Antiandrogen hepatotoxicity in patients with chronic viral hepatitis.

OBJECTIVE: To assess whether patients with chronic viral hepatitis are at an increased risk for antiandrogen hepatotoxicity. METHODS: We retrospectively reviewed 121 prostate cancer patients who received long-term antiandrogen, either flutamide (n = 56) or cyproterone acetate (n = 65), and had normal pretreatment serum alanine aminotransferase (ALT) levels. Serological markers of hepatitis B and C viruses (HBV and HCV) were checked in 42 of the 121 patients. RESULTS: Twenty-two (18%) of the 121 patients had ALT elevations during antiandrogen therapy. Thirteen (59%) of the 22 patients were positive for either one of the two viral markers, including 7 for HBV, 4 for HCV, and 2 for both. This percentage was higher than the combined prevalence rate of positivity for HBV and/or HCV markers (<20%) in Taiwan. There was no significant differences in the percentage of positive makers among the two antiandrogen groups (p = 0.092). Although a higher incidence of hepatotoxicity was noted in the flutamide (13/56, 23%) than in the cyproterone acetate group (9/65, 14%), there were no significant differences between the two groups (p = 0.27). The time period between initiation of antiandrogen and first ALT elevation varied significantly (from 4 to 1,398 days with a median of 151 days). Half of the 14 HBV carriers and all of the 6 patients with anti-HCV developed antiandrogen hepatotoxicity. CONCLUSION: Our limited data suggested that patients with chronic viral hepatitis probably are at a higher risk of developing antiandrogen hepatotoxicity. Close monitoring of liver functions in patients with chronic viral hepatitis is advised if antiandrogen therapy is necessary. However, a large-scale study is necessary for a definitive conclusion.