The Efficacy of Vosevi in Treating DAA-experienced Patients

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180590
• Other study ID #: LCYJ-2023-005
• Status: Recruiting
• Start date: February 28, 2023
• Est. completion date: February 28, 2027

Study information

• Verified date: June 2023
• Source: The Third Affiliated Hospital of Guangzhou Medical University
• Contact: Xingfei Pan, PhD
• Phone: 13662517686
• Email: panxf0125[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Drug-Related Side Effects and Adverse Reactions
• Hepatitis C
• Hepatitis C, Chronic
• Medication Reaction

Intervention

Drug:
• Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
Evaluate the efficacy of Vosevi in DAAs-experienced patients

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of sustained virologic response after 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	The proportion of ALT normalization after 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
Secondary	The proportion of virologic relapse after antiviral therapy	Testing HCV-RNA in patients at 12 weeks during off-treatment	in 12 weeks after completed the antiviral therapy
Secondary	The proportion of hepatitis C patients developed into cirrhosis or liver cancer during off-treatment	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