A randomized, placebo-controlled study of the NS5B inhibitor beclabuvir with peginterferon/ribavirin for HCV genotype 1

Summary Beclabuvir is a potent, non‐nucleoside inhibitor of the HCV NS5B RNA polymerase, with nanomolar activity against HCV genotypes 1, 3, 4, 5 and 6 in vitro. This study evaluated the efficacy and safety of beclabuvir, in combination with peginterferon alfa‐2a (pegIFN) and ribavirin (RBV), in HCV...

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Bibliographic Details
Published in:Journal of viral hepatitis 2015-08, Vol.22 (8), p.658-664
Main Authors: Tatum, H., Thuluvath, P. J., Lawitz, E., Martorell, C., DeMicco, M., Cohen, S., Rustgi, V., Ravendhran, N., Ghalib, R., Hanson, J., Zamparo, J., Zhao, J., Cooney, E., Treitel, M., Hughes, E.
Format: Article
Language:English
Subjects:
Adult
all-oral regimen
Antiviral Agents - administration & dosage
Antiviral Agents - adverse effects
Benzazepines - administration & dosage
Benzazepines - adverse effects
direct-acting antiviral
Double-Blind Method
Drug Therapy, Combination - adverse effects
Drug Therapy, Combination - methods
Drug-Related Side Effects and Adverse Reactions - epidemiology
Drug-Related Side Effects and Adverse Reactions - pathology
Female
Genotype
Genotype & phenotype
Hepacivirus - classification
Hepacivirus - enzymology
Hepacivirus - genetics
Hepacivirus - isolation & purification
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - virology
HIV
Human immunodeficiency virus
Humans
IL28B non-CC
Indoles - administration & dosage
Indoles - adverse effects
Interferon-alpha - administration & dosage
Male
Middle Aged
NS5B polymerase inhibitor
Placebos - administration & dosage
Ribavirin - administration & dosage
RNA polymerase
Treatment Outcome
triple therapy
Viral Load
Viral Nonstructural Proteins - antagonists & inhibitors
Young Adult
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Summary:Summary Beclabuvir is a potent, non‐nucleoside inhibitor of the HCV NS5B RNA polymerase, with nanomolar activity against HCV genotypes 1, 3, 4, 5 and 6 in vitro. This study evaluated the efficacy and safety of beclabuvir, in combination with peginterferon alfa‐2a (pegIFN) and ribavirin (RBV), in HCV genotype 1. In this randomized (1:1:1), double‐blinded, placebo‐controlled, dose‐ranging phase 2a study, 39 treatment‐naive patients chronically infected with HCV genotype 1 were treated for 48 weeks with beclabuvir (75 mg or 150 mg) plus pegIFN (180 μg) and RBV (1000 mg/day [
ISSN:1352-0504
1365-2893
DOI:10.1111/jvh.12372