We studied hepatic transaminases among rural Ugandans initiating highly active antiretroviral therapy (HAART) and assessed the impact of positive serology for hepatitis B surface antigen (HBsAg) and coadministration of therapy for tuberculosis. From July 2003 to December 2004, persons with symptomatic HIV disease or a CD4 count less than 250 cells/mm(3) and who had alanine transferase (ALT) or aspartate transferase (AST) less than 5 times the upper limit of normal were started on HAART including nevirapine (96%) or efavirenz (4%). Repository sera from a subset of 596 participants were analyzed for hepatic transaminase levels. A transaminase elevation was present before therapy for 249 (42%) of 596, at 3 months for 140 (25%) of 553, 12 months for 59 (11%) of 520, and 24 months for 67 (13%) of 508. In multivariate analyses, a transaminase elevation at 3 months was associated with male gender (odds ratio [OR], 1.55; 95% confidence interval [CI], 1.02-2.35), body mass index less than 18 kg/m(2) (OR, 2.10; 95% CI, 1.34-3.30), transaminase elevation at baseline (OR, 1.97; 95% CI, 1.30-2.99), and treatment for tuberculosis (OR, 4.68; 95% CI, 2.28-9.59). HBsAg status was not associated with transaminase elevations at baseline or while on HAART. The prevalence of hepatic transaminase elevations decreased during non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral therapy in this cohort of HIV-infected persons in rural Uganda.
Trial registration: ClinicalTrials.gov NCT00119093.