title: Rilpivirine versus efavirenz in HIV-1-infected subjects receiving emtricitabine/tenofovir DF: pooled 96-week data from ECHO and THRIVE Studies.
abstract: OBJECTIVE
  Week 96 efficacy and safety of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (RPV) was compared to efavirenz (EFV) in subset of 1,096 subjects who received emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in pooled data from 2 phase 3 studies.
  
  
  METHODS
  ECHO and THRIVE are double-blind, double-dummy, randomized, active-controlled, non-inferiority phase 3 studies of RPV versus EFV plus 2 NRTIs in antiretroviral-naïve adult subjects. The primary and secondary endpoints were the proportion of subjects with HIV-1 RNA <50 copies/ mL using an intent-to-treat, time to loss of virologic response (ITT-TLOVR) analysis at weeks 48 and 96, respectively. Safety, tolerability, immunologic response, adherence level, and other measures were also evaluated.
  
  
  RESULTS
  At week 48, noninferior efficacy of RPV+FTC/TDF over EFV+FTC/TDF was established, and at week 96 RPV+FTC/TDF remained noninferior (77% overall response rate in both groups). Through week 96, rates of virologic failure were higher in the RPV+FTC/ TDF group, with low and similar rates of virologic failure and resistance mutations occurring during the second year of follow-up. Treatment with RPV+FTC/TDF was associated with a lower rate of discontinuation due to adverse events and grade 2-4 adverse events including dizziness, abnormal dreams/nightmares, rash, and lipid abnormalities.
  
  
  CONCLUSIONS
  The pooled ECHO and THRIVE studies demonstrated noninferiority of RPV+FTC/TDF in achieving virologic response with safety and tolerability advantages over EFV+FTC/TDF through 96 weeks. Higher rates of virologic failure in the RPV+FTC/TDF group were balanced with higher rates of discontinuations due to adverse events in the EFV+FTC/TDF group.
authors.affiliation: Chelsea and Westminster Hospital, London, UK SW10 9NH. mark.nelson@chelwest.nhs.uk
authors.forename: M R
authors.initials: MR
authors.lastname: Nelson
authors.forename: R A
authors.initials: RA
authors.lastname: Elion
authors.forename: C J
authors.initials: CJ
authors.lastname: Cohen
authors.forename: A
authors.initials: A
authors.lastname: Mills
authors.forename: S L
authors.initials: SL
authors.lastname: Hodder
authors.forename: S
authors.initials: S
authors.lastname: Segal-Maurer
authors.forename: M
authors.initials: M
authors.lastname: Bloch
authors.forename: W
authors.initials: W
authors.lastname: Garner
authors.forename: B
authors.initials: B
authors.lastname: Guyer
authors.forename: S
authors.initials: S
authors.lastname: Williams
authors.forename: S
authors.initials: S
authors.lastname: Chuck
authors.forename: S
authors.initials: S
authors.lastname: Vanveggel
authors.forename: H
authors.initials: H
authors.lastname: Deckx
authors.forename: M
authors.initials: M
authors.lastname: Stevens
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000293:Adolescent; D000328:Adult; D000368:Aged; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D048588:Benzoxazines / Q000008:administration & dosage; D003521:Cyclopropanes; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D054303:HIV Reverse Transcriptase / Q000037:antagonists & inhibitors; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage; D063065:Organophosphonates / Q000008:administration & dosage; D011743:Pyrimidines / Q000008:administration & dosage; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage; D000068696:Rilpivirine; D000068698:Tenofovir; D055815:Young Adult
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D009570:Nitriles; D063065:Organophosphonates; D011743:Pyrimidines; D018894:Reverse Transcriptase Inhibitors; D003841:Deoxycytidine; D000068698:Tenofovir; D054303:HIV Reverse Transcriptase; D000068696:Rilpivirine; D000068679:Emtricitabine; D000225:Adenine; C098320:efavirenz