Conventional interferon mono-therapy fails to achieve virological clearance in most hepatitis C-infected patients.
The use of high-dose induction regimens has been suggested to improve the initial clearance of virus, while the addition of ribavirin appears to improve the rates of sustained response once clearance is achieved.
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 mono-therapy was assessed by Dr A.H. Malik and colleagues.
The research group, based at the Division of Digestive and Liver Diseases at the University of Texas Southwestern Medical Center in Dallas, Texas, USA, recruited previous virological non-responders to standard dose interferon (3-5 MU three times weekly for 12 weeks).
These patients were randomized into two groups, A and B.
Group A received, unblind, 10 MU interferon alpha-2b daily for 10 weeks, then 5 MU daily for 74 days, then 5 MU three times weekly for 24 weeks (total 36 weeks)
|Interferon alpha-2b plus ribavirin - 33% sustained response rate|
|Alimentary Pharmacology and Therapeutics|
The second group received 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.
At the end of treatment, the virological response was noted in one of ten (10%) patients in Group A and in 8 of 15 (54%) patients in Group B.
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).
The research group concluded that a 36-week high-dose induction interferon mono-therapy 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.
Dr Malik, speaking on behalf of his fellow authors, commented, "The therapy was well tolerated, despite the higher doses of interferon used and the addition of ribavirin.
He concluded, "High-dose interferon with ribavirin appears to be a therapeutic option for non-responders to conventional interferon mono-therapy."