RIBAVIRIN TREATMENT FOR PATIENTS WITH CHRONIC HEPATITIS-C - RESULTS OF A PLACEBO-CONTROLLED STUDY

Background/Aims: Small, uncontrolled studies of ribavirin for patients with chronic hepatitis C have reported efficacy in chronic hepatitis C. We have evaluated the efficacy and safety of a 24-week course of or al ribavirin in patients with chronic hepatitis C, compared to placebo . Methods: A total of 114 patients were randomised to ribavirin or pla cebo, Ribavirin was administered in doses of 1000 or 1200 mg/day for 2 4 weeks. Efficacy was determined in the intention-to-treat population: 76 received ribavirin and 38 placebo. Results: Ribavirin was signific antly more effective than placebo in reducing and normalising serum AL T levels: 42/76 (55%) of ribavirin-treated patients vs 2/38 (5%) place bo recipients had either normalisation of the ALT levels or a reductio n from baseline of at least 50% (p<0.001), ALT levels were normal in 2 2/76 (29%) of ribavirin-treated patients vs 0/38 placebo recipients (p <0.001). Twenty-four weeks after stopping ribavirin, the majority of p atients had abnormal ALT levels, There was no difference between the t reatment groups in reduction or disappearance of HCV-RNA levels, HCV R NA disappeared during treatment in 3% of ribavirin-treated patients an d 3% of placebo recipients, More ribavirin than placebo patients showe d improvement in total Knodell score (45% vs 31%), but these differenc es were not statistically significant, Analysis of each component of a histology activity index revealed no statistically significant differ ences between treatment groups, Ribavirin patients had fewer lymphoid aggregates than did placebo recipients at the post-treatment assessmen t (p=0.05), Ribavirin was associated with reversible haemolytic anaemi a: a fall in haemoglobin occurred in 3% of placebo- and 32% (25/78) of ribavirin-treated patients, respectively (p<0.001). Conclusions: Thes e data indicate that ribavirin was no more effective than placebo in r educing or eliminating HCV-RNA levels, and was not significantly more effective than placebo in improving hepatic histology after 6 months o f treatment, The role of a 6-month treatment of chronic hepatitis C wi th ribavirin alone, without a significant effect on HCV RNA, is theref ore limited.