Hepatitis B or Hepatitis C Virus Infection is a Risk Factor for Severe Hepatic Cytolysis After Initiation of Protease Inhibitor Containing Antiretroviral Regimen in Human Immunodeficiency Virus-Infected Patients [Saves M, et al. Antimicrob Ag Chemother 2000;44:3451]: This is a retrospective study of a multicenter cohort from France named APROCO. The analysis concerned 1,047 patients who started PI therapy to determine risk factors for an increase in ALT to greater than five times the upper limits of normal, which is defined by the ACTG as a grade 3 or grade 4 complication (2%). Comparison of patients with and without severe hepatotoxicity showed that risk was associated with injection drug use (52% of those with severe liver toxicity compared to 16% in those without), positive serology for HCV (70% versus 24%), and for positive HBs antigen (22% versus 4%). With multivariate analysis, only HCV and HBV showed significant associations. There were no significant differences based on baseline CD4 cell count, baseline viral load, duration of exposure to PIs, or the specific PI given. The authors urge that patients beginning PI therapy should have an assessment for baseline liver enzymes and serology for HCV and HBV.
Comment: It is important to emphasize that 90% of patients with HCV do not develop hepatic toxicity with PI therapy so that current recommendations for HAART apply to this population as well as to those without HCV. This report suggests an association between chronic hepatitis and PI-associated hepatitis, which could be a result of PI toxicity or increased inflammatory response against HBV or HCV. Data on HCV and HBV coinfection seem to be rapidly expanding, and this study adds to the total data by virtue of its sheer size, but the study also emphasizes the relatively sparse number of patients who developed severe hepatic toxicity with PI therapy in general.
posted 1/4/2001

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