Background:  Data on the effectiveness and safety of HAART in resource-limited settings are limited. This study assessed the clinical outcomes of HAART in African patients.

Methods:  This open-label cohort program recruited 206 HAART-naïve HIV-1-infected patients in 4 urban clinics in Senegal (Dakar), Côte d’Ivoire (Abidjan), Uganda (Kampala), and Kenya (Nairobi). Treatment was a regimen of saquinavir/ritonavir (SQV/RTV) (1600/100 mg once daily), lamivudine (3TC) (150 mg twice daily), and zidovudine (ZDV) (300 mg twice daily). Primary outcome was a plasma HIV-1 RNA viral load <400 copies/mL at week 96. Secondary analyses included the change in CD4 cells between baseline and week 96 and the occurrence of serious adverse events.

Results:  At baseline, median age of the patient group was 36 years; 38% were male; 35% of the patients was in CDC stage C; median CD4 cell count was 119 cells/mL (IQR 70 to 225), and median plasma viral load was 304,210 copies/mL (IQR 79,572 to 695,000). High overall patient attendance was observed, and 166 patients (81%) were still receiving HAART after 96 weeks. In the early phase, however, attendance of clinic visits was poor in 1 of the sites, but, from week 36 on this improved significantly. On-treatment (OT) results are based on the number of evaluable patients and the intent-to-treat (ITT) results, on the number of enrolled patients. At week 96, 65%/52% (OT/ITT) of the patients had a plasma viral load <400 copies/mL. This proportion varied between the sites:  while in Nairobi and Dakar 51%/40% and 56%/46%, was found, respectively, Abidjan and Kampala showed proportions of 69%/54% and 83%/69%, respectively. These proportions were statistically significant different (a = 0.05) between the sites (p = 0.0131/0.0217). Median increase in CD4 cell count was 198 cells/mL (IQR 86 to 319), ranging from 191 to 292 cells/mL between the sites. However, no statistically significant differences were observed between the sites with respect to these numbers (p = 0.4312).

Between 8 and 96 weeks follow-up, 14 patients (6.8%) died, while 18 (9%) developed a CDC C HIV-event in this period. Non-HIV-related serious adverse events were reported in 55 patients (26.7%); 35 patients (17%) changed treatment for toxicity reasons.

Conclusions:  This program shows that the virologic and immunologic response to HAART in resource-limited African settings can be as good as in western settings. However, a statistically significant difference was observed between the sites with respect to virologic success.