Abstract
Background
Benefit of adding amantadine to antiviral therapy for hepatitis C is controversial.
Aims
We aimed to examine whether such policy enhances sustained viral response in treatment-naïve
patients.
Methods
297 naïve hepatitis C patients were randomized for treatment with amantadine 200 mg or placebo, combined with weight-based ribavirin and 12-day high-dose interferon
alpha-2b induction therapy, followed by PEG-interferon alpha-2b (1.5 μg/kg/week up to 26 weeks and thereafter, 1.0 μg/kg/week until week 52). Treatment was discontinued if hepatitis C virus (HCV) RNA
was positive at week 24.
Results
49% of patients were (former) drug users. Genotype 1 occurred in 45%, high viral load
in 70% and severe fibrosis/cirrhosis in 32%, without differences between amantadine
or placebo groups. 90 patients prematurely discontinued treatment, mainly because
of grade 3 or 4 toxicity. Intention-to-treat analysis revealed sustained viral response
in 47% and 51% of amantadine and placebo groups (p = 0.49). Amantadine did not enhance sustained viral response in patients with genotype
1 or high viral load nor did it improve primary non-response, breakthrough or relapse
rates. Genotype non-1 and lower pre-treatment γGT levels were independent predictors
for sustained viral response.
Conclusion
Adding amantadine to antiviral therapy of previously untreated chronic hepatitis C
patients has no beneficial effects.
Keywords
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Article info
Publication history
Published online: December 17, 2009
Accepted:
October 28,
2009
Received:
January 11,
2009
Footnotes
☆This investigator-driven study was supported by a grant by Schering-Plough BV, Maarssen, The Netherlands.
Identification
Copyright
© 2009 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Inc. All rights reserved.
