1. Severe Hepatotoxicity Associated with Nevirapine Use in HIV‐Infected Subjects
- Author
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Robert G. Gish, Audrey L. Shaw, Herve Mommeja-Marin, Charles Wakeford, Gary Maartens, Michael M. Lederman, Franck Rousseau, John Bartlett, Ian Sanne, Joseph B. Quinn, and John Hinkle
- Subjects
Adult ,Male ,medicine.medical_specialty ,Efavirenz ,Nevirapine ,Anti-HIV Agents ,HIV Infections ,Emtricitabine ,Gastroenterology ,chemistry.chemical_compound ,Acquired immunodeficiency syndrome (AIDS) ,Risk Factors ,Internal medicine ,medicine ,Humans ,Immunology and Allergy ,Aspartate Aminotransferases ,Sida ,biology ,business.industry ,Stavudine ,Lamivudine ,Alanine Transaminase ,medicine.disease ,biology.organism_classification ,Treatment Outcome ,Infectious Diseases ,Liver ,chemistry ,Immunology ,HIV-1 ,Regression Analysis ,Reverse Transcriptase Inhibitors ,Drug Therapy, Combination ,Female ,business ,Viral load ,medicine.drug - 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 level35 g/L, mean corpuscular volume85 fL, plasma HIV-1 RNA load20,000 copies/mL, aspartate aminotransferase level75 IU/L, and lactate dehydrogenase level164 IU/L. The use of nevirapine in female patients with a low BMI should be discouraged.
- Published
- 2005
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