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

Sponsor

Cerrahpasa Medical Faculty Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT06010524

Collaborator

(none)

450

Enrollment

Location

10.9

Anticipated Duration (Months)

41.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C

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

Efficacy and safety of 8-week Pangenotypic SOF/VEL/VOX for treatment naive non-cirrhotics
Efficacy and safety of 12-week Pangenotypic SOF/VEL/VOX for treatment naive compensate cirrhotics
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 Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cerrahpasa Medical Faculty	Istanbul		Turkey

Sponsors and Collaborators

Cerrahpasa Medical Faculty Foundation

Investigators

Principal Investigator: Fehmi Tabak, Prof, Cerrahpasa Medical Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cerrahpasa Medical Faculty Foundation

ClinicalTrials.gov Identifier:

NCT06010524

Other Study ID Numbers:

HEPCTURKEY_2

First Posted:

Aug 24, 2023

Last Update Posted:

Aug 29, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cerrahpasa Medical Faculty Foundation

Hepatitis C

VOSEVI

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2023