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Thymosin‐ α 1 plus interferon‐ α for naive patients with chronic hepatitis C: results of a randomized controlled pilot trial
Author(s) -
Andreone P.,
Gramenzi A.,
Cursaro C.,
Felline F.,
Loggi E.,
D'Errico A.,
Spinosa M.,
Lorenzini S.,
Biselli M.,
Bernardi M.
Publication year - 2004
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1046/j.1365-2893.2003.00470.x
Subject(s) - medicine , thymosin , alpha interferon , alpha (finance) , interferon , gastroenterology , hepatitis c , chronic hepatitis , randomized controlled trial , hepatitis c virus , immune system , interferon alfa , immunology , virus , surgery , construct validity , patient satisfaction
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‐ α 2b (3 million units three times a week) plus thymosin‐ α l (900 μ g/m 2 body surface area) and 19 received interferon‐ α 2b 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.