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Induction interferon and ribavirin for re‐treatment of chronic hepatitis C patients unresponsive to interferon alone
Author(s) -
Sievert W.,
Batey R.,
Mollison L.,
Pianko S.,
Mcdonald J.,
Marinos G.,
Reed W.,
Warner S.,
Bowden S.,
De Solom R.,
Bhathal P.
Publication year - 2003
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2003.01544.x
Subject(s) - ribavirin , medicine , gastroenterology , interferon , odds ratio , regimen , alpha interferon , hepatitis c , confidence interval , placebo , interferon alfa , hepatitis c virus , immunology , virus , pathology , alternative medicine
Summary Background : The optimal treatment for hepatitis C patients unresponsive to interferon is unclear. High‐dose induction interferon may enhance early viral clearance, whilst ribavirin reduces relapse; in combination, they may improve sustained virological response rates. Aim : To compare the efficacy and safety of re‐treatment with interferon induction, with or without ribavirin, in interferon non‐responders. Methods : We randomized 218 biochemical interferon non‐responders to 10 MU interferon α2b daily for 4 weeks, followed by 5 MU thrice weekly for 48 weeks plus ribavirin (II + R), or to the same interferon regimen plus placebo (II + P). All patients were viraemic at entry. Results : The sustained virological response in the II + R group was 39%[95% confidence interval (CI), 30–48%], compared with 16% (95% CI, 9–23%) in the II + P group ( P < 0.002). The study drug was discontinued for intolerable symptoms during induction in 9% of the II + R group and in 5% of the II + P group. By logistic regression, a sustained virological response was more likely following II + R treatment (odds ratio, 4.4; 95% CI, 2.1–9.7) and less likely in patients with genotype 1 or 4 (odds ratio, 0.16; 95% CI, 0.07–0.36). Conclusion : High‐dose induction interferon plus ribavirin is well tolerated and effective for patients unresponsive to interferon alone.