Risk and determinants of developing severe liver toxicity during therapy with nevirapine-and efavirenz-containing regimens in HIV-infected patients

• Published in: International journal of STD & AIDS Vol. 14; no. 11; pp. 776 - 781
• Main Authors: ENA, Javier, AMADOR, Concepcion, BENITO, Conception, FENOLL, Vicenta, PASQUAU, Francisco
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.11.2003; Royal Society of Medicine Press; Sage Publications Ltd
• Subjects: Adult; Alanine Transaminase - blood; Alcoholism - blood; Alcoholism - complications; Anti-HIV Agents - adverse effects; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Benzoxazines; Biological and medical sciences; Chemical and Drug Induced Liver Injury; Cohort Studies; Drug Therapy, Combination; efavirenz; Female; Hepatitis C Antibodies - blood; Hepatitis C, Chronic - complications; HIV Infections - complications; HIV Infections - drug therapy; HIV Protease Inhibitors - adverse effects; Human immunodeficiency virus 1; Human viral diseases; Humans; Infectious diseases; Liver Diseases - blood; Male; Medical sciences; Multivariate Analysis; nevirapine; Nevirapine - adverse effects; Oxazines - adverse effects; Pharmacology. Drug treatments; Reverse Transcriptase Inhibitors - adverse effects; Risk; Risk Factors; Transaminases - blood; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; DISEASES; HEPATITIS; LIVER; DRUG TOXICITY; HEPATITIS C ANTIBODIES; ALCOHOLISM; HAART; RNA-directed DNA polymerase; Acetylenic compound; Nevirapine; Toxicity; Non nucleoside compound; Alcohol; Hepatic disease; Multivariate analysis; Efavirenz; drug toxicity; Reverse transcriptase inhibitor; Antiviral; liver diseases; Viral hepatitis C; Human; Immunopathology; Serine endopeptidases; Omptin; Enzyme; Antibody; Critically ill; Transferases; Alcoholism; Enzyme inhibitor; AIDS; hepatitis; Immune deficiency; Adhesion; Infection; Virus; Peptidases; Nucleotidyltransferases; Chemotherapy; hepatitis C antibodies; Treatment; Surveillance; Viral disease; Transaminases; Risk factor; Digestive diseases; Hydrolases; Flaviviridae; Severe; Hepatitis C virus; Hepacivirus; Protease inhibitor
• ISSN: 0956-4624; 1758-1052
• DOI: 10.1258/09564620360719840

We examined the risk and determinants of developing severe liver toxicity in 108 HIV-infected patients showing adherence to nevirapine- and efavirenz-containing regimens. Between January 1997 and December 2000, 70 patients were treated with nevirapine- and 38 patients with efavirenz-containing regimens, for a median period of 127 days (interquartile range 65-240). Severe liver toxicity was defined as grade 3-4 elevations (>5×upper limit of normal) of aminotransferases AST or ALT. A total of 22 (20%) patients showed severe liver toxicity, 17 of them were treated with nevirapine- and five with efavirenz-containing regimens (relative risk [RR]: 1.85, 95% confidence intervals [CIs] 0.74-4.61; P=not significant). Multivariate analysis showed the association of severe liver toxicity with hepatitis C antibody positive (RR 7.64; 95% CI: 1.48-39.52; P=0.01), nevirapine- or efavirenz-containing regimens combined with a protease inhibitor (RR: 3.07, 95% CI: 1.01-9.32, P=0.04) and alcohol intake greater than 40 g per day (RR: 3.09, 95% CI: 1.27-7.54, P=0.01). These findings have potential implications for selecting and monitoring antiretroviral therapy in HIV-infected patients with hepatitis C virus coinfection and for avoiding alcohol intake during antiretroviral therapy.