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

Autor: Puigvehí M; Hospital del Mar, IMIM, Universitat Autònoma de Barcelona, Barcelona, Spain., De Cuenca B; Hospital Universitario de Getafe, Getafe, Spain., Viu A; Hospital del Mar, IMIM, Universitat Autònoma de Barcelona, Barcelona, Spain., Diago M; Hospital General de Valencia, Valencia, Spain., Turnes J; Complejo Hospitalario Universitario de Pontevedra, IIS Galicia Sur, Pontevedra, Spain., Gea F; Hospital Universitario Ramón y Cajal, CIBERehd, Madrid, Spain., Pascasio JM; Hospital Universitario Virgen del Rocío, Sevilla, Spain., Lens S; Hospital Clínic, IDIBAPS, CIBERehd, Universitat de Barcelona, Barcelona, Spain., Cabezas J; Hospital Marqués de Valdecilla, Santander, Spain., Badia E; Hospital Universitario de Burgos, Burgos, Spain., Olveira A; Hospital Carlos III/La Paz, Madrid, Spain., Morillas RM; Hospital Germans Trias i Pujol, CIBERehd, Badalona, Spain., Torras X; Hospital de la Santa Creu i Sant Pau, CIBERehd, Barcelona, Spain., Montoliu S; Hospital Universitari Joan XXIII, Tarragona, Spain., Cordero P; Hospital Virgen de la Macarena, Sevilla, Spain., Castro JL; Hospital Severo Ochoa, Leganés, Spain., Salmerón J; Hospital Universitario San Cecilio, Granada, Spain., Molina E; Centro Hospitalario de Santiago de Compostela, Santiago de Compostela, Spain., Sánchez-Ruano JJ; Hospital Universitario de Toledo, Toledo, Spain., Moreno J; Hospital General de Segovia, Segovia, Spain., Antón MD; Hospital Universitari Dr. Peset, Valencia, Spain., Moreno JM; Centro Hospitalario Universitario de Albacete, Albacete, Spain., De la Vega J; Hospital San Agustín, Avilés, Spain., Calleja JL; Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain., Carrión JA; Hospital del Mar, IMIM, Universitat Autònoma de Barcelona, Barcelona, Spain.
Jazyk: angličtina
Zdroj: Liver international : official journal of the International Association for the Study of the Liver [Liver Int] 2019 Jan; Vol. 39 (1), pp. 90-97. Date of Electronic Publication: 2018 Nov 12.
DOI: 10.1111/liv.13950
Abstrakt: 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.
(© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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