Health outcomes associated with sofosbuvir- based single-tablet regimens for initial and re-treatment of chronic hepatitis c in the US.

BACKGROUND Ledipasvir/sofosbuvir (LDV/SOF) and sofos-buvir/velpatasvir (SOF/VEL) are oral single-tablet regimens (STRs) with excellent efficacy, tolerability, and real-world effectiveness in treatment-naïve (TN) and treatment-ex-perienced (TE) chronic hepatitis C virus (HCV) patients . For patients previously failing direct-acting antivirals, sofos-buvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) is the only STR re-treatment (RT) that has been extensively studied in patients with NS5A, NS3, and NS5A+NS3 resistance, and leads to high sustained virologic rates (SVR) regard-less of patients’ baseline resistance associated mutations .With the availability of SOF-based STRs as first-line and RT options, this study evaluated the health outcomes for HCV treatment using SOF-based regimens vs . no treatment (NT) .METHODS A model simulated the health outcomes of a cohort of 10,000 HCV genotype (GT) 1-6 non-cir-rhotic (NC) and compensated cirrhotic (CC) patients with an average age of 52 from a US payer perspective over a lifetime horizon . The model assumed 73 .3% of patients were GT1; 13 .1%, GT2; 12 .1%, GT3; 1 .3%, GT4; and, 0 .1% GT5/6 . 14 .6% of GT1-2/4-6 patients were CC (20 .4% forGT3) . The proportion of TN and TE patients varied by genotype . Outcomes for LDV/SOF for 8W for GT1 TN NC patients with viral load (VL) \u3c6 million (mn) copies and SOF/VEL for all other GT1-6 patients, with or without RT with SOF/VEL/VOX, were compared to NT .Model inputs were sourced from clinical trials, published literature, or expert opinion .RESULTS Initiation of LDV/SOF for 8W for GT1 TN NC patients with VL \u3c6 mn copies and SOF/VEL in treatment of all other GT1-6 patients yields favorable health outcomes (Table) . RT with SOF/VEL/VOX results in a higher SVR (99 .94%), fewer patients developing decom-pensated cirrhosis (0 .52%), hepatocellular carcinoma (1 .3%), liver transplant (0 .11%), or liver-related deaths (1 .3%), and a gain of 4 .04 quality-adjusted life years per patient .CONCLUSION SOF-based STRs have demonstrated high SVR rates in both clinical and real-world settings . With the addition of SOF/VEL/VOX as an efficacious RT option, close to 100% of chronic HCV patients are projected to be cured