Hepatotoxicity during nevirapine-based fixed-dose combination antiretroviral therapy in kampala, Uganda.
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/mm(3) (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.


CONCLUSIONS
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.
Hahn
Judith A
JA
Epidemiology and Preventions Center, Department of Medicine, San Francisco General Hospital, University of California, San Francisco, CA 94143-1372, USA. jhahn@epi-center.ucsf.edu
Maier
Marissa
M
Byakika-Tusiime
Jayne
J
Oyugi
Jessica H
JH
Bangsberg
David R
DR
D019380:Anti-HIV Agents / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D019829:Nevirapine / Q000627:therapeutic use; D011446:Prospective Studies; D014454:Uganda
D019380:Anti-HIV Agents; D019829:Nevirapine