Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

• ClinicalTrials.gov Identifier: NCT03118843
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Results First Posted: April 3, 2019
• Last Update Posted: April 3, 2019
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

Tracking Information

• First Submitted Date: April 13, 2017
• First Posted Date: April 18, 2017
• Results First Submitted Date: March 8, 2019
• Results First Posted Date: April 3, 2019
• Last Update Posted Date: April 3, 2019
• Actual Study Start Date: April 25, 2017
• Actual Primary Completion Date: March 19, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2019)

• Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
  SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
• Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to Week 12 ]

Original Primary Outcome Measures (submitted: April 17, 2017)

Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]

SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

Current Secondary Outcome Measures (submitted: March 8, 2019)

• Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
  SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
• Percentage of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Weeks 2, 4, 8, and 12 ]
• Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 12 ]
  Virologic failure was defined as:

  • On-treatment virologic failure:
    • Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA < LLOQ), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
  • Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit
• Change From Baseline in HCV RNA [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]

Original Secondary Outcome Measures (submitted: April 17, 2017)

• Proportion of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]
  SVR4 is defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
• Proportion of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Up to 12 weeks ]
• Proportion of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 12 ]
  Virologic failure is defined as:

  • On-treatment virologic failure:
    • Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA < LLOQ), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through treatment)
  • Virologic relapse:
    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
• Change From Baseline in HCV RNA [ Time Frame: Baseline and up to 12 weeks ]

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

Descriptive Information

• Brief Title: Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
• Official Title: An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
• Brief Summary: The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hepatitis C Virus Infection

Intervention

Drug: SOF/VEL/VOX

400/100/100 mg FDC tablet administered orally once daily with food

Other Names:

• GS-7997/GS-5816/GS-9857
• Vosevi®

Study Arms

Experimental: SOF/VEL/VOX

SOF/VEL/VOX for 12 weeks

Intervention: Drug: SOF/VEL/VOX

• Publications *: Ruane P, Strasser SJ, Gane EJ, Hyland RH, Shao J, Dvory-Sobol H, et al. Retreatment with Sofosbuvir/Velpatasvir/Voxilaprevir for 12 weeks is safe and effective for patients who have previously received Sofosbuvir/Velpatasvir or Sofosbuvir/Velpatasvir/Voxilaprevir [Abstract LBO-06]. 16th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD); 2018 14-17 June; Toronto, Canada

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 11, 2017): 31
• Original Estimated Enrollment (submitted: April 17, 2017): 50
• Actual Study Completion Date: March 19, 2018
• Actual Primary Completion Date: March 19, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: Australia, Canada, France, Germany, New Zealand, United Kingdom, United States
• Removed Location Countries: Puerto Rico

Administrative Information

• NCT Number: NCT03118843
• Other Study ID Numbers: GS-US-367-4181; 2017-000179-98 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.
• URL: https://www.gilead.com/about/ethics-and-code-of-conduct/policies

• Responsible Party: Gilead Sciences
• Study Sponsor: Gilead Sciences
• Collaborators: Not Provided

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

• PRS Account: Gilead Sciences
• Verification Date: March 2019