title: Risk and determinants of developing severe liver toxicity during therapy with nevirapine-and efavirenz-containing regimens in HIV-infected patients.
abstract: 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 x 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.
authors: HIV Unit, Internal Medicine Department, Marina Baixa Hospital, Partida de Galandú, 5, Villajoyosa, 03570 Alicante, Spain. ena_jav@gva.es
authors: Javier
authors: J
authors: Ena
authors: Concepción
authors: C
authors: Amador
authors: Concepción
authors: C
authors: Benito
authors: Vicenta
authors: V
authors: Fenoll
authors: Francisco
authors: F
authors: Pasquau
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000437:Alcoholism / Q000097:blood / Q000150:complications; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects*; D048588:Benzoxazines; D056486:Chemical and Drug Induced Liver Injury; D015331:Cohort Studies; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects; D018937:Hepatitis C Antibodies / Q000097:blood; D019698:Hepatitis C, Chronic / Q000150:complications; D006801:Humans; D008107:Liver Diseases / Q000097:blood; D008297:Male; D015999:Multivariate Analysis; D019829:Nevirapine / Q000009:adverse effects*; D010078:Oxazines / Q000009:adverse effects*; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects; D012306:Risk; D012307:Risk Factors; D000637:Transaminases / Q000097:blood
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D017320:HIV Protease Inhibitors; D018937:Hepatitis C Antibodies; D010078:Oxazines; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; D000637:Transaminases; D000410:Alanine Transaminase; C098320:efavirenz