The Efficacy of Vosevi in Treating DAA-experienced Patients

March 11, 2024 updated by: The Third Affiliated Hospital of Guangzhou Medical University

A Prospective Cohort Study: the Efficacy of Vosevi in Treating Direct Antiviral Agent Therapy Failure Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Third Affiliated Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

We enroll DAAs-experienced hepatitis C patients in The Third Affiliated Hospital of Guangzhou Medical University

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vosevi Group
Patients are administrated with once-daily oral Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir: 400mg/100mg/100mg)
Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
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
Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
Evaluate the efficacy of Vosevi in DAAs-experienced patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of sustained virologic response after antiviral therapy
Time Frame: in one week after completed the antiviral therapy
Testing HCV-RNA in patients after antiviral therapy using Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin
in one week after completed the antiviral therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of ALT normalization after antiviral therapy
Time Frame: in one week after completed the antiviral therapy
Testing for ALT level in patients after antiviral therapy using Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin
in one week after completed the antiviral therapy
The proportion of virologic relapse after antiviral therapy
Time Frame: in 12 weeks after completed the antiviral therapy
Testing HCV-RNA in patients at 12 weeks during off-treatment
in 12 weeks after completed the antiviral therapy
The proportion of hepatitis C patients developed into cirrhosis or liver cancer during off-treatment
Time Frame: Liver ultrasound every half a year after completed the antiviral therapy until the study ending
Testing in patients every half a year during off-treatment
Liver ultrasound every half a year after completed the antiviral therapy until the study ending

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Investigators

  • Study Director: Xingfei Pan, PhD, The Third Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCYJ-2023-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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