HIV salvage therapy does not require Nucleoside reverse transcriptase inhibitors a randomized, controlled trial

Karen T. Tashima, Laura M. Smeaton, Carl J. Fichtenbaum, Adriana Andrade, Joseph J. Eron, Rajesh T. Gandhi, Victoria A. Johnson, Karin L. Klingman, Justin Ritz, Sally Hodder, Jorge L. Santana, Timothy Wilkin, Richard H. Haubrich, Evelyn Hogg, Katie Mollan, Kimberly Hollabaugh, Dave Rusin, Fred Sattler, Amy Sbrolla, Eric StetsLauren Petrella, Peter Piliero, Charles Walworth, Pamela Clax, David Anderson

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral regimens in treatmentexperienced patients in the absence of data from randomized trials. Objective: To compare treatment success between participants who omit versus those who add NRTIs to an optimized antiretroviral regimen of 3 or more agents. Design: Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT00537394) Setting: Outpatient HIV clinics. Participants: Treatment-experienced patients with HIV infection and viral resistance. Intervention: Open-label optimized regimens (not including NRTIs) were selected on the basis of treatment history and susceptibility testing. Participants were randomly assigned to omit or add NRTIs. Measurements: The primary efficacy outcome was regimen failure through 48 weeks using a noninferiority margin of 15%. The primary safety outcome was time to initial episode of a severe sign, symptom, or laboratory abnormality before discontinuation of NRTI assignment. Results: 360 participants were randomly assigned, and 93% completed a 48-week visit. The cumulative probability of regimen failure was 29.8% in the omit-NRTIs group versus 25.9% in the add-NRTIs group (difference, 3.2 percentage points [95% CI, - 6.1 to 12.5 percentage points]). No significant between-group differences were found in the primary safety end points or the proportion of participants with HIV RNA level less than 50 copies/mL. No deaths occurred in the omit-NRTIs group compared with 7 deaths in the add-NRTIs group. Limitation: Unblinded study design, and the study may not be applicable to resource-poor settings. Conclusion: Treatment-experienced patients with HIV infection starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. Primary Funding Sources: National Institute of Allergy and Infectious Diseases, Boehringer Ingelheim, Janssen, Merck, ViiV Healthcare, Roche, and Monogram Biosciences (LabCorp).

Original languageEnglish (US)
Pages (from-to)908-917
Number of pages10
JournalAnnals of internal medicine
Volume163
Issue number12
DOIs
StatePublished - Dec 15 2015

ASJC Scopus subject areas

  • Internal Medicine

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