Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders

Phase 4

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]; Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin

• Registration Number: NCT04695769
• Lead Sponsor: Helwan University

Brief Summary

This study aims to assess the role of ribavirin as an adjuvant to sofosbuvir/velpatasvir/voxilaprevir combination in retreatment of chronic hepatitis C with previous treatment failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-21
• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2021-01-03
• Study First Posted: 2021-01-05
• Primary Completion: 2021-10-21
• Study Completion: 2021-10-21
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

• Adult (≥ 18 years) patients with chronic hepatitis C and detectable HCV RNA by Polymerase Chain Reaction (PCR) after completion of previous direct-acting antiviral regimen, and eligible for antiviral treatment.

Exclusion Criteria

• Patients with decompensated cirrhosis (Child-Pugh score B and C).
• Patients with platelet count less than 50000/ mm³.
• Patients with HCC or extrahepatic malignancy.
• Pregnancy or inability to use an effective contraceptive method.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B: SOF/VEL/VOX	Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]	Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily). Another name: Vosevi
Group A: SOF/VEL/VOX with RBV	Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin	Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily) plus Ribavirin (weight-based dose 1000 or 1200 mg daily according to patient body weight: \< or \> 60 kg). Another name: Vosevi, RBV

Primary Outcome Measures

Name	Time	Method
Achievement of sustained virological response (SVR)	12 weeks post treatment	Percentage of patients with Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) SVR12 is defined as HCV RNA \< the lower limit of quantitation 12 weeks following the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Tolerability	During 12 weeks of treatment	Tolerability assessment by reporting any adverse events in addition to laboratory abnormalities via continuous monitoring of CBC, transaminases, serum bilirubin, and serum creatinine at baseline and every 4 weeks during treatment.

Trial Locations

Locations (1)

Faculty of medicine Helwan University; 🇪🇬 Cairo, Egypt