Hepatitis B or hepatitis C virus infection is a risk factor for severe hepatic cytolysis after initiation of a protease inhibitor-containing antiretroviral regimen in human immunodeficiency virus-infected patients

In a cohort of 1,047 human immunodeficiency virus type 1-infected patients started on protease inhibitors (PIs), the incidence of severe hepatic cytol ysis (alanine aminotransferase concentration five times or more above the u pper limit of the normal level greater than or equal to 5N) was 5% patient- years after a mean follow-up of 5 months. Only positivity for hepatitis C v irus antibodies (hazard ratio [HR], 7.95; P < 10(-3)) or hepatitis B virus surface antigen (HR, 6.67; P < 10(-3)) was associated with severe cytolysis . Before starting patients on PIs, assessment of liver enzyme levels and vi ral coinfections is necessary.