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Thymosin-α 1 plus interferon-α for naive patients with chronic hepatitis C: results of a randomized controlled pilot trial


Pietro Andreone MD, Dipartimento di Medicina Interna, Cardioangiologia ed Epatologia, Policlinico S.Orsola, Via Massarenti, 9, 40138 Bologna, Italy.


Summary.  In this pilot study, we evaluated the efficacy of interferon-α (IFN) plus Thymosin-α 1 (TA1) to that of IFN alone in naive patients with chronic hepatitis C. Twenty-two patients were randomized to receive interferon-α2b (3 million units three times a week) plus thymosin-α l (900 μg/m2 body surface area) and 19 received interferon-α2b alone at the same dose. Patients were treated for 6 months and followed up for another 6 months. Biochemical (alanine aminotransferase values) and virological (hepatitis C virus-RNA) responses to treatment were determined. Combination treatment showed significantly higher efficacy than monotherapy in achieving virological end-of-treatment response (P = 0.03). At 6-month follow up, the sustained biochemical and virological response was not different between the two groups. Our results indicate that the immune modulator TA1 may enhance the end-of-treatment response in naive patients with chronic hepatitis C. Higher doses and/ore more prolonged courses as well as the association with new interferon formulation such as pegylated interferons could improve the sustained response rates to this treatment.