Interferon-alpha 2a Ribavirin versus Interferon- alpha 2a alone for the retreatment of hepatitis C patients who relapse after a standard course of Interferon

Aim. To compare the efficacy of a descalating dose of interferon (48 weeks) versus a combination therapy of interferon and ribavirin (24 weeks) in hep atitis C positive subjects who relapsed within six months of cessation of a standard six month course of interferon three million units thrice weekly. Methods. All 32 subjects had biopsy proven chronic hepatitis C, were PCR po sitive and had elevated transaminase enzymes at least one and a half times the upper limit of normal. Subjects were randomly assigned to either a desc alating dose of interferon-alpha-2a six million units thrice weekly for 24 weeks followed by 3 MIU 3x for 24 weeks or interferon three million units t hrice weekly for 24 weeks plus ribavirin 1000 mg/day for 12 weeks. A comple te virological response was defined as a negative PCR for HCV RNA at 24 wee ks after cessation of therapy. Results. Sixteen patients were assigned to each arm and the sustained virol ogical response was 50% for both the interferon and combination therapy arm (pNS). The biochemical response correlated with the virological response; 7/8 virological responders in the interferon alone had normalisation of tra nsaminase 24 weeks post treatment as did 8/8 of those in the combination ar m. One patient withdrew from treatment in the descalating interferon group and three required dose reduction. No subjects in the combination arm disco ntinued therapy but dose reduction was required in three subjects. Conclusion. High dose descalating interferon-alpha 2a and a combination of interferon-alpha 2a and ribavirin were effective in achieving a sustained v irological response in 50% of subjects who had relapsed after a standard si x month course of interferon.