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| |  Viramune, First Drug in Non-Nucleoside Class of Agents, Effective in 1st Year VANCOUVER, British Columbia, July 9, 1996 -- A triple combination therapy including VIRAMUNE (R)(nevirapine) demonstrated a sustained twelve month reduction in viral load below the limit of detection in Trial BI (Boehringer Ingelheim) 1046, which was presented today at the International AIDS Conference in Vancouver, British Columbia. This presentation updated the six month data that supported the recent accelerated approval of VIRAMUNE in the United States as the first drug in the non-nucleoside reverse transcriptase inhibitor class of compounds. VIRAMUNE has a different mechanism of action and a distinct side effect profile from other approved agents. "This study has shown that we do not have to use protease inhibitors to attain long-term suppression of the virus," said Dr. Julio Montaner of the Canadian HIV Trial Network and Program Co-Chair for the International AIDS Conference, and who presented these findings at a session on Antiretroviral Combination Therapy. Trial BI 1046, an international randomized, double-blind, placebo-controlled trial, investigated VIRAMUNE in previously untreated patients. The twelve month results from this study compared the combinations of AZT, ddI and VIRAMUNE; AZT and ddI; and AZT and VIRAMUNE in 151 HIV infected adults with entry CD4 counts between 200 and 600. "This trial showed a significant improvement in CD4 cell counts from triple over double therapy which tends to persist and is enhanced at the one year mark," said Dr. Montaner. "In addition, there was a profound and sustained effect on viral load, which was still present at one year. There is a substantial advantage of triple drug therapy to drive viral load below levels of detection." At the end of one year, the triple drug regimen using VIRAMUNE decreased the viral load below the limit of detection in over 50% of the patients, which was significantly greater than the two double therapy regimens. At present, there are no results from controlled clinical trials evaluating the effects of VIRAMUNE with nucleoside analogues on the clinical progression of HIV-1 infection, such as the incidence of opportunistic infections or survival. In the six month safety analysis, rash was the most important adverse event observed. Rash occurred in 28% of the patients in the triple therapy arm and in 13% of patients on ZDV and ddI. Most rashes were mild and easily managed. Seven percent of VIRAMUNE patients discontinued due to rash. The Food and Drug Administration on June 21 cleared VIRAMUNE for use in combination with nucleoside analogues for the treatment of HIV infected adults who have experienced clinical and/or immunoloic deterioration. VIRAMUNE is expected to be available in August. VIRAMUNE is a product of original research at Boehringer Ingelheim Pharmaceuticals, Inc., located in Ridgefield, Conn. In addition to Boehringer Ingelheim Pharmaceutical, two other affiliate companies of Boehringer Ingelheim Corporation (Ridgefield, Conn.) -- BI Chemicals, Inc. (Petersburg, VA) and Roxane Laboratories, Inc. (Columbus, Ohio) -- are collaborating in the introduction of VIRAMUNE. This collaboration capitalized on Boehringer Ingelheim Pharmaceuticals' extensive development and clinical capabilities, BI Chemicals' strength in the production of fine chemical substances, and Roxane Laboratories' experience in the HIV/AIDS arena. Boehringer Ingelheim Corporation is a member of the Boehringer Ingelheim worldwide group of companies, based in Ingelheim, Germany. A privately held company, founded in 1885, Boehringer Ingelheim is a major pharmaceutical, chemical, animal health, and bakery products manufacturer with operations in more than 100 countries around the world.
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