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 (1.5μg/kg/week up to 26 weeks and thereafter, 1.0μg/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.

Additional Metadata
Keywords Amantadine, Hepatitis C, PEG-interferon, Ribavirin, adult, agranulocytosis, alpha2b interferon, amantadine, anemia, anorexia, article, catatonia, chill, chronic obstructive lung disease, clinical trial, controlled clinical trial, controlled study, depression, diarrhea, disease exacerbation, dizziness, double blind procedure, drug dose reduction, drug effect, drug induced headache, drug megadose, drug withdrawal, fatigue, female, fever, gamma glutamyltransferase, gastroenteritis, genotype, health care policy, hepatitis C, human, inner ear perianal abscess, placebo, priority journal, pruritus, randomized controlled trial, relapse, retina vein occlusion, rhabdomyolysis, ribavirin, side effect, sleep disorder, thrombocytopenia, thyroid disease, toxic hepatitis, treatment response, virus RNA, virus load
Persistent URL dx.doi.org/10.1016/j.dld.2009.10.006, hdl.handle.net/1765/21159
Citation
van Soest, H., van der Schaar, P.J., Koek, G.H., de Vries, R.A., Ooteghem, N.A., van Hoek, B., … Boland, G.J.. (2010). No beneficial effects of amantadine in treatment of chronic hepatitis C patients. Digestive and Liver Disease, 42(7), 496–502. doi:10.1016/j.dld.2009.10.006