Background:  A determinant of the success of the President’s Emergency Plan for AIDS Relief, which aims to provide ART for 2 million HIV patients in resource-limited settings, is the extent to which patients can tolerate and stay on ART. We describe toxicities associated with ART among patients receiving care in a clinic in the Kibera slums in Nairobi, Kenya.

Methods:  From February 2003 to February 2005, patients with symptomatic HIV disease or CD4⁺ cell count <200 cells/mm³ treated with ART were evaluated for clinical and lab toxicities at scheduled intervals. Toxicities were graded 1 to 4 (grades 3 to 4 were considered severe) and cumulative probabilities (Kaplan-Meier) were calculated.

Results:  A total of 284 patients (70% women; median CD4⁺ cell count: 159 cells/mm³) started ART (stavudine and lamivudine for 279, plus either nevirapine for 267 or efavirenz for 12). In 253.7 patient-years of observation (median 0.9 years/patient), any clinical toxicity was recorded for 184 (65%) patients, including neuropathy for 65 (23%), rash for 58 (20%), hepatotoxicity for 4 (1.4%), and lipodystrophy for 2 (0.7%). Of these patients, 17 (6%) had severe toxicity, including neuropathy for 7 (3%), rash for 4 (1.4%), hepatotoxicity for 4 (1.4%), lipodystrophy for 1 (0.4%), and diarrhea for 1 (0.4%). Among 233 patients with ≥1 aspartate aminotransferase (AST) drawn, AST was elevated ≥1 grade from baseline for 117 (49%) patients and grade 3 to 4 for 3 (1.3%) patients. Cumulative probabilities for not developing clinical toxicity at 6, 12, and 18 months were 0.47, 0.26, and 0.17 and from severe toxicity were 0.98, 0.95, and 0.89, respectively. Cumulative probabilities for remaining free from elevated AST at 6, 12, and 18 months were 0.45, 0.27, and 0.21 and from grade 3 to 4 elevated AST were 0.98, 0.98, and 0.98, respectively. For 13 cases of toxicity—including rash (4), hepatitis (4), neuropathy (3), lipodystrophy (1), and diarrhea (1)—12 (5%) patients changed therapy The probability of remaining on the original regimen at 6, 12, and 18 months was 0.98, 0.97, and 0.96, respectively. No patients permanently discontinued taking ART, nor were known to have died from toxicity.

Conclusions:  Toxicities were common in this cohort, but most were mild. Although some patients had severe toxicities, ART was continued with an alternative regimen. These results indicate that among populations in resource-limited settings, ART tolerance should not represent a significant barrier to care.