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| |  ECCATH: Viramune (Nevirapine) Improves Lipoprotein Profile in HIV Positive Patients ATHENS, GREECE -- October 29, 2001 -- Findings from two studies presented at the 8th European Conference on Clinical Aspects and Treatment of HIV Infection (ECCATH) demonstrate that human immunodeficiency virus (HIV)-positive individuals taking a Viramune® (nevirapine)-based anti-HIV treatment combination were observed to have an improved lipoprotein profile. Researchers examined critical criteria, including increases in high-density lipoprotein (HDL) cholesterol, improvements in total cholesterol/HDL ratio and triglyceride levels. Viramune is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analysis of changes in surrogate end-points, such as viral load or CD4+ count. At present there are no results from controlled clinical trials evaluating the effect of Viramune in combination on the clinical progression of HIV-1 infection. Resistant virus emerges rapidly when Viramune is administered alone. Ninety-six week findings from the Fat Redistribution and Metabolic Sub-study (FRAMS) of the Atlantic trial showed that patients treated with Viramune, ddI and d4T achieved an improved lipoprotein profile. Specifically, after 96 weeks of treatment, patients in the Viramune arm demonstrated a 40 percent increase from baseline in HDL cholesterol and a decrease in the total cholesterol/HDL-cholesterol ratio. In contrast, patients receiving the protease inhibitor indinavir demonstrated significant increases in total and LDL-cholesterol, as well as an increase in the total/HDL-cholesterol ratio. The primary objective of this sub-study was to evaluate potential differences in patients' lipoprotein profile using three treatment strategies. The three study arms were d4T and ddI combined with Viramune, indinavir, or 3TC. Researchers evaluated 98 representative patients of the 298 participants enrolled in the Atlantic trial who remained on randomly allocated treatment for at least 96 weeks and who had HDL-cholesterol results available from both week zero and 96. In the Atlantic study, the most frequently observed adverse events related to Viramune treatment were rash, nausea, diarrhea and fatigue. Dr. Bonaventura Clotet of the Hospital Universitari Germans Trias i Pujol in Barcelona reported 12-month findings of an additional study at a conference satellite symposium. In this randomized, prospective, open label study, patients taking a protease inhibitor (PI)-based regimen either maintained PI therapy (n=26) or switched to a regimen containing the NNRTIs Viramune (n=26) or efavirenz (n=25). "We found that mean total and LDL cholesterol, as well as triglyceride levels, fell significantly in patients receiving Viramune, but were unchanged in the other two groups evaluated," said Dr. Clotet. All three regimens provided durable suppression of HIV-1 replication: 96 percent of patients receiving Viramune, 92 percent receiving efavirenz and 92 percent remaining on PI had plasma viral loads less than 80 copies/mL after 12 months of follow-up (post switch). The mean CD4+ cell count increased by 115 cells/mm3 in the Viramune group, 106 cells/mm3 in the efavirenz group and 67 CD4+ cells/mm3 in the PI group. Patients in the Viramune group achieved a significant mean decrease in total cholesterol (22 mg/dL), LDL cholesterol (11 mg/dL) and triglycerides (43 mg/dL), while no significant decreases were observed in the efavirenz or PI groups at 12 months. The treatment regimens were generally well tolerated. Six patients discontinued therapy due to treatment-related toxicities: one patient in the Viramune group due to liver toxicity; three patients in the efavirenz group due to central nervous system toxicity; and two patients in the PI group due to diarrhea and kidney toxicity (nephrolithiasis). SOURCE: Boehringer Ingelheim Pharmaceuticals, Inc. Related Links: Viramune (nevirapine) and Boehringer Ingelheim Pharmaceuticals, Inc.
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