@article{3104108,
    title = "Global real-world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts",
    author = "Mangia, A. and Milligan, S. and Khalili, M. and Fagiuoli, S. and Shafran, S.D. and Carrat, F. and Ouzan, D. and Papatheodoridis, G. and Ramji, A. and Borgia, S.M. and Wedemeyer, H. and Losappio, R. and Pérez-Hernandez, F. and Wick, N. and Brown, R.S., Jr. and Lampertico, P. and Doucette, K. and Ntalla, I. and Ramroth, H. and Mertens, M. and Vanstraelen, K. and Turnes, J.",
    journal = "Liver International",
    year = "2020",
    volume = "40",
    number = "8",
    pages = "1841-1852",
    publisher = "Wiley-Blackwell Publishing Ltd",
    issn = "1478-3223, 1478-3231",
    doi = "10.1111/liv.14537",
    keywords = "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",
    abstract = "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"
}