PRELIMINARY-RESULTS OF THYMOSIN-ALPHA-1 VERSUS IFN-ALPHA TREATMENT INPATIENTS WITH HBEAG NEGATIVE AND HBV-DNA POSITIVE CHRONIC ACTIVE HEPATITIS

Thymosin-alpha 1 (T alpha 1) is a thymic hormone that has been demonst rated to induce disease remission and inhibition of hepatitis B virus (HBV) replication in patients affected by chronic active hepatitis (CA H). A randomized pilot trial was started of T alpha 1 treatment versus IFN-alpha in patients with histologically and serologically proven HB eAb and HBV-DNA positive CAH. To date, 15 patients have been enrolled in the study and randomly assigned to receive for 6 months either T al pha 1 at 900 mu glm(2) body surface area twice weekly (n=8), or IFN-al pha at 5 million units three times a week (n=7). All patients complete d the treatment period, but only 6 (3 in the T alpha 1 group and 3 in the IFN group) have completed 3 months of follow-up. ALT normalization was observed in 50% of T alpha 1 and in 42% of IFN treated patients, while HBV-DNA loss was obtained in 50% and 75% patients respectively. After 3 months of follow-up, 33% of T alpha 1 and 100% of IFN treated patients showed ALT flares, while HBV-DNA redeveloped in 33% and 0% re spectively. Unlike IFN-alpha, treatment with T alpha 1 was well tolera ted in all patients. The results of this study, even if preliminary an d on a small number of patients, confirm that T alpha 1 is able to ind uce the inhibition of HBV replication also in patients affected by HBe Ab positive CAH. If confirmed by further studies, this drug should be considered as a valid alternative to IFN-alpha, in particular for its excellent tolerability.