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- Title
A randomized trial of high-dose interferon alpha-2b, with or without ribavirin, in chronic hepatitis C patients who have not responded to standard dose interferon.
- Authors
Malik, A. H.; Kumar, K. S.; Malet, P. F.; Ostapowicz, G.; Adams, G.; Wood, M.; Yarbrough, K.; Jones, A.; Lee, W. M.
- Abstract
Background: Conventional interferon monotherapy fails to achieve virological clearance in most hepatitis C-infected patients. The use of high-dose induction regimens may improve the initial clearance of virus, while the addition of ribavirin appears to improve the rates of sustained response once clearance is achieved. Aim: To compare the efficacy and safety of re-treatment with an induction regimen of high-dose interferon alpha-2b, with or without ribavirin, in chronic hepatitis C patients who have not responded to standard dose interferon monotherapy. Methods: Previous virological non-responders to standard dose interferon (3–5 MU three times weekly for ≥ 12 weeks) were randomized to receive, unblind, either 10 MU interferon alpha-2b daily for 10 days, then 5 MU daily for 74 days, then 5 MU three times weekly for 24 weeks (total 36 weeks) (group A), or the above regimen with the addition of ribavirin, 1000–1200 mg/day, at day 11 (group B). All patients were followed up for 24 weeks after completion of therapy. Results: End of treatment virological response was noted in one of 10 (10%) patients in group A and in eight of 15 (54%) patients in group B (P =0.04). The sole end treatment responder in group A and three in group B relapsed on follow-up. The apparent improvement in response in group B compared to group A nearly reached statistical significance (group B 5/15 vs. group A 0/10; P =0.06). Conclusions: In this small pilot study, a 36-week high-dose induction interferon monotherapy protocol did not yield sustained responses in previous non-responders to standard dose interferon. However, the same regimen with ribavirin yielded a 33% sustained response rate, nearly reaching statistical significance. The therapy was well tolerated, despite the higher doses of interferon used and the addition of ribavirin. High-dose interferon with ribavirin appears to be a therapeutic option for non-responders to conventional interferon monotherapy.
- Subjects
RIBAVIRIN; INTERFERONS; HEPATITIS C; PATIENTS
- Publication
Alimentary Pharmacology & Therapeutics, 2002, Vol 16, Issue 3, p381
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1046/j.1365-2036.2002.01201.x