Hepatotoxicity During Nevirapine-Based Fixed-Dose Combination Antiretroviral Therapy in Kampala, Uganda

Abstract

Background: Generic, low-cost, nevirapine (NVP)-based antiretroviral therapy (ART) has improved survival in HIV-infected individuals living in resource-limited settings. However, there is concern about the potential hepatotoxicity of these regimens. Methods: The authors conducted a prospective study of persons initiating self-pay Triomune or Maxivir therapy in Kampala, Uganda. Results: The 97 study participants were predominantly women (64%), median age was 35 (interquartile range [IQR] 30-40), median CD4 at baseline was 56 cells/mm3 (IQR 8-138), and 19% had lifetime alcohol problems (CAGE ≥ 2). Severe liver enzyme elevations (LEEs) of grade 3-4 were rare (2.2%); however, 1 patient died in the setting of grade 4 LEEs. Grade 1-4 LEEs occurred among 22.2% of participants, and 9.8% had new grade 1-4 LEEs after the initiation of treatment. Discussion: The authors found that LEEs were common but that severe hepatotoxicity in persons initiating NVP-based ART was infrequent yet potentially life-threatening. Monitoring for NVP-related severe hepatic toxicity should be part of expanding antiretroviral treatment programs in resource-limited settings.