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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.

Background and Aim: Approved hepatitis C virus (HCV) treatments for patients on dialysis are associated with complexities, including drug-drug interactions, baseline resistance testing, use of ribavirin, and risk of hepatotoxicity. Despite higher concentrations of the primary circulating sofosbuvir (SOF) metabolite, GS-331007, in severe renal impairment, real-world case series showed substantial use of SOF-based regimens in this population, with no safety concerns identified. This study evaluated the safety, efficacy, and pharmacokinetics of sofosbuvir-velpatasvir (SOF/VEL) for 12 weeks in patients with HCV infection on dialysis. Method(s): Treatment-naive or -experienced patients, of any genotype, with or without compensated cirrhosis and undergoing hemodialysis or peritoneal dialysis, were enrolled to receive an open-label SOF/VEL (400 mg/100 mg daily) fixed-dose combination once daily for 12 weeks. The primary efficacy end-point was comparison of the sustained virological response 12 weeks after treatment (SVR12) to a prespecified historic control rate of 83%. The primary safety end-point was the proportion of patients who discontinued therapy due to adverse events (AEs). Secondary endpoints included safety, viral resistance, and pharmacokinetics. Result(s): A total of 59 patients were enrolled at 21 sites in Canada, the United Kingdom, Spain, Israel, Australia, and New Zealand. The median age was 60 years (range, 33-91), 59% were male, 53% white, 22% treatment-experienced, and 29% had cirrhosis. Most patients had HCV genotype 1 (42%), 2 (12%), or 3 (27%). Most (92%) were on hemodialysis, with a mean dialysis duration of 7.3 years (range, 0-40). Treatment was well tolerated; no one discontinued therapy due to AEs. One patient was discontinued from therapy on day 74 for non-compliance, with 48% study medication adherence by pill count. Overall, 56/59 patients (95%) achieved SVR12. Two (3%) had virological relapse (one with non-adherence). One patient did not achie

Background and Aim: Approved hepatitis C virus (HCV) treatments for patients on dialysis are associated with complexities, including drug-drug interactions, baseline resistance testing, use of ribavirin, and risk of hepatotoxicity. Despite higher concentrations of the primary circulating sofosbuvir (SOF) metabolite, GS-331007, in severe renal impairment, real-world case series showed substantial use of SOF-based regimens in this population, with no safety concerns identified. This study evaluated the safety, efficacy, and pharmacokinetics of sofosbuvir-velpatasvir (SOF/VEL) for 12 weeks in patients with HCV infection on dialysis. Method(s): Treatment-naive or -experienced patients, of any genotype, with or without compensated cirrhosis and undergoing hemodialysis or peritoneal dialysis, were enrolled to receive an open-label SOF/VEL (400 mg/100 mg daily) fixed-dose combination once daily for 12 weeks. The primary efficacy end-point was comparison of the sustained virological response 12 weeks after treatment (SVR12) to a prespecified historic control rate of 83%. The primary safety end-point was the proportion of patients who discontinued therapy due to adverse events (AEs). Secondary endpoints included safety, viral resistance, and pharmacokinetics. Result(s): A total of 59 patients were enrolled at 21 sites in Canada, the United Kingdom, Spain, Israel, Australia, and New Zealand. The median age was 60 years (range, 33-91), 59% were male, 53% white, 22% treatment-experienced, and 29% had cirrhosis. Most patients had HCV genotype 1 (42%), 2 (12%), or 3 (27%). Most (92%) were on hemodialysis, with a mean dialysis duration of 7.3 years (range, 0-40). Treatment was well tolerated; no one discontinued therapy due to AEs. One patient was discontinued from therapy on day 74 for non-compliance, with 48% study medication adherence by pill count. Overall, 56/59 patients (95%) achieved SVR12. Two (3%) had virological relapse (one with non-adherence). One patient did not achie