title: Scaling up of highly active antiretroviral therapy in a rural district of Malawi: an effectiveness assessment.
abstract: BACKGROUND
  The recording of outcomes from large-scale, simplified HAART (highly active antiretroviral therapy) programmes in sub-Saharan Africa is critical. We aimed to assess the effectiveness of such a programme held by Médecins Sans Frontières (MSF) in the Chiradzulu district, Malawi.
  
  
  METHODS
  We scaled up and simplified HAART in this programme since August, 2002. We analysed survival indicators, CD4 count evolution, virological response, and adherence to treatment. We included adults who all started HAART 6 months or more before the analysis. HIV-1 RNA plasma viral load and self-reported adherence were assessed on a subsample of patients, and antiretroviral resistance mutations were analysed in plasma with viral loads greater than 1000 copies per mL. Analysis was by intention to treat.
  
  
  RESULTS
  Of the 1308 patients who were eligible, 827 (64%) were female, the median age was 34.9 years (IQR 29.9-41.0), and 1023 (78%) received d4T/3TC/NVP (stavudine, lamivudine, and nevirapine) as a fixed-dose combination. At baseline, 1266 individuals (97%) were HAART-naive, 357 (27%) were at WHO stage IV, 311 (33%) had a body-mass index of less than 18.5 kg/m2, and 208 (21%) had a CD4 count lower than 50 cells per muL. At follow-up (median 8.3 months, IQR 5.5-13.1), 967 (74%) were still on HAART, 243 (19%) had died, 91 (7%) were lost to follow-up, and seven (0.5%) discontinued treatment. Low body-mass index, WHO stage IV, male sex, and baseline CD4 count lower than 50 cells per muL were independent determinants of death in the first 6 months. At 12 months, the probability of individuals still in care was 0.76 (95% CI 0.73-0.78) and the median CD4 gain was 165 (IQR 67-259) cells per muL. In the cross-sectional survey (n=398), 334 (84%) had a viral load of less than 400 copies per mL. Of several indicators measuring adherence, self-reported poor adherence (<80%) in the past 4 days was the best predictor of detectable viral load (odds ratio 5.4, 95% CI 1.9-15.6).
  
  
  CONCLUSIONS
  These data show that large numbers of people can rapidly benefit from antiretroviral therapy in rural resource-poor settings and strongly supports the implementation of such large-scale simplified programmes in Africa.
authors.affiliation: Epicentre, Paris, France. msffr.comed@online.com.kh
authors.forename: Laurent
authors.initials: L
authors.lastname: Ferradini
authors.forename: Arnaud
authors.initials: A
authors.lastname: Jeannin
authors.forename: Loretxu
authors.initials: L
authors.lastname: Pinoges
authors.forename: Jacques
authors.initials: J
authors.lastname: Izopet
authors.forename: Didakus
authors.initials: D
authors.lastname: Odhiambo
authors.forename: Limangeni
authors.initials: L
authors.lastname: Mankhambo
authors.forename: Gloria
authors.initials: G
authors.lastname: Karungi
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Szumilin
authors.forename: Serge
authors.initials: S
authors.lastname: Balandine
authors.forename: Gaëlle
authors.initials: G
authors.lastname: Fedida
authors.forename: M Patrizia
authors.initials: MP
authors.lastname: Carrieri
authors.forename: Bruno
authors.initials: B
authors.lastname: Spire
authors.forename: Nathan
authors.initials: N
authors.lastname: Ford
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Tassie
authors.forename: Philippe J
authors.initials: PJ
authors.lastname: Guerin
authors.forename: Chris
authors.initials: C
authors.lastname: Brasher
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D003430:Cross-Sectional Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality; D006801:Humans; D008295:Malawi / Q000453:epidemiology; D008297:Male; D010349:Patient Compliance; D012423:Rural Health; D016896:Treatment Outcome; D019562:Viral Load