-- The primary efficacy endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL at week 48, using an intent to treat noncompleter equals failure approach comparing once-daily and twice-daily groups. A secondary efficacy endpoint was mean change from baseline in CD4+ T-cell count.
-- The primary safety endpoint was the proportion of patients reporting a treatment-emergent adverse event of diarrhea during the first eight weeks of dosing. Additional safety analyses included the proportion of subjects reporting treatment-emergent adverse events, grade 3+ lab abnormalities, and mean changes from baseline for lab determinations through 48 weeks.
Primary Efficacy Results:
-- At week 48, the primary efficacy analysis showed that 77 percent of the once-daily-treated patients and 76 percent of the twice-daily treated patients achieved a viral load <50 copies/mL. The once-daily regimen was determined to be non-inferior to the twice-daily regimen.
-- Through week 48, 14.7 percent and 16.6 percent of the patients discontinued treatment on the once-daily and twice-daily regimens, respectively. A similar percentage of patients on the once-daily regimen discontinued due to adverse events, as on the twice-daily regimen (4.8 percent and 3 percent, respectively).
-- With respect to the comparison of the SGC to the tablet formulation through week eight, there were no statistically significant differences in the following areas: the number of patients discontinuing due to gastrointestinal adverse events or other adverse events; the incidence of treatment-emergent adverse events of diarrhea of any severity and of moderate or greater severity and related to the study drug; the proportion of patients with Grade 3+ lab abnormalities; or the mean change from baseline for total cholesterol or triglycerides at any time point during the first eight weeks of treatment.
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