Thymosin alpha 1 in combination with interferon alpha and ribavirin in chronic hepatitis C patients who are non-responders or relapsers to interferon alpha plus ribavirin.

OBJECTIVE: Interferon alpha (IFN-alpha) with or without ribavirin is an approved therapy for patients with chronic hepatitis C. However, a sustained response is achieved in less than 40% of all treated cases. Retreatment of relapsers or non-responders usually fails. Thymosin alpha 1 (Ta-1) is a polypeptide with immunomodulatory properties that has been suggested to increase response rates in patients with chronic hepatitis C. The aim of present study was to evaluate the efficacy of a novel triple regimen which includes Ta-1 for relapsers and non-responders to the combination of TA-1 and ribavirin. METHODS: In the present study, 11 patients who relapsed (n=5) or did not respond (n=6) to previous INF-alpha-based therapy were retreated with combination Ta-1, INF-alpha and ribavirin for 12 months, and followed up for a further six months. RESULTS: Four out of five relapsers had a sustained response. One of the non-responders cleared the HCV RNA during the post-treatment follow-up. Minor adverse effects were observed during treatment with this combination therapy and no dose reduction or discontinuations were needed. CONCLUSION: This data suggests that thymosin alpha 1 may add to the efficacy of INF-alpha plus ribavirin in the retreatment of relapsers or non-responders to previous INF-alpha-based hepatitis C therapy.