Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor (POLARIS-4)
Primary Purpose
Hepatitis C Virus Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SOF/VEL/VOX
SOF/VEL
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring Chronic
Eligibility Criteria
Key Inclusion Criteria:
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months)
- Treatment experienced with a direct acting antiviral medication not including a NS5A Inhibitor for HCV
- Use of protocol specified methods of contraception
Key Exclusion Criteria:
- Current or prior history of clinically significant illness that may interfere with participation in the study
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Pregnant or nursing female
- Chronic liver disease not caused by HCV
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SOF/VEL/VOX
SOF/VEL
Arm Description
SOF/VEL/VOX for 12 weeks
SOF/VEL for 12 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
Secondary Outcome Measures
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ On Treatment
Change From Baseline in HCV RNA
Percentage of Participants With Virologic Failure
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02639247
Brief Title
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Acronym
POLARIS-4
Official Title
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 23, 2015 (Actual)
Primary Completion Date
October 5, 2016 (Actual)
Study Completion Date
January 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOF/VEL/VOX
Arm Type
Experimental
Arm Description
SOF/VEL/VOX for 12 weeks
Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
SOF/VEL for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SOF/VEL/VOX
Other Intervention Name(s)
Vosevi®, GS-7977/GS-5816/GS-9857
Intervention Description
400/100/100 mg FDC tablet administered orally once daily with food
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
Epclusa®, GS-7977/GS-5816
Intervention Description
400/100 mg FDC tablet administered orally once daily without regard to food
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With HCV RNA < LLOQ On Treatment
Time Frame
Weeks 1, 2, 4, 8 and 12
Title
Change From Baseline in HCV RNA
Time Frame
Weeks 1, 2, 4, 8, and 12
Title
Percentage of Participants With Virologic Failure
Description
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.
Time Frame
Up to Posttreatment Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Willing and able to provide written informed consent
HCV RNA ≥ 10^4 IU/mL at screening
Chronic HCV infection (≥ 6 months)
Treatment experienced with a direct acting antiviral medication not including a NS5A Inhibitor for HCV
Use of protocol specified methods of contraception
Key Exclusion Criteria:
Current or prior history of clinically significant illness that may interfere with participation in the study
Screening ECG with clinically significant abnormalities
Laboratory results outside of acceptable ranges at screening
Pregnant or nursing female
Chronic liver disease not caused by HCV
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Long Beach
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Palo Alto
State/Province
California
Country
United States
City
Pasadena
State/Province
California
Country
United States
City
Rialto
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Englewood
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Gainesville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Wellington
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Bastrop
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Catonsville
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Hillsborough
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Fayetteville
State/Province
North Carolina
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Providence
State/Province
Rhode Island
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Murray
State/Province
Utah
Country
United States
City
Falls Church
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
City
Camperdown
State/Province
New South Wales
Country
Australia
City
Darlinghurst
State/Province
New South Wales
Country
Australia
City
Herston
State/Province
Queensland
Country
Australia
City
Clayton
State/Province
Victoria
Country
Australia
City
Melbourne
State/Province
Victoria
Country
Australia
City
Calgary
State/Province
Alberta
Country
Canada
City
Edmonton
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Brampton
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Clermont-Ferrand
Country
France
City
Clichy
Country
France
City
Grenoble
Country
France
City
Lille
Country
France
City
Limoges
Country
France
City
Lyon
Country
France
City
Marseille
Country
France
City
Montpellier
Country
France
City
Nice
Country
France
City
Paris
Country
France
City
Pessac
Country
France
City
Toulouse
Country
France
City
Vandoeuvre-les-Nancy
Country
France
City
Villejuif
Country
France
City
Berlin
Country
Germany
City
Bonn
Country
Germany
City
Frankfurt am Main
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
City
Köln
Country
Germany
City
Grafton
State/Province
Auckland
Country
New Zealand
City
San Juan
Country
Puerto Rico
City
London
Country
United Kingdom
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
https://www.gilead.com/about/ethics-and-code-of-conduct/policies
Citations:
PubMed Identifier
28564569
Citation
Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
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