Back to resultsSofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
Primary Purpose
Hepatitis C Virus Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SOF/VEL
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring Sofosbuvir, SOF/GS-5816, GS-5816, Hepatitis C, HCV, Cirrhosis, Velpatasvir
Eligibility Criteria
Key Inclusion Criteria:
- Willing and able to provide written informed consent
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
- HCV RNA ≥ 10^4 IU/mL at screening
- Classification as treatment naive or treatment experienced
- Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Key Exclusion Criteria:
- Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
- Screening electrocardiogram (ECG) with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
- 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 Type
Experimental
Arm Label
SOF/VEL
Arm Description
SOF/VEL for 12 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Secondary Outcome Measures
Percentage of Participants With Sustained Virologic Response 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 following the last dose of study drug, respectively.
Percentage of Participants With HCV RNA < LLOQ While on Treatment
HCV RNA Change From Baseline
Percentage of Participants With Virologic Failure
Virologic failure was defined as:
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
NCT02346721
Brief Title
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
Official Title
An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 23, 2015 (Actual)
Primary Completion Date
March 23, 2016 (Actual)
Study Completion Date
June 15, 2016 (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
No
5. Study Description
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
Sofosbuvir, SOF/GS-5816, GS-5816, Hepatitis C, HCV, Cirrhosis, Velpatasvir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOF/VEL
Arm Type
Experimental
Arm Description
SOF/VEL for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SOF/VEL
Other Intervention Name(s)
GS-7977/GS-5816, Epclusa®
Intervention Description
400/100 mg tablet administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 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 following the last dose of study drug, respectively.
Time Frame
Posttreatment Weeks 4 and 24
Title
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Time Frame
Baseline to Week 12
Title
HCV RNA Change From Baseline
Time Frame
Baseline to Week 12
Title
Percentage of Participants With Virologic Failure
Description
Virologic failure was defined as:
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
Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
HCV RNA ≥ 10^4 IU/mL at screening
Classification as treatment naive or treatment experienced
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Key Exclusion Criteria:
Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
Screening electrocardiogram (ECG) with clinically significant abnormalities
Laboratory results outside of acceptable ranges at screening
Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
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
ZIP/Postal Code
90822
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0272
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z2C7
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
City
Toronto
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
City
Clichy
ZIP/Postal Code
92110
Country
France
City
Creteil
ZIP/Postal Code
94000
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Limoges
ZIP/Postal Code
87042
Country
France
City
Lyon
ZIP/Postal Code
69004
Country
France
City
Marseille
ZIP/Postal Code
13008
Country
France
City
Paris
ZIP/Postal Code
75014
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Villejuif
ZIP/Postal Code
94804
Country
France
City
Duesseldorf
State/Province
North Rhine-Westphalia
ZIP/Postal Code
40237
Country
Germany
City
Koln
State/Province
NRW
ZIP/Postal Code
50932
Country
Germany
City
Berlin
ZIP/Postal Code
D-10969
Country
Germany
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
München
ZIP/Postal Code
81377
Country
Germany
City
Hong Kong
Country
Hong Kong
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
City
Firenze
ZIP/Postal Code
50012
Country
Italy
City
San Juan
ZIP/Postal Code
09027
Country
Puerto Rico
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
City
London
ZIP/Postal Code
E1 4AT
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
City
Oxford
ZIP/Postal Code
OX3 9DU
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 http://www.gilead.com/research/disclosure-and-transparency.
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
http://www.gilead.com/research/disclosure-and-transparency
Citations:
Citation
Asselah T, Shafran S, Bourgeois S, Lai CL, Cramp M, Mathurin P, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in HCV Infected Patients Previously Treated With Placebo: Results of the Deferred Treatment Study (GS-US-342-1446 Study) [Abstract SAT-279]. J Hepatology 2016;64:S827-8.
Results Reference
background
PubMed Identifier
31216086
Citation
Asselah T, Shafran SD, Bourgeois S, Lai CL, Mathurin P, Willems B, Nguyen MH, Davis MN, Huang KC, Svarovskaia E, Osinusi A, McNally J, Brainard DM, Shaikh OS, Tran TT. Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. J Viral Hepat. 2019 Oct;26(10):1229-1232. doi: 10.1111/jvh.13159. Epub 2019 Aug 4.
Results Reference
derived
Learn more about this trial
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
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