Abstract

Objective: To evaluate the effect of Highly Active AntiRetroviral Therapy (HAART) and cotrimoxazole prophylaxis usage (CTX) on incidence of morbidity within the first year of HAART-eligibility. Methods: Between July 1999 and April 2006, we collected information on morbidity from an open cohort of HAARTeligible patients (according to WHO criteria). We compared morbidity among patients initiating HAART to morbidity before the stepwise introduction of HAART and CTX. We used available patients on HAART to select randomly a historical group of HAART-naive but eligible patients who had proportionally the same WHO stage and sex distribution. Patients aged 16 years or older, visited the study team 6-monthly and when ill. Patients’ demographics, WHO stage, HAART status, CTX, any new morbidity event (disease, drug-related and recurrent), haemoglobin and CD4 counts were collected from the beginning of follow up to the first year after initiating HAART or becoming HAART-eligible. We estimated the overall effect of HAART onmorbidity; adjusted for the effect of CTX by Mantel-Haenszel methods and adjusted for the effect of other confounders by negative binomial regression. Results: 219 HAART patients (median age 37 years; 73% women; 85% CTX; median Hb 11.7 g/dl and median CD4 131 cells/ul) experienced 94 events. They contributed 127 Person-Years of Observations (PYOs). 616 HAART-naive patients (median age 33 years; 70% women; 33% CTX; median Hb 11.2 g/dl and median CD4 131 cells/ml) experienced 862 events. They contributed 474 PYOs. The overall morbidity among HAART patients during their first year of treatment was 78% lower (HR = 0.22, 95% CI: 0.15—0.31) than the overall incidence among HAART-naive patients in unadjusted analysis. CTX also had a protective effect against morbidity (adjusted HR = 0.55, 95% CI: 0.38—0.79). Conclusions: Morbidity reduced significantly within the first year of initiating HAART in this setting. CTX had additional significant protection against morbidity.

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