Paritaprevir/r/Ombitasvir + Dasabuvir 8 weeks in HCV-genotype 1b with mild-moderate fibrosis: Results from a Real World Cohort.

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 during 8 or 12 weeks, but data regarding the 8-week treatment is 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: Multicenter observational study from Spanish Hepa-C database with patients receiving 8 weeks of PTV/r/OBV/DSV (October'16-November'17). Those with advanced fibrosis, non-genotype 1b or treatment-experienced were excluded.

RESULTS: 211 patients were registered from 23 Spanish centers; eleven were excluded. At baseline, 42.5% (n=85) were male, median (range) age was 57 (23-86), ALT 45 (11-494) IU/mL, viral load 6.1 (3.3-8.2) log10 IU/mL, 74.5% had mild liver fibrosis (F0-1) 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 were 96% (192/200). Regarding treatment safety, 2 patients developed ALT elevation >5xULN, 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 show excellent efficacy and safety in real-life similarly to clinical trials. Clinicaltrials. gov: NCT03122132. This article is protected by copyright. All rights reserved.