Background:  AIDSRelief is a care and treatment program supported by the President’s Emergency Plan for AIDS Relief working in 9 countries. The program started treatment of patients with ART in August 2004. Recorded for quality assurance and evaluation are outcomes data, including mortality, lost to follow-up, and ART-associated toxicity leading to a change in treatment. Here we report the ART-associated toxicity reported between August 2004 and June 1, 2006, for 6520 treated patients in Kenya, Zambia, and Uganda.

Methods:  A standardized medical record format is used in the 3 countries. Only drug-associated toxicities leading to a clinical decision to change an ART medication are recorded within the medical record and subsequently abstracted into CareWare electronic database. All providers have access to basic chemistry assays, including creatinine, amylase, aminotransferasem alanine aminotransferase, hematocrit or hemoglobin, triglycerides, and blood glucose. The frequencies of associated toxicities were aggregated across the 3 countries regardless of the drug with which the regimen was combined.

Results:  A total of 1007 patients experienced a toxicity that resulted in a drug switch.  Of 2149 patient treated with stavudine (d4T), 24% switched because of an associated toxicity, including neuropathy, lipoatrophy, pancreatitis, or lactic acidosis. Of the 1433 patients treated with zidovudine (AZT), 12% switched because of anemia or gastrointestinal intolerance. Of the 2938 treated with tenofovir (TDF), 0.6% switched because of renal insufficiency. Of the 4288 patients treated with nevirapine (NVP), 5% switched because of rash or hepatic toxicity. Of the 3657 patients treated with efavirenz (EFV), 2% switched because of central nervous system intolerance, rash, or hepatic toxicity. Of the 622 patients treated with lopinavir/ritonavir (LPV/r), 1.3% switched because of metabolic abnormalities, liver toxicity, or diarrhea.

Conclusions:  Toxicities reported in our program are similar to other published reports in Africa. The comparably low toxicity rates of TDF and EFV support the preferential use of these agents for a “public health” approach over the current predominately used agents. Limitations of the study include an underestimation of toxicities and reliance on provider diagnosis and discretion to change therapy.