COMBINATION LOW-DOSE LYMPHOBLASTOID INTERFERON AND THYMOSIN ALPHA(1) THERAPY IN THE TREATMENT OF CHRONIC HEPATITIS-B

This Open label study was initiated to assess the safety and efficacy of lymphoblastoid interferon-alpha (IFN-alpha) and thymosin alpha(1) ( T alpha(1)) in the treatment of 11 patients with chronic hepatitis B, who had failed to respond to standard IFN-alpha 2b therapy, and in fou r interferon naive patients, These fifteen hepatitis B surface antigen (HBsAg) positive and serum hepatitis B virus (HBV) DNA positive patie nts were given T alpha(1) (1 mg) subcutaneously (sc) on 4 consecutive days. Low-dose lymphoblastoid IFN-alpha (3 MU) was administered intram uscularly (TM) on the fourth day, Beginning with the second and for th e subsequent 25 weeks, patients self-administered T alpha(1) twice wee kly in the morning followed, 12 h later, by 3 million units (MU) lymph oblastoid IFN-alpha, Patients were followed-up for 12 months. Nine (60 %) of the 15 patients, including six (55%) of the 11 patients previous ly treated with IFN-alpha 2b, responded by losing serum HBV DNA and no rmalizing alanine aminotransferase (ALT) values, Six of the nine respo nders seroconverted to HBsAg negativity, Significant improvements in t he Knodell histological activity index were observed in the responders and no significant adverse effects were observed, Combination low-dos e lymphoblastoid IFN-alpha and T alpha(1) treatment may provide a safe and potentially effective therapeutic approach in chronic hepatitis B . These results require confirmation in future randomized controlled s tudies.