title: Antiretroviral therapy using zidovudine, lamivudine, and efavirenz in South Africa: tolerability and clinical events.
abstract: OBJECTIVE
  To describe the safety and tolerability of zidovudine, lamivudine, and efavirenz in a low-income setting.
  
  
  METHODS
  We conducted a prospective cohort study in a workplace HAART programme in South Africa, which uses a first-line regimen of efavirenz, zidovudine, and lamivudine and provides routine clinical and laboratory monitoring 6-monthly pre-HAART and at 2, 6, 12, 24, 36, 48 weeks during HAART.
  
  
  METHODS
  We assessed the incidence of specified clinical and laboratory events (AIDS Clinical Trials Group grade 3 or higher) and associated regimen changes, hospitalizations, and deaths one year before HAART initiation and one year on-HAART using person-year analysis.
  
  
  RESULTS
  Between November 2002 and October 2005, 853 subjects (98% male, median age 40 years, and median CD4 cell count at HAART initiation 186 cells/mul) met enrollment criteria. The incidence of events on-HAART was higher than pre-HAART for neutropenia and nausea/vomiting. Dizziness was common early after HAART initiation (not evaluated pre-HAART). Of those with neutropenia, 88% had no apparent clinical consequences. The incidence of anemia, hepatotoxicity, peripheral neuropathy, and rash was similar or higher pre-HAART than on-HAART. Mean hemoglobin rose during the time on-HAART and was higher at 24 and 48 weeks than at baseline (P < 0.001).
  
  
  CONCLUSIONS
  This regimen was well tolerated with a short-term increase in neutropenia, nausea, and probably neurocerebellar events. Most significantly, in contrast to reports from high-income countries, we observed a long-term improvement in the hemoglobin concentration.
authors: Aurum Institute for Health Research, Johannesburg, South Africa. choffmann@jhmi.edu
authors: Christopher J
authors: CJ
authors: Hoffmann
authors: Katherine L
authors: KL
authors: Fielding
authors: Salome
authors: S
authors: Charalambous
authors: Mark S
authors: MS
authors: Sulkowski
authors: Craig
authors: C
authors: Innes
authors: Chloe L
authors: CL
authors: Thio
authors: Richard E
authors: RE
authors: Chaisson
authors: Gavin J
authors: GJ
authors: Churchyard
authors: Alison D
authors: AD
authors: Grant
mesh_terms: D000328:Adult; D000480:Alkynes; D000740:Anemia; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines / Q000627:therapeutic use*; D015331:Cohort Studies; D003521:Cyclopropanes; D003906:Developing Countries; D004244:Dizziness / Q000139:chemically induced; D004361:Drug Tolerance; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D013019:South Africa; D016896:Treatment Outcome; D019562:Viral Load; D014839:Vomiting / Q000139:chemically induced; D015215:Zidovudine / Q000627:therapeutic use*
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D019259:Lamivudine; D015215:Zidovudine; C098320:efavirenz