PLoS ONE (Jan 2019)

SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience.

  • Alessandra Mangia,
  • Valeria Piazzolla,
  • Anna Giannelli,
  • Egidio Visaggi,
  • Nicola Minerva,
  • Vincenzo Palmieri,
  • Immacolata Carraturo,
  • Domenico Potenza,
  • Nicola Napoli,
  • Gianfranco Lauletta,
  • Vincenzo Tagarielli,
  • Rosanna Santoro,
  • Ernesto Piccigallo,
  • Sergio De Gioia,
  • Angelo Chimenti,
  • Giuseppe Cuccorese,
  • Antonio Metrangolo,
  • Michele Mazzola,
  • Ernesto Agostinacchio,
  • Giuseppe Mennea,
  • Carlo Sabbà,
  • Marina Cela,
  • Massimiliano Copetti,
  • Ruggiero Losappio

DOI
https://doi.org/10.1371/journal.pone.0215783
Journal volume & issue
Vol. 14, no. 5
p. e0215783

Abstract

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Background and objectivesThe pangenotypic single tablet regimen of NS5B inhibitor sofobuvir (SOF) and NS5A inhibitor velpatasvir (VEL) is advised for 12 weeks in HCV-infected patients including those with compensated cirrhosis. Addition of ribavirin (RBV) may be considered in genotype 3 (GT3) with compensated and is recommended in decompensated cirrhosis. Real-life results with SOF/VEL are limited. To evaluate efficacy and safety in a large real-world-cohort including patients with different GTs and various fibrosis stages.DesignIn total, 1429 patients were treated with SOF/VEL 400/100 mg for 12 weeks in the Puglia registry between June 2017 and May 2018. 1319 (92.3%) reached week 12 post-treatment (SVR12) at the moment. Only 41 received RBV. Diagnosis of cirrhosis was based on transient elastography and/or APRI or FIB-4 scores. Sensitivity analysis in the population including all patients except non virological failure was conducted. Primary efficacy endpoint was the percentage of patients with SVR12.ResultsPatients' mean age was 63.8 years, 42.3% had GT1. The majority were naïve and 735 (55.5%) F0/F2. Of the remaining 587, 282 had cirrhosis. SVR12 was 98.5%, 98.0% in GT1, 99.4% in GT2, 97.1% in GT3, 100% in GT4. Overall, SVR12 by sensitivity analysis was 99.4%; 99.7% among F0-F1. Among 218 PWID, SVR12 was 94.5%. Discontinuation rates were 3.7% among PWID and 0.7% among non-PWID (p = 0.004).ConclusionsSOF/VEL treatment of chronic HCV infection reaches very high cure rates in a variety of patients; including those with F0/F1 and PWID.