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Combination low‐dose lymphoblastoid interferon and thymosin α 1 therapy in the treatment of chronic hepatitis B
Author(s) -
Rasi G.,
Mutchnick M. G.,
Virgilio D. Di,
SinibaldiVallebona P.,
Pierimarchi P.,
Colella F.,
Favalli C.,
Garaci E.
Publication year - 1996
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 - 10.1111/j.1365-2893.1996.tb00094.x
Subject(s) - medicine , hbsag , gastroenterology , lymphoblast , thymosin , interferon , hepatitis b , hepatitis b virus , immunology , alpha interferon , virus , biology , genetics , cell culture
SUMMARY. This open label study was initiated to assess the safety and efficacy of lymphoblastoid interferon‐α (IFN‐α) and thymosin α 1 (Tα 1 ) in the treatment of 11 patients with chronic hepatitis B, who had failed to respond to standard IFN‐α2b therapy, and in four interferon naive patients. These fifteen hepatitis B surface antigen (HBsAg) positive and serum hepatitis B virus (HBV) DNA positive patients were given Tα 1 (1 mg) subcutaneously (sc) on 4 consecutive days. Low‐dose lymphoblastoid IFN‐α (3 MU) was administered intramuscularly (IM) on the fourth day. Beginning with the second and for the subsequent 25 weeks, patients self‐administered Tα 1 twice weekly in the morning followed, 12 h later, by 3 million units (MU) lymphoblastoid IFN‐α. Patients were followed‐up for 12 months. Nine (60%) of the 15 patients, including six (55%) of the 11 patients previously treated with IFN‐α2b, responded by losing serum HBV DNA and normalizing alanine aminotransferase (ALT) values. Six of the nine responders seroconverted to HBsAg negativity. Significant improvements in the Knodell histological activity index were observed in the responders and no significant adverse effects were observed. Combination low‐dose lymphoblastoid IFN‐α and Tα 1 treatment may provide a safe and potentially effective therapeutic approach in chronic hepatitis B. These results require confirmation in future randomized controlled studies.