title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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 100000  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 100000 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%).
  
  
  CONCLUSIONS
  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 100000  copies/ml or less at week 48.
authors: 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.
authors: Calvin
authors: C
authors: Cohen
authors: David
authors: D
authors: Wohl
authors: Jose R
authors: JR
authors: Arribas
authors: Keith
authors: K
authors: Henry
authors: Jan
authors: J
authors: Van Lunzen
authors: Mark
authors: M
authors: Bloch
authors: William
authors: W
authors: Towner
authors: Edmund
authors: E
authors: Wilkins
authors: Ramin
authors: R
authors: Ebrahimi
authors: Danielle
authors: D
authors: Porter
authors: Kirsten
authors: K
authors: White
authors: Ivan
authors: I
authors: Walker
authors: Susan
authors: S
authors: Chuck
authors: Shampa
authors: S
authors: De-Oertel
authors: Todd
authors: T
authors: Fralich
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D044966:Anti-Retroviral Agents; D012367:RNA, Viral