REINFORCED REGIMEN OF INTERFERON ALPHA-2A REDUCES THE INCIDENCE OF CIRRHOSIS IN PATIENTS WITH CHRONIC HEPATITIS-C - A MULTICENTER RANDOMIZED TRIAL

Background/Aims: Our aim was to assess and compare the long-term effec t of interferon at standard (6 months) and reinforced dose and duratio n regimens in chronic hepatitis C. Methods: A multicentre institutiona l trial included 244 previously untreated patients with chronic hepati tis C, without cirrhosis, who were randomly allocated to either standa rd (3 MU thrice a meek for 24 weeks; n=120) or reinforced (6 MU daily for 12 days, 6 MU thrice a week for 22 weeks, 3 MU thrice a week for 2 4 weeks; n=124) regimens. The main endpoint was sustained ALT response at 72 weeks (18 months); secondary end-points mere virological (branc hed DNA and PCR) and histological responses (incidence of cirrhosis) a t month 18. Results: Sustained ALT response was observed in five patie nts (4%, 95% confidence interval 0-8%) in the standard group and in 21 patients (18%, 95% confidence interval 11-25%), from the reinforced g roup (p=0.002), in agreement with virological response in 21 (81%) pat ients. Cirrhosis at month 18 was observed in ten (10%) patients in the standard group and one (1%) in the reinforced group (p=0.004). Conclu sions: The standard regimen of interferon, in chronic hepatitis C, con fers a minimal sustained response rate at 18 months and may not preven t the occurrence of cirrhosis. Reinforced regimens allow sustained res ponse to be reached in a limited number of patients and reduce the ris k of cirrhosis during 18 months of follow-up.