title: Quality of life in patients treated with first-line antiretroviral therapy containing nevirapine and/or efavirenz.
abstract: OBJECTIVE
  To assess whether differences in safety profiles between nevirapine (NVP) and efavirenz (EFV), as observed in the 2NN study, translated into differences in 'health related quality of life' (HRQoL).
  
  
  METHODS
  A sub-study of the 2NN study, with antiretroviral-naive patients randomly allocated to NVP (once or twice daily), EFV or NVP+EFV, in addition to stavudine and lamivudine.
  
  
  METHODS
  Comparing differences in changes of HRQoL over 48 weeks as measured with the Medical Outcomes Study HIV Health Survey (MOS-HIV) questionnaire, using analysis of variance.
  
  
  RESULTS
  The 2NN study enrolled 1216 patients. No validated questionnaires were available for 244 patients, and 55 patients had no HRQoL data at all, leaving 917 patients eligible for this sub-study. A total of 471 (51%) had HRQoL measurements both at baseline and week 48. The majority (69%) of patients without HRQoL measurements did, however, complete the study. The change in the physical health score (PHS) was 3.9 for NVP, 3.4 for EFV and 2.4 for NVP+EFV (P=0.712). For the mental health score (MHS) these values were 6.1, 7.0 and 3.9, respectively (P=0.098). A baseline plasma HIV-1 RNA concentration (pVL) > or = 100,000 copies/ml and a decline in pVL (per log10) were independently associated with an increase of PHS. An increase of MHS was only associated with pVL decline. Patients experiencing an adverse event during follow-up had a comparable change in PHS but a significantly smaller change in MHS, compared with those without an adverse event.
  
  
  CONCLUSIONS
  First-line ART containing NVP and/or EFV leads to an improvement in HRQoL. The gain in HRQoL was similar for NVP and EFV, but slightly lower for the combination of these drugs.
authors.affiliation: Department of Internal Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. f.vanleth@iatec.com
authors.forename: Frank
authors.initials: F
authors.lastname: van Leth
authors.forename: Brian
authors.initials: B
authors.lastname: Conway
authors.forename: Hector
authors.initials: H
authors.lastname: Laplumé
authors.forename: Des
authors.initials: D
authors.lastname: Martin
authors.forename: Martin
authors.initials: M
authors.lastname: Fisher
authors.forename: Ante
authors.initials: A
authors.lastname: Jelaska
authors.forename: Ferdinand W
authors.initials: FW
authors.lastname: Wit
authors.forename: Joep M A
authors.initials: JM
authors.lastname: Lange
mesh_terms: D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D048588:Benzoxazines; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D019829:Nevirapine / Q000627:therapeutic use*; D010078:Oxazines / Q000627:therapeutic use*; D011788:Quality of Life; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D010078:Oxazines; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; C098320:efavirenz