The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China — BDTAF  

Chronic Hepatitis B Clinical Trial

Official title: The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China : a Mutil-center,Prospective,Single-arm,Open-label Trial

Status Recruiting

Clinical Trial Summary

Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients.

All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. In total, Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment , Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64, Group 2 patients will continue NUC treatment but pay by themselves. For those who is GT3 cirrhosis patients, RBV added simultaneously with SOF/VEL for 12 weeks. For patients weighing < 75 kg, the dose is 500 mg twice; for patients weighing ≥ 75 kg, the dose is 600 mg twice.

Clinical Trial Description

Subjects can be classified into two groups, Group 1 include non-cirrhotic patients, Group 2 include cirrhotic patients.

All the patients will be received prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. In total, Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment , Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64, Group 2 patients will continue NUC treatment but pay by themselves. For those who is GT3 cirrhosis patients, RBV added simultaneously with SOF/VEL for 12 weeks. For patients weighing < 75 kg, the dose is 500 mg twice; for patients weighing ≥ 75 kg, the dose is 600 mg twice.

The primary objective of this study is:

•To evaluate efficacy and safety of SOF/VEL in HBsAg-positive patients with HCV (GT1-6) co-infection.

The secondary objectives of this study are:

• To evaluate the proportion of subjects with HBV reactivation during the treatment and after cessation of treatment.

• To evaluate the proportion of subjects with virologic failure (virological breakthrough/ viral relapse)of HCV/ HBV. ;

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Chronic Hepatitis C
• Coinfection
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

• NCT number: NCT04997564
• Study type: Interventional
• Source: Peking University First Hospital
• Contact: XiaoYuan Xu
• Phone: +86-13001185762
• Email: xiaoyuanxu6@163.com
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2021
• Completion date: December 2023