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| |  DRUG RESISTANCE MEETING: Epivir Remains Active Against HIV With Common Resistance Mutation LAVAL, QC -- June 25, 1999 -- BioChem Pharma Inc. announced that results from an analysis of five HIV clinical trials suggest that Epivir® (lamivudine), also known as 3TC®, continues to have antiviral activity in HIV patients whose virus develops a mutation associated with reduced susceptibility to nucleoside reverse transcriptase inhibitors (NRTIs). The analysis was presented yesterday (June 24) at the Third International Workshop on HIV Drug Resistance and Treatment Strategies in San Diego by Joep Lange, M.D., Director, National AIDS Treatment Evaluation Center, Amsterdam. The analysis included data from five trials - AMC, AVANTI-2, AVANTI-3, CNA 3003 and CNA 3009 - in which patients received initial treatment with one of two NRTI combinations: Epivir+Retrovir®(zidovudine) or Epivir+d4T (Zerit® (stavudine); Bristol-Myers Squibb). Dual combination treatment continued for a period of 12 to 48 weeks, depending upon the study. At that time, 92 percent of patients (166/181) exhibited the M184V mutation, commonly associated with marked reductions in susceptibility to lamivudine. Despite the emergence of this mutation, there was a marked, maintained reduction in HIV RNA levels ("viral load") among patients in all five trials following the addition of a third NRTI or protease inhibitor to the Epivir-containing regimen. In the AMC study, for example, which had a median baseline viral load of 4.9 log, 83 percent of patients (30/36) had HIV RNA levels below 50 copies/mL (Roche Ultrasensitive Assay) 24 weeks after adding the protease inhibitor indinavir (Crixivan ®; Merck & Co., Inc.) to their Epivir-based combination. “The data presented demonstrates that combination therapies which contain 3TC/Epivir remain potent and continue to suppress HIV even in the presence of 3TC/Epivir resistant mutants. Resistance to drugs is one of the most significant challenges in HIV/AIDS therapy. The results demonstrating that 3TC/Epivir continues to show antiviral activity are very encouraging,” said Dr. Gervais Dionne, Executive Vice President, Research and Development, BioChem Pharma. Viral resistance testing is used increasingly by physicians to detect mutations and help decide whether a patient should switch to a new treatment combination. “As genotypic resistance testing becomes a common tool used to build and adjust HIV regimens, it is important to understand the full implications of different viral mutations,” said Dr. Lange. “The mere presence of a mutation identified by genotypic testing does not mean that a drug is no longer helping at all. This analysis will help physicians to identify which drugs can be added or retained as part of combination therapy, and shows the need for further clinical studies of the M184V mutation.” In three other trials (AVANTI-2, AVANTI-3 and CNA 3003), after 36 to 48 weeks of follow-up, there was no clear difference in the percentage of patients with HIV RNA levels below 50 copies/mL at weeks 36-48 between those receiving initial treatment with tree drugs versus those receiving Epivir+Retrovir initially, followed by the addition of a third drug. However the trials were not statistically powered for this comparison. In clinical trials in HIV, Epivir was generally well tolerated, with the most commonly reported side effects including headache, nausea, malaise and fatigue, nasal congestion and runny nose, and diarrhea. Under agreement, BioChem Pharma receives royalties from Glaxo Wellcome on sales of its discovery lamivudine for use in both HIV/AIDS (3TC/Epivir/Combivir) and HBV (Zeffix/Epivir-HBV). Glaxo Wellcome has the right to develop, manufacture and sell lamivudine worldwide, except in Canada, where BioChem Pharma and Glaxo Wellcome have formed a commercialization partnership.
Related Links: Epivir, BioChem Pharma
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