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

• ClinicalTrials.gov Identifier: NCT04695769
• Recruitment Status: Completed
• First Posted: January 5, 2021
• Last Update Posted: September 2, 2022
• Sponsor: Helwan University
• Information provided by (Responsible Party): Mohammed Emadeldeen, Helwan University

Tracking Information

• First Submitted Date: December 24, 2020
• First Posted Date: January 5, 2021
• Last Update Posted Date: September 2, 2022
• Actual Study Start Date: November 21, 2020
• Actual Primary Completion Date: October 21, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 31, 2022)

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.

Original Secondary Outcome Measures (submitted: January 3, 2021)

Tolerability [ Time Frame: During 12 weeks of treatment ]

Tolerability assessment by reporting of treatment related adverse events

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders
• Official Title: The Role of Combined Ribavirin and Sofosbuvir/Velpatasvir/Voxilaprevir in Treatment of Chronic Hepatitis C Non-responders; A Randomized Controlled Trial
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Hepatitis C

Intervention

• 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
• Drug: Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
  Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.
  Other Name: Vosevi

Study Arms

• 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

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

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 31, 2022): 281
• Original Estimated Enrollment (submitted: January 3, 2021): 400
• Actual Study Completion Date: October 21, 2021
• Actual Primary Completion Date: October 21, 2021 (Final data collection date for primary outcome measure)

Eligibility 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:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04695769
• Other Study ID Numbers: HelwanU 76-2020
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mohammed Emadeldeen, Helwan University
• Original Responsible Party: Same as current
• Current Study Sponsor: Helwan University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Helwan University
• Verification Date: August 2022