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This Week: Nelfinavir and Pregnancy; Erythromycin/PI Interaction; and More
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September 15, 2004
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| ANTIRETROVIRAL NEWS & RESEARCH |
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Nelfinavir Levels a Third Lower in Pregnant Women
Pregnancy appears to reduce nelfinavir (Viracept) plasma levels by a mean of 34%, according to a study conducted by Dutch researchers published in the Sep. 1 issue of Clinical Infectious Diseases. All but 1 of the 27 pregnant, HIV-infected women in the study still had undetectable viral loads despite the lower nelfinavir levels. The researchers recommended monitoring nelfinavir's levels in pregnant women and doubling the drug's dose if it falls below therapeutic levels.
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Some Reverse Transcriptase Mutations May Increase Susceptibility to Efavirenz-Based Regimens
Four reverse transcriptase mutations -- M41L, M184V, L210W and T215Y -- appear to transiently improve virological outcome in patients on efavirenz-based HAART regimens, according to the results of an Italian study published in the May 1 issue of the Journal of Infectious Diseases.
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New Developments in HIV Pharmacology
Mark Mascolini provides an informative and interesting recap of highlights from the 5th International Workshop on Clinical Pharmacology of HIV Therapy, which included research on new antiretrovirals and drug-drug interactions.
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Truvada May Lower Viral Load More Effectively Than Combivir, Preliminary Data Show
The newly approved, once-daily, fixed-dose combination drug tenofovir/emtricitabine (Truvada) appears to slow HIV progression more effectively than the twice-daily, fixed-dose combination drug zidovudine/lamivudine (Combivir), according to preliminary data released from a Phase III clinical study by Gilead, the maker of tenofovir/emtricitabine. When each drug was used in combination with efavirenz (Sustiva, Stocrin) in treatment-naive patients, tenofovir/emtricitabine reportedly reduced HIV viral loads to less than 400 copies/mL after 24 weeks in 88% of patients, compared with 80% of patients taking zidovudine/lamivudine. A spokesperson from GlaxoSmithKline, which produces zidovudine/lamivudine, countered that the study data was "far from conclusive."
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New Labeling Cites Efavirenz's Long-Term Durability in Naive Patients
The U.S. Food and Drug Administration (FDA) has approved new labeling for efavirenz (Sustiva, Stocrin) that describes data from a recent clinical trial showing that the drug is effective at suppressing HIV viral loads in patients who have taken an efavirenz-containing regimen for 3 years.
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HIV TREATMENT & PATIENT CARE |
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The Body Pro's AIDS 2004 Coverage Is Now Available in PDF (8.6MB)
The Body Pro is pleased to offer a PDF version of our XV International AIDS Conference coverage. This popular feature, which we offer following the conclusion of every major HIV conference, highlights 39 key studies presented in Bangkok, analyzed by The Body Pro's team of outstanding medical faculty.
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Of course, our PDF represents only a portion of our extensive coverage of AIDS 2004. For a searchable archive of key research disseminated within the conference center's presentation rooms, as well as multimedia coverage of important events that occurred outside of them, visit The Body Pro's AIDS 2004 home page!
One Quarter of U.S. Women Who Need HAART Don't Use It
One in 4 HIV-infected female patients who are clinically eligible to receive HAART report not using the therapy, according to an analysis of data from the U.S. Women's Interagency HIV Study. The likelihood of using HAART was lower if the woman was currently using recreational drugs, was not white or had reported experiencing physical or sexual abuse. "Childhood sexual abuse prevention, more intensive abuse treatment, and continuing drug treatment may enhance HIV disease treatment of women," the researchers concluded.
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Early Viral Load Testing After Starting HAART May Help Predict Treatment Success
A patient's viral load level, measured 1 month after beginning HAART, may predict whether the patient's viral load will be undetectable after 6 months of treatment, according to a study by British and German researchers. As a result, early viral load testing could help spot potential problems with a patient's regimen before complications emerge.
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Responses to HIV Treatment in Older Adults
HIV is increasingly becoming a disease of those over 50 in the United States, as HAART continues to prolong lives and HIV prevention fails to reach this population. However, an understanding of how older patients respond to treatment remains largely lacking. AIDS Community Research Initiative of America offers a brief review of what we know to date about the impact of age on antiretroviral therapy.
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Injection Drug Users Should Start HAART Earlier, Study Suggests
Injection drug users must initiate HAART earlier than HIV treatment guidelines currently indicate to ensure the same odds of survival as HIV-infected patients who do not use injection drugs, according to the results of a U.S. study appearing in the Sep. 15 issue of the Journal of Infectious Diseases. The study recommended that injection drug users should start treatment while their CD4+ cell count is still above 350.
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Total Lymphocyte Count May Be Effective, Low-Cost Surrogate for CD4+ Cell Count
In resource-limited settings where the cost of a CD4+ cell count is prohibitive, the total lymphocyte count may serve as an acceptable replacement in patients who have recently initiated HAART, according to a study conducted among 126 HIV-infected patients in Rhode Island.
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HIV/HAART-RELATED COMPLICATIONS |
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Coadministration of Erythromycin, PIs Sharply Increases Cardiac Risk
Concurrent use of the antibiotic erythromycin and drugs that inhibit its metabolization, including protease inhibitors (PIs), quintuples a patient's risk of sudden cardiac death, according to a new study published in the Sep. 9 issue of the New England Journal of Medicine. Use of erythromycin alone doubles a patient's risk of sudden cardiac death, the study found.
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Stroke Risk, Odds of Bypass Surgery Increase for Every Year on HAART
New results from the landmark D:A:D study show that HAART use may not only increase a patient's risk of myocardial infarction by 26% per year (as was reported last year), but that it may similarly increase the risk of stroke and the likelihood that a patient will require invasive heart surgery.
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New Hepatitis C Regimen May Cause Serious Ophthalmic Problems
Treatment with peginterferon alfa-2b (PEG-Intron) and ribavirin can cause potentially serious ophthalmic complications, including cotton wool spots, cataracts and reduced red-green color vision, in patients who are coinfected with HIV and hepatitis C, according to U.S. researchers. The researchers don't suggest avoiding the combination therapy, since they are unsure of the mechanism for the complications. However, they did recommend regular ophthalmologic eye exams for any patients taking the two drugs.
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Women and HIV in the Spotlight at AIDS 2004
The XV International AIDS Conference (AIDS 2004) may have been short on breaking treatment research, but it presented a significant amount of science regarding the impact of HIV on women. In this recap for The Hopkins HIV Report, Jean R. Anderson, M.D., highlights AIDS 2004 research regarding pregnancy, menopause and gender disparities in manifestations of opportunistic infections.
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Rosiglitazone Linked to Benign Tumors in HIV-Infected Patient With Lipodystrophy
Rosiglitazone (Avandia), a drug under investigation as a possible treatment for facial lipoatrophy in HIV-infected patients, may increase lipoma risk, according to a case report by U.S. physicians. Studies have thus far shown mixed results regarding the effectiveness of rosiglitazone in treating lipoatrophy, and much remains unknown about its potential adverse effects. This case report is based on observations of a single HIV-infected, male patient who had been using rosiglitazone for the past 2 years.
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New Antifungal Class Matches Fluconazole in Safety, Efficacy
Anidulafungin and micafungin, members of a new class of antifungals called echinocandins, are as safe and effective as fluconazole in treating esophageal candidiasis in HIV-infected patients, according to findings from a pair of studies published in the Sep. 15 issue of Clinical Infectious Diseases. These drugs are not yet approved in the United States or European Union.
This read the abstract for the micafungin study, click here. For the anidulafungin study, click here.
A Closer Look at HHV-8 and Kaposi's Sarcoma
Kaposi's sarcoma and the virus that causes it, human herpesvirus-8 (HHV-8), continue to affect HIV-infected patients well into the HAART era. In this highly informative, newly updated chapter from the HIV InSite Knowledge Base, Corey Casper, M.D., M.P.H., reviews the available epidemiological and virological research regarding the virus.
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Roche Applies for FDA Approval of Pegasys/Copegus Combo for HIV/HCV Patients
Roche has filed an application with the U.S. Food and Drug Administration (FDA) to market peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) as a combination therapy to treat patients coinfected with HIV and chronic hepatitis C (HCV).
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The Role of HIV in Fertility and Conception
More and more HIV-infected people want to have children. What is the impact of HIV on fertility, and how can serodiscordant couples safely conceive? In this report for the San Francisco AIDS Foundation, Shari Margolese examines these fertility-related issues, as well as the advancing knowledge regarding reproductive technologies that improve the chances of parenthood for HIV-infected or serodiscordant couples.
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Oral Candidiasis Signals Immunosuppression
Infection with oral candidiasis is significantly associated with a CD4+ cell count below 200 among HIV-infected Thai patients, and may act as an effective indicator of immunosuppression in lieu of CD4+ cell counts in limited-resource settings, according to the results of a study by Thai and U.S. researchers.
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MENTAL HEALTH & QUALITY OF LIFE |
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Women's Psychosocial Health Hasn't Improved in HAART Era, Study Finds
Psychosocial distress remains a problem for many HIV-infected women, despite the dramatic improvements in physical health brought about by the advent of HAART. Interviews with 74 HIV-infected women who are on HAART and living in New York revealed that psychosocial health has not significantly improved since 1994-1996. The study appears in the July 2004 issue of the American Journal of Public Health.
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Chronic Depression in HIV-Infected Women Linked to Increased Mortality Risk
HIV-infected women who met research criteria for chronic depression were 1.7 times as likely to die from AIDS-related complications as those who were not depressed, even after adjusting for other factors, according to research published in the July 2004 issue of the American Journal of Public Health. The research is an analysis of 7 years' worth of data from 1,716 participants in the U.S. Women's Interagency HIV Study.
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U.S. HIV TREATMENT POLICY |
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ADAP in Peril: A Long, Painful Decline
A growing number of low-income Americans with HIV are still being denied access to HIV treatment through AIDS Drug Assistance Programs (ADAPs), despite a federal infusion of emergency funding this summer. Sadly, the situation still appears to be worsening. How did we get to this point, and what can be done to rectify the situation? Fred Dillon, Deputy Director of Policy and Communications for San Francisco AIDS Foundation, offers this report.
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House Budget Would Keep Ryan White Funding Flat, Fund Drug Trials for Children
The U.S. House of Representatives has overwhelmingly approved a health, labor and education spending bill that would maintain "flat" funding for the Ryan White CARE Act but includes provisions that would fund clinical trials of generic drugs used by children. The Senate has yet to vote on its version of the spending bill.
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Mississippi Seeks Federal Funds to Assist Patients Dropped From Medicaid
Mississippi state health officials are attempting to obtain federal funds to subsidize prescription drug costs for HIV-infected patients and others who were dropped from the state's Medicaid program. Approximately 65,000 patients, an unknown number of whom are HIV infected, had been eligible for Medicaid under the state's "Poverty Level Aged and Disabled" category, but were dropped from the program last spring when the category was eliminated.
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U.S. HIV EPIDEMIOLOGY & PREVENTION |
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Prisons, Not Men on the "Down Low," Are Where the HIV Threat Lies
The U.S. public's overreaction to the HIV threat from men on the "down low" -- men in ostensibly committed heterosexual relationships who have sex with men on the sly -- has left us blind to a much more immediate problem, writes columnist Brent Staples in The New York Times. The problem? Unsafe sex between men in prisons, where inmates often become desperate for intimacy and condom access is far too limited. When these men reenter society, any new sexual partners they meet (or old partners they reunite with) pay the price of their risky behavior in prison. (Note: free registration at The New York Times is required to read this article)
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New U.S. Needle-Exchange Fund Announces $1M in Grants
The newly formed Syringe Access Fund announced its first round of grants aimed at supporting needle-exchange programs and policy activities to prevent the spread of HIV among injection drug users in the United States. The grants total $950,000 and were awarded to 20 organizations in California, Florida, New Jersey, New York, Texas and Washington, D.C.
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AIDS Vaccine Conference Concludes With Call for More Collaboration
Scientists at the conclusion of the AIDS VACCINE '04 conference in Lausanne, Switzerland, called for more collaboration in developing an HIV vaccine and said that such a vaccine is at least a decade away. Although scientists have learned about the structure of HIV and how the virus attacks the immune system, the "questions that have been answered are outnumbered by those that have not," said Emilio Emini, Senior President and Chief of Vaccine Development for the International AIDS Vaccine Initiative.
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U.S. Agency to Purchase $4M in OraQuick HIV Tests
OraSure Technologies, Inc. has announced that the U.S. Substance Abuse and Mental Health Services Administration will invest $4 million in purchasing its OraQuick Rapid HIV Antibody Tests and confirmatory test services, which will be deployed to more than 22,000 substance abuse treatment and prevention sites across the nation.
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Patient Education: Basic Questions About HIV/AIDS
Do you have patients or clients in need of basic information about HIV? This document from the U.S. Centers for Disease Control and Prevention offers ground-level responses to some of the most fundamental questions individuals are likely to have.
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PUBLIC ACCESS TO HIV RESEARCH |
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Top Journal Editors Demand Public Preregistration of All Published Studies
The International Committee of Medical Journal Editors (ICMJE) has announced that its member publications will refuse to publish research from drug companies' clinical trials unless the studies are part of a national registry accessible to the public at no charge -- "a step designed to ferret out unpublished studies that find medications to be ineffective or dangerous," the Washington Post reports. ICMJE consists of 12 publications, including the Journal of the American Medical Association, The Lancet, the New England Journal of Medicine and the U.S. National Library of Medicine.
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NIH Proposes Free Public Access to Research Its Funds
All scientists who receive U.S. National Institutes of Health (NIH) funding would be required to make their research results available to the public for free, under a new proposed policy posted on the NIH Web site. Patient advocates have been lobbying for the shift, but publishers claim the move could drive some journals out of business and bankrupt some scientific societies that use journal profits to fund their research and educational efforts.
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HIV/AIDS OUTSIDE THE U.S. |
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Vertical HIV Transmission: Focusing on the Mother as Well as the Child
Prevention of mother-to-child transmission (MTCT) of HIV is only a part of the ongoing efforts to ensure that families in the developing world remain whole and healthy despite the onslaught of the AIDS epidemic. In this interview done prior to the XV International AIDS Conference, Allan Rosenfield, M.D., the dean of Columbia University's Mailman School of Public Health, discusses the recent shift in the focus of MTCT programs.
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Community-Level Concerns Demand Focus of Anti-HIV Efforts
The clinical priorities in battling the global HIV pandemic are well known, but those priorities often fail to filter down to the community level, where other concerns can prevent those clinical priorities from being achieved. Gracia Violeta Ross of the International Community of Women Living With HIV/AIDS explains how gender disparities, underutilized youth power and stigma all play a pivotal role in the development of effective solutions to combat HIV.
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Japan Pledges US$890K to Help Launch HIV Prevention Program in Central Asia
The Japanese government has agreed to provide approximately US$890,000 to help fight HIV in the Central Asian nations of Kyrgyzstan, Tajikistan, Uzbekistan and Kazakhstan. The funds will be used to help launch a 5-year, $25 million project aimed at curbing the spread of HIV in the region and minimizing its economic and social impact.
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