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Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02378935
Recruitment Status : Completed
First Posted : March 4, 2015
Results First Posted : December 8, 2017
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: VOX Drug: SOF/VEL Drug: RBV Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection
Actual Study Start Date : February 17, 2015
Actual Primary Completion Date : February 1, 2016
Actual Study Completion Date : April 12, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C
Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
Experimental: VOX+SOF/VEL 6 wk, TN, without cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Experimental: VOX+SOF/VEL 8 wk, TN, without cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Experimental: VOX+SOF/VEL 6 wk, TN, with cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Experimental: VOX+SOF/VEL 8 wk, TN, with cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Experimental: VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®

Drug: RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Experimental: VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Experimental: VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Experimental: VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Experimental: VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®
Experimental: VOX+SOF/VEL 12 wk (GS-US-338-1121)
VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)
 Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857

Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
  • GS-7977/GS-5816
  • Epclusa®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 Weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) ]
  3. HCV RNA Change From Baseline [ Time Frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) ]
  4. Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    • On-treatment virologic failure:

      • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Individuals with chronic HCV infection
  • HCV RNA ≥10^4 IU/mL at screening
  • HCV genotype 1
  • Cirrhosis determination; a liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of two contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

  • Pregnant or nursing female
  • Current or prior history of hepatic decompensation
  • Hepatocellular carcinoma (HCC) or other clinically significant malignancy
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

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

Contacts and Locations
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Information from the National Library of Medicine

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): NCT02378935


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Publications of Results:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02378935    
Other Study ID Numbers: GS-US-367-1168
First Posted: March 4, 2015    Key Record Dates
Results First Posted: December 8, 2017
Last Update Posted: March 6, 2020
Last Verified: November 2017
Individual Participant Data (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/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Supporting Materials: Study Protocol
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/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis C
Disease Attributes
Pathologic Processes
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Velpatasvir
Antiviral Agents
Anti-Infective Agents