title: A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population.
abstract: BACKGROUND
  Although efavirenz is a universally recommended treatment for naive HIV-infected individuals, neuropsychiatric adverse events are common.
  
  
  METHODS
  The Study of Efavirenz NeuropSychiatric Events versus Etravirine (SENSE) trial is a double-blind, placebo-controlled study in which 157 treatment-naive individuals with HIV-RNA higher than 5000 copies/ml were randomized to etravirine 400 mg once daily (n = 79) or to efavirenz 600 mg once daily (n = 78), with two investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). The primary end point was the percentage of patients with grade 1-4 drug-related treatment-emergent neuropsychiatric adverse events up to week 12.
  
  
  RESULTS
  The study population were 81% men and 85% whites, with a median age of 36 years, baseline CD4 cell counts of 302 cells/μl and HIV-RNA of 4.8 log10 copies/ml. In the intent-to-treat analysis, 13 of 79 individuals (16.5%) in the etravirine arm and 36 of 78 individuals (46.2%) in the efavirenz arm showed at least one grade 1-4 drug-related treatment-emergent neuropsychiatric adverse event (P < 0.001). The number with at least one grade 2-4 drug-related treatment-emergent neuropsychiatric adverse event was four of 79 individuals (5.1%) in the etravirine arm and 13 of 78 individuals (16.7%) in the efavirenz arm (P = 0.019). The change in HIV-RNA to week 12 was -2.9 log10 in both treatment arms. The median rise in CD4 cell counts was 146 cells/μl in the etravirine arm and 121 cells/μl in the efavirenz arm.
  
  
  CONCLUSIONS
  After 12 weeks, first-line treatment with etravirine 400 mg once daily with two NRTIs was associated with significantly fewer neuropsychiatric adverse events when compared with efavirenz with two NRTIs. The virological and immunological efficacy profile was similar between the two arms.
authors.affiliation: St Stephens Centre, Chelsea and Westminster Hospital, London, UK. mark.nelson@chelwest.nhs.uk
authors.forename: Mark
authors.initials: M
authors.lastname: Nelson
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Stellbrink
authors.forename: Daniel
authors.initials: D
authors.lastname: Podzamczer
authors.forename: Dénes
authors.initials: D
authors.lastname: Banhegyi
authors.forename: Brian
authors.initials: B
authors.lastname: Gazzard
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
authors.forename: Yvon
authors.initials: Y
authors.lastname: van Delft
authors.forename: Johan
authors.initials: J
authors.lastname: Vingerhoets
authors.forename: Thomas
authors.initials: T
authors.lastname: Stark
authors.forename: Stephan
authors.initials: S
authors.lastname: Marks
mesh_terms: D000293:Adolescent; D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects*; D048588:Benzoxazines / Q000009:adverse effects*; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D009570:Nitriles; D011724:Pyridazines / Q000009:adverse effects*; D011743:Pyrimidines; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D009570:Nitriles; D011724:Pyridazines; D011743:Pyrimidines; C451734:etravirine; C098320:efavirenz