Vol.:(0123456789) 1 3 Digestive Diseases and Sciences https://doi.org/10.1007/s10620-020-06234-1 ORIGINAL ARTICLE Evolution of Hepatitis C Virus Treatment During the Era of Sofosbuvir‑Based Therapies: A Real‑World Experience in France Denis Ouzan 1  · Dominique Larrey 2  · Dominique Guyader 3  · André‑Jean Remy 4  · Ghassan Riachi 5  · Fréderic Heluwaert 6  · Régine Truchi 7  · Jean‑Marc Combis 8  · François Bailly 9  · Isabelle Rosa 10  · Christophe Hézode 11  · Denise Glorian‑Petraud 11  · Olivier Libert 11  · Heribert Ramroth 12  · Tarik Asselah 13,21  · Gérard Thiefn 14  · Dominique Roulot 15  · Bruno Roche 16  · Vincent Leroy 17  · Jérôme Dumortier 18  · Dominique Thabut 19  · Stanislas Pol 20  on behalf of the HELIOS study group Received: 24 September 2018 / Accepted: 24 March 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020 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 confrm efectiveness and safety in clinical practice, particularly in vulnerable populations. Aims To assess real-world efectiveness 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 efectiveness, 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 avail- able ≥ 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 efective for the treatment of HCV in real-world clinical practice. This is an important step towards HCV elimination. Keywords Hepatitis C · Sofosbuvir · Treatment outcome · Practice guidelines as topic · France Abbreviations ALT Alanine aminotransferase AP-HP Assistance Publique-Hôpitaux de Paris BMI Body mass index CCTIRS Comité consultatif sur le traitement de l’information en matière de recherche CI Confdence interval CNIL Commission nationale de l’informatique et des libertés DAA Direct-acting antiviral agent DCV Daclatasvir EOT End of treatment EQ-5D EuroQOL fve dimensions F Fibrosis stage GT Genotype HBV Hepatitis B virus HCC Hepatocellular carcinoma HCV Hepatitis C virus HRQoL Health-related quality of life HELIOS HEpatitis C real-LIfe study for patients On Sofosbuvir HIV Human immunodefciency virus Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10620-020-06234-1) contains supplementary material, which is available to authorized users. * Stanislas Pol stanislas.pol@aphp.fr Extended author information available on the last page of the article