The Efficacy of Vosevi in Treating DAA-experienced Patients

NCT ID: NCT06180590

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2027-02-28

Brief Summary

Hepatitis C virus (HCV) infection remains a significant health problem in our country. The World Health Organization estimated that 71 million people worldwide had chronic HCV infection in 2015. And 399,000 people died from cirrhosis or primary hepatocellular carcinoma caused by HCV infection. In 2006, the positive rate of HCV antibody in the population aged 1-59 was 0.43%. Therefore, it was estimated that there were about 5.6 million HCV infected people in the general population, and about 10 million cases of HCV infected people in high-risk groups and high incidence areas.

Universal genotype direct antiviral agent (DAA) is the preferred antiviral therapy for hepatitis C. Sofosbuvir/velpatasvir are direct antiviral agents for hepatitis C. The results of Asian clinical trials mainly in Chinese population showed that the sustained virologic response (SVR) rates of sofosbuvir/velpatasvir at 12 weeks in genotype 1a, 1b, 2, 3a, 3b and 6 were 100%, 100%, 100%, 95%, 76% and 99%, respectively. Limited data showed that the SVR rate of sofosbuvir/velpatasvir at 12 weeks was 96% in Chinese genotype 3b patients without cirrhosis and 50% in patients with cirrhosis.

After standard antiviral therapy for hepatitis C, there are still some patients who cannot obtain SVR, and these patients are defined as DAA-experienced patients. The guidelines recommend that Sofosbuvir/Velpatasvir combined with ribavirin be used as salvage therapy for patients with DAA-experienced failure. Vosevi is a new generation of antiviral therapy for hepatitis C, which contains three components, (Sofosbuvir, Velpatasvir and Voxilaprevir. It was a salvage treatment plan for DAAs-experienced patients which was recommended by the Chinese hepatitis C prevention and treatment guidelines in 2019. However, there are insufficient data on the proportion of SVR acquired in Vosevi treated DAAs-experienced patients in Asian populations and the effectivity of antiviral therapy between Vosevi and Sofosbuvir/Velpatasvir combined with ribavirin.

In the present study, the investigators enroll DAAs-experienced hepatitis C patients. The participants are randomly divided into two groups. Then the participants are treated with Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin respectively. All enrolled participants are followed-up for 3 years. Objectives of the present study are as follows:

A. To clarify the sustained virologic response rate after Vosevi therapy for DAAs-experienced patients.

B. To clarify the safety and efficacy between the Vosevi therapy and the Sofosbuvir/Velpatasvir combined with ribavirin therapy.

C. To clarify the changes of biochemistry indexes in DAAs-experienced patients after Vosevi therapy.

D. To clarify the virological relapse rate at 12 weeks after Vosevi therapy. E. To clarify the rate of cirrhosis and liver cancer during the follow-up.

Conditions

Chronic Hepatitis C; Medication Reaction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Vosevi Group

Patients are administrated with once-daily oral Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir: 400mg/100mg/100mg)

Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]

Intervention Type: DRUG

Evaluate the efficacy of Vosevi in DAAs-experienced patients

Sofosbuvir/Velpatasvir combined with ribavirin Group

Patients are administrated with once-daily oral Sofosbuvir/Velpatasvir (400mg/100mg) combined with ribavirin（500mg）twice a day

Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]

Intervention Type: DRUG

Evaluate the efficacy of Vosevi in DAAs-experienced patients

Interventions

Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]

Evaluate the efficacy of Vosevi in DAAs-experienced patients

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age of 20-70 years.
• Accepted the standard direct antiviral agent before
• HCV-RNA still positive
• Patients are administrated with once-daily oral Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir: 400mg/100mg/100mg) or Sofosbuvir/Velpatasvir (400mg/100mg) combined with ribavirin（500mg）twice a day treatment for rescue therapy.
• The good compliance of patients.

Exclusion Criteria

• Patients with antibodies against HIV, HBV, HDV, concretion or other forms of infectious disease.
• Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.
• Concurrent treatment with glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.
• Pregnancy.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xingfei Pan, PhD

Role: STUDY_DIRECTOR

The Third Affiliated Hospital of Guangzhou Medical University

Locations

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingfei Pan, PhD

Role: CONTACT

panxf0125@163.com

13662517686

Facility Contacts

Xingfei Pan, PhD

Role: primary

panxf0125@163.com

13662517686

Other Identifiers

LCYJ-2023-005

Identifier Type: -

Identifier Source: org_study_id