Τίτλος:
Global real-world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background and aims: Achieving sustained virological response (SVR; cure) in hepatitis C patients using a simple regimen is key to making elimination by 2030 possible. In the largest real-world analysis to date, the effectiveness of pangenotypic, panfibrotic, single-tablet, sofosbuvir/velpatasvir (SOF/VEL) once-daily for 12 weeks was assessed in 12 clinical real-world cohorts from various geographical areas, settings and treatment practices. Factors affecting risk of not achieving SVR were assessed. Methods: Adults treated with SOF/VEL 400/100 mg, without ribavirin, were included. All HCV patients reaching Week 12 or 24 post-treatment were assessed for SVR12/24. Factors associated with not achieving SVR12/24 for virological reasons were evaluated using logistic regression analysis. Results: Overall, 5552 patients were included: 13.3% treatment-experienced; 20.7% compensated cirrhotic; 30.2% genotype 1; 29.5% genotype 2; 32.9% genotype 3; 4.7% genotype 4; 3.7% HIV coinfection; 13.4% current/former intravenous drug use. Of the 5196 patients evaluated for effectiveness, 98.9% achieved SVR12/24. High SVR12/24 rates occurred in all genotypes including genotype 3 (98.3%; 1649/1677) and in those with compensated cirrhosis (97.9; 1055/1078). Only 55 patients did not achieve SVR12/24 due to a virological reason; the only factor statistically significantly associated with an increased risk of not achieving SVR12/24 was compensated cirrhosis (P =.002). Overall, 6% (332/5552) of patients did not achieve SVR12/24 for non-virological reasons (67% lost to follow-up; 26.5% early treatment discontinuation). Conclusions: In this large cohort, representative of clinical practice, a simple 12-week regimen of SOF/VEL without ribavirin resulted in high SVR12/24 rates in diverse patient populations, even among those with compensated cirrhosis. © 2020 The Authors. Liver International published by John Wiley & Sons Ltd
Συγγραφείς:
Mangia, A.
Milligan, S.
Khalili, M.
Fagiuoli, S.
Shafran, S.D.
Carrat, F.
Ouzan, D.
Papatheodoridis, G.
Ramji, A.
Borgia, S.M.
Wedemeyer, H.
Losappio, R.
Pérez-Hernandez, F.
Wick, N.
Brown, R.S., Jr.
Lampertico, P.
Doucette, K.
Ntalla, I.
Ramroth, H.
Mertens, M.
Vanstraelen, K.
Turnes, J.
Περιοδικό:
Liver International
Εκδότης:
Wiley-Blackwell Publishing Ltd
Λέξεις-κλειδιά:
boceprevir; glecaprevir plus pibrentasvir; peginterferon; proteinase inhibitor; proton pump inhibitor; ribavirin; simeprevir; sofosbuvir; sofosbuvir plus velpatasvir; sofosbuvir plus velpatasvir plus voxilaprevir; telaprevir, adult; antiviral therapy; Article; Canada; chronic hepatitis C; clinical evaluation; cohort analysis; compensated liver cirrhosis; controlled study; drug efficacy; drug use; drug withdrawal; Europe; evidence based medicine; female; follow up; Hepatitis C virus genotype 1; Hepatitis C virus genotype 2; Hepatitis C virus genotype 3; Hepatitis C virus genotype 4; human; Human immunodeficiency virus infection; intravenous drug abuse; liver cirrhosis; liver fibrosis; logistic regression analysis; major clinical study; male; middle aged; mixed infection; multicenter study; outcome assessment; risk factor; sustained virologic response; tablet; treatment duration; treatment refusal; treatment response; United States; unspecified side effect
