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    Short-duration treatment with the novel non-nucleoside inhibitor CDI-31244 plus sofosbuvir/velpatasvir for chronic hepatitis C: An open-label study.

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    Author
    Chua, Joel V
    Ntem-Mensah, Afua
    Abutaleb, Ameer
    Husson, Jennifer
    Mutumbi, Lydiah
    Lam, Ka Wing
    Ghosh, Alip
    Romani, Sara
    Poonia, Bhawna
    Lee, Sam
    Luz Pascual, M
    Frumkin, Lyn R
    Kottilil, Shyamsundaran
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    Date
    2020-11-05
    Journal
    Journal of Medical Virology
    Publisher
    Wiley-Blackwell
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1002/jmv.26652
    Abstract
    Combination regimens of direct-acting antiviral agents (DAAs) for chronic genotype 1 hepatitis C virus (HCV) infection given for 8 or 12 weeks have high cure rates. Shortened treatment durations that maintain high cure rates may lessen treatment barriers related to affordability and drug adherence. We enrolled 12 treatment-naïve adults with chronic genotype 1 HCV infection without cirrhosis in a single-center, open-label trial to receive 2 weeks of the highly potent and selective non-nucleoside inhibitor (NNI) CDI-31244 concurrent with 6 weeks of sofosbuvir/velpatasvir. The main efficacy endpoints were sustained virologic response at 12 (SVR12) and 24 (SVR24) weeks after treatment completion. In all patients, plasma HCV RNA levels rapidly decreased during the first 2 days of treatment and were below the lower limit of quantification by the end of the 6-week treatment period. Eight of 12 (67%) patients achieved both SVR12 and SVR24. Four patients had virological relapse at Week 10, 4 weeks after end of treatment. The most common adverse event was headache, occurring in five (42%) patients. Pharmacokinetic analysis showed no relevant drug interactions between CDI-31244, sofosbuvir, and velpatasvir. In this pilot study of short-duration combination therapy involving a novel NNI with a fixed-combination DAA, 8 of 12 treatment-naïve patients with chronic genotype 1 HCV infection without cirrhosis achieved virologic cure. Future trials might evaluate whether extending the NNI duration beyond 2 weeks with combination DAAs results in higher cure rates comparable with currently approved longer duration therapy.
    Rights/Terms
    © 2020 The Authors. Journal of Medical Virology published by Wiley Periodicals LLC.
    Keyword
    chronic hepatitis C
    clinical trial
    direct-acting antiviral
    therapeutics
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/14194
    ae974a485f413a2113503eed53cd6c53
    10.1002/jmv.26652
    Scopus Count
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