Evolution of Hepatitis C Virus Treatment During the Era of Sofosbuvir-Based Therapies: A Real-World Experience in France.

Adult Aged Aged, 80 and over Antiviral Agents / administration & dosage Carbamates / administration & dosage Drug Therapy, Combination Female France Hepacivirus Hepatitis C, Chronic / drug therapy Heterocyclic Compounds, 4 or More Rings / administration & dosage Humans Male Middle Aged Patient Reported Outcome Measures Prospective Studies Quality of Life Sofosbuvir / administration & dosage Sustained Virologic Response Young Adult

France Hepatitis C Practice guidelines as topic Sofosbuvir Treatment outcome

Journal

Digestive diseases and sciences

ISSN: 1573-2568

Titre abrégé: Dig Dis Sci

Pays: United States

ID NLM: 7902782

Informations de publication

Date de publication:
03 2021

Historique:

received: 24 09 2018

accepted: 24 03 2020

pubmed: 19 4 2020

medline: 17 8 2021

entrez: 19 4 2020

Statut: ppublish

Résumé

Treatment of hepatitis C virus (HCV) has been dramatically improved with the introduction of direct-acting antiviral agents (DAAs). Universal access to pangenotypic DAAs was provided in France from 2017, expanding the type of patients treated. Real-world studies are important to confirm effectiveness and safety in clinical practice, particularly in vulnerable populations. To assess real-world effectiveness and safety of sofosbuvir-based therapy in adults with chronic HCV infection before and after universal access to DAAs in France. This multicenter, non-interventional, prospective study assessed the effectiveness, safety, patient-reported outcomes and adherence with sofosbuvir-based regimens from October 2015 to July 2016 (Period 1: sofosbuvir-based therapy excluding sofosbuvir/velpatasvir) and from October 2017 to July 2018 (Period 2: pangenotypic sofosbuvir/velpatasvir-based therapy). Baseline data were documented for 1029 patients. Overall, 797 (77%) had sustained virologic response data available ≥ 9 weeks after treatment completion. Per protocol response was high (97%) irrespective of age, alcohol consumption, recreational drug use, or HIV/HCV coinfection. Adverse events occurred in approximately 25% of patients with the majority experiencing Grade 1 or 2 events. Sofosbuvir-based regimens improved health-related quality of life from baseline to end of treatment in patients with data at all timepoints. Overall, 99% of patients reported total or almost total adherence to therapy. Sofosbuvir-based therapy, including pangenotypic sofosbuvir/velpatasvir, is effective for the treatment of HCV in real-world clinical practice. This is an important step towards HCV elimination.

Sections du résumé

BACKGROUND

AIMS

To assess real-world effectiveness and safety of sofosbuvir-based therapy in adults with chronic HCV infection before and after universal access to DAAs in France.

METHODS

This multicenter, non-interventional, prospective study assessed the effectiveness, safety, patient-reported outcomes and adherence with sofosbuvir-based regimens from October 2015 to July 2016 (Period 1: sofosbuvir-based therapy excluding sofosbuvir/velpatasvir) and from October 2017 to July 2018 (Period 2: pangenotypic sofosbuvir/velpatasvir-based therapy).

RESULTS

Baseline data were documented for 1029 patients. Overall, 797 (77%) had sustained virologic response data available ≥ 9 weeks after treatment completion. Per protocol response was high (97%) irrespective of age, alcohol consumption, recreational drug use, or HIV/HCV coinfection. Adverse events occurred in approximately 25% of patients with the majority experiencing Grade 1 or 2 events. Sofosbuvir-based regimens improved health-related quality of life from baseline to end of treatment in patients with data at all timepoints. Overall, 99% of patients reported total or almost total adherence to therapy.

CONCLUSIONS

Sofosbuvir-based therapy, including pangenotypic sofosbuvir/velpatasvir, is effective for the treatment of HCV in real-world clinical practice. This is an important step towards HCV elimination.

Identifiants

DOI: 10.1007/s10620-020-06234-1 PMID: 32303953

pubmed: 32303953

doi: 10.1007/s10620-020-06234-1

pii: 10.1007/s10620-020-06234-1

doi:

Substances chimiques

Antiviral Agents 0

Carbamates 0

Heterocyclic Compounds, 4 or More Rings 0

velpatasvir KCU0C7RS7Z

Sofosbuvir WJ6CA3ZU8B

Types de publication

Evaluation Study Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

881-898

Investigateurs

None Ajana

None Bellaiche

None Bourlière

None Bronowicki

None Cadranel

None Canva-Delcambre

None Causse

None Cotte

None Dao

None de Lédinghen

None Desmorat

None Di Martino

None Donnadieu-Rigole

None Fontanges

None Gournay

None Grange

None Habersetzer

None Hanslik

None Jezequel

None Leroy

None Loustaud-Ratti

None Molina

None Neau

None N'Guyen Khac

None Njike-Naksu

None Portal

None Renou

None Ribard

None Rosenthal

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