BACKGROUND: The aim of the study was to compare the efficacy and tolerability of pegylated interferon (PEG-IFN) plus ribavirin (RIB) and PEG-IFN monotherapy after unsuccessful initial therapy with interferon-alpha2b (IFN) plus RIB after recurrent post-transplantation hepatitis C. METHODS: Twenty-four patients with either no response (n = 10) or relapse (n = 14) after treatment with IFN plus RIB were prospectively randomized in the two treatment arms: 1) PEG-IFN monotherapy at a dosage of 0.8 mug/kg per week (n = 12) and 2) PEG-IFN (0.8 mug/kg per week) plus RIB (800-1200 mg/d) (n = 12). RESULTS: Twenty-one patients (86%) were treated for at least six months. Three patients are still being treated. At the end of therapy, 18 patients (75%) were HCV RNA negative. Five (45%) patients in PEG-IFN and five (50%) in PEG-IFN plus RIB arms had sustained virological response. Two patients (10%) died from recurrent hepatocellular carcinoma. The histologic activity indices significantly improved in both treatment arms. In the PEG-IFN arm, one patient experienced an acute rejection and discontinued therapy. CONCLUSIONS: Both treatment arms showed to be effective, well tolerated and lead to an improvement in histologic outcome. Because of lower rates in side effects and equal outcome, PEG-IFN monotherapy is an adequate option for antiviral re-treatment.
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