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

Helwan University

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis C

Treatments: Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]; Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04695769

HelwanU 76-2020

Details and patient eligibility

About

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.

Enrollment: 281 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

281 participants in 2 patient groups

Group A: SOF/VEL/VOX with RBV

Experimental group

Description:

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

Treatment:

Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin

Group B: SOF/VEL/VOX

Active Comparator group

Description:

Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily). Another name: Vosevi

Treatment:

Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]