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Session 95 Poster Session Organ Specific Toxicities/Complications Session Time: 4:30-6:30 pm Room 4E-F

724-T. Hepatotoxicity among a Cohort of Thai HIV-Infected Patients Enrolled in HIV-NAT Antiretroviral Therapy Trials P. Law*1, G. Dore1, C. Duncombe1, M. Law1, J. Lange2, P. Phanuphak3, and D. A. Cooper1 1Natl. Ctr. in HIV Epidemiology and Clin. Res., Univ. of New South Wales, Australia; 2Natl. AIDS Therapy Evaluation Ctr., Univ. of Amsterdam, The Netherlands; and 3Thai Red Cross AIDS Res. Ctr., Bangkok Background: Hepatotoxicity is emerging as a major issue for people with HIV/AIDS commenced on antiretroviral therapy. However, the incidence and predictors of hepatotoxicity require further examination, particularly in non-Caucasian and developing country populations. Methods: Hepatotoxicity was examined within a cohort of Thai HIV-infected patients enrolled in 8 HIV-NAT randomized controlled trials. All patients (n=692) received at least 2 nucleoside reverse transcriptase inhibitors (NRTI), while 215 received a non-nucleoside reverse transcriptase (NNRTI)-containing regimen and 135 received a protease inhibitor (PI)-containing regimen. Severe hepatotoxicity was defined as an increase in alanine aminotransferase (ALT) level to 5 times the upper limit of normal. Liver function tests were available at baseline, and week 4, 8, 12, 24, 36, 48. Serological testing for hepatitis B virus (HBV) and hepatitis C virus (HCV) was performed on stored specimens. Results: Median age was 32.3 years, 52% were male, 11% had CDC category C HIV disease at baseline, and 22% had received prior antiretroviral therapy. Prevalence of HBsAg and HCV antibody was 9.1% and 7.7%, respectively. Incidence of severe hepatotoxicity was 6.1/100 person-years (95% CI=4.3-8.3/100 person-years), with median time to development 56 days. Risk of severe hepatotoxicity was associated with HIV/HBV (hazard ratio [HR]=3.9, p=0.001) and HIV/HCV (HR=3.0, p=0.02) co-infection, absence of prior antiretroviral therapy (HR=3.7, p=0.03), and NNRTI-containing regimens (HR=6.8, p<0.0001). Severe hepatotoxicity was uncommon among patients receiving protease inhibitor (PI)-containing regimens (1.4/100 person-years). Conclusions: Incidence of severe hepatotoxicity among Thai HIV-infected patients receiving antiretroviral therapy appears similar to other settings. Risk of severe hepatotoxicity was highest among patients with HIV/viral hepatitis co-infection and those receiving NNRTIs. A combination of immune reconstitution reactivation of viral hepatitis and direct toxicity of the NNRTI class may explain these findings.

©2002 9th Conference on Retroviruses and Opportunistic Infections