A COMPARISON OF 3 INTERFERON ALFA-2B REGIMENS FOR THE LONG-TERM TREATMENT OF CHRONIC NON-A, NON-B-HEPATITIS

Background. We studied the effects of long-term treatment with interfe ron on histologic features of the liver and serum alanine aminotransfe rase concentrations in patients with chronic non-A, non-B hepatitis. M ethods. Consecutive patients who met the inclusion criteria were enrol led in the study, The diagnosis of chronic non-A, non-B hepatitis was established on the basis of the liver-biopsy findings and an abnormal serum alanine aminotransferase value (more than 1.5 times the normal v alue) for at least one year. All patients were treated for 6 months wi th 3 million units of interferon alfa-2b given subcutaneously three ti mes a week and were then randomly assigned to the same treatment for a n additional 12 months (group 1), a regimen of 1 million units three t imes a week for 12 months (group 2), or no further treatment (group 3) . Patients in group 3 who had elevated serum alanine aminotransferase concentrations for three consecutive months underwent the initial regi men once again. Follow-up continued for two years after the discontinu ation of treatment. Histologic improvement was defined as a decrease o f at least one point in the score for necroinflammatory activity (0, n o activity; 1, mild; 2, moderate; or 3, severe) between the first live r biopsy and a biopsy performed at 18 months. Results. Of the 329 pati ents initially treated, 303 were randomized: 103 to group 1, 101 to gr oup 2, and 99 to group 3. Of the 286 patients tested, 252 (88.1 percen t) had antibodies to hepatitis C virus. In an intention-to-treat analy sis, 46 of the patients in group 1 (44.7 percent) had normal serum ala nine aminotransferase values at 18 months, as compared with 27 of the patients in group 2 (26.7 percent, P=0.008) and 30 of those in group 3 (30.3 percent, P=0.04). Between 19 and 42 months, 23 of the patients in group 1 (22.3 percent) continued to have normal serum alanine amino transferase values (measured every 6 months), as compared with 10 of t he patients in group 2 (9.9 percent, P=0.02) and 8 of those in group 3 (8.1 percent, P=0.005). Among the 176 patients with repeated liver bi opsies at 18 months, more patients in group 1 had improved histologic- activity scores (69.6 percent) than in group 2 (47.6 percent, P=0.02) or group 3 (38.6 percent, P<0.001). Conclusions. Among patients with c hronic non-A, non-B hepatitis, a regimen of 3 million units of interfe ron alfa-2b given three times a week for 18 months produced better his tologic findings and serum alanine aminotransferase values than regime ns involving a lower dose or a shorter duration of treatment.