Hepatitis B and C virus co-infection and the risk for hepatotoxicity of highly active antiretroviral therapy in HIV-1 infection

Objective: To investigate the risk of hepatotoxicity after initiation of pr otease inhibitor-containing highly active antiretroviral therapy (HAART) fo r HIV-I infected patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) co-infection. Design: Retrospective study with 394 HIV-1 infected patients initiating HAA RT at a single university clinic. Methods: Liver enzyme elevation (LEE) was defined as alanine aminotransfera se or aspartate aminotransferase at least five times the upper limit of nor mal and an absolute increase of > 100 U/I. Relative risks for time to LEE w ere estimated using Cox proportional hazards models. Results: Of 394 patients 7% were hepatitis B surface antigen (HBsAg)-positi ve and 14% were anti-HCV-positive. Patients with chronic hepatitis had a hi gher risk for LEE compared with patients without co-infection: 37% versus 1 2% respectively. After adjustment for higher baseline transaminases, the pr esence of HBsAgor anti-HCV remained associated with an increased risk of LE E - relative risk 2.78 (95% confidence interval, 1.50-5.16) and 2.46 (95% c onfidence interval, 2.43-4.24) respectively, in patients with LEE, transami nases declined whether HAART was continued or modified. Of patients with ch ronic HBV infection 38% lost HBeAg or developed anti-HBe after initiation o f HAART, and one seroconverted from HBsAg-positive to anti-HBs-positive. Ho wever, there was no clear relationship with LEE. Conclusions: HIV-1-infected patients co-infected with HBV or HCV were at co nsiderably higher risk of developing LEE when HAART was initiated compared with patients without co-infection, but it is usually not necessary to modi fy antiretroviral therapy. (C) 2000 Lippincott Williams & Wilkins.