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

BACKGROUND AND OBJECTIVES: The 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...

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Autores principales: Mangia, Alessandra, Piazzolla, Valeria, Giannelli, Anna, Visaggi, Egidio, Minerva, Nicola, Palmieri, Vincenzo, Carraturo, Immacolata, Potenza, Domenico, Napoli, Nicola, Lauletta, Gianfranco, Tagarielli, Vincenzo, Santoro, Rosanna, Piccigallo, Ernesto, De Gioia, Sergio, Chimenti, Angelo, Cuccorese, Giuseppe, Metrangolo, Antonio, Mazzola, Michele, Agostinacchio, Ernesto, Mennea, Giuseppe, Sabbà, Carlo, Cela, Marina, Copetti, Massimiliano, Losappio, Ruggiero
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6519817/
https://www.ncbi.nlm.nih.gov/pubmed/31091254
http://dx.doi.org/10.1371/journal.pone.0215783
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author Mangia, Alessandra
Piazzolla, Valeria
Giannelli, Anna
Visaggi, Egidio
Minerva, Nicola
Palmieri, Vincenzo
Carraturo, Immacolata
Potenza, Domenico
Napoli, Nicola
Lauletta, Gianfranco
Tagarielli, Vincenzo
Santoro, Rosanna
Piccigallo, Ernesto
De Gioia, Sergio
Chimenti, Angelo
Cuccorese, Giuseppe
Metrangolo, Antonio
Mazzola, Michele
Agostinacchio, Ernesto
Mennea, Giuseppe
Sabbà, Carlo
Cela, Marina
Copetti, Massimiliano
Losappio, Ruggiero
author_facet Mangia, Alessandra
Piazzolla, Valeria
Giannelli, Anna
Visaggi, Egidio
Minerva, Nicola
Palmieri, Vincenzo
Carraturo, Immacolata
Potenza, Domenico
Napoli, Nicola
Lauletta, Gianfranco
Tagarielli, Vincenzo
Santoro, Rosanna
Piccigallo, Ernesto
De Gioia, Sergio
Chimenti, Angelo
Cuccorese, Giuseppe
Metrangolo, Antonio
Mazzola, Michele
Agostinacchio, Ernesto
Mennea, Giuseppe
Sabbà, Carlo
Cela, Marina
Copetti, Massimiliano
Losappio, Ruggiero
author_sort Mangia, Alessandra
collection PubMed
description BACKGROUND AND OBJECTIVES: The 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. DESIGN: In 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. RESULTS: Patients’ 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). CONCLUSIONS: SOF/VEL treatment of chronic HCV infection reaches very high cure rates in a variety of patients; including those with F0/F1 and PWID.
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spelling pubmed-65198172019-05-31 SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience Mangia, Alessandra Piazzolla, Valeria Giannelli, Anna Visaggi, Egidio Minerva, Nicola Palmieri, Vincenzo Carraturo, Immacolata Potenza, Domenico Napoli, Nicola Lauletta, Gianfranco Tagarielli, Vincenzo Santoro, Rosanna Piccigallo, Ernesto De Gioia, Sergio Chimenti, Angelo Cuccorese, Giuseppe Metrangolo, Antonio Mazzola, Michele Agostinacchio, Ernesto Mennea, Giuseppe Sabbà, Carlo Cela, Marina Copetti, Massimiliano Losappio, Ruggiero PLoS One Research Article BACKGROUND AND OBJECTIVES: The 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. DESIGN: In 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. RESULTS: Patients’ 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). CONCLUSIONS: SOF/VEL treatment of chronic HCV infection reaches very high cure rates in a variety of patients; including those with F0/F1 and PWID. Public Library of Science 2019-05-15 /pmc/articles/PMC6519817/ /pubmed/31091254 http://dx.doi.org/10.1371/journal.pone.0215783 Text en © 2019 Mangia et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Mangia, Alessandra
Piazzolla, Valeria
Giannelli, Anna
Visaggi, Egidio
Minerva, Nicola
Palmieri, Vincenzo
Carraturo, Immacolata
Potenza, Domenico
Napoli, Nicola
Lauletta, Gianfranco
Tagarielli, Vincenzo
Santoro, Rosanna
Piccigallo, Ernesto
De Gioia, Sergio
Chimenti, Angelo
Cuccorese, Giuseppe
Metrangolo, Antonio
Mazzola, Michele
Agostinacchio, Ernesto
Mennea, Giuseppe
Sabbà, Carlo
Cela, Marina
Copetti, Massimiliano
Losappio, Ruggiero
SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience
title SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience
title_full SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience
title_fullStr SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience
title_full_unstemmed SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience
title_short SVR12 rates higher than 99% after sofosbuvir/velpatasvir combination in HCV infected patients with F0-F1 fibrosis stage: A real world experience
title_sort svr12 rates higher than 99% after sofosbuvir/velpatasvir combination in hcv infected patients with f0-f1 fibrosis stage: a real world experience
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6519817/
https://www.ncbi.nlm.nih.gov/pubmed/31091254
http://dx.doi.org/10.1371/journal.pone.0215783
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