Efficacy and safety of combination therapy with interferon-alpha 2b and ribavirin for chronic hepatitis C in HIV-infected patients

Objectives: To evaluate the efficacy and safety of a combination therapy of interferon-alpha 2b (IFN) and ribavirin for the treatment of chronic hepat itis C in HIV-seropositive patients. Design: Open prospective trial. Methods: Twenty patients co-infected with hepatitis C virus (HCV) and HIV, with a mean CD4 cell count of 350 +/- 153 x 10(6)/l were treated with IFN ( 3 MU three times per week) in combination with ribavirin (500 mg or 600 mg twice a day) for 6 months. Tolerance and efficacy were monitored at weeks 1 2 (month 3) and 24 (month 6). The primary endpoint was a complete virologic al response, as defined by the lack of detectable HCV RNA in serum. Results: Baseline values of alanine aminotransferase (ALT) and aspartate am inotransferase (AST) were 121 +/- 72 IU/l and 75 +/- 67 IU/l, respectively. The total Knodell score was 10.4 +/- 2.4, with nine patients showing histo logical evidence of active cirrhosis (45%). All patients exhibited circulat ing HCV RNA. The treatment was well tolerated, with no impact on the course of HIV infection. After 6 months of combination therapy with IFN and ribav irin, 10 patients (50%) exhibited no further detectable HCV RNA viraemia, s even of whom achieved undetectable viraemia at month 3. Levels of ALT and A ST decreased after 6 months of treatment from a mean of 121 +/- 72 to 51 +/ - 40 IU/l and from a mean of 129 +/- 58 IU/l to 68 +/- 61 IU/l, respectivel y (P < 0.0002 and P < 0.0001). Conclusion: Our results indicate that combination therapy with IFN and riba virin is effective in 50% of cases in clearing serum HCV RNA and may thus p rovide effective means of therapy in HIV-HCV-coinfected patients as initial treatment or in patients who have previously failed IFN monotherapy. (C) 2 000 Lippincott Williams & Wilkins.