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| |  Epivir + Retrovir: Widely Used to Combat HIV RESEARCH TRIANGLE PARK, N.C., July 3, 1996 -- Glaxo Wellcome today issued the following: Epivir(R) (lamivudine; 3TC) + Retrovir(R) (zidovudine; AZT), a widely used combination of antiretroviral drugs to combat the human immunodeficiency virus (HIV), has also emerged as a widely used foundation for three-drug combination studies. Epivir was released under the accelerated approval regulations by the U.S. Food and Drug Administration in November of 1995 for use in combination with Retrovir for the treatment of HIV and AIDS. The clearance by the FDA was based on the combination's effect in clinical trials on the surrogate markers of HIV disease (CD4 cell counts; viral load). Prior to being cleared for marketing, Epivir was being provided at no charge to approximately 30,000 patients in the U.S. through the largest expanded access program ever undertaken for an HIV compound. In clinical trials, the combination of Epivir + Retrovir demonstrated superior antiviral activity when compared to Retrovir alone while not significantly increasing the toxicity associated with treatment with Retrovir alone. In addition, data from these pivotal trials suggest a unique resistance profile for this combination. Data from a small number of patients suggest that Epivir may delay the development of viral resistance to Retrovir in patients with no previous treatment history, while possibly reversing resistance to Retrovir in a small number of patients who had received extensive prior therapy with Retrovir. However, strains of HIV resistant to both Epivir and Retrovir have been seen. This resistance information is not yet fully understood and continues to be studied in ongoing trials. Recently reported data regarding combinations of Epivir + Retrovir with a protease inhibitor have resulted in some of the more dramatic results seen to date on surrogate markers of HIV. For example, 20 of 22 patients in a study who received the combination of Epivir + Retrovir + Crixivan (indinavir; Merck protease inhibitor) had the amount of HIV in their blood fall below the levels that can be detected through currently available tests. These patients also experienced average increases of approximately 100 CD4 cells at the conclusion of the 24-week study. The effects of Epivir + Retrovir, or Epivir + Retrovir + Crixivan, on the clinical outcomes of HIV (i.e., disease progression or survival) are unknown, although trials to determine such an effect are underway for each combination. Data on these combinations to date have focused entirely on their effects on surrogate markers of HIV disease. The clinical significance of reductions in viral load has not yet been clearly established. There are at least 11 ongoing triple combinations being studied in clinical trials which use Epivir + Retrovir as the two-drug foundation to which a third drug is added. These studies include adding protease inhibitors, nucleoside (analogue) reverse transcriptase inhibitors, and non-nucleoside reverse transcriptase inhibitors to Epivir + Retrovir. Early results from many of these studies will be presented at the XI International Conference on AIDS in Vancouver, July 7-12. Epivir + Retrovir was generally well tolerated in clinical trials, with the most commonly reported side effects including headache (35%), nausea (33%), malaise and fatigue (27%), nasal congestion and runny nose (20%), diarrhea (18%), low white blood cell counts (7.2%) and anemia (2.7%). In addition, pancreatitis was observed in 15 percent of pediatric patients in clinical trials, especially in children who had received prior nucleoside analogue therapy. Glaxo Wellcome (NYSE: GLX) is a world leader in developing new treatments for HIV disease and AIDS. In 1987, Retrovir became the first drug to be released by the FDA for use in treating HIV and AIDS. In November of 1995, Epivir was released under the FDA's accelerated approval regulations for use in combination with Retrovir. In addition, Glaxo Wellcome discovered, developed and markets several products for the treatment of HIV-related opportunistic infections. CONTACT: Ramona Jones of Glaxo Wellcome, 919-483-2839 (GLX)
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