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| |  Zerit (Stavudine) Once-Daily Extended Release Appears Comparable to Zerit Immediate Release PRINCETON, NJ -- March 1, 2002 -- Data presented this week at a major human immunodeficiency (HIV) medical meeting suggest that the investigational one-capsule, once-daily extended release formulation of Bristol-Myers Squibb's anti-HIV drug Zerit™® (stavudine) had similar virologic activity to the currently approved immediate release formulation of Zerit through 24 weeks of combination HIV treatment. Based on a virologic response treated analysis (ITT analysis for treated subjects), data from BMS Study 099 show that 80 percent (n=392) of patients in the arm containing Zerit extended release + Sustiva® (efavirenz) + Epivir® (3TC) achieved viral load suppression below 400 copies/mL after 24 weeks of treatment compared to 82 percent (n=391) in the arm containing Zerit immediate release + Sustiva +Epivir (extended release-immediate release difference, -1.5, 95% CI -7.0, 4.0). After the same period of time, 55 percent in each arm achieved a viral load of less than 50 copies/ml (extended release-immediate release difference, 0.3, 95% CI -6.6, 7.3). "We are encouraged by the results of this potential once-a-day formulation of Zerit," said Richard Pollard, MD, Professor of Internal Medicine, UC Davis Medical Center, University of California, Davis, Sacramento, California. "One of the goals of HIV treatment is to create regimens that are powerful, yet convenient for the patient to take." Additionally, a mean change of -2.79 log10 copies/ml in HIV RNA was observed through 24 weeks in both study arms. The mean increase in CD4 cell count observed at week 24 was 142 cells/mm3 in the Zerit extended release arm and 136 cells/mm3 in the Zerit immediate release arm. BMS Study 099 is a Phase III multinational, prospective, randomised, double-blind, placebo-controlled study to evaluate the antiviral activity, safety and tolerability of Zerit extended release compared to Zerit immediate release when used in combination with Sustiva (a non nucleoside reverse transcriptase inhibitor, or NNRTI) and 3TC (a NRTI) in antiretroviral naive patients at 24 and 48 weeks. Median plasma HIV-RNA at baseline was 4.8 log10 copies/ml in both the extended release and immediate release arms and the median CD4 cell count was 285 cells/mm3 in the extended release arm and 272 cells/mm3 in the immediate release arm. All patients enrolled in the trial received 600 mg of Sustiva once-daily and 150 mg of 3TC twice-daily. In the extended release arm, patients received 100 mg of Zerit extended release once-daily if the patient's weight was greater than 60 kg or 75 mg if the weight was less than 60 kg. Patients also received Zerit immediate release placebo twice-daily. In the immediate release arm, patients received 40 mg of Zerit immediate release twice-daily if the patient's weight was greater than 60 kg or 30 mg twice-daily if the weight was less than 60 kg. Additionally, patients received Zerit extended release placebo once-daily. Discontinuations were similar in the Zerit extended release (9 percent, 36/392) and Zerit immediate release arms (10 percent, 40/391). Of these discontinuations, 12/36 in the Zerit extended release arm were for adverse events compared to 9/40 in the Zerit immediate release arm. The safety and tolerability profiles of both study arms in BMS Study 099 are consistent with what has been reported in previous clinical trials using Zerit immediate release, Sustiva and 3TC. The company submitted a NDA filing for the extended release formulation of Zerit to the United States Food and Drug Administration (FDA) in December of 2001. SOURCE: Bristol-Myers Squibb
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