TY - JOUR
T1 - No beneficial effects of amantadine in treatment of chronic hepatitis C patients
AU - van Soest, Hanneke
AU - van der Schaar, Peter J.
AU - Koek, Ger H.
AU - de Vries, Richard A.
AU - van Ooteghem, Nancy A.
AU - van Hoek, Bart
AU - Drenth, Joost P. H.
AU - Vrolijk, Jan M.
AU - Lieverse, Rob J.
AU - Houben, Peter
AU - van der Sluys Veer, Annet
AU - Siersema, Peter D.
AU - Schipper, Marguerite E. I.
AU - van Erpecum, Karel J.
AU - Boland, Greet J.
PY - 2010/7
Y1 - 2010/7
N2 - 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. © 2009 Editrice Gastroenterologica Italiana S.r.l.
AB - 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. © 2009 Editrice Gastroenterologica Italiana S.r.l.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=77955554384&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/20018575
U2 - https://doi.org/10.1016/j.dld.2009.10.006
DO - https://doi.org/10.1016/j.dld.2009.10.006
M3 - Article
C2 - 20018575
SN - 1590-8658
VL - 42
SP - 496
EP - 502
JO - Digestive and liver disease
JF - Digestive and liver disease
IS - 7
ER -