TENOXICAM, A NONSTEROID ANTIINFLAMMATORY DRUG, IS UNABLE TO INCREASE THE RESPONSE RATE IN PATIENTS WITH CHRONIC HEPATITIS-C TREATED BY ALPHA-INTERFERON

The purpose of this study is to compare a combination of interferon (I FN)-alpha(2)a (Roferon) + Tenoxicam with IFN-alpha(2)a alone in the tr eatment of chronic hepatitis C. This prospective, randomized double-bl ind study included 149 patients, all of whom were diagnosed with activ e chronic hepatitis C but non-cirrhotic (ALT greater than or equal to 1.5 upper limit of normal, anti-hepatitis C virus (HCV) positive by en zyme-linked immunosorbant assay, and RIBA(3)). The patients were rando mized in two groups, as follows: G1 (n = 76): IFN alpha(2)a 3 million units times per week during 6 months + placebo; and G2 (n = 73): IFN a lpha(2)a 3 million units three times per week + Tenoxicam (20 mg/day) during 6 months. Alanine aminotransferase (ALT) and HCV RNA were deter mined before and at months 6 and 12 of treatment. 2'5' oligoadenylate synthetase activity (2'5' AS) was dosed in mononuclear cells before an d at 3-month treatment intervals in 28 patients. Liver biopsy was perf ormed before and 6 months after the end of therapy. Parameters were si milar before therapy for both groups. Biochemical and virological resp onses were similar for both groups at month 6 (49.3% vs. 42.9% and 43. 3% vs. 38.3%, respectively) and month 12 (28.3% vs. 23.8% and 17.2% vs . 17.5%, respectively). HCV RNA level significantly decreased in both groups at month 6, with no difference whatever the therapy; however, t he HCV RNA level returned to initial values at month 12 and was the on ly significant prognostic factor of a sustained response. No peak of 2 '5' AS activity was observed during treatment in patients with dual th erapy. A histological improvement was also noted in both groups withou t difference, regardless of therapy. The percentage of adverse events was identical for both groups. Paracetamol intake, assessed in 80 pati ents, was 49.1 g per 6 months in the G1 group and 22.5 g per 6 months in the G2 group (not significant). In conclusion, the non-steroid anti -inflammatory drug, Tenoxicam, does not increase IFN alpha efficacy in the treatment of chronic hepatitis C. This combination is well tolera ted and partially lowers Paracetamol intake, but not preexisting alpha -IFN adverse events.