PHASE IIB STUDY SHOWS REVERSET HELPS HIV PATIENTS
Incyte announced positive results from Study 203, a six-month randomized double-blind Phase IIb trial, involving 199 patients and 25 clinical sites in the U.S. and Europe to evaluate the efficacy, dose response, safety and tolerability of Reverset in treatment-experienced human immunodeficiency virus (HIV) infected patients who are failing their current treatment regimens. Results from the first two stages of Study 203 presented today at the Third International AIDS Society (IAS) Conference on HIV Pathogenesis and Treatment, in Rio de Janeiro, suggest that the highest of three once-daily doses of Reverset provided the greatest antiviral suppression in these highly treatment-experienced patients who have a wide variety of HIV mutations.
The protocol for Study 203 was divided into three stages. The first two stages of the study were designed to evaluate three different doses of Reverset versus placebo at two different time points, at Week 2 and Week 16. The third stage of the trial, which begins at Week 16 and ends at Week 24, allows all placebo patients to crossover to receive either the 100- or 200-MG dose of Reverset, and permits an additional optimization of background therapy and allows for additional longer-term safety data.
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