title: Severe hepatotoxicity associated with nevirapine use in HIV-infected subjects.
abstract: 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.
authors.affiliation: Clinical HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Ian
authors.initials: I
authors.lastname: Sanne
authors.forename: Herve
authors.initials: H
authors.lastname: Mommeja-Marin
authors.forename: John
authors.initials: J
authors.lastname: Hinkle
authors.forename: John A
authors.initials: JA
authors.lastname: Bartlett
authors.forename: Michael M
authors.initials: MM
authors.lastname: Lederman
authors.forename: Gary
authors.initials: G
authors.lastname: Maartens
authors.forename: Charles
authors.initials: C
authors.lastname: Wakeford
authors.forename: Audrey
authors.initials: A
authors.lastname: Shaw
authors.forename: Joseph
authors.initials: J
authors.lastname: Quinn
authors.forename: Robert G
authors.initials: RG
authors.lastname: Gish
authors.forename: Franck
authors.initials: F
authors.lastname: Rousseau
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D019380:Anti-HIV Agents / Q000009:adverse effects*; D001219:Aspartate Aminotransferases / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008099:Liver / Q000187:drug effects*; D008297:Male; D019829:Nevirapine / Q000009:adverse effects*; D012044:Regression Analysis; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects*; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase