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

Epidemiology and Preventions Center, Department of Medicine, San Francisco General Hospital, University of California, San Francisco, jhahn{at}epi-center.ucsf.edu

Marissa Maier

School of Medicine, University of California, San Francisco

Jayne Byakika-Tusiime, MSc

Makerere University, Kampala, Uganda

Jessica H. Oyugi, MD

United States Agency for International Development

David R. Bangsberg, MD, MPH

Epidemiology and Preventions Center, Department of Medicine, San Francisco General Hospital, University of California, San Francisco

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.

Key Words: HIV • antiretroviral therapy • Uganda • hepatotoxicity

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