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 Moreno; María D. Antón; José M. Moreno; Juan De la Vega; José L. Calleja; José A. Carrión

Disclosures

Liver International. 2019;39(1):90-97. 

In This Article

Abstract and Introduction

Abstract

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.

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