STAR Study: single tablet regimen emtricitabine/rilpivirine/tenofovir DF is non-inferior to efavirenz/emtricitabine/tenofovir DF in ART-naïve adults

Simplified antiretroviral treatment (ART) regimens improve quality of life and long-term medication adherence. Emtricitabine/rilpivirine/tenofovir DF (FTC/RPV/TDF) is a well-tolerated, once daily single tablet regimen (STR) treatment option. This is the first study to directly compare the safety and efficacy of the two STRs FTC/RPV/TDF and efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF) in treatment-naive adults. STaR is a randomized, open-label, multi-center, international, 96-week study to evaluate the safety and efficacy of the STR FTC/RPV/TDF compared to the STR EFV/FTC/TDF in treatment-naive HIV-1-infected subjects. Subjects were randomized 1:1 to FTC/RPV/TDF or EFV/FTC/TDF. Eligibility criteria included screening HIV-1 RNA ≥2,500 c/mL, genotypic sensitivity to EFV, FTC, TDF, and RPV, and no prior ARV therapy. Randomization was stratified by HIV-1 RNA level (≤100,000 c/mL or >100,000 c/mL) at screening. The primary endpoint was the proportion of subjects with HIV-1 RNA 100,000 c/mL (n=276), 80% FTC/RPV/TDF vs 82% EFV/FTC/TDF (difference -1.8%, 95% CI [-11.2%, 7.5%]). Overall, virologic failure, defined as HIV RNA ≥50 c/mL at Week 48, discontinuation due to lack of efficacy per investigator or discontinuation of study drug for reasons other than an adverse event (AE) with HIV RNA ≥50 copies/mL was 8% for FTC/RPV/TDF vs 6% for EFV/FTC/TDF (difference 2.7%, 95% CI [-0.9%, 6.3%]). There were fewer study drug discontinuations due to AEs in the FDA snapshot analysis in FTC/RPV/TDF (2%) compared to EFV/FTC/TDF (8%). The STR FTC/RPV/TDF demonstrated overall non-inferior efficacy and improved tolerability compared to the STR EFV/FTC/TDF as well as superior efficacy for subjects with a baseline viral load ≤100,000 c/mL in treatment-naive HIV-1-infected subjects. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Cohen C et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18221 http://www.jiasociety.org/index.php/jias/article/view/18221 | http://dx.doi.org/10.7448/IAS.15.6.18221