INTERFERON-ALPHA PLUS INDOMETHACIN COMBINED THERAPY IN HBEAG POSITIVECHRONIC HEPATITIS-B NONRESPONDER TO A PREVIOUS IFN-ALPHA COURSE - RESULTS OF A PILOT-STUDY

Background: interferon-alpha is able to induce a sustained inhibition of hepatitis B virus replication in about 30-40% of patients with chro nic hepatitis B. There is evidence that non-steroidal antiinflammatory drugs can enhance the synthesis of antiviral proteins induced by inte rferon-alpha. Aim: to evaluate the efficacy and tolerability of combin ed therapy with interferon-alpha plus indomethacin in HBeAg and HBV-DN A positive patients affected by chronic active hepatitis non-responder s to a previous interferon-alpha treatment. Methods: after six months of retreatment with interferon-alpha (6 MU thrice weekly) six patients were enrolled, without stopping the therapy, to receive interferon-al pha (with the same schedule) plus indomethacin (25 mg orally twice dai ly) for an additional six month course. Results: at the end of treatme nt and after six months of follow-up alanine transaminase normalinatio n was seen in three (50%) and four (66.7%) patients, HBV-DNA loss in o ne (17%) and three (50%), HBeAg/HBeAb serum conversion in one (17%) an d two (33%), respectively. The combined therapy was well tolerated and no indomethacin side-effects were observed. The treatment was stopped in one patient after 4 months because of a remarkable increase of ala nine transaminase levels, and in another after five months because of hyperthyroidism occurrence. Conclusions: the results of this study, ev en if obtained in a small number of patients, are encouraging and sugg est a randomized controlled trial to be confirmed.