Long-term response to interferon plus ribavirin in patients with chronic hepatitis C refractory to interferon

Objective: a sustained response (SR) to interferon (IFN) is only observed i n 15-20% of patients with chronic hepatitis C (CHC). The aim of this study was to determine the long-term effectiveness and safety of the treatment wi th IFN plus ribavirin (RIB) over two years in CHC patients without SR to IF N. Design: a prospective and open longitudinal follow-up study was conducted o ver 3 years. Patients and methods: a total of 77 CHC patients were included : 63 non-responders (NR) and 14 relapsers (R) to IFN. Patients were treated with IFN (3 MU sc three times a week) and RIB (1,000- 1,200 mg po daily) for 12 months. Treatment tolerance and viral response (H CV-RNA in serum <1,000 copies/ml) were assessed after 1, 3, 6 and 12 months of treatment. SR and relapsing rates were subsequently evaluated 6, 12 and 24 months after the end of the treatment, together with those variables ca pable of predicting SR. Results: at the end of the treatment, 19/77 patients responded (24.7%), 9/6 3 (14.3%) were non-responders and 10/14 (71.4%) relapsers, and these same p atients exhibited SR after 6 months, The SR rate two years after treatment was 22.1% [8/63 (12.7%) NR and 9/14 (64.3%) R]. The relapse rate after 6 mo nths and two years was respectively 0 and 10.5% (2/77). Independent variabl es capable of predicting SR were negative viremia conversion within the fir st month of treatment, maintenance of such negative viremia after 6 months, and R status to IFN. Side effects were recorded in 90.9% of cases (70/77), the most frequent being pseudoinfluenza syndrome. Treatment had to be disc ontinued in 33.8% of patients (26/77). Conclusions: combined IFN-RIB therapy for 12 months in CHC patients without SR to IFN obtains a long-term SR of 22.1%, this rate being higher in relap sers to prior IFN therapy (64.3% in R versus 12.7% in NR).