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The efficacy of STRIBILD is based on the results from Study 103 and Study 102 – two randomized, double-blind, active-controlled trials in treatment-naive HIV-1 infected adults with baseline estimated creatinine clearance ≥70 mL/min.1 The primary endpoint of both noninferiority trials was the percentage of treatment-naive subjects with an HIV-1 viral load <50 copies/mL at week 48 using FDA snapshot analysis. Week 96 and week 144 analyses were secondary endpoints of the studies.1-3
In Study 103 (N=708), STRIBILD (n=353) was compared to ATV + RTV + FTC/TDF (n=355). The charts below show the primary endpoint data (snapshot analysis) and the intent-to-treat (ITT), missing = failure (M=F) analysis.
In Study 102 (N=700), STRIBILD (n=348) was compared to coformulated EFV/FTC/TDF (n=352).
STRIBILD is indicated as a complete single-tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive.
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