Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders
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|ClinicalTrials.gov Identifier: NCT04695769|
Recruitment Status : Completed
First Posted : January 5, 2021
Last Update Posted : September 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||281 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial|
|Actual Study Start Date :||November 21, 2020|
|Actual Primary Completion Date :||October 21, 2021|
|Actual Study Completion Date :||October 21, 2021|
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.
Other Name: Vosevi + RBV
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.
Other Name: Vosevi
- Achievement of sustained virological response (SVR) [ Time Frame: 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.
- Tolerability [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695769
|Faculty of medicine Helwan University|