Objective: To describe the safety and tolerability of zidovudine, lamivudine, and efavirenz in a low-income setting.
Design: 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/μl) 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).
Discussion: 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.
From the aAurum Institute for Health Research, Johannesburg, South Africa
bJohns Hopkins University School of Medicine, Baltimore, Maryland, USA
cLondon School of Hygiene and Tropical Medicine, London, UK
dCentre for AIDS Research in South Africa, University of Kwa-Zulu Natal, Kwa-Zulu Natal, South Africa.
Received 18 April, 2007
Revised 31 August, 2007
Accepted 7 September, 2007
Correspondence to Christopher J. Hoffmann, Johns Hopkins University School of Medicine, Division of Infectious Diseases, 1840 E. Monument St. Rm 401, Baltimore, MD 21205, USA. Tel: +1 410 502 2177; fax: +1 410 955 7889; e-mail: email@example.com