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.
Sanne
Ian
I
Clinical HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
Mommeja-Marin
Herve
H
Hinkle
John
J
Bartlett
John A
JA
Lederman
Michael M
MM
Maartens
Gary
G
Wakeford
Charles
C
Shaw
Audrey
A
Quinn
Joseph
J
Gish
Robert G
RG
Rousseau
Franck
F
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
D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase