Sustained virological response in patients with HCV treated with daclatasvir plus sofosbuvir, with or without ribavirin: a large, field-practice study.
HCV NS5A inhibitors
HCV replication complex
daclatasvir
direct-acting antivirals
ribavirin
sofosbuvir
Journal
Drugs in context
ISSN: 1745-1981
Titre abrégé: Drugs Context
Pays: England
ID NLM: 101262187
Informations de publication
Date de publication:
2020
2020
Historique:
received:
04
04
2020
revised:
03
11
2020
accepted:
14
11
2020
entrez:
7
1
2021
pubmed:
8
1
2021
medline:
8
1
2021
Statut:
epublish
Résumé
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). 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
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.
Identifiants
pubmed: 33408749
doi: 10.7573/dic.2020-4-11
pii: dic-2020-4-11
pmc: PMC7747789
pii:
doi:
Types de publication
Journal Article
Langues
eng
Informations de 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.
Déclaration de conflit d'intérêts
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
Références
BMC Nephrol. 2019 Feb 4;20(1):36
pubmed: 30717681
J Viral Hepat. 2011 Oct;18(10):e516-22
pubmed: 21914071
J Hepatol. 2018 Aug;69(2):461-511
pubmed: 29650333
Hepatology. 2016 May;63(5):1493-505
pubmed: 26754432
Liver Int. 2016 Jul;36(7):971-6
pubmed: 26786792
World J Gastrointest Pharmacol Ther. 2017 May 6;8(2):137-146
pubmed: 28533924
Int J Appl Basic Med Res. 2015 May-Aug;5(2):82
pubmed: 26097811
Nurs Clin North Am. 2020 Sep;55(3):347-359
pubmed: 32762855
P T. 2017 May;42(5):316-329
pubmed: 28479841
BMC Gastroenterol. 2020 Mar 5;20(1):47
pubmed: 32138687
J Med Chem. 2010 Oct 14;53(19):7202-18
pubmed: 20845908
Hepatology. 2015 Apr;61(4):1127-35
pubmed: 25614962
Virology. 2015 Feb;476:168-179
pubmed: 25546252
Rev Esp Quimioter. 2018 Jun;31(3):226-236
pubmed: 29771105
J Med Virol. 2010 Oct;82(10):1647-54
pubmed: 20827760
Semin Liver Dis. 2014 Feb;34(1):22-9
pubmed: 24782255
N Engl J Med. 2015 Aug 20;373(8):714-25
pubmed: 26196502
J Hepatol. 2017 Jan;66(1):39-47
pubmed: 27622858
Clin Mol Hepatol. 2020 Jul;26(3):251-260
pubmed: 32188235
Virusdisease. 2020 Sep;31(3):235-240
pubmed: 32904762
J Med Virol. 2020 Mar 4;:
pubmed: 32129507
Gastroenterol Hepatol (N Y). 2017 Jan;13(1):22-31
pubmed: 28420944
Antiviral Res. 2017 Jun;142:83-122
pubmed: 28238877
Curr Drug Saf. 2020;15(1):53-60
pubmed: 31573893
N Engl J Med. 2014 Jan 16;370(3):211-21
pubmed: 24428467
Liver Int. 2018 Feb;38 Suppl 1:21-27
pubmed: 29427481
Gut. 2016 Nov;65(11):1861-1870
pubmed: 27605539
Hepatology. 2013 Apr;57(4):1333-42
pubmed: 23172780
Rev Esp Quimioter. 2019 Apr;32(2):137-144
pubmed: 30761823
Hepat Med. 2015 Nov 02;7:51-70
pubmed: 26586968