Efficacy and safety of sofosbuvir–velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial

Abstract

Sofosbuvir-velpatasvir for 12 weeks provides a highly effective and well-tolerated therapy for Japanese patients with HCV and decompensated cirrhosis. Ribavirin did not improve efficacy but increased toxicity.

Long-awaited treatment for hepatitis C virus decompensated cirrhosis

“…In a study published in this issue, Takehara et al demonstrate that administration of sofosbuvir ? velpatasvir ± ribavirin combination therapy against HCV decompensated cirrhosis is sufficiently safe and effective [12]. Regardless of ribavirin involvement, the SVR 12 is 92%, which is comparable to that of the previous reports from other Western countries [13].…”

High serum angiopoietin‐2 level predicts non‐regression of liver stiffness measurement‐based liver fibrosis stage after direct‐acting antiviral therapy for hepatitis C

“…Recent development in DAAs has dramatically change anti‐HCV therapy with high SVR rate and safety, even in patients with other complications and advanced liver fibrosis, including decompensated liver cirrhosis . After successful HCV eradication, the risks of HCC occurrence and liver fibrosis progression have generally decreased; however, a definite number of patients experienced liver fibrosis progression even after successful HCV eradication by DAAs .…”

“…Hepatitis C virus (HCV) infection is the major cause of liver cirrhosis and hepatocellular carcinoma (HCC); thus, effective and safe treatment is crucial. Recently developed direct‐acting antiviral agents (DAAs) revolutionized the treatment of HCV‐infected patients; thus, even HCV‐infected patients with complications such as advanced liver fibrosis, renal dysfunction, and co‐infection of HIV could achieve sustained viral response (SVR) at a high rate …”

Involvement of portosystemic shunts in impaired improvement of liver function after direct‐acting antiviral therapies in cirrhotic patients with hepatitis C virus

“…Furthermore, in Japan, velpatasvir (VEL) was approved as a combination tablet with sofosbuvir (SOF) for patients with decompensated cirrhosis caused by genotypes 1 and 2 HCV in January 2019. According to a phase III trial carried out in Japan, 47 of 51 patients with decompensated cirrhosis showed SVR after VEL/SOF administration for 12 weeks . In this trial, among the 94 patients in whom SVR was achieved after DAA therapy using VEL/SOF or VEL/SOF plus ribavirin (RBV), the Child–Pugh scores improved, as compared with the baseline, by 12 weeks after the end of treatment (EOT) in 24 patients, remained unchanged in 68 patients, and deteriorated in two patients .…”

“…According to a phase III trial carried out in Japan, 47 of 51 patients with decompensated cirrhosis showed SVR after VEL/SOF administration for 12 weeks . In this trial, among the 94 patients in whom SVR was achieved after DAA therapy using VEL/SOF or VEL/SOF plus ribavirin (RBV), the Child–Pugh scores improved, as compared with the baseline, by 12 weeks after the end of treatment (EOT) in 24 patients, remained unchanged in 68 patients, and deteriorated in two patients . However, the long‐term outcomes of patients with decompensated cirrhosis in whom SVR has been achieved needs to be elucidated.…”