NCT04997564

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

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: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Hepatitis C
• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir Alafenamide 25 MG	All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment .
DRUG	Sofosbuvir / Velpatasvir	All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64.

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-08-09
• Last updated: 2021-08-09

Locations

1 site across 1 country: China