B.A.R.C.O.S. (Brazilian Argentine Hepatitis C Collaborative Observational Study): Effectiveness and clinical outcomes of HCV treatment with daclatasvir and sofosbuvir with or without ribavirin.
Adolescent
Adult
Aged
Aged, 80 and over
Antiviral Agents
/ therapeutic use
Argentina
Brazil
Carbamates
Female
Hepatitis C, Chronic
/ drug therapy
Humans
Imidazoles
/ therapeutic use
Male
Middle Aged
Prospective Studies
Pyrrolidines
Ribavirin
/ therapeutic use
Sofosbuvir
/ therapeutic use
Sustained Virologic Response
Treatment Outcome
Valine
/ analogs & derivatives
Young Adult
daclatasvir
hepatitis C
real-world evidence
sofosbuvir
treatment
Journal
Journal of viral hepatitis
ISSN: 1365-2893
Titre abrégé: J Viral Hepat
Pays: England
ID NLM: 9435672
Informations de publication
Date de publication:
10 2019
10 2019
Historique:
received:
27
12
2018
revised:
17
03
2019
accepted:
14
05
2019
pubmed:
30
5
2019
medline:
17
7
2020
entrez:
30
5
2019
Statut:
ppublish
Résumé
Real-world data evaluating the effectiveness of direct-acting antivirals (DAAs) in hepatitis C virus (HCV) treatment have been reported from different regions. Our aim was to evaluate the effectiveness and clinical outcomes of daclatasvir (DCV) and sofosbuvir (SOF) ± ribavirin (RBV) in a prospective multicentre cohort study including patients from Argentina and Brazil who received DCV/SOF ± RBV for 12 or 24 weeks from 2015 to 2018. Multivariable logistic regression models were carried out to identify factors associated with failure to achieve sustained virologic response (SVR) as a primary end point, and to death, decompensation, hepatocellular carcinoma (HCC) or liver transplantation (LT) as a composite secondary end point. From a total of 1517 patients treated with DCV/SOF, 906 completed 12 weeks post-treatment evaluation and were included in the analysis. Overall SVR12 rate was 96.1% (95% CI: 94.6%-97.2%), and 95% (95% CI: 92.8%-96.6%) in patients with cirrhosis. LT recipients and presence of cirrhosis were independently associated with failure to achieve SVR. During post-SVR12 follow-up, cumulative incidence of the secondary end point was 2.4% (95% CI: 1.5%-3.6%); two patients died from nonliver-related causes and two from HCC, five underwent LT, 12 developed HCC and 17 patients developed hepatic decompensation. Independent variables associated with these composite secondary end points were prior to HCV treatment and presence of cirrhosis. In conclusion, although the high pangenotypic effectiveness of DCV/SOF ± RBV was confirmed in our real-life cohort, patients with compensated and decompensated cirrhosis showed higher risk of non-SVR and complication appearance during treatment or after achieving SVR.
Substances chimiques
Antiviral Agents
0
Carbamates
0
Imidazoles
0
Pyrrolidines
0
Ribavirin
49717AWG6K
Valine
HG18B9YRS7
daclatasvir
LI2427F9CI
Sofosbuvir
WJ6CA3ZU8B
Types de publication
Journal Article
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1200-1209Informations de copyright
© 2019 John Wiley & Sons Ltd.
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