Research Initiative Treatment Action (RITA!); Vol 5, No. 3 July 1999
The year was 1983. After many of these things have been long forgotten, the MACS study has reached its fifteen-year mark, a milestone in the history of HIV. MACS began a study of over 5,000 homosexual and bisexual men in order to determine if, when, and why they would contract HIV. This study led to the development of physician guidelines for when to begin anti-retroviral therapy, when HIV might develop into full-blown AIDS (based on viral load and CD4 counts), and, in general, monitored the progression of the disease over the past fifteen years. MACS included 5,622 participants in four sites around the United States and has provided an invaluable body of data on HIV. Along with this data, MACS helped to identify the factors involved and the manner in which HIV is transmitted and has established a repository of biologic specimens which have been used by AIDS researchers nationwide.
According to Reuters, Abbott Laboratories, Inc. submitted an application for the approval of a soft-gel capsule formulation of its protease inhibitor ritonavir (Norvir) to the U.S. Food and Drug Administration in March 1999. This reformulation followed the discovery that the formation of an undesired crystalline structure was being produced in its capsules, affecting the manner in which the body metabolized the drug. Abbott made ritonavir available in liquid form so as not to disrupt the drug regimens of the roughly 60,000 patients who were taking the capsules. It is not known when the soft-gel capsule might be approved, although it is speculated that the capsules will be available as early as July 1999. Until then, liquid ritonavir will be available.
The Health Care Finance Administration (HCFA) reversed its decision allowing Medicaid to deny reimbursement for human growth hormone (Serostim), an anabolic (protein building) and anticatabolic (protein sparing) growth hormone. Human growth hormone, used to treat AIDS wasting, was previously classified by the HCFA as a cosmetic weight gain drug, giving states the option of refusing coverage regardless of its use to fight a life threatening condition. HCFA's reversal is effective February 1999 and all states are now required to reimburse the cost of human growth hormone.
Lamivudine (Epivir) is active against both HIV and hepatitis B virus (HBV). The May issue of Clinical Infectious Diseases reports that patients who are diagnosed with both HIV and HBV may have a flare up of HBV if lamivudine is discontinued or lamivudine resistance occurs. In a retrospective study of five dually-diagnosed patients initially treated with lamivudine who experienced HBV flares, two experienced this flare after being switched from an antiretroviral regimen that contained lamivudine to a highly active antiretroviral treatment that did not contain lamivudine. In one case, the patient's HBV flare improved after the reintroduction of lamivudine. The other patient died. The other three patients were still taking lamivudine when their HBV condition worsened, due to the likely occurrence of lamivudine resistance. It is not yet known which factors contribute to HBV flares in HIV infected individuals. More research into the natural course of the disease in people on highly active antiretroviral therapy is needed.
Pentafuside (T-20), Trimeris Inc.'s first HIV fusion inhibitor is still in phase II trials. The U.S. Food and Drug Administration has granted fast-track status to T-1249, Trimeris' second HIV fusion inhibitor. T-1249 is designed to block HIV from entering host cells. It has been highly effective in both animal studies and laboratory cultures and is predicted to be active against pentafuside resistant virus.
A study in the Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology concludes that HIV-infected individuals in "traditionally disadvantaged" communities are receiving sub-optimal treatment. The study included 1,034 HIV-infected subjects. After controlling for sociodemographic variables, the study found that those who were not taking protease inhibitors were, "most likely to be African American, non-English speaking, earning <$9600 US annually, and not college educated." The researchers found a high correlation between using protease inhibitors and being both college educated and having a sense of overall health.
Male patients with AIDS who have a pet are less likely to become depressed than patients without a pet. Researchers at the University of California Los Angeles School of Public Health evaluated the results of 1,872 surveyed subjects. The benefits of having a pet were mainly seen in AIDS patients who had few confidants and in those individuals who had strong attachments to their pets. The study, published in the April issue of AIDS Care, found that while being HIV positive does not influence one's psychological state, having AIDS does have an impact on depression. If safe pet handling methods are utilized when owning an animal, the personal benefits of pet ownership are strong, according to this study.
For over 20 years, the production and distribution of marijuana used for clinical research has been restricted, making it difficult for many non-federally funded researchers to obtain. This restrictive policy was overturned by the Clinton administration on May 21, 1999, making research-quality marijuana, grown by the government, available to private researchers, both scientists and physicians, who want to study the drugs medical benefits. The Institute of Medicine released a report in March stating that marijuana does have medical benefits and a panel of experts at the National Academy of Sciences did not find marijuana to be addictive or a gateway drug. Studies utilizing this drug will be strictly monitored by guidelines set out by The Department of Health and Human Services.
The Data Safety Monitoring Board (DSMB) of the Immune Response Corporation recently recommended the phase III trials of the HIV-1 immunogen (Remune) be ended. The DSMB noted that differences between the placebo and treatment groups were not observed and not likely to be observed in the near term. The phase III trials were designed to gauge the therapeutic effects of the HIV-1 immunogen when added to antiviral therapies. The increasing use of highly active antiretroviral therapies (HAART) may have contributed to a lack of showing of efficacy of the HIV-1 immunogen. A separate analysis of a cohort of 250 patients within the study showed a greater reduction of viral load and significantly greater increases in lymphocyte proliferation in those who added the HIV-1 immunogen to their underlying antiviral therapy compared to those who did not. The Immune Response Corporation, in collaboration with its new partner, Agouron Pharmaceuticals, Inc., is planning new pivotal clinical trials to address the question of whether adding the HIV-1 immunogen to HAART will extend the anti-HIV response induced by the latter.
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Copyright © 1999 - Research Initiative Treatment Action (RITA!). Reproduced with permission. RITA! is published by The Center for AIDS. Contact Thomas Gegeny, MS, ELS, Editor, RITA! for permission to reproduce RITA!. tom@centerforaids.org. http://www.centerforaids.org
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