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

Cerrahpasa Medical Faculty Foundation

Status: Enrolling

Conditions: Hepatitis C

Study type: Observational

Funder types: Other

Identifiers

NCT06010524

HEPCTURKEY_2

Details and patient eligibility

About

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.

Full 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)

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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