Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild-moderate fibrosis: Results from a real-world cohort

Marc Puigvehí, Beatriz De Cuenca, Ana Viu, Moisés Diago, Juan Turnes, Francisco Gea, Juan M. Pascasio, Sabela Lens, Joaquín Cabezas, Ester Badia, Antonio Olveira, Rosa M. Morillas, Xavier Torras, Silvia Montoliu, Patricia Cordero, José L. Castro, Javier Salmerón, Esther Molina, Juan J. Sánchez-Ruano, Javier MorenoMaría D. Antón, José M. Moreno, Juan De la Vega, José L. Calleja, José A. Carrión

    Research output: Contribution to journalArticleResearch

    4 Citations (Scopus)

    Abstract

    © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd Background & Aims: The interferon-free regimen paritaprevir/ritonavir, ombitasvir + dasabuvir (PTV/r/OBV/DSV) has shown high efficacy in patients with hepatitis C virus (HCV) genotype 1b infection when administered for 8 or 12 weeks, but data regarding the 8-week treatment are scarce. The aim of our study was to assess the efficacy and safety of the 8-week administration of PTV/r/OBV/DSV in a real-world cohort. Methods: We performed a multicentre observational study from Spanish Hepa-C database including patients receiving 8 weeks of PTV/r/OBV/DSV (October 2016-November 2017). Those with advanced fibrosis, with non-genotype 1b or who were treatment-experienced were excluded. Results: A total of 211 patients were registered from 23 Spanish centres; eleven were excluded. At baseline, 42.5% (n = 85) were male, median (range) age was 57 (23-86), ALT was 45 (11-494) IU/mL, viral load was 6.1 (3.3-8.2) log10 IU/mL, and 74.5% had mild liver fibrosis (F0-F1) and 25.5% moderate fibrosis (F2). At the end of treatment (EOT), HCV viral load was undetectable in 100% (200/200). Seven patients relapsed after treatment discontinuation. Sustained virological response (SVR12) rates by intention-to-treat analysis were 96% (192/200). Regarding treatment safety, 2 patients developed ALT elevation >5x ULN, but there were no treatment discontinuations. One patient died 7 weeks after EOT. Conclusion: Treatment with PTV/r/OBV/DSV in genotype 1b-infected treatment-naive patients with mild-moderate fibrosis shows excellent efficacy and safety in real life, similarly to clinical trials. Clinicaltrials.gov, number: NCT03122132.
    Original languageEnglish
    Pages (from-to)90-97
    JournalLiver International
    Volume39
    DOIs
    Publication statusPublished - 1 Jan 2019

    Keywords

    • dasabuvir
    • ombitasvir
    • paritaprevir
    • sustained virological response

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