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Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild‐moderate fibrosis: Results from a real‐world cohort
Author(s) -
Puigvehí Marc,
De Cuenca Beatriz,
Viu Ana,
Diago Moisés,
Turnes Juan,
Gea Francisco,
Pascasio Juan M.,
Lens Sabela,
Cabezas Joaquín,
Badia Ester,
Olveira Antonio,
Morillas Rosa M.,
Torras Xavier,
Montoliu Silvia,
Cordero Patricia,
Castro José L.,
Salmerón Javier,
Molina Esther,
SánchezRuano Juan J.,
Moreno Javier,
Antón María D.,
Moreno José M.,
De la Vega Juan,
Calleja José L.,
Carrión José A.
Publication year - 2019
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.13950
Subject(s) - ombitasvir , paritaprevir , dasabuvir , medicine , ritonavir , gastroenterology , discontinuation , hepatitis c , regimen , cohort , viral load , hepatitis c virus , ribavirin , surgery , immunology , virus , antiretroviral therapy
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 ( SVR 12) 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: NCT 03122132.