A RANDOMIZED STUDY COMPARING RIBAVIRIN AND INTERFERON-ALPHA MONOTHERAPY FOR HEPATITIS-C RECURRENCE AFTER LIVER-TRANSPLANTATION

Hepatitis C virus (HCV) infection usually recurs after orthotopic live r transplantation (OLT), and most patients develop graft damage, This study compared the efficacy of interferon alfa (IFN-alpha) and ribavir in monotherapies in liver transplant recipients with chronic hepatitis C in the graft. Thirty OLT recipients with chronic hepatitis C were r andomized to receive either IFN-alpha (3 MU three times a week) or rib avirin (up to 1.2 g daily) for 24 weeks. Virological, biochemical, and histological responses to treatment were assessed. Twenty-eight patie nts completed the treatment regimen, two ribavirin-treated patients be ing withdrawn because of severe hemolysis. Normalization of serum aspa rtate aminotransferase was achieved in 13 of 14 patients receiving rib avirin (93%) and 6 of 14 patients receiving IFN-alpha (43%; P = .01). Lobular inflammation was reduced in 9/14 ribavirin-treated (64%) and 3 of 14 IFN-alpha-treated patients (21%; P = .05), each of whom had a b iochemical response. However, the total histological activity index di d not improve in either the interferon (P = .43) or the ribavirin (P = .96) group. Posttreatment viremia levels were significantly reduced i n IFN-alpha-treated (P = .05) but not in ribavirin-treated (P = .88) p atients. Hemolysis occurred in all ribavirin-treated patients, with se rum hemoglobin decreasing to <10 g/dL in 50%. Total leukocyte and lymp hocyte counts decreased significantly during ribavirin treatment (P = .02 and P = .004, respectively). We concluded that in patients with ch ronic hepatitis C after OLT, IFN-alpha retains an antiviral effect whe reas ribavirin is superior in achieving normalization of serum asparta te aminotransferase levels and reducing lobular inflammation, but not the total histological activity index. These findings provide a ration ale for combination therapy in the post-OLT setting, although patients must be carefully monitored for hemolysis.