title: HIV Salvage Therapy Does Not Require Nucleoside Reverse Transcriptase Inhibitors: A Randomized, Controlled Trial.
abstract: BACKGROUND
  Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral regimens in treatment-experienced 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.
  
  
  METHODS
  Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT00537394).
  
  
  METHODS
  Outpatient HIV clinics.
  
  
  METHODS
  Treatment-experienced patients with HIV infection and viral resistance.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Unblinded study design, and the study may not be applicable to resource-poor settings.
  
  
  CONCLUSIONS
  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.
  National Institute of Allergy and Infectious Diseases, Boehringer Ingelheim, Janssen, Merck, ViiV Healthcare, Roche, and Monogram Biosciences (LabCorp).
authors.forename: Karen T
authors.initials: KT
authors.lastname: Tashima
authors.forename: Laura M
authors.initials: LM
authors.lastname: Smeaton
authors.forename: Carl J
authors.initials: CJ
authors.lastname: Fichtenbaum
authors.forename: Adriana
authors.initials: A
authors.lastname: Andrade
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.forename: Rajesh T
authors.initials: RT
authors.lastname: Gandhi
authors.forename: Victoria A
authors.initials: VA
authors.lastname: Johnson
authors.forename: Karin L
authors.initials: KL
authors.lastname: Klingman
authors.forename: Justin
authors.initials: J
authors.lastname: Ritz
authors.forename: Sally
authors.initials: S
authors.lastname: Hodder
authors.forename: Jorge L
authors.initials: JL
authors.lastname: Santana
authors.forename: Timothy
authors.initials: T
authors.lastname: Wilkin
authors.forename: Richard H
authors.initials: RH
authors.lastname: Haubrich
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination; D005260:Female; D006678:HIV / Q000235:genetics; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors