A Study of Chronic Hepatitis C Patients Treated With SOF/VEL/VOX

Hepatitis C Clinical Trial

— VOSEVI_Reg  

Official title:

A Retrospective Study of Chronic Hepatitis C Patients Treated With SOF/VEL/VOX: Real Life Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06010524
• Other study ID #: HEPCTURKEY_2
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Cerrahpasa Medical Faculty Foundation
• Contact: Fehmi Tabak, Prof
• Phone: +905322763788
• Email: fehmitabak[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective, non-interventional study. Investigators from infectious diseases and gastroenterology departments will participate this study.

Patients data will be collected from hospital medical records.

Description:

Pangenotypic Sofosbuvir/Velpatasvir/Voxilaprevir for 8-12 weeks has been shown highly effective, safe, and well-tolerated in treating patients with chronic HCV infection in clinical trial settings, however, there are no real-world setting data are available.This is the first opportunity from all over the world to demonstrate SOF/VEL/VOXs efficacy and safety in Real World setting especially for the naive patients.

SOF/VEL/VOX is often positioned in retreatment by international guidelines. Previously the reimbursement guideline in Turkey did not allow patients to be re-treated after the failure of DAA treatments. With current guideline Vosevi is approved as the only option for failures of DAA treatments. In the past years in Turkey, SOF+RBV in GT2, SOF+PEF+RBV in GT3, LDV/SOF in GT1.4-6 patients and Viekirax/Exviera in GT1,4 patients have been used and unfortunately, some patients did not benefit from these suboptimal treatments. The efficacy and safety of SOF/VEL/VOX in patients who have experienced treatment failure in real life will be another objective of the research.

This research will support

1. Efficacy and safety of 8-week Pangenotypic SOF/VEL/VOX for treatment naive non-cirrhotics

2. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for treatment naive compensate cirrhotics

3. Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for retreatment of NS5A or NS3A4 and non-NS5A treatment-experienced patients (incl. noncirrhotics and cirrhotics)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed as chronic hepatitis C and aged 18 and older

• Patients received SOF/VEL/VOX treatment

Exclusion Criteria:

• Decompensated cirrhotic HCV patients

• Having HCC

• eGFR<30 ml/min

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Locations

Country	Name	City	State
Turkey	Cerrahpasa Medical Faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Cerrahpasa Medical Faculty Foundation

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virology Response 12	Rate of the patients with undetectabled HCVRNA after 12 weeks of the completion of SOF/VEL/VOX treatment	From start date of treatment to 12 weeks after the completion of treatment