Global real‐world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: Analysis of 5552 patients from 12 cohorts. (9th June 2020)

• Record Type: Journal Article
• Authors: Mangia, Alessandra; Milligan, Scott; Khalili, Mandana; Fagiuoli, Stefano; Shafran, Stephen D.; Carrat, Fabrice; Ouzan, Denis; Papatheodoridis, George; Ramji, Alnoor; Borgia, Sergio M.; Wedemeyer, Heiner; Losappio, Ruggero; Pérez‐Hernandez, Francisco; Wick, Nicole; Brown, Robert S.; Lampertico, Pietro; Doucette, Karen; Ntalla, Ioanna; Ramroth, Heribert; Mertens, Michael; Vanstraelen, Kim; Turnes, Juan
• Is Part Of: Liver international. Volume 40:Number 8(2020)
• Page Start: 1841
• Page End: 1852
• Publication Date: 2020-06-09
• Subjects: HCV elimination -- Hepatitis C -- heterogenous -- real‐world -- sofosbuvir/velpatasvir -- sustained virological response; Liver -- Periodicals; Liver -- Diseases -- Periodicals; 616.362
• DOI: 10.1111/liv.14537
• Languages: English
• ISSNs: 1478-3223

Abstract

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.