Denis Ouzan1, Dominique Larrey2, Dominique Guyader3, André-Jean Remy4, Ghassan Riachi5, Fréderic Heluwaert6, Régine Truchi7, Jean-Marc Combis8, François Bailly9, Isabelle Rosa10, Christophe Hézode11, Denise Glorian-Petraud11, Olivier Libert11, Heribert Ramroth12, Tarik Asselah13,14, Gérard Thiefin15, Dominique Roulot16, Bruno Roche17, Vincent Leroy18, Jérôme Dumortier19, Dominique Thabut20, Stanislas Pol21. 1. Institut Arnault Tzanck, Saint-Laurent-du-Var, France. 2. Hôpital Saint Eloi, Montpellier, France. 3. Hôpital Pontchaillou, Rennes, France. 4. Centre Hospitalier de Perpignan, Perpignan, France. 5. Hôpital Charles Nicolle, Rouen, France. 6. Centre Hospitalier Annecy Genevois, Pringy, France. 7. University Hospital of Nice and University of Nice-Sophia-Antipolis, Nice, France. 8. Clinique Ambroise Pare, Toulouse, France. 9. Hospices Civils de Lyon, Lyon, France. 10. Centre Hospitalier Intercommunal de Créteil, Créteil, France. 11. Gilead Sciences SAS, Boulogne-Billancourt, France. 12. Gilead Sciences Europe Ltd., Stockley Park, UK. 13. Hôpital Beaujon, Clichy, France. 14. Inserm UMR1149, Université Paris Diderot, Paris, France. 15. Centre Hospitalier Universitaire de Reims, Reims, France. 16. Hôpital Avicenne AP-HP, Bobigny, France. 17. Hôpital Paul Brousse AP-HP, Villejuif, France. 18. Hôpital Henri Mondor AP-HP, Créteil, France. 19. Hôpital Edouard Herriot, Lyon, France. 20. APHP Sorbonne Université, Hôpital Pitié-Salpêtrière, Paris, France. 21. Département D'Hépatologie, Inserm U1223, Hôpital Cochin AP-HP, 27, rue du Faubourg Saint Jacques, 75014, Paris, France. stanislas.pol@aphp.fr.
Abstract
BACKGROUND: 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. 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.
BACKGROUND: 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. 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.
Entities:
Keywords:
France; Hepatitis C; Practice guidelines as topic; Sofosbuvir; Treatment outcome
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