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A Cohort Study

Lara R. Fairall, PhD; Max O. Bachmann, PhD; Goedele M. C. Louwagie, MD; Cloete van Vuuren, MD; Perpetual Chikobvu, PhD; Dewald Steyn, MD; Gillian H. Staniland; Venessa Timmerman, MSc; Mpumelelo Msimanga, MSc; Chris J. Seebregts, PhD; Andrew Boulle, MSc; Ralph Nhiwatiwa, MD; Eric D. Bateman, MD; Merrick F. Zwarenstein, MSc; Ronald D. Chapman, MD

Arch Intern Med. 2008;168(1):86-93.

Background  The effectiveness of the South African government's expanding antiretroviral treatment program is unknown. Observational studies of treatment effectiveness are prone to selection bias, rarely compare patients receiving antiretroviral treatment with similar patients not receiving antiretroviral treatment, and underestimate mortality rates unless patients are actively followed up.

Methods  We followed up 14 267 patients in the Public Sector Anti-Retroviral Treatment project in Free State, South Africa, for up to 20 months after enrollment. A total of 3619 patients received highly active triple antiretroviral treatment (HAART) for up to 19 months (median, 6 months; interquartile range, 3-9 months) after enrollment. Patients' clinical data were linked with the national mortality register. Marginal structural regression models adjusted for baseline and time-varying covariates.

Results  Of 4570 patients followed up for at least 1 year, 53.2% died. Eighty-seven percent of patients who died had not received HAART. HAART was associated with lower mortality (hazard ratio, 0.14; 95% confidence interval [CI], 0.11-0.18) and with the presence of tuberculosis (hazard ratio, 0.61; 95% CI, 0.46-0.81) after adjusting for age, sex, weight, clinic, district, CD4 cell count, cotrimoxazole therapy, tuberculosis at baseline, and previous antiretroviral therapy. Cotrimoxazole therapy was associated with lower mortality (hazard ratio, 0.37; 95% CI, 0.32-0.42). Each month of HAART was associated with an increase in CD4 cell count of 15.1 cells/µL (95% CI, 14.7-15.5 cells/µL) and with an increase in body weight of 602 g (95% CI, 548-658 g).

Conclusions  HAART provided through these South African government health services seems as effective as that provided in high-income countries. Delays starting HAART contributed to high mortality rates. Faster expansion and timely commencement of HAART are needed.

Author Affiliations: Knowledge Translation Unit, University of Cape Town Lung Institute (Dr Fairall), Infectious Disease Epidemiology Unit, School of Public Health and Family Medicine (Dr Boulle), and Department of Medicine (Dr Bateman), University of Cape Town, and Biomedical Informatics Research Division, Medical Research Council (Mss Staniland and Timmerman, Mr Msimanga, and Dr Seebregts), Cape Town, and Department of Community Health, Faculty of Health Sciences (Drs Louwagie and Chikobvu), and Division of Infectious Diseases, Department of Internal Medicine (Drs van Vuuren, Steyn, and Nhiwatiwa), University of the Free State, and Free State Department of Health (Dr Chapman), Bloemfontein, South Africa; Health Services Research, School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, England (Dr Bachmann); and Li Ka Shing Knowledge Institute, St Michaels Hospital, and Department of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada (Dr Zwarenstein).