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Experimental Drug Shows Promise In Combination With AZT and 3TC CAMBRIDGE, MA. -- October 14, 1997 -- Preliminary data from Vertex Pharmaceuticals Inc.’s Phase II study of 141W94 (VX-478) has shown the drug -- in comination with RetroviR (AZT) and EpiviR (3TC) -- to be generally well-tolerated and produced potent antiviral activity. In the triple combination study (141W94, AZT, 3TC), approximately 70 percent of patients had undetectable viral load at 12 weeks. The results of the Phase II study of 141W94 (VX-478), an HIV protease inhibitor currently in Phase III clinical trials, was presented at the Sixth European Conference on Clinical Aspects and Treatment of HIV-infection in Hamburg, Germany. "This study is the first of a series of data to be presented on 141W94 and support the favorable tolerability and antiviral profile of the compound," explained Dr. Vicki Sato, senior vice president of research and development and chief scientific officer of Vertex. "Additional 141W94 data from a number of treatment regimens is expected in the coming months." At the conference, Dr. Stephane de Wit of Saint-Pierre University Hospital in Brussels, Belgium, reported results from the Vanguard study, a pilot efficacy trial of three doses (900 mg, 1,050 mg and 1,200 mg, twice daily) of 141W94 in combination with RetrovirR and EpivirR. At 12 weeks, patients taking 141W94 at the highest dose plus RetrovirR and EpivirR had a median 2.65 log reduction in viral load (greater than 99.8 percent) from baseline as compared to a 1.33 log reduction for the control arm, RetrovirR and EpivirR. At 12 weeks, approximately 70 percent of patients across all 141W94 dose groups experienced drops in HIV viral load to below the limits of detection (400 copies HIV RNA/ml) for the assay used. The combination was generally well-tolerated with diarrhea, headache, nausea and rash being the most commonly reported adverse events for patients treated with these three drugs. 141W94, a second generation HIV protease inhibitor, was designed at Vertex Pharmaceuticals and is being developed by Glaxo Wellcome worldwide, outside of the Far East, and Kissei Pharmaceutical Co., Ltd. (Matsumoto-City, Japan) in the Far East. More information on: Vertex, Retrovir, Epivir E-mail this page to a friend or colleague! To print, use this version