Sustained virological response in patients with HCV treated with daclatasvir plus sofosbuvir, with or without ribavirin: a large, field-practice study

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Authors
Rodolfo Sacco MD, PhD, Vincenzo Messina MD, Umberto Vespasiani Gentilucci MD, Luigi Elio Adinolfi MD, Antonio Ascione MD, Giorgio Barbarini MD, Angelo Barlattani MD, Giuseppe Cariti MD, Raffaele Cozzolongo MD, Basilio Fimiani MD, Ruggiero Francavilla MD, Caterina Furlan MD, Giovanni Garrucciu MD, Vincenzo Iovinella MD, Luca Rinaldi MD, Massimo Marignani MD, Paola Begini MD, Valeria Pace Palitti MD, Adriano M Pellicelli MD, Gaetano Scifo MD, Antonio Facciorusso MD, Luca Giacomelli PhD, Aashni Shah BSc, Gaetano Bertino MD, Serena Perazzo MD, Giampaolo Bresci MD, Antonio Izzi MD

Article Type
Original Research

DOI
10.7573/dic.2020-4-11

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Abstract

Background: The once-daily oral combination of daclatasvir (DCV) and sofosbuvir (SOF), with or without ribavirin (RBV), is effective and well tolerated in patients with hepatitis C virus (HCV). However, further field-practice studies are necessary to investigate the effectiveness and safety of the DCV+SOF combination in diverse subpopulations of patients with HCV, including those who are more challenging to treat such as patients with a genotype 3 (G3) infection. The aim of this retrospective, multicenter, field-practice study was to investigate the therapeutic efficacy and safety of the oral combination of DCV and SOF, with or without RBV (DCV+SOF±RBV), in a large unselected cohort of patients with chronic HCV infection (CHC).

Patients and methods: Consecutive patients received DCV+SOF±RBV for 12 or 24 weeks. The efficacy endpoint was sustained virological response at 12 weeks after the end of treatment (SVR12). Safety factors were also considered.

Results: A total of 620 patients were included in this study; the predominant genotype was G3 (55.3%). Of the total sample, 248 (40%) patients were treated with DCV+SOF+RBV and 372 (60%) did not receive RBV. The majority of patients assessed at week 12 (98%, 596/608) achieved SVR12. Among G3 patients, 98.8% (335/339) achieved SVR12. The most common adverse event was elevated bilirubin (30.6%), recorded in 4.9% of cases as a grade 3–4 adverse event.

Conclusion: This study shows the high pan-genotypic effectiveness and safety of the DCV+SOF±RBV combination in a large, unselected sample of CHC patients with G1–4, including a wide proportion of G3 CHC patients.

Keywords: daclatasvir, direct-acting antivirals, HCV NS5A inhibitors, HCV replication complex, ribavirin, sofosbuvir.

Citation: Sacco R, Messina V, Gentilucci UV, Adinolfi LE, Ascione A, Barbarini G, Barlattani A, Cariti G, Cozzolongo R, Fimiani B, Francavilla R, Furlan C, Garrucciu G, Iovinella V, Rinaldi L, Marignani M, Begini P, Palitti VP, Pellicelli AM, Scifo G, Facciorusso A, Giacomelli L, Shah A, Bertino G, Perazzo S, Bresci G, Izzi A. Sustained virological response in patients with HCV treated with daclatasvir + sofosbuvir, with or without ribavirin: a large, field-practice study. Drugs in Context 2020; 9: 2020-4-11. DOI: 10.7573/dic.2020-4-11

Contributions: All authors equally contributed to patients’ management, data collection, and evaluation, except AS and LG who analyzed and evaluated data. All authors equally contributed to the drafting of the manuscript. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest relevant to this manuscript. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2020/12/dic.2020-4-11-COI.pdf

Acknowledgements: None.

Funding declaration: There was no funding associated with the preparation of this article.

Copyright: Copyright © 2020 Sacco R, Messina V, Gentilucci UV, Adinolfi LE, Ascione A, Barbarini G, Barlattani A, Cariti G, Cozzolongo R, Fimiani B, Francavilla R, Furlan C, Garrucciu G, Iovinella V, Rinaldi L, Marignani M, Begini P, Palitti VP, Pellicelli AM, Scifo G, Facciorusso A, Giacomelli L, Shah A, Bertino G, Perazzo S, Bresci G, Izzi A. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2020 Sacco R, Messina V, Gentilucci UV, Adinolfi LE, Ascione A, Barbarini G, Barlattani A, Cariti G, Cozzolongo R, Fimiani B, Francavilla R, Furlan C, Garrucciu G, Iovinella V, Rinaldi L, Marignani M, Begini P, Palitti VP, Pellicelli AM, Scifo G, Facciorusso A, Giacomelli L, Shah A, Bertino G, Perazzo S, Bresci G, Izzi A. https://doi.org/10.7573/dic.2020-4-11. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/sustained-virological-response-in-patients-with-hcv-treated-with-daclatasvir-sofosbuvir-with-or-without-ribavirin-a-large-field-practice-study

Correspondence: Rodolfo Sacco, Gastroenterology and Metabolic Diseases Unit, Pisa University Hospital, Via Paradisa 2, 56124 Pisa, Italy. r.sacco@ao-pisa.toscana.it

Provenance: Submitted; externally peer reviewed.

Submitted: 4 April 2020; Peer review comments to author: 8 May 2020; Revised manuscript received: 3 November 2020; Accepted: 14 November 2020; Publication date: 15 December 2020.

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