Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Group A: SOF/VEL/VOX with RBV 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
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.
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Active Comparator: Group B: SOF/VEL/VOX 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]
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.
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Outcome Measures
Primary Outcome Measures
- 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
- Tolerability [During 12 weeks of treatment]
Tolerability assessment by reporting of treatment related adverse events
Eligibility Criteria
Criteria
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:
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Patients with decompensated cirrhosis (Child-Pugh score B and C).
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Patients with platelet count less than 50000/ mm³.
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Patients with HCC or extrahepatic malignancy.
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Pregnancy or inability to use an effective contraceptive method.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Faculty of medicine Helwan University | Cairo | Egypt |
Sponsors and Collaborators
- Helwan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HelwanU 76-2020