Efficacy of Ribavirin Monotherapy Following Combination Therapy with Interferon Alfa-2b (Intron A) and Ribavirin in Patients with Chronic Hepatitis C

Reappearance of HCV RNA followed by exacerbation of biochemical parameters after combination therapy consisting of [standard] interferon and ribavirin is an obstacle to achieving a sustained response (SVR) and improving long-term prognosis.

In the current study, Japanese researchers hypothesized that ribavirin monotherapy after 6 months of combination therapy might improve sustained viral and biochemical responses.

They conducted a prospective, randomized and controlled study. Thirty-eight patients with chronic hepatitis C treated with combination therapy for 6 months and who at end of treatment had no detectable serum HCV RNA were enrolled and allocated into two arms. 

Group I (n = 19) was continuously administered oral ribavirin for an additional 6 months, and group II (n = 19) was followed up without any further treatment.

Results

·  At the end of the trial, HCV RNA negativity was 11/19 (58%) in group I, and 6/19 (32%) in group II (p = 0.191). Multivariate analysis demonstrated that ribavirin monotherapy was not a predictor for the eradication of HCV RNA.

·  In cases without sustained viral responses, serum ALT levels at baseline and at the end of 48 weeks’ trial were 54.6 and 44.4 in group I (p = 0.237).

·  A significant reduction in ALT levels following ribavirin monotherapy was not observed.

The authors conclude, “Ribavirin monotherapy following combination therapy fails to improve sustained viral response as well as biochemical response.”

The outcome of this trial is a reminder that for best results, relapsers and nonresponders to standard interferon plus ribavirin should be retreated with peginterferon monotherapy or peginterferon/ribavirin.

Teikyo University School of Medicine; Ankoh Medical Center; Akabane Central Hospital; and Tokyo Musashino Hospital, Tokyo, Japan.

06/10/05

Reference
R Nagayama. Efficacy of ribavirin monotherapy following combination therapy with interferon alfa-2b and ribavirin for patients with chronic hepatitis C. Hepatology Research. Posted online May 3, 2005.


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