Severe hepatotoxicity associated with nevirapine use in HIV-infected subjects

Human immunodeficiency virus (HIV) - infected South African patients (n = 468) received blinded lamivudine or emtricitabine stavudine, and either nevirapine or efavirenz ( based on screening viral load). Baseline characteristics were analyzed in univariate and multivariate regression, to identify risk factors for hepatotoxicity ( grade 3 or greater increase in serum aminotransferase levels). The occurrence of early hepatotoxicity was 17% in the nevirapine group and 0% in the efavirenz group and was balanced between the lamivudine and emtricitabine arms. Two subjects died of hepatic failure. Independent risk factors were body-mass index (BMI) < 18.5, female sex, serum albumin level < 35 g/L, mean corpuscular volume >85 fL, plasma HIV-1 RNA load <20,000 copies/mL, aspartate aminotransferase level <75 IU/L, and lactate dehydrogenase level < 164 IU/L. The use of nevirapine in female patients with a low BMI should be discouraged.