Objectives: To compare treatment outcomes by starting CD4 cell counts using data from the Comprehensive International Program of Research on AIDS-South Africa trial.
Design: An observational cohort study.
Methods: Patients presenting to primary care clinics with CD4 cell counts below 350 cells/μl were randomized to either doctor or nurse-managed HIV care and followed for at least 2 years after antiretroviral therapy (ART) initiation. Clinical and laboratory outcomes were compared by baseline CD4 cell counts.
Results: Eight hundred and twelve patients were followed for a median of 27.5 months and 36% initiated ART with a CD4 cell count above 200 cells/μl. Although 10% of patients failed virologically, the risk was nearly double among those with a CD4 cell count of 200 cells/μl or less vs. above 200 cells/μl (12.2 vs. 6.8%). Twenty-one deaths occurred, with a five-fold increased risk for the low CD4 cell count group (3.7 vs. 0.7%). After adjustment, those with a CD4 cell count of 200 cells/μl had twice the risk of death/virologic failure [hazard ratio 1.9; 95% confidence interval (CI), 1.1–3.3] and twice the risk of incident tuberculosis (hazard ratio 1.90; 95% CI, 0.89–4.04) as those above 200 cells/μl. Those with either a CD4 cell count of 200 cells/μl or less (hazard ratio 2.1; 95% CI, 1.2–3.8) or a WHO IV condition (hazard ratio 2.9; 95% CI, 0.93–8.8) alone had a two-to-three-fold increased risk of death/virologic failure vs. those with neither, but those with both conditions had a four-fold increased risk (hazard ratio 3.9; 95% CI, 1.9–8.1). We observed some decreased loss to follow-up among those initiating ART at less than 200 cells/μl (hazard ratio 0.79; 95% CI, 0.50–1.25).
Conclusion: Patients initiating ART with higher CD4 cell counts had reduced mortality, tuberculosis and less virologic failure than those initiated at lower CD4 cell counts. Our data support increasing CD4 cell count eligibility criteria for ART initiation.
aCenter for Global Health and Development, Boston University, Boston, Massachusetts, USA
bHealth Economics and Epidemiology Research Office, Johannesburg, South Africa
cFaculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
dDepartment of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA
eUniversity of Cape Town, Cape Town, South Africa
fNational Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland
gUniversity of North Carolina, Chapel Hill, North Carolina, USA
hANOVA Health Institute, Johannesburg, South Africa.
Received 18 March, 2010
Revised 12 May, 2010
Accepted 25 May, 2010
Correspondence to Matthew P. Fox, Center for Global Health and Development, Boston University, Crosstown Center, 3rd Floor, 801 Massachusetts Avenue, Boston, MA 02118, USA. Tel: +1 617 414 1260; fax: +1 617 414 1261; e-mail: firstname.lastname@example.org