2 DOSE REGIMENS OF RECOMBINANT INTERFERON-ALPHA-2B IN CHRONIC HEPATITIS-C VIRUS-INFECTION - BIOCHEMISTRY, HEPATITIS-C VIRUS RNA, AND LIVER HISTOLOGY AS RESPONSE INDICES

Background: Recombinant interferon remains the cornerstone of treatmen t of chronic hepatitis C virus (HCV) infection. Still, evaluation of t reatment on the basis of response indicators and long-term effect of t he treatment raises several questions. Methods: Seventy-four patients with chronic HCV infection were randomized to a high (3 MIU, 3/7 days) or low (1 MIU, 3/7 days) dose of recombinant interferon-alpha-2b for 48 weeks after a 4-week course of 3 MIU, 3/7 days. Response to treatme nt was assessed by means of liver enzymes (transaminases), HCV RNA, an d liver histology. Results: The higher maintenance dose was associated with a significantly higher rate of sustained alanine aminotransferas e (ALAT) response (45% versus 19%) and with a significantly better cha nce of becoming HCV RNA-negative during therapy (47% versus 23%). In t he high maintenance dose group 14 of the 29 (48%) patients with availa ble HCV RNA data were negative at the 3-month follow-up, compared with 4 of 27 (15%) in the low maintenance dose group. Significantly more p atients had improved liver biopsy findings after interferon in the hig h maintenance dose group (79%) than in the low maintenance dose group (36%). There was a close correlation between ALAT response and HCV RNA response. Of 17 patients who were HCV RNA-negative 3 months after the end of treatment, 10 remained HCV RNA-negative 2-4 years later. Concl usion: The study demonstrates a higher response rate as assessed by bi ochemistry, HCV RNA, and liver histology in the higher dose group.