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

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial

Conditions
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Chronic Hepatitis C

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: SOF/VEL/VOX with RBV<br>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 | Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin<br>* Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.<br>* Other names: Vosevi + RBV;|
| Active Comparator: Group B: SOF/VEL/VOX<br>Drug: Sofosbuvir/Velpatasvir/Voxilaprevir 400/100/100 mg tablets (single pill combination administered orally once daily). Another name: Vosevi | Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]<br>* Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.<br>* Other names: Vosevi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of sustained virological response (SVR) | 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. | 12 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | 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. | During 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, Relapse, treatment failure