Ribavirin and interferon‐α combination therapy vs interferon‐α alone in the retreatment of chronic hepatitis C: a randomized clinical trial

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Abstract
Summary. Interferon‐aL (IFN‐α) induces sustained remission of chronic hepatitis C in approximately 25% of patients. In patients who are non‐responders to the first course of therapy, retreatment with IFN‐α is of limited efficacy. Ribavirin has also been used to treat chronic hepatitis C, but it induces only a transient response. In this study, we evaluated the efficacy of ribavirin and IFN‐α combination therapy for IFN‐α resistant chronic hepatitis C. Twenty‐four IFN‐α non‐responders and 24 relapsers were randomized to receive either ribavirin (1000 mg per day) together with IFN‐α (3–6 million units (MU) thrice weekly) or the same dose of IFN‐α alone, for 6 months. Both at the end of treatment and 6 months later, normal transaminase levels were more common in the patients receiving combination therapy than in the group receiving IFN‐α alone: 17 (70.8%) vs seven (29.2%) patients (P= 0.009) and six (25%) vs one (4.2%) patient (P= 0.034), respectively. At the end of treatment and 6 months later, serum HCV RNA was no longer detectable in eight (33.3%) and five (20.8%) patients in the combination therapy group and in six (25%) and one (4.2%) patient in the IFN‐α therapy group, respectively. Three patients (12.5%) were withdrawn prematurely from combination therapy because of side‐effects; ribavirin therapy was ceased or dosage reduced in six other patients (25%), again because of side‐effects. In conclusion, this combination treatment was more effective than retreatment with IFN‐α, alone, in inducing sustained biochemical remission of chronic hepatitis C that was resistant to a previous course of IFN‐α. The combination treatment, however, was frequently associated with significant side‐effects.