BIOCHEMICAL AND VIROLOGICAL OUTCOME OF PATIENTS WITH CHRONIC HEPATITIS-C TREATED WITH INTERFERON ALFA-2B FOR 6 OR 12 MONTHS - A 4-YEAR FOLLOW-UP OF 211 PATIENTS

To compare two interferon (IFN) schedules for the treatment of chronic hepatitis C, we followed 211 patients who received 3 million units IF N-alpha 2b thrice weekly for either 6 months (group 1; 85 patients) or 12 months (group 2; 126 patients), with a median follow-up of 3.4 (0. 1-8.4) and 4.2 (0.7-8.7) years, respectively. The biochemical and viro logical responses at the end of treatment were 34.1% and 16.5% versus 62.7% and 41.2% for-the 6- and the 12-month regimens, respectively. La te biochemical responses (after the third month of treatment) occurred in 30.6% of responding patients, and they were not particularly assoc iated with an adverse long-term treatment outcome. In a multivariate a nalysis, patients with a primary response were significantly more freq uently infected with a non-lb HCV genotype (relative risk [RR]: 14.4), had been treated for 12 months (RR: 6.0), and had an early stage of l iver fibrosis (RR: 5.2), Baseline serum HCV-RNA and ferritin levels al so bore a significant, though weaker, association with a primary respo nse. Using a set of pretreatment variables in a model of discriminant analysis, we could correctly predict the long-term virological outcome in 86.6% of the individual cases, At the end of follow-up, a biochemi cal and virological sustained response was observed in 14.1% and 11.8% versus 40.5% and 31% of groups 1 and 2, respectively. Significantly p redictors of a virological sustained response were a virological prima ry response (RR: 41.2) and the pretreatment level of serum HCV-RNA (RR : 10.3 per each 10(6)-Eq/mL decrease), Patients with a ''good treatmen t profile,'' including an early stage of liver fibrosis, a non-1b geno type and serum HCV-RNA <0.35 X 10(6) Eq/mL, had a 66.7% rate of observ ed virological SR, compared with a zero response for those with the op posite, a ''bad treatment profile.'' We conclude chat a 12-month IFN t reatment, along with a non-1b genotype and the absence of advanced sta ge of fibrosis, are the main determinants for the induction of a virol ogical primary response in chronic hepatitis C. Such response, along w ith a low pretreatment serum HCV-RNA level, are the main predictors fo r a 4-year virological response to IFN.