Hepatitis C
Conditions
Keywords
Hepatitis C, VOSEVI
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)
Interventions
None listed
Sponsors
Cerrahpasa Medical Faculty Foundation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Contacts
Primary ContactFehmi Tabak, Prof
Backup ContactIlker Kurkcu
Outcome results
None listed