A MULTICENTER REAL-WORLD COHORT TO VALIDATE THE EFFICACY AND SAFETY OF DIRECT ANTIVIRAL AGENTS FOR HEPATITIS C, AND RELATED RISK FACTORS FOR NON-SVR IN DECOMPENSATED CIRRHOSIS

Abstract

Introduction and Objectives: Clinical trials demonstrated the efficacy and safety of direct antiviral agents (DAA) to treat hepatitis C virus infection (HCV) in patients with decompensated cirrhosis (DC); however, very few real-world studies have been reported in this group. Moreover, predictive factors for non-achieving sustained virological response (SVR) in DC are not entirely understood. Therefore, the aim was to verify the efficacy and safety of DAA and to identify risk factors for failure to achieve SVR in DC. Materials and Methods: A real-world cohort study included HCV patients with DC [Child-Pugh B/C or A but with a history of previous clinical decompensation events like variceal bleeding (VB), hepatic encephalopathy (HE), or ascites]. All patients treated before transplant had MELD ≤ 20 and Child-Pugh ≤ 12 according to AASLD guidelines. Results: 222 patients, 118 (53.2%) were women, mean age 57.2±11.5 year-old, 61 (27.5%) were treated with Sofosbuvir(SOF)/Ledipasvir, 152 (68.5%) with SOF/Velpatasvir, and 9 (4.1%) with SOF/Daclatasvir, 175 (78.8%) used also ribavirin, 209 (94.1%) achieved SVR, despite non-significant difference, Child-Pugh C patients had a suboptimal response (SVR 20 and Child-Pugh C >12 are related to non-SVR; however, our study also shows that additional clinical factors have a negative impact on SVR: history of recurrent VB and episodic and persistent HE; therefore, these criteria should also be considered to decide to treat previous or after liver transplantation. In addition, acute decompensation and mortality events are very high in those who do not achieve SVR. Conclusions: SOF based on regimens without PIs are effective and safe in VHC with DC. Additional to classic criteria (MELD >20, Child-Pugh > 12), recurrent VB and HE are predictors of failure to achieve SVR in VHC with DC.The authors declare that there is no conflict of interest.