Rilpivirine vs. efavirenz-based single-tablet regimens in treatment-naive adults: Week 96 efficacy and safety from a randomized phase 3b study

Jan Van Lunzen, Andrea Antinori, Calvin J. Cohen, Jose R. Arribas, David A. Wohl, Armin Rieger, Anita Rachlis, Mark Bloch, Sorana Segal-Maurer, Will Garner, Danielle Porter, Matthew Bosse, David Piontkowsky, Susan K. Chuck, Shampa De-Oertel

Research output: Contribution to journalArticle

Abstract

Objectives: To compare efficacy, safety, tolerability, and patient-reported outcomes between two single-tablet regimens, rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) and efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF), in HIV-1-infected, treatment-naive adults. Design: This was a phase 3b, 96-week, randomized, open-label, international, noninferiority trial. Methods: A total of 799 participants were randomized (1: 1) to receive RPV/FTC/TDF or EFV/FTC/TDF. The primary efficacy endpoint evaluated proportions of participants with HIV-1 RNA less than 50 copies/ml using the Snapshot algorithm. Additional assessments included CD4 cell counts, genotypic/phenotypic resistance, adverse events, patient-reported outcomes, and quality of life questionnaires. Results: At week 96, trial completion rates were 80.2% (316/394; RPV/FTC/TDF) and 74.0% (290/392; EFV/FTC/TDF). Overall, RPV/FTC/TDF was noninferior to EFV/FTC/TDF [HIV-1 RNA

Original languageEnglish
Pages (from-to)251-259
Number of pages9
JournalAIDS (London, England)
Volume30
Issue number2
DOIs
Publication statusPublished - 2016

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

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    Van Lunzen, J., Antinori, A., Cohen, C. J., Arribas, J. R., Wohl, D. A., Rieger, A., Rachlis, A., Bloch, M., Segal-Maurer, S., Garner, W., Porter, D., Bosse, M., Piontkowsky, D., Chuck, S. K., & De-Oertel, S. (2016). Rilpivirine vs. efavirenz-based single-tablet regimens in treatment-naive adults: Week 96 efficacy and safety from a randomized phase 3b study. AIDS (London, England), 30(2), 251-259. https://doi.org/10.1097/QAD.0000000000000911