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

Recruiting

• Conditions: Hepatitis C

• Registration Number: NCT06010524
• Lead Sponsor: Cerrahpasa Medical Faculty Foundation

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-20
• Study First Submitted QC: 2023-08-20
• Study First Posted: 2023-08-24
• Last Update Submitted: 2023-08-26
• Last Update Posted: 2023-08-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained Virology Response 12	From start date of treatment to 12 weeks after the completion of treatment	Rate of the patients with undetectabled HCVRNA after 12 weeks of the completion of SOF/VEL/VOX treatment

Trial Locations

Locations (1)

Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Turkey