IDDF2021-ABS-0167 Real-world efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir in NS5A-inhibitor experienced patients: an international multicenter study from Asia

Abstract

<h3>Background</h3> Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) was approved as salvage therapy for NS5A-experienced hepatitis C virus (HCV) infected patients. However, the real-world data of SOF/VEL/VOX remained limited in Asia. We aim to analyse the real-world efficacy and safety of SOF/VEL/VOX among NS5A-experienced Asian HCV patients. <h3>Methods</h3> This was a cross-sectional, multicenter, international study assessing the efficacy of retreatment using SOF/VEL/VOX among Asian HCV patients with prior direct-acting antiviral (DAA) failure. Our primary aim is sustained-virological response 12 weeks after completion of treatment (SVR12). Data on safety and treatment outcomes were also recorded. <h3>Results</h3> Nineteen patients were included from 5 hospitals. Median age was 57, 84% were male, 47% were ex-IVDU and 63% had liver cirrhosis. Among 12 patients with liver cirrhosis, 75% were Child-Turcotte-Pugh Class A and 25% were Class B. Commonest genotype (GT) requiring retreatment using SOF/VEL/VOX was GT3 (68%), followed by GT1, GT2 and GT6 (11%). Prior DAA include SOF/VEL (79%), HARVONI (11%), Glecaprevir/Pibrentasvir (5%) and Daclatasvir/Asunaprevir (5%). The overall SVR12 rate by intention-to-treat and per-protocol (PP) analysis was 84.1% and 94.1%, respectively. Two patients were demised before treatment completion from HCC progression and septic shock, and were excluded from PP analysis. The SVR12 was not significantly different in patients with GT3 (GT3: 91%, non-GT3: 100%, p=0.647). The only patient with virological failure had compensated GT3 cirrhosis with portal hypertension after completed 12 weeks of SOF/VEL/VOX. Significant improvement observed in median serum ALT, AST and bilirubin following SVR12 (p&lt;0.05) <h3>Conclusions</h3> In this real-world international study, we found that SOF/VEL/VOX is an efficacious and safe salvage regimen among NS5A-experienced HCV patients in Asia.