Clinical trial NCT06010524: A Study of Chronic Hepatitis C Patients Treated With SOF/VEL/VOX
Official title: A Retrospective Study of Chronic Hepatitis C Patients Treated With SOF/VEL/VOX: Real Life Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C
Keywords: Hepatitis C
VOSEVI
Lead sponsor: Cerrahpasa Medical Faculty Foundation
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All CHC patients who received Soforbuvir/Velpatasvir/Voxilaprevir combination therapy will be included in this study. The information of these patients will be recorded retrospectively from the Hospital registry system.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Sustained Virology Response 12
timeFrame: From start date of treatment to 12 weeks after the completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty
Study officials:
affiliation: Cerrahpasa Medical Faculty
name: Fehmi Tabak, Prof
role: PRINCIPAL_INVESTIGATOR
References: