Objectives: To compare the safety and efficacy of the two single-tablet regimens (STRs), rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) and efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF), in HIV-1-infected, treatment-naive adults.
Design: This is a phase 3b, randomized, open-label, multicenter, international, 96-week study.
Methods: Participants were randomized 1 : 1 to receive either RPV/FTC/TDF or EFV/FTC/TDF. The primary endpoint was the proportion of participants with HIV-1 RNA less than 50 copies/ml at week 48 by the Snapshot algorithm.
Results: A total of 786 participants were randomized. RPV/FTC/TDF was noninferior to EFV/FTC/TDF (85.8 vs. 81.6%) at week 48 for HIV-1 RNA less than 50 copies/ml [difference 4.1%, 95% confidence interval (CI) −1.1 to 9.2%]. A statistically significant difference in efficacy favoring RPV/FTC/TDF was demonstrated for participants with baseline HIV-1 RNA 100 000 copies/ml or less [(n = 510) 88.8% RPV/FTC/TDF vs. 81.6% EFV/FTC/TDF (difference 7.2%, 95% CI 1.1–13.4%)]. In participants with baseline HIV-1 RNA more than 100 000 copies/ml (n = 276), RPV/FTC/TDF demonstrated noninferior efficacy compared with EFV/FTC/TDF (79.9 vs. 81.7%, respectively, difference −1.8%, 95% CI −11.1 to 7.5%). In the RPV/FTC/TDF arm, more virologic failure was observed as baseline HIV-1 RNA levels increased. There were more participants with emergent resistance in the RPV/FTC/TDF arm than in the EFV/FTC/TDF arm (4 vs. 1%, respectively). There were fewer discontinuations because of adverse events with RPV/FTC/TDF (2.5%) than with EFV/FTC/TDF (8.7%).
Conclusion: In treatment-naive participants, RPV/FTC/TDF demonstrated noninferior efficacy and improved tolerability compared with EFV/FTC/TDF, as well as a statistically significant difference in efficacy for participants with baseline HIV-1 RNA 100 000 copies/ml or less at week 48.
aCommunity Research Initiative of New England, Boston, Massachusetts
bUniversity of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
cHospital La Paz, Madrid, Spain
dHIV Program Hennepin County Medical Center, Minneapolis, Minnesota, USA
eUniversity Medical Center Hamburg-Eppendorf, Hamburg, Germany
fHoldsworth House Medical Practice, Darlinghurst, New South Wales, Australia
gDepartment of Infectious Disease, Kaiser Los Angeles Medical Center, Los Angeles, California, USA
hNorth Manchester General Hospital, Manchester, UK
iGilead Sciences, Foster City, California, USA.
Correspondence to Todd Fralich, MD, 333 Lakeside Drive, Foster City, CA 94404, USA. Tel: +1 650 524 3000; e-mail: firstname.lastname@example.org
Received 15 August, 2013
Revised 28 November, 2013
Accepted 28 November, 2013
Meetings at which parts of the data have been presented: Cohen C, Wohl D, J Arribas J, et al. STaR Study: single tablet regimen emtricitabine/rilpivirine/tenofovir DF is noninferior to efavirenz/emtricitabine/tenofovir DF in ART-naive adults; 11–15 November 2012; Glasgow, UK [abstract 0425].
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