Week 48 results from a randomized clinical trial of rilpivirine/ emtricitabine/tenofovir disoproxil fumarate vs. efavirenz/emtricitabine/ tenofovir disoproxil fumarate in treatment-naive HIV-1-infected adults

Calvin Cohen, David Wohl, Jose R. Arribas, Keith Henry, Jan Van Lunzen, Mark Bloch, William Towner, Edmund Wilkins, Ramin Ebrahimi, Danielle Porter, Kirsten White, Ivan Walker, Susan Chuck, Shampa De-Oertel, Todd Fralich

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)989-997
Number of pages9
JournalAIDS
Volume28
Issue number7
DOIs
StatePublished - Apr 24 2014
Externally publishedYes

Keywords

  • HIV-1
  • antiretroviral therapy
  • efavirenz
  • rilpivirine
  • single-tablet regimens
  • treatment-naive

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