Long-term efficacy of combination therapy with interferon-alpha 2b and ribavirin for severe chronic hepatitis C in HIV-infected patients

Background: We have assessed the long-term efficacy and safety of a combina tion therapy of interferon alpha-2b (IFN) and ribavirin (RBV) for the treat ment of severe chronic hepatitis C in co-infected HIV-seropositive patients in an open prospective study. Methods: Fifty-one patients were treated for 12 months. Mean baseline CD4 c ell count, alanine aminotransferase and aspartate aminotransferase were 412 +/- 232 x 10(6)/1, 113 +/- 75 IU/l and 111 +/- 84 IU/l respectively. The m ean Knodell score was 11.5 +/- 2.1 with 28 patients (55%) exhibiting histol ogical evidence of active cirrhosis. Results: Fifteen (29%) patients discontinued the treatment prematurely beca use of adverse events. An end of treatment response (ETR) as defined by the lack of detectable hepatitis C virus (HCV) RNA in plasma at the end of tre atment was achieved in 15 patients (29%). A sustained virological response (SVR), defined by the lack of detectable HCV RNA in plasma 6 months after c ompletion of combination therapy, was achieved in 11 patients (21%). The HC V genotype 3a was associated with ETR and SVR (P=0.002 and P=0.003, respect ively). HCV viraemia at baseline was lower in patients who achieved SVR and ETR than in those who did not (6.7 +/- 7.8 versus 24 +/- 26.7 x 10(6) geno me equivalents/ml, P=0.03 and 14.3 +/- 28.7 versus 22.5 +/- 23, P=0.05, res pectively). Conclusion: Our results indicate that combination therapy with IFN and RBV is effective in approximately 20% of co-infected patients with severe liver disease. (C) 2001 Lippincott Williams & Wilkins.