Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.

Not yet recruiting

• Conditions: Hepatitis C Infection

• Registration Number: NCT05601518
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

Chronic hepatitis C is a long-lasting infectious disease caused by hepatitis C virus (HCV). According to statistics by the World Health Organization (WHO), the global HCV prevalence is estimated at 2.8%, equating to approximately 185 million. Chronic HCV infection can lead to chronic inflammatory necrosis and fibrosis in the liver, and in some patients can develop into hepatic cirrhosis and even hepatocellular carcinoma (HCC), endangering the health and life of patients.

The development of direct-acting antiviral agents (DAAs) since 2011 markedly improved antiviral efficacy and significantly shortened treatment cycle, making the drugs convenient for clinical use. Small molecule DAAs exert target-specific effects on proteins involved in the HCV life cycle and have been included in the treatment guidelines by leading associations for the study of liver diseases worldwide.

Treatment regimen for hepatitis C - coblopasvir hydrochloride capsules combined with sofosbuvir tablets:

Coblopasvir hydrochloride capsule is an NS5A inhibitor that inhibits the replication and assembly of HCV, and sofosbuvir tablet is a NS5B polymerase inhibitor. The primary efficacy results (sustained virologic response 12 weeks post-treatment, SVR12) were comparable between the phase II and III clinical studies: the overall SVR12 in subjects was 97%. The SVR12 after coblopasvir hydrochloride capsules combined with sofosbuvir tablets in genotype 3 infection with cirrhosis and genotype 3b infection with cirrhosis were superior to the results of sofosbuvir and velpatasvir tablets obtained in clinical studies in Asia (83% vs. 72%; 67% vs. 50%).

Coblopasvir hydrochloride capsule and sofosbuvir tablet were approved for marketing by National Medical Products Administration of China in Feb. 2020 and Mar. 2020, respectively. This study is designed to evaluate the safety and efficacy of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in clinical practice after marketing.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Study Start: 2022-11-01
• Study First Posted: 2022-11-01
• Last Update Posted: 2022-11-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Chronic hepatitis C infection
2. Age 18 years and over
3. Patients who treated with coblopasvir hydrochloride capsules/sofosbuvir tablets;

Read More

Exclusion Criteria

1. Patients who are receiving other DAAs drugs at the same time;
2. Subjects with poor compliance who are unable to complete treatment or follow-up.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained virologic response (SVR)	24 weeks	The proportion of patients with undetectable levels is detected by highly sensitive HCV RNA assay (lower limit of detection \< 15 IU/mL)

Secondary Outcome Measures

Name	Time	Method
Adverse events	24 weeks	Record AEs during the study (observe and record at any time).

Trial Locations

Locations (1)

Bejing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Bejing, China