If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ICAAC: Results Show Agenerase Effective In AIDS Patients SAN FRANCISCO, CA. -- September 27, 1999 -- Forty-eight week results from a study comparing Agenerase™ (amprenavir) + Epivir® (lamivudine) + Retrovir® (zidovudine) to a placebo + Epivir + Retrovir were presented today at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Agenerase is an HIV protease inhibitor discovered at Vertex Pharmaceuticals and licensed for development to Glaxo Wellcome. This randomized, double-blind, Phase III clinical trial was conducted to assess the antiviral activity, safety and tolerability of Agenerase + Epivir + Retrovir over 48 weeks. Researchers randomized 232 HIV patients with no prior treatment experience to receive either Agenerase or a placebo twice-daily in combination with Epivir + Retrovir. "These data, together with the twice-daily dosing of Agenerase, support consideration of Agenerase in combination therapy," said W. David Hardy, M.D., Scientific Director of Research, Pacific Oaks Research, Beverly Hills, CA. This study of triple therapy with Agenerase + Epivir + Retrovir demonstrated a significant difference in the number of patients who achieved viral loads below the limit of detection of a standard assay (less than 400 copies; Roche Amplicor MONITOR™ assay; Version 1.0) between the two treatment arms. In the more conservative ‘intent-to-treat’ analysis where missing data are counted as failures at week 48, 41 percent of patients (n=48) in the Agenerase arm had viral load reductions to <400 copies/mL, versus 3 percent (n=3) in the placebo arm. In the ‘as treated’ comparison at week 48, 93 (n=50) percent of patients in the Agenerase arm achieved viral loads <400 copies/mL as compared to 42 percent (n=5) in the placebo arm. CD4 cell counts increased by over 100 cells in both arms (ITT as collected). Agenerase in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV RNA levels and CD4 cell counts in controlled studies up to 24 weeks in duration. At present, no results from controlled trials evaluating long-term suppression of HIV RNA or disease progression with Agenerase have been presented to the FDA for evaluation. In this study, nausea, vomiting, rash and circumoral parasthesia were more common in the treatment arm containing Agenerase. Most adverse events, including rash, were mild to moderate in intensity and few were treatment limiting. The incidence of laboratory abnormalities, including cholesterol, triglycerides and glucose was not statistically different between treatment arms. The safety of Agenerase was studied in over 1,400 adult patients. In patients receiving protease inhibitors, diabetes mellitus, hyperglycemia, acute hemolytic anemia and redistribution/accumulation of fat have been reported. Severe and life-threatening drug interactions could be associated with therapy with Agenerase (see full prescribing information for specific drug interactions). Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, have been associated with Agenerase. There have been reports of spontaneous bleeding in patients with hemophilia A and B treated with protease inhibitors. The majority of adverse events were of mild to moderate intensity, early to onset and transient in nature. The most frequently reported adverse events were nausea, diarrhea, vomiting, rash and perioral paresthesia.
|
