Effectiveness and safety of SOF/VEL containing rescue therapy in treating chronic HCV-GT4 patients previously failed NS5A inhibitors-based DAAs

Abstract

Background and aimsNS5A inhibitors are an important option for treating chronic HCV-GT4 patients. Retreatments after NS5A-based DAAs failure are limited. We aimed to determine the effectiveness and safety of SOF/VEL-containing regimens for HCV retreatment after NS5A-regimen failure.MethodsProspective cohort study assessing the efficacy and safety of retreatment with SOF/VEL in addition to either voxilaprevir or ribavirin in patients who had failed previous NS5A-based DAA treatment. The primary outcome was SVR12. Safety and tolerability data were collected.ResultsOne hundred fifty patients were included. The mean age was 53 years, 64% were male, and 50% of included patients had liver cirrhosis, with a mean FIB-4 score of 3.12 (± 2.30) and Child-Turcotte-Pugh (CTP) score of 7.27 (± 0.48), and failed previous SOF/DCV + RBV, they were assigned to 24 weeks of SOF/VEL + RBV. The remaining 50% of participants had no liver cirrhosis and failed previous SOF/DCV, they were assigned to 12 weeks of treatment with SOF/VEL/VOX. Overall, SVR12 was achieved by 96% (n = 144/150) of included patients; 97.33% for SOF/VEL/VOX and 94.67% for SOF/VEL/RBV. Thirty-one patients experienced mild AEs; the most commonly reported mild AE in the SOF/VEL + RBV group was hyperbilirubinemia (n = 9) whereas in the SOF/VEL/VOX group were headache (n = 4) and vertigo (n = 4). Only one patient in SOF/VEL + RBV reported moderate treatment-related AE in the form of anemia and no reported severe AE.ConclusionRetreatment of non-cirrhotic patients with 12 weeks SOF/VEL/VOX and treatment of cirrhotic patients with 24 weeks with SOF/VEL + RBV after the failure of first-line NS5A-based therapy was an effective and well-tolerated treatment option.