclear cells (PBMCs) were isolated from 20 patients with asthma sensitized to house dust mite, 24 asymptomatic subjects sensitized to house dust mite and 22 nonallergic subjects. Cells were cultured without stimulation and with rDer p 1. Frequencies and proliferations of CD4+CD25+ T cells and CD4+IL-10+ T cells were measured by flow cytometry. Concentrations of IL-10, IL-4, interferon (IFN)-gamma and tumor growth factor beta(1) in culture supernatants and sera were determined by ELISA. PBMCs derived from sensitized asthmatic patients had the lowest percentage of CD4+CD25+ T(reg) cells and the highest IL-4 level in response to allergen among the 3 groups. PBMCs derived from sensitized asymptomatic subjects had higher percentages of both CD4+CD25+ T(reg) cells and CD4+IL-10+ ! T cells than those from sensitized asthmatic patients in rDer-p-1-stimulated cultures, and they had the highest levels of IL-10 and IFN-gamma responses to allergen among the 3 groups. Patients with allergic asthma had an insufficient CD4+CD25+ T(reg) cell response and an excessive Th2 response to specific allergen," wrote L.H. Wang and colleagues, Wuhan University. The researchers concluded: "The high levels of T(reg) cell response and IL-10 and IFN-gamma responses to specific allergen can partly explain the immunological characteristics associated with sensitized asymptomatic subjects." Wang and colleagues published their study in International Archives of Allergy and Immunology (Insufficient increment of CD4+CD25+ regulatory T cells after stimulation in vitro with allergen in allergic asthma. International Archives of Allergy and Immunology, 2009;148(3):199-210).
~News RX - 03/02/2009 | | | | (03/02) Researchers from Oswaldo Cruz Institute detail new studies and findings in the area of hepatitis A virus | A new study, 'Should Brazilian patients with chronic hepatitis C virus infection be vaccinated against hepatitis A virus,' is now available. "Hepatitis A virus (HAV) superinfection is associated with a high risk of liver failure and death in patients with hepatitis C virus (HCV) infection. The aim of this study was to investigate the presence of serological and molecular HAV markers in a population of HCV-infected patients in order to determine a cost-effective strategy to vaccinate against HAV," scientists writing in the Journal of Gastroenterology and Hepatology report. "The presence of total and immunoglobulin (Ig)M anti-HAV antibodies was investigated in 399 patients (median age, 50 years; range, 4-81) referred to the Public Health Central Laboratory of Pernambuco State who tested positive for anti-HCV antibodies and HCV RNA. HAV RNA was investigated by reverse transcription-nested polymerase chain reaction in these patients. Three hundred and eighty-four (96%) patients were positive for anti-HAV total and negative for IgM anti-HAV antibodies (immune patients). Three patients had IgM (and total) anti-HAV antibodies, showing an acute infection, and two of them had HAV RNA detected in serum samples. HAV RNA was also found in another patient in the absence of detectable anti-HAV antibodies. By nucleotide sequencing, it was demonstrated that the HAV isolates infecting these patients belonged to subgenotype 1B. This study provides valuable new data on anti-HAV prevalence among HCV carriers in Brazil," wrote L.M. Villar and colleagues, Oswaldo! Cruz Institute. The researchers concluded: "In the present study, we found a high proportion of patients with anti-HAV positivity, indicating that anti-HAV testing of HCV-infected patients is a cost-effective strategy and should be carried out before vaccination against HAV in these patients, particularly in regions such as our geographical area with high total anti-HAV prevalence." Villar and colleagues published their study in the Journal of Gastroenterology and Hepatology (Should Brazilian patients with chronic hepatitis C virus infection be vaccinated against hepatitis A virus? Journal of Gastroenterology and Hepatology, 2009;24(2):238-42).
~News RX - 03/02/2009 | | | February, 2009 | | (02/27) Role of Combination Therapy in Chronic Hepatitis B | Combination therapy includes the use of two or more antivirals for the treatment of chronic hepatitis B. No study has shown that combination therapy is superior to monotherapy in naive patients for achieving treatment end points, but combination appears to result in a lower incidence of resistance. Moreover, the higher-potency compounds have not yet been studied. Consideration should be given to treating lamivudine-resistant patients with combination therapy, preferably with a nucleotide analogue in conjunction with a nucleoside analogue. Combination therapy should be considered in patients with decompensated cirrhosis who are unable to achieve an undetectable viral level on monotherapy and in naive patients who still have a detectable viral level 6 to 12 months after starting therapy. Click title for more information.
~Hepatitis B Foundation - 02/27/2009 | | | | (02/27) Factors Used to Identify HBV Patients at High Risk for Liver Cancer | Using such factors as age, gender, HBV DNA levels, core promoter mutations, and cirrhosis, researchers have developed a statistical scoring system to estimate the chance of a person with chronic HBV developing primary liver cancer (hepatocelluar carcinoma, HCC). As published in the Journal of Hepatology (Jan 2009;50(1):80-88), this risk-based system can be used to identify HBV patients for treatment and screening of hepatocelluar carcinoma ...(continued)
~Hepatitis B Foundation - 02/27/2009 | | | | (02/27) FDA Halts Reviews of Pending Ranbaxy Applications, Cites Fraudulent Lab Tests | FDA on Wednesday halted its review of all pending applications from India's Ranbaxy Laboratories, citing fraudulent laboratory tests dating back to 2006, the Washington Post reports. This is the second sanction against Ranbaxy in six months -- officials in September 2008 blocked the company from importing some drugs made at its plants in Dewas and Paonta Sahib (Layton, Washington Post, 2/26). Ranbaxy manufactures generic antiretroviral drugs used in the U.S. and in the President's Emergency Plan for AIDS Relief, as well as other generic drugs (Kaiser Daily HIV/AIDS Report, 9/17/08) ...(continued)
~Kaiser Network - 02/27/2009 | | | | (02/24) U.K., Gates Foundation Award Grant Money for Microbicide Research | The British government and the Bill & Melinda Gates Foundation recently awarded more than 90 million British pounds -- almost $130 million -- in grant money to continue development on microbicides for HIV prevention, London's Times reports. The grant follows the results from a clinical trial of an experimental microbicide, called PRO 2000 and developed by Indevus Pharmaceuticals (Lister, Times, 2/23). Research presented earlier this month suggests that the vaginal gel is 30% effective in preventing HIV infection, though the findings were not statistically significant. A second, larger clinical trial -- involving 9,000 women and led by teams in Tanzania, South Africa and Uganda -- is expected to finish in August, with results reported by November (Kaiser Daily HIV/AIDS Report, 2/10) ...(continued)
~Kaiser Network - 02/24/2009 | | | | (02/24) Lack of Circumcision Coverage in U.S. Medicaid Programs Could Increase HIV Transmission Risk, Researchers Say | Utah's Medicaid program does not cover routine circumcisions for infant boys, which could put men in the state at a higher risk of HIV and other sexually transmitted infections, according to a recent study by researchers at the University of California-Los Angeles, the Salt Lake Tribune reports. The policy also could widen health disparities along socioeconomic lines, the researchers said. Utah officials in 2003 cut circumcision funding from the state's Medicaid program "because of the elective, non-therapeutic nature of the procedure rather than medical necessity," according to a Medicaid Information Bulletin published that year ...(continued)
~Kaiser Network - 02/24/2009 | | | | (02/24) New hepatitis B virus immunology research from Erasmus University discussed | Research findings, 'Hepatitis B virus surface antigen impairs myeloid dendritic cell function: a possible immune escape mechanism of hepatitis B virus,' are discussed in a new report. According to recent research published in the journal Immunology, "Chronic hepatitis B virus (HBV) infection is the result of an inadequate immune response towards the virus. Myeloid dendritic cells (mDC) of patients with chronic HBV are impaired in their maturation and function, resulting in more tolerogenic rather than immunogenic responses, which may contribute to viral persistence."
"The mechanism responsible for altered mDC function remains unclear. The HBV-infected patients display large amounts of HBV particles and viral proteins in their circulation, especially the surface antigen HBsAg, which allows multiple interactions between the virus, its viral proteins and DC. To assess whether HBV directly influences mDC function, the effects of HBV and HBsAg on human mDC maturation and function were investigated in vitro. As already described for internalization of HBV by DC, the present study shows that peripheral blood-derived mDC of healthy controls also actively take up HBsAg in a time-dependent manner. Cytokine-induced maturation in the presence of HBV or HBsAg resulted in a significantly more tolerogenic mDC phenotype as demonstrated by a diminished up-regulation of costimulatory molecules and a decreased T-cell stimulatory capacity, as assessed by T-cell proliferation and interferon-gamma production. In addition, the presence of HBV significantly re! duced interleukin-12 production by mDC. These results show that both HBV particles and purified HBsAg have an immune modulatory capacity and may directly contribute to the dysfunction of mDC in patients with chronic HBV," wrote den Brouw M.L. Op and colleagues, Erasmus University.
The researchers concluded: "The direct immune regulatory effect of HBV and circulating HBsAg particles on the function of DC can be considered as part of the mechanism by which HBV escapes immunity." Op and colleagues published their study in Immunology (Hepatitis B virus surface antigen impairs myeloid dendritic cell function: a possible immune escape mechanism of hepatitis B virus. Immunology, 2009;126(2):280-9).
~Kaiser Network - 02/24/2009 | | | | (02/23) Scientists at Johns Hopkins University, Medical Department publish new data on HIV/AIDS | According to recent research from the United States, "The frequency of HIV dementia in a recent study of HIV + individuals at the Infectious Disease Institute in Kampala, Uganda, was 31%. Coformulated generic drugs, which include stavudine, are the most common regimens to treat HIV infection in Uganda and many other parts of Africa."
"To evaluate the benefits and risks of stavudine-based highly active antiretroviral therapy (HAART) for HIV-associated cognitive impairment and distal sensory neuropathy. The study compared neuropsychological performance changes in HIV + individuals initiating HAART for 6 months and HIV + individuals receiving no treatment for 6 months. The risk of antiretroviral toxic neuropathy as a result of the initiation of stavudine-based HAART was also examined. At baseline, 102 HIV + individuals in Uganda received neurologic, neuropsychological, and functional assessments; began HAART; and were followed up for 6 months. Twenty-five HIV-individuals received identical clinical assessments and were followed up for 6 months. In HIV + individuals, there was improvement in verbal memory, motor and psychomotor speed, executive thinking, and verbal fluency. After adjusting for differences in sex, HIV + individuals demonstrated significant improvement in the Color Trails 2 test (p = 0.025) c! ompared with HIV-individuals. Symptoms of neuropathy developed in 38% of previously asymptomatic HIV + patients after initiation of the stavudine-based HAART. After the initiation of highly active antiretroviral therapy (HAART) including stavudine, HIV + individuals with cognitive impairment improve significantly as demonstrated by improved performance on a test of executive function. However, peripheral neurotoxicity occurred in 30 patients, presumably because of stavudine-based HAART, suggesting the need for less toxic therapy," wrote N. Sacktor and colleagues, Johns Hopkins University, Medical Department.
The researchers concluded: "Neurology (R) 2009; 72:165-170'." Sacktor and colleagues published their study in Neurology (Benefits and risks of stavudine therapy for HIV-associated neurologic complications in Uganda. Neurology, 2009;72(2):165-170). | | | | (02/20) Pfizer Ordered To Pay Wisconsin $9M for Defrauding Medicaid Program | A Dane County, Wis., jury on Monday ruled that Pharmacia, which Pfizer acquired in 2003, inflated the prices of medications sold to the state Medicaid program, the Milwaukee Journal Sentinel reports. The jury ordered Pfizer to pay the state $9 million, which includes $7 million for monetary losses and $2 million for violations of consumer protection laws. The federal government will receive about 58% of the $7 million and might seek a portion of the $2 million. In addition, the jury ruled that Pharmacia violated state Medicaid fraud law 1.4 million times; each violation of the law can result in a fine of between $100 and $15,000. Pfizer spokesperson Chris Loder said that the company plans to appeal the verdict (Marley/Boulton, Milwaukee Journal Sentinel, 2/17).
~Kaiser Network - 02/20/2009 | | | | (02/19) High Mortality among Patients with AIDS Who Received a Diagnosis of Tuberculosis in the First 3 Months of Antiretroviral Therapy | We analyzed mortality among 201 patients with AIDS and tuberculosis in Haiti. Patients who received a diagnosis of tuberculosis during the first 3 months after the initiation of antiretroviral therapy were 3.25 times more likely to die than were other patients with AIDS and tuberculosis. Failure to recognize active tuberculosis at initiation of antiretroviral therapy leads to increased mortality. Click title for full report.
~Chicago Journals - 02/19/2009 | | | | (02/19) Fact Sheet: The HIV/AIDS Epidemic in the United States | This updated fact sheet provides the latest data on the U.S. epidemic, including key trends over time, impact by region and population, and data on the U.S. government's response. Click to view.
~Kaiser Network - 02/19/2009 | | | | (02/18) Gene Therapy Study Shows Method Is Safe, Somewhat Beneficial, Researchers Report | A study of gene therapy to treat HIV has shown that the treatment is safe and somewhat beneficial -- a "major advance" in efforts to combat the virus -- researchers said in a study published recently in the journal Nature Medicine, AFP/Google.com reports. According to the researchers, the study -- which was headed by Ronald Mitsuyasu of the University of California-Los Angeles -- confirms that this avenue of gene therapy in HIV research is a valid approach (AFP/Google.com, 2/15). The study involved 74 HIV-positive people, half of whom received blood stem cells that included a molecule, called OZ1, which is designed to block HIV from replicating by targeting two key proteins (BBC News, 2/16). The other half were given a placebo. The study aimed to determine whether the stem cells would survive the body's immune system and if this would curb the replication of HIV. The researchers found that after 48 weeks, there was no statistical difference between the two groups. However, after 100 weeks, the group that received the RNA enzyme gene had higher levels of CD4+ T cells and low HIV viral loads. The study also showed that the new blood stem cells depleted over time -- although DNA tests showing that the modified cells were present in 94% of the gene group at four weeks, this fell to 12% by week 48 and 7% by week 100. According to the researchers, the study's results showed the treatment was "safe" and modestly effective. Mitsuyasu said that instead of putting the technique through to a Phase III trial, the team plans to modify the technique and introduce new tests on a smaller group of participants. He said the study "gives some hope" to the gene therapy approach as a treatment for HIV and other diseases, such as cancer, adding, "It's a positive finding for the field and should move the field forward" (AFP/Google.com, 2/15) ...(continued)
~Kaiser Network - 02/18/2009 | | | | (02/17) Research in the area of hepatitis B virus prevention reported from University of Hong Kong, Department of Medicine | New investigation results, 'Intracellular levels of hepatitis B virus DNA and pregenomic RNA in peripheral blood mononuclear cells of chronically infected patients,' are detailed in a study published in Journal of Viral Hepatitis. "It remains uncertain whether hepatitis B virus (HBV) covalently closed circular DNA (cccDNA) and pregenomic RNA (pgRNA) can be detected in the serum or peripheral blood mononuclear cells (PBMC) of patients with chronic hepatitis B (CHB) infection. We examined HBV cccDNA and pgRNA in the serum and PBMC, and investigated the effect of lamivudine therapy on the viral loads in the PBMC of CHB patients," scientists writing in the Journal of Viral Hepatitis report.
"Paired serum and PBMC samples from 50 treatment-naïve CHB patients [25 hepatitis B e antigen (HBeAg) positive and 25 HBeAg negative] were quantified for total HBV DNA, cccDNA and pgRNA by real time polymerase chain reaction. HBV cccDNA and pgRNA were below the lower detection limit in all serum samples, and in 84% of PBMC. HBV DNA (r=0.889, p<0.001) and pgRNA (r=0.696, p<0.001) in PBMC correlated with the HBV DNA in serum. In the longitudinal study, 30 patients treated with lamivudine therapy for a median duration of 34 weeks (range 12-48 weeks) were examined. The median HBV DNA reduction in PBMC before and after treatment was 1.318 (range -0.471 to 3.846) log units, which was significantly lower than serum HBV DNA reduction [3.371 (range -0.883 to 9.454) log units, p<0.05]. HBV cccDNA and pgRNA were undetectable in the serum of CHB patients. HBV viral loads in PBMC correlated with serum HBV DNA," wrote L. Lu and colleagues, University of Hong Kong, Department ! of Medicine.
The researchers concluded: "Lamivudine therapy had less effect on the HBV viral loads in PBMC compared with the serum viral loads." Lu and colleagues published their study in the Journal of Viral Hepatitis (Intracellular levels of hepatitis B virus DNA and pregenomic RNA in peripheral blood mononuclear cells of chronically infected patients. Journal of Viral Hepatitis, 2009;16(2):104-12).
~News RX - 02/16/2009 | | | | (02/17) GSK Announces Plan To Reduce Drug Prices in Developing Countries, Suggests Patent Pool To Create Drugs for Neglected Diseases | GlaxoSmithKline CEO Andrew Witty on Friday announced a plan to reduce the prices of several of its patented medications in 50 of the lowest-income countries worldwide and invest 20% of its profits from low-income countries into health clinics and other infrastructure, the Wall Street Journal reports ...(continued)
~Kaiser Network - 02/17/2009 | | | | (02/16) Reports summarize HIV/AIDS study results from Y. Madec and co-researchers | In this recently published article, scientists in Paris, France conducted a study "To clarify early correlates and natural history of HIV long-term nonprogressors (LTNPs) since HIV diagnosis. Patients enrolled in the French ANRS SEROCO/HEMOCO cohort with CD4 count <500 cells/mm(3) at HIV diagnosis."
"LTNP status was defined as being asymptomatic, antiretroviral free, and with CD4 cell count <500 cells/mm(3) for <8 years after HIV diagnosis. In LTNPs, we modeled the biological markers' progression through a joint model. Factors associated with loss of LTNP status were identified through a Cox model. Sixty (9%) of 664 patients were identified as LTNPs during follow-up. At enrollment, HIV RNA was <= 2.6 log copies/mL in 24% of LTNPs and HIV DNA was <= 1.85 log copies/10(6) peripheral blood mononuclear cells (PBMCs) in 31% vs. 3% and 8% in others. In LTNPs. HIV RNA and HIV DNA levels increased by 0.04 log copies/mL per year and 0.07 log copies/10(6) PBMCs per year during the: first 8 years after diagnosis. LTNP status was lost in 36 subjects;, baseline HIV DNA <1.85 log copies/10(6) PBMCs and high HIV DNA increase were associated with an increased risk of losing LTNP status adjusted hazard ratio: 2.8 (1.2-6.8) and 2.2 (1.0-4.8), respectively)," wrote Y.! Madec and colleagues.
The researchers concluded: "LTNP status is established in the first years of HIV infection, low HIV DNA level at enrollment and slow increase of HIV DNA being associated with maintained LTNP status." Madec and colleagues published their study in Jaids - Journal of Acquired Immune Deficiency Syndromes (Early Control of HIV-1 Infection in Long-Term Nonprogressors Followed Since Diagnosis in the ANRS SEROCO/HEMOCO Cohort. Jaids - Journal of Acquired Immune Deficiency Syndromes, 2009;50(1):19-26).
~News RX - 02/16/2009 | | | | (02/16) African-Americans aware and accepting, but often do not receive, the HPV vaccine | Although only 25 percent of eligible African-American adolescents have received the HPV vaccine, a new survey presented at the American Association for Cancer Research conference on the Science of Cancer Health Disparities, suggests they have a positive view of the treatment and might respond to more education. The Pennsylvania Department of Public Health is funding research to develop ways to increase the rate of HPV vaccination among those at highest risk. HPV vaccination prevents cervical cancer by inoculating against the human papillomavirus. "The consensus among those surveyed in our study was that it would be a good, beneficial option," said Ian Frank, M.D., professor of medicine in the Infectious Diseases Division of the University of Pennsylvania. The HPV vaccine, approved for use in the United States as Gardasil and manufactured by Merck and Co., has been shrouded in controversy since it was released in June 2006. Frank said the controversies break down into four basic areas. Following approval, Merck pushed for mandatory vaccination, which is generally opposed by citizens in the United States who believe health care decisions should not be forced. Others were concerned about the long-term efficacy of the vaccine or its possible side effects. Most famously, some groups insisted that if adolescents were aware that they could inoculate themselves against the human papillomavirus, which is spread through sexual contact, they would be more likely to have early sexual relations. "I doubt that whether or not she is at risk for cervical cancer is on an adolescent's mind in the heat of the moment," said Frank. Frank said the African-Americans who participated in the survey conducted by his research group were aware of these controversies, but they did not outweigh their positive views of the vaccine as an option. Researchers surveyed 71 females for the study; 94 percent were African-American and the mean age was 15.3 years. Approximately 60 percent of them had had their first sexual encounter when they were 14 years old. Of those who had not received the vaccine, 43.9 percent said they were very likely or likely to do so soon. A majority believed it was a "good" or "very good" idea and they generally viewed the vaccine as "safe," "effective" and a "wise choice." Forty-five caregivers of adolescents also participated in the study, all of whom were African-American, 94 percent were female and 47.9 percent had a high school diploma. The caregivers agreed that the vaccine was "safe," "effective" and a "wise choice," but two-thirds of them could not recall their health care provider ever mentioning the HPV vaccine. "Many of these caregivers, most of whom were women, reported feeling overwhelmed by the challenges of raising an adolescent girl, but they wanted to protect their daughters from health and emotional risks," said Frank. "This suggests they would respond positively to an increased effort to inoculate."
~News RX - 02/16/2009 | | | | (02/16) New findings from Florida State University, Medical Department in the area of immunization published | According to recent research from the United States, "For human papillomavirus (HPV) vaccination to have maximum benefit to public health, both men and women should be vaccinated. Although efficacy trials in men are still ongoing, the HPV vaccine will likely be licensed for men in the near future." "Little is known about men's interest in HPV vaccination. This study assessed whether informing men about the benefits of male HPV vaccination for their female sexual partner(s) boosted interest in the HPV vaccine beyond informing them about the benefits to men alone. Predictors of HPV vaccine acceptability were also identified. Heterosexual male college students (n = 356) were randomly assigned to receive a self-protection versus a self-protection and partner protection message about HPV and the quadrivalent HPV vaccine. Participants provided demographic and sexual history information, HPV-related awareness and knowledge. health beliefs, and HPV vaccination intentions. Men reported moderate interest in the HPV vaccine; vaccine acceptability did not differ by experimental condition. A multivariate regression model identified several independent predictors of HPV vaccine acceptability including sexual activity, perceived susceptibility to HPV, perceived benefits of the vacci! ne, perceived hassle and cost of vaccination, self-efficacy for vaccination, and perceived norms for vaccination. Informing men about the benefits of male HPV vaccination for reducing cervical cancer risk in women did not increase men's interest in the vaccine. Correlates of vaccine acceptability among men were generally consistent with those identified for women," wrote M.A. Gerend and colleagues, Florida State University, Medical Department. The researchers concluded: "Findings have important implications for future HPV vaccination campaigns targeting young adult men." Gerend and colleagues published their study in Sexually Transmitted Diseases (Human Papillomavirus Vaccine Acceptability Among Young Adult Men. Sexually Transmitted Diseases, 2009;36(1):58-62).
~News RX - 02/16/2009 | | | | (02/12) Updated HIV/AIDS Fact Sheets On Medicaid, Medicare, and Ryan White | The Kaiser Family Foundation has updated three fact sheets focused on the major public programs that provide care to people with HIV in the United States. These include Medicaid, the nation's safety-net health insurance program for low-income Americans; Medicare, the federal health insurance program for seniors and people with disabilities; and
Ryan White, the single largest federal program designed specifically for people with HIV in the U.S. All the Foundation's HIV/AIDS fact sheets are available online. Click title for full article.
~Kaiser Network - 02/12/2009 | | | | (02/11) IL-2 Immunotherapy Fails to Benefit HIV-Infected Individuals Already Taking Antiretrovirals | Providing a synthetic form of the immune system protein interleukin-2 (IL-2) to HIV-infected individuals already taking combination antiretroviral therapy boosts their numbers of CD4+ T cells, the key white blood cells destroyed by HIV, but fails to reduce their risk of HIV-associated opportunistic diseases or death compared with combination antiretroviral therapy alone. These are the findings of two large international clinical trials presented today at the Conference on Retroviruses and Opportunistic Infections (CROI) in Montreal ...(continued)
~National Institutes of Health - 02/10/2009 | | | | (02/11) HBV JOURNAL REVIEW: Experts Recommend New Guidelines for Monitoring and Treating Hepatitis B | A team of hepatitis B researchers have published new recommendations for monitoring and treating patients chronically infected
with the hepatitis B virus (HBV). The recommendations integrate the latest research findings into guidelines that address who should be treated, when, and with what medication ...(continued)
~HBV Advocate - 02/11/2009 | | | | (02/11) Drugs in Clinical Development (General) | Click the title of this article to see Drugs on Hepatitis C Treatments.
~HCV Advocate - 02/11/2009 | | | | (02/11) Adherence to HCV Therapy Helps Boost Response | NEW YORK (Reuters Health) Jan 30 - High adherence to hepatitis C virus (HCV) therapy prompts significantly better response than does suboptimal drug exposure, Philadelphia-based researchers report in the January 15th issue of Clinical Infectious Diseases. As lead investigator Dr. Vincent Lo Re III told Reuters Health, "we found that adherence of 85% or more to the hepatitis C treatment regimen of PEG-interferon and ribavirin, as measured by pharmacy refill data, was associated with increased hepatitis C viral suppression and early virologic response to treatment" ...(continued)
~HCV Advocate - 02/11/2009 | | | | (02/11) Human Genome hepatitis C drug may work, but will it pay? | BANGALORE - When Human Genome Sciences Inc releases data from a crucial late-stage trial of its drug to treat hepatitis C, analysts will be looking for more than just positive results ...(continued)
~HCV Advocate - 02/11/2009 | | | | (02/11) iTherX Pharmaceuticals to Initiate Proof of Concept Clinical Study for First-in-Class Treatment for Hepatitis C | SAN DIEGO — iTherX Pharmaceuticals Inc, a privately held biopharmaceutical company developing novel antiviral products, today announced that it will initiate a Phase 2a clinical study of ITX5061, a potential therapy targeted at inhibiting the entry of the Hepatitis C virus (HCV) into liver cells. The placebo-controlled, randomized trial is a parallel-group dose-response study of the ability of ITX5061 to reduce viral load in treatment-naive and previously treated patients with HCV infection, when ITX5061 is administered as a single agent ...(continued)
~HCV Advocate - 02/11/2009 | | | | (02/11) Hepatitis C is killing liver cells | It has long been thought that liver disease in hepatitis C patients is caused by the patient's immune system attacking the infected liver, ultimately killing the cells. University of Alberta researchers have discovered something different though. Michael Joyce and his team transplanted human liver cells into mice, which lack an adaptive immune system. The researchers then infected the liver cells with the hepatitis C virus. The researchers found that the virus itself damages liver cells and leads to liver cell death. They also found hepatitis C causes inflammation, which is the second step in liver disease. Joyce's finding sheds new light on the virus and gives researchers more targets for therapy. His study is published in the February edition of PLoS Pathogens.
~HCV Advocate - 02/11/2009 | | | | (02/11) New Orleans Program Will Provide HIV, STI Testing, Treatment to Inmates | A new program launched at the New Orleans Parish jail will provide inmates with testing and treatment for HIV and other sexually transmitted infections, Criminal Sheriff Marlin Gusman announced on Friday, the New Orleans Times-Picayune reports. According to Gusman, the program also will provide people with information about clinics that can continue care after they are released ...(continued)
~Kaiser Network - 02/10/2009 | | | | (02/11) Montagnier Emphasizes Importance of HIV Prevention Amid Efforts To Develop Vaccine, Cure | Luc Montagnier -- who shared the 2008 Nobel Prize in medicine for his work in the discovery of HIV -- on Monday during a speech in Canada said that the rush to develop an HIV/AIDS vaccine or cure should not deemphasize the importance of prevention, the CP/Google.com reports. According to Montagnier, hopes for a vaccine or cure might be contributing to the spread of HIV by making people complacent about prevention. "It seems that the young generation has forgotten about prevention, because they think there are cures for HIV, that it's no big deal," Montagnier said ...(continued)
~Kaiser Network - 02/11/2009 | | | | (02/10) NIH Scientists See Retrovirus Capsid Pentamer for First Time | For the first time, scientists can see an elusive protein that forms part of the shell of a retrovirus—a finding that may help in the development of therapies to disrupt the functioning of retroviruses, which include the HIV/AIDS virus. The study, led by scientists at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health, appears in the current issue of the journal Nature ...(continued)
~National Institutes of Health - 02/10/2009 | | | | (02/09) A Message from AIDS Vaccine Advocacy Coalition: | Dear Advocates,
Researchers from the microbicide effectiveness study known as HPTN 035 announced important, intriguing results this morning at the Conference on Retroviruses and Opportunistic Infections (CROI) being held in Montréal. These results could be the first evidence of a topical, vaginal microbicide reducing women's risk of HIV infection during sex. The trial evaluated the safety and effectiveness of two different candidate microbicides (BufferGel and PRO 2000). Scientists announced a strong trend towards reduced rates of infections in women who received PRO 2000. This trend was not statistically significant, meaning that further studies are needed to confirm the finding. But it is important and exciting nonetheless. To help understand these results, the study sponsors have developed a fact sheet, Q&A and media resource that are available here, and which provide excellent background information. We've quoted from these materials and also focused on a few additional questions that may be of interest to advocates:
* What does "30 percent effective" mean in the context of this trial?
* What does this finding mean for an individual woman?
* The background documents state: "Although the volunteers in the PRO 2000 study arm had a 30 percent lower rate of HIV infection compared with the other three study groups, this finding was not statistically significant." What does this mean? Is the finding real?
* What does this mean for trials of other microbicides and other prevention strategies, like PrEP?
* What will happen next?
Background
HPTN 035 is the name of a trial that had four study groups, or arms. One group of women received an experimental candidate called BufferGel plus condoms, STI treatment and counseling. Another group received PRO 2000 plus condoms, STI treatment and counseling. A third group received a placebo gel with no active ingredient plus condoms, STI treatment and counseling. The fourth group received condoms, STI treatment and counseling with no experimental or placebo gel.
A total of 3,099 women were enrolled at sites in Malawi, South Africa, the United States, Zambia and Zimbabwe. Work on HPTN 035 was completed by a team of leading African and US researchers associated with the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network established and funded by the US National Institutes of Health. Overall, there were 194 HIV infections over the course of the 3.5-year study. There were 36 infections among women who received PRO 2000 gel along with condoms, counseling and STI treatment, 54 infections occurred among women who received BufferGel along with condoms, counseling and STI treatment, 51 infections in participants who received the placebo gel along with condoms, counseling and STI treatment, and 53 infections among women who received condoms, STI treatment and counseling only. The study showed that both BufferGel and PRO 2000 were safe for vaginal use during the course of the trial.
What does "30 percent effective" mean in the context of this trial?
In any trial, the rate of effectiveness is calculated by comparing numbers of infections in participants who received an experimental agent, versus participants who did not. In this trial, the women who received either BufferGel or PRO 2000 were compared to both the placebo gel arm and the no gel arm. Researchers found that there were 30 percent fewer infections in the group of women who received PRO 2000 along with condoms, counseling and STI treatment compared to the groups of women who received the placebo gel and the women who received condoms, counseling and STI treatment only. There were also 30 percent fewer infections in the PRO 2000 group compared to the BufferGel group, indicating that, while it was safe, BufferGel had no effect on reducing risk of HIV infection.
What does a finding of "30 percent effective" mean for an individual woman?
As explained above, the study data suggest that in this trial the group of women who used PRO 2000 had lower rates of HIV than groups of women who used the placebo gel, BufferGel or no gel at all. Many people will ask: how does this finding translate into benefit for an individual woman? This is an excellent question, and one of the reasons why follow-up research is needed. More information is needed to confirm the observed risk reduction in HPTN 035 and also to learn about patterns of gel use, numbers of sex partners, and rates of risk behavior in different groups of women. However, if the HPTN 035 finding is confirmed through other research and PRO 2000 is approved by regulatory authorities, then it will mean that individual women might be able to use PRO 2000 in combination with other HIV risk reduction strategies to further reduce their risk of acquiring HIV.
The background documents from the study sponsor state: "Although the volunteers in the PRO 2000 study arm had a 30 percent lower rate of HIV infection compared with the other three study groups, this finding was not statistically significant." What does this mean? Is the finding "real"?
One of the most important aspects of designing a clinical trial is deciding what level of benefit, or effectiveness, will be considered "real" as opposed to based on chance or coincidence. The scientific term for "real" data is statistically significant. This means that researchers are confident that the effect that's been observed has something to do with the experimental intervention, and is not a coincidence or chance. Decisions about what data will be considered statistically significant are in place at the beginning of the trial and do not change. The data that come at the end of the study need to meet the criteria that were defined at the beginning for statistical significance.
HPTN 035 was designed to find out whether use of either candidate gel--PRO 2000 or BufferGel--reduced women's risk of HIV by 33 percent or more. Neither gel met this criterion. A finding below this threshold of 33 percent has some level of uncertainty associated with it.
The finding of a 30 percent reduction in HIV infections among women who used PRO 2000 compared to those who did not is not statistically significant. It is, however, a very intriguing finding.
It's a clear message that further research is needed to learn with certainty whether PRO 2000 could be a tool to help reduce women's risk of HIV via vaginal sex. (An effective microbicide might also be used during anal sex; this usage would need to be studied separately, and a study of PRO 2000 for anal sex is planned--see below.) Additional data on PRO 2000 will be forthcoming from another ongoing trial of PRO 2000, one sponsored by the UK-based Microbicide Development Programme and known as MDP 301. This study involves nearly 9,400 women in South Africa, Tanzania, Uganda and Zambia and results are expected by the end of 2009.
What does this mean for trials of other microbicides and other prevention strategies, like PrEP?
The data from HPTN 035 are intriguing but not statistically significant, according to the trial investigators. Additional studies are needed and some answers will come from MDP 301, the trial described above. If there's clear evidence of benefit in that study, then there will need to be discussions, with extensive community input, about the best way to design future trials and about whether and how the product should be introduced for use by women as an HIV risk reduction tool. A product that reduced HIV risk by 30 percent could have an impact on womens' risk of acquiring HIV however it would not eliminate the need for new and additional tools, including a vaccine, PrEP and additional microbicides. Future trials might also assess the benefits of PRO 2000 used in combination with other experimental strategies such as pre-exposure prophylaxis (PrEP) or other candidate microbicides.
What will happen next?
One important next step is to see whether MDP 301 trial has similar findings to those seen in HPTN 035. Also, another PRO 2000 study is scheduled to begin this year to evaluate the rectal safety profile of PRO 2000 in sexually active gay men and other men who have sex with men. This trial will take place at sites in the UK and, like MDP 301, is sponsored by the UK's Microbicide Development Programme.
At the same time, the US National Institute of Allergy and Infectious Diseases (NIAID) which funded the HPTN 035 trial is entering into discussions with Indevus Pharmaceuticals, the makers of PRO 2000, to discuss the way forward. NIAID will make decisions about whether it will look to fund additional studies of PRO 2000 after data from the MDP 301 study are available.
Advocacy groups working on HIV prevention and women's sexual and reproductive health also have a critical role to play, even while we wait for additional results. Communities need to understand and discuss their views on partially effective products. Civil society groups will provide critical leadership and advocacy around planning to ensure affordable, sustainable global access to any new biomedical prevention tool that emerges. And there's also a role for all of us to advocate for forward-looking research that aims to improve on initial findings, whether through development of new products, innovative delivery strategies or combination prevention.
Follow up on participants who became HIV infected during the course of the study is also critical. HPTN 035 referred participants for treatment and care, including antiretrovirals. Documenting the experiences of women who choose to access care can provide invaluable information for future trials; it must also be done in a way that honors the confidentiality of participants.
Initial discussion of these and other questions and priorities will be possible on an upcoming advocates' conference call, sponsored by the Global Campaign for Microbicides. The call will give civil society stakeholders the opportunity to discuss the findings with the researchers involved in HPTN 035, including Salim Abdool Karim who is the protocol chair of the trial and will lead the discussion. The call will take place Wednesday, 11 February 2009 at 14:00 GMT (09:00 US EST; 16:00 Johannesburg; 15:00 Geneva; 19:30 India). Please see below for call-in details and if you have any questions about the call please email gwolnitzek@path.org.
To access the call from the US, please dial 1-800-377-8846
To access the call from Canada, please dial 1-888-276-7715
To access the call from India, please dial 000-800-100-6064
To access the call from in South Africa, please dial 0-800-998-242
To access the call from the UK, please dial 0-800-028-1126
Participant access code: 36597307#
These are exciting times in the HIV prevention research field! As always, please contact us with any questions or comments at avac@avac.org.
Best,
~AIDS Vaccine Advocacy Coalition - 02/09/2009 | | | | (02/09) Anti-HIV Gel Shows Promise in Large-scale Study in Women | An investigational vaginal gel intended to prevent HIV infection in women has demonstrated encouraging signs of success in a clinical trial conducted in Africa and the United States. Findings of the recently concluded study, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, were presented today at the Conference on Retroviruses and Opportunistic Infections in Montreal ...(continued)
~National Institutes of Health - 02/09/2009 | | | | (02/09) Recent findings in HIV/AIDS described by K.M. Harrison and colleagues | In this recent study, researchers in the United States conducted a study "To estimate relative survival (RS) after human immunodeficiency virus (HIV) diagnosis, by race/ethnicity and county-level socioeconomic status (SES). We estimated 5-year RS by age, race/ethnicity, transmission category, sex, diagnosis year, CD4 count, and by county-level SES variables from the U.S. Census."
"Data, from the national HIV/AIDS Reporting System, were for HIV-infected persons ages <= 13 years (diagnosis during 1996-2003 and follow-up through 2005). We calculated RS proportions by using a maximum likelihood algorithm and modeled the relative risk of excess death (RR) using generalized linear models, with poverty as a random effect. For men, RS was worse in Counties with larger proportions of people living below the 2000 U.S. poverty level (87.7% for poverty of <= 20% vs. 90.1% for poverty of < 5.0%) and where unemployment was greater (87.8% where unemployment < 7.1% vs. 90.5% where unemployment < 4.0%). The effects of county-level SES on RS of women were similar. In multilevel multivariate models, RR for men and women within 5 years after an HIV diagnosis was significantly worse in counties where 10.0-19.9% (compared with < 5.0%) lived below the poverty level (RR = 1.3 [95% CI 1.2-1.5] and RR = 1.8 [95% CI 1.4-2.2], respectively). RS was wors! e in lower SES areas," wrote K.M. Harrison and colleagues.
The researchers concluded: "To help address the impact of county-level SES, resources for HIV testing, care, and proven economic interventions should be directed to areas with concentrations of economically disadvantaged people." Harrison and colleagues published their study in Annals of Epidemiology (County-Level Socioeconomic Status and Survival After HIV Diagnosis, United States. Annals of Epidemiology, 2008;18(12):919-927).
~News RX - 02/09/2009
| | | | (02/06) Uganda Procures Antiretroviral Treatment for 350,000 HIV-Positive People, Health Minister Says | Uganda's government has obtained antiretroviral drugs to provide 350,000 HIV-positive people with the therapy under its treatment program, Health Minister Stephen Mallinga announced recently, the New Vision/AllAfrica.com reports. According to Mallinga, 150,000 people currently have access to antiretrovirals, and the government aimed to add 200,000 people to this group. Mallinga said that Uganda's antiretroviral treatment program is one of the leading programs in Africa, with treatment initiatives available in 11 referral hospitals nationwide. The treatment program also will be introduced in health centers, according to Mallinga. He added that about 25% of people in Uganda are aware of their HIV status and that the program aims to promote HIV/AIDS awareness. Mallinga also noted that HIV/AIDS is contributing to the spread of tuberculosis in the country ...(continued)
~Kaiser Network - 02/06/2009 | | | | (02/05) HIV/AIDS, TB, Malaria Account for 80% of Disease Funding in Developing Countries, Report Says | HIV/AIDS, tuberculosis and malaria initiatives accounted for about 80% of the $2.5 billion that was spent on research and drug development for developing countries in 2007, according to a report published Tuesday in PLoS Medicine, Reuters reports. In the report, which was funded by the Bill & Melinda Gates Foundation, researchers from the George Institute for International Health at the University of Sydney wrote that other tropical diseases kill millions of people in developing countries but do not receive the same attention or funding as HIV/AIDS, TB and malaria (Tan, Reuters, 2/4) ...(continued)
~Kaiser Network - 02/05/2009 | | | | (02/05) Boston Technology Business Owner Makes $100 Million Donation to HIV/AIDS Vaccine Research | Phillip Ragon, founder of the database software company InterSystems, has made a $100 million dollar donation to create a Boston-based institute for HIV/AIDS vaccine research, the Boston Globe reports. The donation of $10 million annually for the next 10 years will be directed to Massachusetts General Hospital and shared with other institutions -- such as Harvard University and the Massachusetts Institute of Technology -- in an effort to bring physicians, engineers and biologists together under one institute, according to the Globe. The new institute -- named Phillip T. and Susan M. Ragon Institute -- will be modeled after the Broad Institute and will bring together specialists who might not otherwise collaborate. Researcher Bruce Walker of Massachusetts General and Harvard will oversee the institute ...(continued)
~Kaiser Network - 02/04/2009 | | | | (02/05) Biotechnology Company To Launch Trial of New HIV/AIDS Treatment That Would Target DNA | A biotechnology company on Monday announced plans to start human trials of a new approach to treating HIV/AIDS that targets patients' DNA, Reuters reports. California-based Sangamo BioSciences' drug SB-728-T is designed to disrupt the CCR5 gene -- the protein on the surface of immune cells to which HIV attaches. The study involves removing CD4+ T cells from people living with HIV and treating the cells with the drug, called a "zinc finger nuclease." The treated cells would then be infused back into the patient with the hope that they will flourish and multiply, making the patient's immune system resistant to HIV, Reuters reports. According to Sangamo, 12 people living with advanced stages of HIV will be recruited to participate in the Phase I trial, which will focus only on the safety of the therapy ...(continued)
~Kaiser Network - 02/04/2009 | | | | (02/05) New York Times Examines Company Vestergaard-Frandsen's Efforts To Provide HIV Tests, Other Products in Developing Countries | The New York Times on Tuesday examined the Danish company Vestergaard-Frandsen, which develops products such as insecticide-treated nets and portable water filters for use in developing countries. Kevin Starace, malaria adviser for the United Nations Foundation, said Vestergaard is "different from other companies" that develop similar products because it considers the "end user as a consumer rather than as a patient or a victim" by including features such as cell phone pockets on ITNs ...(continued)
~Kaiser Network - 02/05/2009 | | | | (02/03) More about Cirrhosis | Cirrhosis was the subject of last month’s column. Two points were emphasized. One, the majority of those with chronic hepatitis C virus infection (HCV) will not progress to advanced liver disease. However, roughly one in five of those with HCV have cirrhosis. This leads to the second point. A full, productive life is possible even with this level of liver damage. Now we’ll go into more detail, concluding with how to help ourselves live with cirrhosis or avoid it altogether ...(continued)
~HCV Advocate - 02/02/2009 | | | | (02/03) HCV SnapShots – Drugs in Development | This month’s SnapShots article will focus on the recent news about drugs in development to treat hepatitis C – including the start of a new study of R7128, results from a small phase I study of ITMN-191, a new HCV polymerase inhibitor being developed by Idenix (IDX184), Anadys’ impressive results with ANA598, a new clinical study to evaluate a once-a-month dose of albuferon, and a few new developments on Bristol-Myers’ bold new entrance into the HCV drug treatment arena ...(continued)
~HCV Advocate - 02/03/2009 | | | | (02/03) Medical Writers Circle - HCV Cirrhosis Is a Life Threatening Disease | The reason that HCV is a serious infection is that it causes cirrhosis. Cirrhosis occurs when the normally soft liver is converted by
a disease into a hard organ full of scar tissue. Hepatitis C and alcoholism are the most common causes of cirrhosis in the US. Chronic
liver disease with cirrhosis is the 12th most common cause of death in the US. Cirrhosis from HCV does not happen overnight ...(continued)
~HCV Advocate - 02/02/2009 | | | | (02/03) Research on HIV/AIDS co-infection described by scientists at Centers for Disease Control and Prevention | According to a study from Nonthaburi, Thailand, "Almost half of all new HIV infections in Thailand occur among low-risk partners of people infected with HIV, so it is important to include people infected with HIV in prevention efforts. Risk for HIV transmission was assessed among people with HIV attending routine care at the National Infectious Disease Institute in Thailand." "Sexual risk behaviour, sexually transmitted infection (STI-syphilis, gonorrhoea, chlamydia, trichomoniasis and genital ulcers) prevalence and HIV disclosure status were assessed. Patients were provided with STI care, risk-reduction and HIV disclosure counselling. Baseline data were assessed among 894 consecutive people with HIV (395 men and 499 women) from July 2005 to September 2006. Unprotected last sex with a partner of unknown or negative HIV status (unsafe sex) was common (33.2%) and more likely with casual, commercial or male-to-male sex partners than with steady heterosexual partners (p= 0.03). People receiving antiretroviral treatment were less likely to report unsafe sex (p <0.001). Overall, 10.7% of men and 7.2% of women had a STI (p= 0.08). More women than men had disclosed HIV status to their steady partners (82.5% vs 65.9%; p= 0.05). Indicators for HIV transmission risk were common among people attending HIV care in Bangkok. Efforts need to be strengthened! to reduce unsafe casual and commercial sex and to increase HIV disclosure from men to their partners," wrote P. Tunthanathip and colleagues, Centers for Disease Control and Prevention. The researchers concluded: "A strategy for STI screening and treatment for people with HIV in Thailand should be developed." Tunthanathip and colleagues published the results of their research in Sexually Transmitted Infections (Indicators for sexual HIV transmission risk among people in Thailand attending HIV care: the importance of positive prevention. Sexually Transmitted Infections, 2009;85(1):36-41).
~News RX - 02/03/2009 | | | | (02/02) Latinos Treated with Pegasys plus Ribavirin | It is well-known that the effectiveness of the current standard of care – pegylated interferon plus ribavirin – is different among races and ethnic groups. The effectiveness of current treatment in Latinos, however, has not been well-defined except for some small studies of PegIntron plus ribavirin, which have found lower treatment response rates among Latino patients. Now, results from a study published in The New England Journal of Medicine, by M. Rodriguez-Torres, MD, will add to our understanding of HCV treatment response in Latinos ...(continued)
~HCV Advocate - 02/02/2009 | | | | (02/02) Clinical Update - Debio 025 in Hepatitis C | LAUSANNE, Switzerland - Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today the randomisation of its first patient in a phase IIb clinical study with Debio 025, a selective cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C (HCV) effect. This multinational, double blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of three different treatment regimens combining Debio 025 with Peg interferon alpha 2a (peg-IFNalpha2a) and ribavirin in treatment-naive chronic HCV genotype 1 patients ...(continued)
~HCV Advocate - 02/02/09 | | | | (02/02) Discovery Could Lead to a New Animal Model for Hepatitis C | Newswise — During its career, the potentially fatal hepatitis C virus has banked its success on a rather unusual strategy: its limitations. Its inability to infect animals other than humans and chimpanzees has severely hampered scientists in developing a useful small animal model for the disease. But now, in a breakthrough to be published in the January 29 advance online issue of Nature, Rockefeller University scientists have identified a protein that allows the virus to enter mouse cells, a finding that represents the clearest path yet for developing a much-needed vaccine as well as tailored treatments for the 170 million people across the globe living with the tenacious, insidious and rapidly changing virus ...(continued)
~HCV Advocate - 02/02/2009 | | | | (02/02) Findings in HIV/AIDS reported from World Health Organization | According to recent research published in the journal Lancet, " Roughly 3 million people worldwide were receiving antiretroviral therapy (ART) at the end of 2007, but an estimated 6.7 million were still in need of treatment and a further 2.7 million became infected with HIV in 2007. Prevention efforts might reduce HIV incidence but are unlikely to eliminate this disease."
"We investigated a theoretical strategy of universal voluntary HIV testing and immediate treatment with ART, and examined the conditions under which the HIV epidemic could be driven towards elimination. We used mathematical models to explore the effect on the case reproduction number (stochastic model) and long-term dynamics of the HIV epidemic (deterministic transmission model) of testing all people in our test-case community (aged 15 years and older) for HIV every year and starting people on ART immediately after they are diagnosed HIV positive. We used data from South Africa as the test case for a generalised epidemic, and assumed that all HIV transmission was heterosexual. The studied strategy could greatly accelerate the transition from the present endemic phase, in which most adults living with HIV are not receiving ART, to an elimination phase, in which most are on ART, within 5 years. it could reduce HIV incidence and mortality to less than one case per 1000 peopl! e per year by 2016, or within 10 years of full implementation of the strategy, and reduce the prevalence of HIV to less than 1% within 50 years. We estimate that in 2032, the yearly cost of the present strategy and the theoretical strategy would both be US$1.7 billion; however, after this time, the cost of the present strategy would continue to increase whereas that of the theoretical strategy would decrease. Universal voluntary HIV testing and immediate ART, combined with present prevention approaches, could have a major effect on severe genralised HIV/AIDS epidemics," wrote R.M. Granich and colleagues, World Health Organization.
The researchers concluded: "This approach merits further mathematical modelling, research, and broad consultation. Funding None." Granich and colleagues published their study in Lancet (Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet, 2009;373(9657):48-57).
~News RX - 02/02/2009 | | | | (02/02) Research from V.A. Gyarmathy and co-researchers provides new data on hepatitis C virus therapy | A report, 'The association of syringe type and syringe cleaning with HCV infection among IDUs in Budapest, Hungary,' is newly published data in Drug and Alcohol Dependence. "We assessed whether syringe type, syringe cleaning and distributive syringe sharing were associated with self-reported and laboratory-confirmed HCV infection among Hungarian IDUs. Injecting drug users (N=215) were recruited from non-treatment settings in Budapest, Hungary between October 2005 and December 2006," investigators in Lisbon, Portugal report.
"Multivariate logistic regression models identified correlates of self-report of being HCV infected and testing positive for HCV. While 37% tested positive for HCV, 14% of the total (39% of those who tested positive) self-reported being HCV infected. Using any two-piece syringes was significantly associated with self-reported HCV infection, while distributive syringe sharing was not associated with self-report of being HCV infected. Engaging in receptive sharing of only one-piece syringes but always cleaning before reuse was not associated with testing HCV positive, while any receptive sharing of only one-piece syringes and not always cleaning before reuse was significantly associated with testing HCV positive. Sharing cookers and squirting drugs from one syringe into another syringe were not associated with testing HCV positive. The high percent of those HCV infected who did not know they were infected highlights the need to provide better access to confidential testing an! d counseling services. Counseling should emphasize secondary prevention of HCV among HCV infected IDUs. Our findings also indicate that syringe type and syringe cleaning practices may play a role in HCV transmission. Ethnographic research should identify the reasons why IDUs may use two-piece syringes and suggest means to reduce their use," wrote V.A. Gyarmathy and colleagues.
The researchers concluded: "Thorough cleaning of one-piece syringes when sterile syringes are unavailable may be an efficient way to reduce the risk of HCV infection." Gyarmathy and colleagues published their study in Drug and Alcohol Dependence (The association of syringe type and syringe cleaning with HCV infection among IDUs in Budapest, Hungary. Drug and Alcohol Dependence, 2009;100(3):240-7).
~News RX - 02/02/2009
| | | | (02/02) HIV-Positive People in Indian State Experience Limited Access to Second-Line Antiretrovirals | Some HIV-positive people who are in need of second-line antiretroviral treatment in India's Gujarat state are facing long waiting periods to access the drugs at the state's only center offering the treatment, the Indian Express reports. A limited supply of the drugs means that the treatment center at the Ahmedabad Civil Hospital is administering second-line treatment only to people who officials define as being in serious need, creating a waiting period for many HIV-positive people across the state, according to the Express ...(continued)
~Kaiser Network - 02/02/2009 | | | | (02/02) Study Showing Improved Virologic Response with Nitazoxanide in Chronic Hepatitis C Published in Gastroenterology | A study evaluating nitazoxanide in combination with peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C virus (HCV) infection with genotype 4 was published in the March issue of Gastroenterology, the official journal of the American Gastroenterological Association Institute (AGA Institute). The study showed that the addition of nitazoxanide to standard-of-care therapy increased the rate of sustained virologic response when compared with patients given peginterferon plus ribavirin alone.(1) An accompanying editorial commenting on the study was also published in the Journal.(2) ...(continued)
~HCV Advocate - 02/02/2009 | | | January, 2009 | | (01/30) NIH Consensus Development Conference: Management of Hepatitis B | NIH consensus and state-of-the-science statements are prepared by independent panels of health professionals and public representatives on the basis of (1) the results of a systematic literature review prepared under contract with the Agency for Healthcare Research and Quality (AHRQ), (2) presentations by investigators working in areas relevant to the conference questions during a 2-day public session, (3) questions and statements from conference attendees during open discussion periods that are part of the public session, and (4) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government.
The statement reflects the panel's assessment of medical knowledge available at the time the statement was written. Thus, it provides a "snapshot in time" of the state of knowledge on the conference topic. When reading the statement, keep in mind that new knowledge is inevitably accumulating through medical research, and that the information provided is not a substitute for professional medical care or advice. Click title to view.
~Hepatitis B Foundation - 01/30/2009 | | | | (01/30) FAQ: Is vitamin E treatment for children with chronic hepatitis B helpful? | A: German researchers evaluated the safety and efficacy of vitamin E treatment in children with chronic hepatitis B and found that 23.2% of children treated with vitamin E demonstrated HBeAg seroconversion (loss of HBeAg with appearance of anti-HBe) and undetectable levels of hepatitis B virus DNA after 12 months of therapy. This compared to only 8.7% in the placebo group. The investigators concluded that "there is only a tendency that vitamin E may promote HBeAg seroconversion" and that larger studies on the role of antioxidants in chronic hepatitis B therapy are needed. (World J Gastroenterol, Dec 21, 2008;14(47):7208-13). Click title to view full article.
~Hepatitis B Foundation - 01/30/2009 | | | | (01/29) West Virginia County Passes Resolution To Drop Written Consent Requirements for HIV Tests | The Wheeling-Ohio County Board of Health in West Virginia on Tuesday approved a resolution requesting that state legislators repeal a law requiring written consent prior to HIV tests, the Intelligencer Wheeling News-Register reports. The resolution states that the written consent "requirement for HIV testing has been found to be a barrier to HIV diagnosis interfering with the prevention of the spread of HIV." The board's appeal to the state legislature is in response to recommendations released by CDC in 2006 that HIV testing become a routine part of medical care for people ages 13 to 64 and that requirements for written consent be dropped ...(continued)
~Kaiser Network - 01/29/2009 | | | | (01/29) JAMA Perspective Piece Examines Routine HIV Screening | "Clinicians Advised To Step Up HIV Tests," Journal of the American Medical Association: The article examines recommendations from HIV/AIDS experts regarding routine HIV testing and suggests that many medical service providers miss opportunities to conduct HIV tests. According to the article, HIV/AIDS experts endorse CDC's 2006 recommendations that medical workers offer routine HIV screening to all patients between ages 13 and 64; however, routine HIV tests have not been implemented widely. The article continues that rapid screening using a saliva test can provide an easy, accurate HIV diagnosis in a short amount of time. In addition, routine testing could increase HIV/AIDS awareness and help several thousand people access antiretroviral treatment while preventing new HIV cases. However, a lack of sufficient reimbursement from insurance companies, as well as Medicare and Medicaid, poses obstacles to increasing HIV testing, some experts say. In addition, recent studies indicate that hospital emergency departments often miss opportunities to provide HIV tests to patients who are uninsured and might have no other source of regular health care, according to the article (Voelker, JAMA, 1/28).
~Kaiser Network - 01/29/2008 | | | | (01/29) No Foster Children Died From Participation in New York HIV Drug Trials; Race Not a Selection Factor, Report Says | Foster children in New York City who participated in clinical drug trials for HIV/AIDS medications did not die as a result of participation in the study, and researchers did not specifically select children to participate based on race, according to a report released Wednesday by the Vera Institute of Justice, the New York Times reports. In the late 1980s, the city's Administration for Children's Services developed a policy allowing HIV-positive foster children to enroll in drug trials. According to the Times, hundreds of children received HIV medications in numerous trials conducted until 2005 (Foderaro, New York Times, 1/28). After allegations that ACS might have mismanaged the trials, the city in 2005 hired the Vera Institute to evaluate whether the agency had the necessary permission to include the children in the trials, if the children met the studies' medical criteria and if the enrollments were appropriate given the medical knowledge at the time (Kaiser Daily HIV/AIDS Report, 5/9/05) ...(continued)
~Kaiser Network - 01/28/2009
| | | | (01/28) Cambodia Reports Increase in Antiretroviral Treatment Access | More than 92% of people living with HIV/AIDS in Cambodia had access to antiretroviral treatment in 2008 -- a 7% increase in the number of people who had treatment access compared with the previous year -- Xinhuanet reports. The increase in treatment access brings the country closer to reaching its goal of making antiretrovirals available to almost all people living with HIV/AIDS by 2010, according to Mean ChhiVun, director of the National Center for HIV/AIDS, Dermatology and STDs. No-cost treatment was provided to 31,989 people in 2008 -- including 3,067 children -- in 77 government-run health entities and partner organizations in the country, according to ChhiVun. Cambodia has reduced its HIV prevalence to 0.9% from 3.3% in 1991, according to Xinhuanet (Xinhuanet, 1/26).
~Kaiser Network - 01/28/2009 | | | | (01/26) Research from Johann Wolfgang Goethe University in the area of hepatitis C virus therapy published | Fresh data on hepatitis C virus are presented in the report 'Clinical relevance of the 2'-5'-oligoadenylate synthetase/RNase L system for treatment response in chronic hepatitis C.' "Interferon-alpha induces 2'-5'-oligoadenylate synthetase which activates RNase L. Viral RNA is cleaved by RNase L at UU/UA dinucleotides," scientists writing in the Journal of Hepatology report.
"The clinical relevance of RNase L cleavage for response to an interferon-alpha-based therapy in chronic hepatitis C is unknown. RNase L cleavage sites within pre-treatment sequences coding for structural and non-structural hepatitis C virus proteins were compared between non-responders and responders to an interferon-alpha-based therapy. Furthermore, RNase L cleavage sites were analyzed in full length and partial genome isolates of hepatitis C virus genotype 1b infected non-responders before and during treatment and in different hepatitis C virus genotypes (1b, 2a/b, 3a/b). No differences in RNase L cleavage sites were observed between non-responders and responders within a given hepatitis C genotype. Non-responders with hepatitis C virus genotype 1b infection did not eliminate UA/UU dinucleotides during therapy. Hepatitis C virus genotype 1b isolates showed a lower number of UA/UU dinucleotides than hepatitis C virus genotypes 2/3 (p <0.001). Response or non-response ! to an interferon-alpha-based therapy within a given hepatitis C virus genotype is not explained by differences for RNase L cleavage sites," wrote U. Mihm and colleagues, Johann Wolfgang Goethe University.
The researchers concluded: "General differences of interferon sensitivity between hepatitis C virus genotypes correlate significantly with frequencies of RNase L cleavage sites." Mihm and colleagues published their study in the Journal of Hepatology (Clinical relevance of the 2'-5'-oligoadenylate synthetase/RNase L system for treatment response in chronic hepatitis C. Journal of Hepatology, 2009;50(1):49-58).
~News RX - 01/26/2009
| | | | (01/26) Researchers at INSERM have published new data on HIV/AIDS | "The demonstration of in vitro cardiolipin reactivity with 2 human immunodeficiency virus (HIV)-specific, broadly neutralizing antibodies (2F5 and 4E10) has prompted reevaluation of autoimmune manifestations in HIV infection. We evaluated autoantibodies, particularly anticardiolipin (aCL), in 67 untreated, asymptomatic, HIV-infected individuals with slow progression of HIV disease and their correlation with 2F5-, 4E10-, b12-, and 2G12-like antibodies directed against epitopes involved in broad neutralization, as well as their correlation with immune activation and virological and clinical indicators," investigators in Paris, France report.
"Fifty individuals with chronic HIV infection and standard disease progression were control patients. The majority of the study patients with slow progression of HIV disease were men (78%); their median age was 37 years, their median CD4(+) cell count was 672 cells/mu L, and their median plasma HIV load was 6200 copies/mL. The majority of the control patients were also men (76%), and most (62%) were receiving highly active antiretroviral therapy; their median age was 43 years, their median CD4(+) cell count was 202 cells/mL, and their median plasma HIV load was 2265 copies/mL. aCL immunoglobulin G was detected at similar levels in 49% of patients with slow progression of HIV disease and in 58% of control patients. Viral load was positively associated with aCL in both groups (P <.001), independent of CD4(+) cell counts. In patients with slow progression of HIV disease, aCL levels were also correlated with plasma HIV load and cell-associated DNA level (r=0.486 and r=0.516! , respectively; P<.001), with the proportion of activated CD4(+) cells, human leukocyte antigen-DR+ cells (r=0.445; P= <.001 but not activated CD8(+) T cells, and with the level of B cell activation (quantified by soluble CD23; r=0.354; P=.007. The level of aCL antibodies was associated with the level of antibodies to the membrane proximal region of gp41 (P=.003)," wrote V. Martinez and colleagues, INSERM.
The researchers concluded: "ACL is frequently detected in HIV-infected patients, regardless of disease stage, and is strongly linked with the level of viral replication, the level of CD4(+) T and B cell activation, and the level of antibodies to the membrane proximal external region of gp41, independent of CD4(+) cell deficiency." Martinez and colleagues published their study in Clinical Infectious Diseases (Anticardiolipin Antibodies in HIV Infection Are Independently Associated with Antibodies to the Membrane Proximal External Region of gp41 and with Cell-Associated HIV DNA and Immune Activation. Clinical Infectious Diseases, 2009;48(1):123-132).
~News RX - 01/26/2009 | | | | (01/24) Togo Resumes No-Cost Antiretroviral Treatment Program | People living with HIV/AIDS in Togo will be able to resume or begin no-cost antiretroviral treatment as a result of a restocked government program, which had not been able to supply the drugs since November 2007, IRIN News reports. The National AIDS Control Program estimates that an additional 4,000 people will be able to access the drugs. According to Takouda Pelei -- deputy director of the state medical purchasing agency, CAMEG -- there are enough antriretrovirals to treat people already enrolled in the program, as well as an additional 4,000 people, until August 2009. The country also was approved to receive an additional $94 million in funding from the Global Fund To Fight AIDS, Tuberculosis and Malaria over the next five years. Of the $94 million, $25 million will go toward stocking antiretrovirals and other drugs to treat opportunistic infections ...(continued)
~Kaiser Network - 01/23/2009 | | | | (01/23) Conducting Unlinked Anonymous HIV Surveillance in Developing Countries: Ethical, Epidemiological, and Public Health Concerns | Decades into the pandemic, the public health value of HIV surveillance is obvious. Surveillance is traditionally depicted as the “radar” or “eyes” of public health [1,2]. The World Health Organization (WHO) defines it as “‥ongoing, systematic collection of health data, with analysis, evaluation and interpretation of these data and prompt dissemination of the findings to public health officials and others who need to know how to help shape public health intervention, planning and prevention” [2]. Many organizations (WHO, the Joint United Nations Programme on HIV/AIDS [UNAIDS], the European Union, the United States Agency for International Development, and other bilateral donors) encourage, initiate, and fund HIV surveillance activities worldwide ...(continued)
~PLOS Medicine - 01/22/2009 | | | | (01/23) China To Introduce Two Imported Antiretrovirals To Address Drug Resistance Among HIV-Positive People | China plans to provide access to two imported antiretroviral drugs to address growing drug resistance among some HIV-positive people in the country, Reuters Health reports. Treatment with tenofovir, sold by Gilead Sciences under the brand name Viread, and Kaletra, a combination of the protease inhibitors lopinavir and ritonavir and sold by Abbott Labs, can cost more than $1,500 annually. According to Reuters Health, drugs already available in China can cost about 5,000 yuan, or about $730 ...(continued)
~Kaiser Network - 01/22/2009
| | | | (01/23) A Brief History of Hepatitis C | The management and care of hepatitis C has come a long way in the last decade. While there are still many unanswered questions, we have a much better understanding of hepatitis C transmission, prevention, disease progression and treatment. This factsheet will focus on a brief review of the history of hepatitis C and the major strides made in treating HCV since the identification of the virus ...(continued)
~HCV Advocate - 01/22/2009 | | | | (01/21) New HIV/AIDS data have been reported by M.A. Tello and co-authors | "Women infected with HIV have a high rate of many gynecological problems. Adherence to recommended gynecological care among women enrolled in our urban HIV clinics was hypothesized to be low," scientists in the United States report.
"We conducted an analysis of data from the Johns Hopkins HIV Clinical Cohort Database examining demographic and clinical predictors of clinic visit adherence by women in the HIV primary care and HIV gynecological clinics. Between January 2002 and April 2006, 1,086 women had 26,401 scheduled appointments to the two clinics, of which 21,959 were to HIV primary care and 4,442 were to HIV gynecological care. There were 12,097 (55%) completed primary care visits and 1,609 (36.2%) completed HIV gynecological visits ( p< 0.001, accounting for clustering). By multivariate analysis, age <40 years ( OR 0.81, 95% CI 0.70-0.94) and substance abuse ( OR 0.67, 95% CI 0.61-0.73) were associated with a decreased likelihood of attending an HIV primary care appointment. African American race ( OR 0.63, 95% CI 0.45-0.90), CD4 count <200 cells/mm(3) ( OR 0.73, 95% CI 0.56-0.95), and substance abuse ( OR 0.57, 95% CI 0.45-0.71) were associated with a decreased likelihood of attendin! g an HIV gynecological appointment. This analysis determined that the rate of clinic visit adherence is significantly lower for HIV gynecological care than for HIV primary care in the same population of women. Factors associated with HIV gynecological clinic visit noncompliance included African American race/ethnicity, substance use, and more advanced immunosuppression," wrote M.A. Tello and colleagues.
The researchers concluded: "We have planned additional quantitative and qualitative studies to examine the associations with and barriers to HIV gynecological care, with the goal of creating appropriate interventions toward improving gynecological healthcare utilization among women enrolled in urban HIV clinics."
Tello and colleagues published their study in the Journal of Womens Health (HIV Women's Health: A Study of Gynecological Healthcare Service Utilization in a US Urban Clinic Population. Journal of Womens Health, 2008;17(10):1609-1614).
~News RX - 01/21/2009 | | | | (01/21) Sugar Molecule Can Protect Against HIV, Study Finds | A sugar molecule called the Pk blood group antigen might provide a defense against HIV, according to a study published last week in the journal Blood, Toronto's Globe and Mail reports. Researchers from Toronto's Hospital for Sick Children and Lund University in Sweden studied the sugar molecule, which is found on the surfaces of some red and white blood cells. They found that Pk antigens act as magnets for HIV, neutralizing the virus once it attaches to the antigen and stopping its spread to other immune cells, the Globe and Mail reports ...(continued)
~Kaiser Network - 01/21/2009 | | | | (01/21) Connecticut Theater Hosts Symposium, Play About HIV/AIDS for Medical, Scientific Communities | Long Wharf Theatre in New Haven, Conn., on Jan. 22 will host a one-day symposium about HIV/AIDS for members of the medical and scientific communities at Yale University and Yale-New Haven Hospital, as well as representatives from the pharmaceutical and biotechnology industries, the New York Times reports. A performance of Long Wharf's play "Coming Home" -- which tells the story of a young single mother dying from AIDS-related causes -- will follow the symposium. The symposium will begin with a panel of top researchers who work on HIV/AIDS, drug-resistant tuberculosis and other diseases, and a second panel will include representatives from drug companies involved in these research areas. Michael Fuchs, former HBO chair and producer of the 1993 HIV/AIDS film "And the Band Played On," will moderate a discussion following the play ...(continued)
~Kaiser Network - 01/21/2009 | | | | (01/16) UNICEF Report Examines Maternal, Child Health Worldwide, Including HIV/AIDS Issues | "State of the World's Children 2009," UNICEF: The annual report from UNICEF focuses on maternal and newborn health worldwide and finds that women in developing countries face a much higher risk of dying from pregnancy complications than women in industrialized nations. The report also found some progress in the fight against HIV/AIDS among pregnant women. Among women ages 15 to 24 accessing prenatal clinics, HIV prevalence has decreased in 14 of 17 countries in sub-Saharan Africa with adequate data since 2000 to 2001. In addition, 33% of HIV-positive pregnant women had access to antiretroviral drugs to prevent mother-to-child HIV transmission in 2007, compared with 10% in 2004 ("State of the World's Children," UNICEF, 1/15).
~Kaiser Network - 01/16/2009 | | | | (01/16) STAT-C Resistance | Researchers are studying several specifically targeted antiviral therapies for hepatitis C ("STAT-C"), including HCV protease inhibitors and polymerase inhibitors. While some candidates have produced good results to date, the drawback of this approach is the emergence of drug resistance. As reported in the December 2008 Hepatology (and also at the 2008 AASLD meeting), T. Kuntzen and colleagues analyzed naturally occurring resistance mutations in more than 500 treatment-naive genotype 1 hepatitis C patients in the U.S., Germany, and Switzerland ...(continued)
~HCV Advocate - 01/15/2009 | | | | (01/16) Liver Disease with Undetectable HCV RNA | People infected with HCV (as indicated by antibodies in the blood) who have an undetectable viral load are usually considered to have inactive disease, and undetectable HCV RNA six months after completion of treatment is regarded as a cure. But a study in the December 2008 Hepatology suggests hidden HCV may still cause liver disease progression. M. Hoare and colleagues studied 172 HCV antibody positive but HCV RNA negative individuals who underwent liver biopsies between 1992 and 2000. After 102 were excluded for having other possible causes of liver damage, the remaining 70 participants were analyzed after a median seven years of follow-up ...(continued)
~HCV Advocate - 01/15/2009 | | | | (01/15) Effect of Diet in People with HCV | Chronic hepatitis C is associated with various metabolic complications such as insulin resistance, but the effects of diet on liver fibrosis progression and response to treatment are not well-understood. As reported in the December 2008 American Journal of Gastroenterology, C. Loguercio and colleagues studied 1084 chronic hepatitis C patients – 432 of whom were treated with interferon-based therapy – and 2326 uninfected control subjects. At baseline, there were no differences between the two groups with regard to dietary habits, metabolic status, or alcohol consumption; about half were classified as overweight and about 60% reported drinking alcohol ...(continued)
~HCV Advocate - 01/15/2009 | | | | (01/15) Liver Transplant Allocation | Transplantation is the only treatment for end-stage liver failure, but suitable donor organs are in short supply. A new allocation scheme implemented in 2002 has improved racial disparities among transplant recipients, but women are still at a disadvantage, according to an analysis published in the November 26, 2008 Journal of the American Medical Association. C. Moylan and colleagues assessed the association between race, sex, and liver transplantation following introduction of the Model for End-Stage Liver Disease (MELD) system in February 2002 ...(continued)
~HCV Advocate - 01/15/2009 | | | | (01/14) Drug Abusing Offenders Not Getting Treatment They Need in Criminal Justice System | The vast majority of prisoners who could benefit from drug abuse treatment do not receive it, despite two decades of research that demonstrate its effectiveness, according to researchers at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. In a report published today in the Journal of the American Medical Association, NIDA scientists note that about half of all prisoners (including some sentenced to non-drug-related offenses) are dependent on drugs, yet less than 20 percent of inmates suffering from drug abuse or dependence receive formal treatment ...(continued)
~National Institutes of Health - 01/13/2009 | | | | (01/13) Research from S. Laperche and co-researchers provides new data on hepatitis B virus | According to a study from Paris, France, "To take into account the transient nature of hepatitis B virus (HBV) antigenemia, the calculation of HBV residual risk (RR), based on the incidence/window period model, is adjusted by a correction factor that adds uncertainty to the RR estimates. This new method to estimate the RR for HBV is a weighted sum of the RR derived from hepatitis B surface antigen (HBsAg) incident cases and the one derived from antibody hepatitis B core antigen (HBc) incident cases."
"An anti-HBc incident case was defined as a donation from a blood donor who had made at least one anti-HBc-negative donation followed by a donation that was found positive with two different assays within a 3-year period and positive for at least one of the following markers: 1) antibody to hepatitis B e antigen or hepatitis B e antigen, 2) anti-HBc immunoglobulin M, 3) HBV DNA, 4) hepatitis B surface antibody without HBV vaccination history, or 5) HBV DNA retrospectively found in the previous donation. Five overlapping 3-year study periods between 2000 and 2006 were analyzed. The HBV RR estimated with the classical method ranged from 1.51 (2000-2002) to 0.69 per million donations in 2004 through 2006 with a decrease in 2002 through 2004 due to only two HBsAg incident cases reported in this period. By applying the revised model, the HBV RR ranged from 1.06 (2000-2002) to 0.49 per million donations (2004-2006), with a regular decrease," wrote S. Laperche and colleagues.
~News RX.com - 01/12/2008 | | | | (01/13) MSF To Expand HIV/TB Coinfection Services in Swaziland Province | Medecins Sans Frontieres this month will assist three clinics in Swaziland's southern province of Shiselweni in providing services for people with HIV and tuberculosis coinfection, Inter Press Service reports. Aymeric Peguillan, MSF's head of mission in Swaziland, said the clinics will offer counseling, testing and treatment for both diseases because HIV and TB are "inseparable." He added that MSF intends to expand the program to include three more rural clinics within the next three months and hopes to work with all 19 clinics in the region by the end of 2009 ...(continued)
~Kaiser Network - 01/12/2009 | | | | (01/12) New findings reported from G. Likatavicius and co-authors describe advances in HIV/AIDS | Researchers in France conducted a study "To present HIV surveillance data on men who have sex with men (MSM) in the European Union (EU) and European Free Trade Association (EFTA) countries for the period 2000-6. Data from three sources, HIV reporting, AIDS reporting and HIV prevalence studies, were collated by EuroHIV and analysed for 27 EU and three EFTA countries."
"In 2006, 7693 newly diagnosed HIV infections among MSM were reported (56.7 per million men aged 15-64 years). In 23 countries with data for 2000-6, the number of new HIV diagnoses increased by 86% from 3003 to 5571. In 20 countries reporting individual HIV cases between 2000 and 2006, the median age at HIV diagnosis remained unchanged ( 36 years), whereas the proportion of MSM presenting with an AIDS-defining illness at the time of HIV diagnosis declined from 25% in 2000 to 10% in 2006 (chi(2) = 85.7, p< 0.001). In 30 countries reporting AIDS, incidence among MSM decreased by 40% from 2422 in 2000 to 1445 in 2006 and the number of deaths decreased by 57% from 876 to 373. Reported HIV prevalence ranged between 8% and 68% among MSM with sexually transmitted infections, between 10% and 18% among those recruited in community settings, but remained < 10% in central Europe and Ireland," wrote G. Likatavicius and colleagues.
The researchers concluded: "Whereas the decreasing rates of AIDS diagnoses and AIDS deaths reflect relatively good access to therapy, the increasing numbers of new HIV diagnoses and relatively high prevalence of HIV among MSM suggest the need for Europe-wide HIV prevention among MSM."
Likatavicius and colleagues published the results of their research in Sexually Transmitted Infections (An increase in newly diagnosed HIV cases reported among men who have sex with men in Europe, 2000-6: implications for a European public health strategy. Sexually Transmitted Infections, 2008;84(6):499-505).
| | | | (01/10) Treating Cystic Acne in Patients with HBV | How do I treat a 16-year-old boy who has cystic acne on the face and has had chronic hepatitis B with liver fibroses for 4 years? The hepatitis was treated 2 years ago with interferon but no topical treatment has been successful for the acne ...(continued)
~HCV Advocate - 01/10/2009 | | | | (01/09) ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients | Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced results from the first cohort of an ongoing Phase Ib clinical trial of ANA598, the Company's investigational non-nucleoside polymerase inhibitor. ANA598 was very well-tolerated and demonstrated potent antiviral activity in patients infected with chronic Hepatitis C virus (HCV) in this first cohort of the study ...(continued)
~HCV Advocate - 01/08/2009 | | | | (01/08) Gilead Sciences to Present at the 27th Annual JPMorgan Healthcare Conference on Monday, January 12 | FOSTER CITY, Calif.- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its corporate presentation will be webcast from the 27th Annual JPMorgan Healthcare Conference in San Francisco. John Martin, PhD, Gilead's Chairman and Chief Executive Officer, will provide an overview of the company on Monday, January 12 at 2:30 p.m. Pacific Time (5:30 p.m. Eastern Time). To access the live webcast via the internet log on to www.gilead.com. Please connect to the company's website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be necessary to listen to the webcast. Click for more info.
~Gilead Sciences - 01/07/2009 | | | | (01/07) ELAD(R) Liver Support System Study Initiated at Multiple U.S. Centers | Vital Therapies, Inc. (VTI), a development stage company targeting liver disease, today announced patient enrollment has begun for a randomized, controlled, multi-center, Phase 2 clinical trial that will study the Extracorporeal Liver Assist Device (ELAD) as a treatment for patients with Acute Liver Failure (ALF) under three protocols. The study is open for enrollment at seven U.S. sites, which will be expanded to 15 sites in the U.S. and Europe during the first half of 2009. Six patients have already been enrolled in the first protocol and four patients have been treated under the emergency use Expanded Access regulations ...(continued)
~HCV Advocate - 01/07/2009 | | | | (01/06) New research on HIV/AIDS from University of Washington summarized | "HIV dynamics in seminal plasma during primary HIV infection was evaluated through an observational study of individuals with primary HIV infection at the University of Washington Primary Infection Clinic. Seminal plasma HIV RNA was quantified using a real-time reverse transcription PCR assay," scientists in the United States report.
"Blood plasma RNA was quantified by bDNA or PCR-based assays. Longitudinal analyses of HIV RNA levels over time used random effects regression analysis. From 1993 to 2005, 110 men collected 327 semen specimens. Initial blood and seminal plasma RNA levels in untreated men were only moderately correlated (Spearman r = 0.38, p = 0.0002). Estimated peak and set point levels were lower in semen than blood by 0.8 (p = 0.001) and 0.7 (p = 0.001) log(10) copies/ml, respectively. RNA decay rates were similar in the two compartments (p = 0.4). For 2 months after infection, mean HIV RNA levels in seminal plasma remained above a threshold level (3.8 log(10) copies/ml) that has been associated with recovery of infectious virus in vitro. HIV-positive men are likely to be most infectious in the first months following HIV acquisition. However, the modest relationship between HIV RNA levels in blood and seminal plasma suggests that the relative risk of HIV transmission during primary infect! ion may vary from current estimates that are solely based on blood levels," wrote J. Stekler and colleagues, University of Washington.
The researchers concluded: "Incorporating seminal plasma HIV levels into future mathematical models may increase the accuracy of these models."
Stekler and colleagues published their study in AIDS Research and Human Retroviruses (HIV Dynamics in Seminal Plasma during Primary HIV Infection. AIDS Research and Human Retroviruses, 2008;24(10):1269-1274).
~News RX.com - 01/06/2009 | | | | (01/06) FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C | PLEASANTON, Calif., Dec. 31 /PRNewswire/ -- The United States Food & Drug Administration (FDA) today approved a new nucleic acid test from Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay. The test, called the cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative in vitro test for comprehensive single-assay detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, hepatitis C Virus RNA and hepatitis B Virus DNA in human plasma. The test, which is not intended for use as an aid in diagnosis, is designed to further increase the safety of blood supplies by identifying infections earlier than traditional serology tests ...(continued)
~Hepatitis B Foundation - 01/05/2009 | | | | (01/06) HIV-Positive Infants More Likely To Develop TB, Study Finds | HIV-positive infants are about 20 times more likely to develop tuberculosis than infants without HIV, according to a study recently published in the journal Clinical Infectious Diseases, Reuters/Yahoo! News reports. Researchers from the Desmond Tutu TB Center at Stellenbosch University in South Africa, led by Anneke Hesseling, analyzed the prevalence of HIV and TB among infants attending the hospital between 2004 and 2006. The researchers found that 245 infants were confirmed as having TB, and they estimated that the incidence of TB was 1,596 cases per 100,000 population among HIV-positive infants and 65.9 cases per 100,000 population among HIV-negative infants. The report said, "HIV-infected infants were at a 24.1-fold higher risk of pulmonary tuberculosis and a 17.1-fold higher risk of disseminated tuberculosis" ...(continued)
~Kaiser Network - 01/05/2009 | | | | (01/06) HealthWise: Cirrhosis | In the 1840’s, a French physician looked at a diseased liver and coined the word cirrhosis from the Greek kirrhos for tawny. A common myth is that cirrhosis is caused solely by alcoholism. Actually, there are many causes. Examples are hepatitis B, C, and D, fatty liver disease, excess iron, certain drugs and supplements, and other liver diseases ...(continued)
~HCV Advocate - 01/06/2009 | | | | (01/06) AASLD 2008—Drugs in Development: Part 2 | In last month’s HCV Advocate newsletter I wrote about many new drugs in development to treat hepatitis C that were presented at the American Association for the Study of Liver Diseases (AASLD) conference. The report included four studies on telaprevir as well as the results on boceprevir, nitazoxanide, R7128, and ITMN-191. This month I will report on studies of drugs that are in an earlier phase of clinical development: TMC435, BI 201335, PF-00868554, GI-5005 (a DNA based HCV vaccine) and farglitazar (anti-fibrotic) ...(continued)
~HCV Advocate - 01/06/2009 | | | | (01/06) Debate Over Mandatory HIV Testing Increases in Malaysia, New Cases Up Among Married Women | The Malaysian government plans to expand a rule requiring HIV screening for all couples, despite protests from HIV/AIDS experts and civil rights advocates who argue that such a policy does not prevent transmission of the virus and violates individual rights, Inter Press Service reports ...(continued)
~Kaiser Network - 01/06/2009 | | | | (01/06) Hepatitis A vaccine gives long-lasting protection | NEW YORK (Reuters Health) - Hepatitis A infections, usually transmitted via contaminated food, can cause debilitating illness, but protection afforded by the hepatitis A vaccine last more than a decade, a new study shows. In fact, antibodies against hepatitis A virus persist for up to 27 years after vaccination, report investigators from the Centers for Disease Control and Prevention in Atlanta and the Alaska Native Tribal Health Consortium in Anchorage ...(continued)
~HCV Advocate - 01/06/2009 | | | | (01/06) Development of hepatocellular carcinoma in a patient 13 years after sustained virological response to interferon against chronic hepatitis C: a case report | Although several recent reports have shown that hepatocellular carcinoma (HCC) developed in patients with chronic hepatitis C (CH-C) even after having a sustained virological response (SVR) to interferon (IFN) therapy, it is not common for HCC to develop more than 10 years after SVR. Case presentation – A 73-year-old Japanese man with CH-C who achieved SVR to IFN therapy 13 years ago was admitted into our hospital because of huge multiple liver tumors along with marked elevation of the tumor markers ...(continued)
~HCV Advocate - 01/05/2009 | | | | (01/06) A Dose of Reality | An increase in cases of hepatitis C among injecting drug users has led to calls to reverse the dramatic fall in needle exchanges. In terms of its public profile, hepatitis C is a poor relation of the HIV virus. However, an estimated 170 million people worldwide are infected with the blood-borne virus, and many of them have no idea they are walking around with it until years or even decades later. Twenty years after becoming infected, one in six people develop serious liver damage; after 30 years, the figure is nearly a quarter ...(continued)
~HCV Advocate - 01/05/2009 | | | | (01/06) First Candidate from SCYNEXIS Novel Cyclophilin Inhibitor Platform, SCY-635, Establishes Proof of Concept in HCV-Infected Adults | RESEARCH TRIANGLE PARK, N.C.- Drug discovery company, SCYNEXIS, Inc., today announced top-line results from a Phase 1b randomized, double-blind, placebo-controlled study of its lead oral antiviral drug candidate, SCY-635, in adult patients with chronic hepatitis C (HCV) infection. Treatment with SCY-635 was well tolerated and produced a clinically relevant reduction in plasma HCV RNA. Full results of the study will be presented in 2009. SCY-635, a cyclophilin inhibitor, represents a new class of drugs for the treatment of HCV infection and is the first candidate from a broad platform of proprietary cyclophilin inhibitors developed by SCYNEXIS ...(continued)
~HCV Advocate - 01/05/2009 | | | | (01/05) FDA Approves New HIV Blood Test That Screens Blood, Tissue Donations For Less Common Strains | FDA last week approved a new HIV test manufactured by a Roche subsidiary that screens for two less common forms of the virus in the U.S., in addition to the most common forms of HIV and hepatitis, the AP/Miami Herald reports. The test is designed to screen blood and tissue samples from donors for infectious diseases. According to FDA, the TaqScreen MPX Test is the first to be able to detect HIV-2 and HIV-1 Group O strains of the virus at the same time (AP/Miami Herald, 12/30/08). Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, said, "With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients" (Dooren, Dow Jones/Wall Street Journal, 12/30/08). According to the AP/Herald, the two HIV strains are most commonly found in Africa but have recently been detected by FDA in the U.S. (AP/Miami Herald, 12/30/08).
~Kaiser Network - 01/05/2009 | | | | (01/05) Maternal Neutralizing Antibodies Don't Prevent Hepatitis C Virus Transmission to Infants | In women co-infected with HIV and hepatitis C virus, levels of neutralizing antibodies (nAbs) to hepatitis C do not appear to have any direct relationship with the risk of mother-to-child transmission, researchers report in the December 1st issue of The Journal of Infectious Diseases ...(continued)
~HCV Advocate - 01/05/2009 | | |
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