Safety and Efficacy of Sofosbuvir + Velpatasvir With or W... | NCT01858766 | Trialant
NCT01858766
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Nov 14, 2018Actual
Enrollment
379Actual
Phase
Phase 2
Conditions
Hepatitis C
Interventions
SOF
VEL
RBV
Countries
United States
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT01858766
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-342-0102
Secondary IDs
Not provided
Brief Title
Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
Official Title
A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Jul 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2013
Primary Completion Date
May 2014Actual
Completion Date
Aug 2014Actual
First Submitted Date
May 10, 2013
First Submission Date that Met QC Criteria
May 20, 2013
First Posted Date
May 21, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 27, 2016
Results First Submitted that Met QC Criteria
Jul 27, 2016
Results First Posted Date
Sep 15, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 16, 2015
Certification/Extension First Submitted that Passed QC Review
Jan 16, 2015
Certification/Extension First Posted Date
Jan 28, 2015Estimated
Last Update Submitted Date
Oct 19, 2018
Last Update Posted Date
Nov 14, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C
Keywords
Hepatitis
HCV Genotype 1
HCV Genotype 2
HCV Genotype 3
HCV Genotype 4
HCV Genotype 5
HCV Genotype 6
treatment naive
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
379Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
SOF+VEL 25 mg 12 Weeks (GT1)
Experimental
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 100 mg 12 Weeks (GT1)
Experimental
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)
Experimental
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)
Experimental
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 25 mg 12 Weeks (GT3)
Experimental
Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 100 mg 12 Weeks (GT3)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
SOF
Drug
400 mg tablet administered orally once daily
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF+VEL 100 mg 12 Weeks (GT1)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Chronic HCV infection
Body mass index (BMI) ≥ 18 kg/m^2
HCV RNA ≥ 10000 IU/mL at screening
Use of highly effective contraception methods if female of childbearing potential or sexually active male
Must not have cirrhosis
Exclusion Criteria:
Current or prior history of clinically significant illness other than HCV
Screening ECG with clinically significant abnormalities
Prior exposure to HCV specific direct acting antiviral agent
Prior treatment of HCV with interferon or ribavirin
Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of non-HCV etiology
Hepatitis B
Active drug abuse
Use of any prohibited concomitant medications
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
John McNally, PhD
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UCSD
La Jolla
California
92037
United States
University of California San Diego Medical Center
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Everson GT, Tran TT, Towner WJ , Davis MN, Wyles D, Nahass R, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, Symonds WT, McHutchison JG, Morgan T, Chung RT. Safety and Efficacy of Treatment with the Interferon-Free, Ribavirin-Free Combination of Sofosbuvir + GS-5816 for 12 Weeks in Treatment Naive Patients with Genotype 1-6 HCV Infection. Journal of Hepatology, Volume 60, Issue 1, Supplement, Page S46. April 2014 (EASL 2014).
Result
Tran TT, Morgan TR, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Chung RT, Everson GT. Safety and Efficacy of Treatment with Sofosbuvir+ GS-5816±Ribavirin for 8 or 12 Weeks in Treatment Naïve Patients with Genotype 1-6 HCV Infection. Hepatology (2014), 60: 4 (suppl) 237A.
Result
Doehle B, Gontcharova V, Chodavarapu1 RK, McNally J, Chung RT, Everson GT, McHutchison JG, Miller MD, Mo H. Resistance Analysis of Treatment-Naive HCV Genotype 1-6 Infected Patients Treated with Sofosbuvir in Combination with GS-5816 for 12 Weeks. Hepatology (2014), 60: 4 (suppl) 1138A.
Participants were enrolled at study sites in the United States. The first participant was screened on 22 April 2013. The last study visit occurred on 12 August 2014.
Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 25 mg 8 Weeks (GT1)
Experimental
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
Experimental
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
Drug: SOF
Drug: VEL
Drug: RBV
SOF+VEL 100 mg 8 Weeks (GT1)
Experimental
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
Experimental
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
Drug: SOF
Drug: VEL
Drug: RBV
SOF+VEL 25 mg 8 Weeks (GT2)
Experimental
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
Experimental
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
Drug: SOF
Drug: VEL
Drug: RBV
SOF+VEL 100 mg 8 Weeks (GT2)
Experimental
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
Drug: SOF
Drug: VEL
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
Experimental
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
Drug: SOF
Drug: VEL
Drug: RBV
SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)
SOF+VEL 100 mg 12 Weeks (GT3)
SOF+VEL 100 mg 8 Weeks (GT1)
SOF+VEL 100 mg 8 Weeks (GT2)
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF+VEL 25 mg 12 Weeks (GT1)
SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)
SOF+VEL 25 mg 12 Weeks (GT3)
SOF+VEL 25 mg 8 Weeks (GT1)
SOF+VEL 25 mg 8 Weeks (GT2)
GS-7977
PSI-7977
Sovaldi®
VEL
Drug
Tablet administered orally once daily
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF+VEL 100 mg 12 Weeks (GT1)
SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)
SOF+VEL 100 mg 12 Weeks (GT3)
SOF+VEL 100 mg 8 Weeks (GT1)
SOF+VEL 100 mg 8 Weeks (GT2)
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF+VEL 25 mg 12 Weeks (GT1)
SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)
SOF+VEL 25 mg 12 Weeks (GT3)
SOF+VEL 25 mg 8 Weeks (GT1)
SOF+VEL 25 mg 8 Weeks (GT2)
GS-5816
RBV
Drug
200 mg 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)
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
Ribasphere®
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.
Up to Posttreatment Week 24
La Jolla
California
92093
United States
VA Long Beach Healthcare System
Long Beach
California
90822
United States
Los Angeles Medical Center
Los Angeles
California
90027
United States
Ruane Peter J MD Incorporated
Los Angeles
California
90036
United States
Cedars Sinai Medical Center
Los Angeles
California
90048
United States
National Research Institute
Los Angeles
California
90057
United States
Huntington Medical Research Institutes Liver Center
Pasadena
California
91105
United States
Kaiser Permanente Medical Grp
San Diego
California
92120
United States
Medical Associates Research Group, Inc.
San Diego
California
92123
United States
Kaiser Permante
San Francisco
California
94080
United States
University of Colorado
Denver
Colorado
80220
United States
University of Florida Center for Clinical Trials Research
Gainesville
Florida
32610
United States
Borland-Groover Clinic
Jacksonville
Florida
32216
United States
University of Miami
Miami
Florida
33136
United States
Orlando Immunology Center
Orlando
Florida
32803
United States
Tampa General Hospital
Tampa
Florida
33606
United States
South Florida Center of Gastroenterology, P.A
Wellington
Florida
33414
United States
Center For Hepatitis C/Atlanta Medical Center
Atlanta
Georgia
30344
United States
Gastrointestinal Specialists of Georgia, PC
Marietta
Georgia
30060
United States
Northwestern University
Chicago
Illinois
60611
United States
Indiana University School of Medicine
Indianapolis
Indiana
46202
United States
Indianapolis Gastroenterology & Hepatology, Inc.- ARC
Indianapolis
Indiana
46237
United States
Mercy Medical Ctr
Baltimore
Maryland
21202
United States
Johns Hopkins University
Baltimore
Maryland
21287
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
Henry Ford Health System
Detroit
Michigan
48202
United States
ID Care
Hillsborough
New Jersey
08844
United States
Southwest C.A.R.E. Center
Santa Fe
New Mexico
87505
United States
North Shore/Long Island Jewish PRIME
Lake Success
New York
11041
United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York
New York
10021
United States
Asheville Gastroenterology Associates, P.A.
Asheville
North Carolina
28801
United States
Duke University Medical Center
Durham
North Carolina
27710
United States
Cumberland Research Associates, LLC
Fayetteville
North Carolina
28303
United States
Digestive Health Specialists, PA
Winston-Salem
North Carolina
27103
United States
University of Pennsylvania Health System
Philadelphia
Pennsylvania
19104
United States
UPMC Center For Liver Diseases
Pittsburgh
Pennsylvania
15213
United States
VA Pittsburgh Healthcare System
Pittsburgh
Pennsylvania
15240
United States
University Gastroenterology
Providence
Rhode Island
02905
United States
Gastro One
Germantown
Tennessee
38138
United States
Nashville Gastrointestinal Specialists Inc.
Nashville
Tennessee
37211
United States
Texas Clinical Research Institute, LLC
Arlington
Texas
76012
United States
Methodist Transplant Physicians
Dallas
Texas
75203
United States
Alamo Medical Research, LTD d/b/a American Research Corporation
San Antonio
Texas
78215
United States
Metropolitan Research
Fairfax
Virginia
22031
United States
INOVA Institute of Research & Education
Falls Church
Virginia
22042
United States
The Liver Institute of Virginia
Newport News
Virginia
23602
United States
Digestive and Liver Disease Specialists, Ltd.
Norfolk
Virginia
23502
United States
Virginia Mason Medical Center
Seattle
Washington
98101
United States
Fundacion de Investigacion de Diego
Santurce
00909
Puerto Rico
Result
Everson GT, Towner WJ, Davis MN, Wyles DL, Nahass RG, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, Rabinovitz M, McNally J, Brainard DM, Han L, Doehle B, McHutchison JG, Morgan T, Chung RT, Tran TT. Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial. Ann Intern Med. 2015 Dec 1;163(11):818-26. doi: 10.7326/M15-1000. Epub 2015 Nov 10.
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
FG002
SOF+VEL 25 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
FG003
SOF+VEL 100 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
FG004
SOF+VEL 25 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
FG005
SOF+VEL 100 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
FG006
SOF+VEL 25 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
FG007
SOF+VEL 100 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
FG008
SOF+VEL 25 mg 12 Weeks (GT5)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
FG009
SOF+VEL 25 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
FG010
SOF+VEL 100 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
FG011
SOF+VEL 25 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
FG012
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
FG013
SOF+VEL 100 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
FG014
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
FG015
SOF+VEL 25 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
FG016
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
FG017
SOF+VEL 100 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
FG018
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
FG00027 subjects
FG00128 subjects
FG00211 subjects
FG00310 subjects
FG00427 subjects
FG00528 subjects
FG0067 subjects
FG0077 subjects
FG0081 subjects
FG0094 subjects
FG0105 subjects
FG01130 subjects
FG01230 subjects
FG01329 subjects
FG01431 subjects
FG01526 subjects
FG01625 subjects
FG01727 subjects
FG01826 subjects
COMPLETED
FG00026 subjects
FG00128 subjects
FG00210 subjects
FG00310 subjects
FG00426 subjects
FG00524 subjects
FG0067 subjects
FG0075 subjects
FG0081 subjects
FG0094 subjects
FG0105 subjects
FG01125 subjects
FG01225 subjects
FG01326 subjects
FG01423 subjects
FG01520 subjects
FG01622 subjects
FG01723 subjects
FG01822 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0054 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0115 subjects
FG0125 subjects
FG0133 subjects
FG0148 subjects
FG0156 subjects
FG0163 subjects
FG0174 subjects
FG0184 subjects
Type
Comment
Reasons
Randomized but Never Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
FG0180 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SOF+VEL 25 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
BG001
SOF+VEL 100 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
BG002
SOF+VEL 25 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
BG003
SOF+VEL 100 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
BG004
SOF+VEL 25 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
BG005
SOF+VEL 100 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
BG006
SOF+VEL 25 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
BG007
SOF+VEL 100 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
BG008
SOF+VEL 25 mg 12 Weeks (GT5)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
BG009
SOF+VEL 25 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
BG010
SOF+VEL 100 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
BG011
SOF+VEL 25 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
BG012
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
BG013
SOF+VEL 100 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
BG014
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
BG015
SOF+VEL 25 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
BG016
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
BG017
SOF+VEL 100 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
BG018
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
BG019
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00027
BG00128
BG00211
BG00310
BG00427
BG00527
BG0067
BG0077
BG0081
BG0094
BG0105
BG01130
BG01230
BG01329
BG01431
BG01526
BG01625
BG01726
BG01826
BG019377
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049± 11.4
BG00149± 12.2
BG00242± 14.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00111
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0015
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
HCV Genotype
Number
participants
Title
Denominators
Categories
Genotype 1a
Title
Measurements
BG00022
BG00121
BG002
IL28b Status
The CC, CT, and TT alleles are different forms of the IL28b gene.
Number
participants
Title
Denominators
Categories
CC
Title
Measurements
BG0008
BG0019
BG002
HCV RNA
Mean
Standard Deviation
log10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0006.4± 0.60
BG0016.4± 0.74
BG002
HCV RNA Category
Number
participants
Title
Denominators
Categories
< 800,000 IU/mL
Title
Measurements
BG0004
BG0016
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Posttreatment Week 12
ID
Title
Description
OG000
SOF+VEL 25 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
OG001
SOF+VEL 100 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
OG002
SOF+VEL 25 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
OG003
SOF+VEL 100 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
OG004
SOF+VEL 25 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
OG005
SOF+VEL 100 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
OG006
SOF+VEL 25 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
OG007
SOF+VEL 100 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
OG008
SOF+VEL 25 mg 12 Weeks (GT5)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
OG009
SOF+VEL 25 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
OG010
SOF+VEL 100 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
OG011
SOF+VEL 25 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
OG012
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
OG013
SOF+VEL 100 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
OG014
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
OG015
SOF+VEL 25 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
OG016
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
OG017
SOF+VEL 100 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
OG018
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
Units
Counts
Participants
OG00027
OG00128
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG00096.3(81.0 to 99.9)
OG001100.0(87.7 to 100.0)
OG00290.9(58.7 to 99.8)
OG003
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Safety Analysis Set
Posted
Number
percentage of participants
Up to 12 weeks
ID
Title
Description
OG000
SOF+VEL 25 mg 12 Weeks
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
OG001
SOF+VEL 100 mg 12 Weeks
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
OG002
SOF+VEL 25 mg 8 Weeks
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
OG003
SOF+VEL 25 mg + RBV 8 Weeks
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
OG004
SOF+VEL 100 mg 8 Weeks
Secondary
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Full Analysis Set
Posted
Number
95% Confidence Interval
percentage of participants
Posttreatment Weeks 4 and 24
ID
Title
Description
OG000
SOF+VEL 25 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
OG001
SOF+VEL 100 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
OG002
SOF+VEL 25 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
OG003
SOF+VEL 100 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
Secondary
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 Analysis Set
Posted
Number
percentage of participants
Up to Posttreatment Week 24
ID
Title
Description
OG000
SOF+VEL 25 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
OG001
SOF+VEL 100 mg 12 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
OG002
SOF+VEL 25 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
OG003
Time Frame
Up to 12 weeks plus 30 days
Description
Safety Analysis Set
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
SOF+VEL 25 mg 12 Weeks
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
2
77
38
77
EG001
SOF+VEL 100 mg 12 Weeks
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
1
77
45
77
EG002
SOF+VEL 25 mg 8 Weeks
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
3
56
27
56
EG003
SOF+VEL 25 mg + RBV 8 Weeks
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
1
55
43
55
EG004
SOF+VEL 100 mg 8 Weeks
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
0
55
22
55
EG005
SOF+VEL 100 mg + RBV 8 Weeks
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
0
57
36
57
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cholecystitis acute
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0011 affected77 at risk
EG0020 affected56 at risk
EG0030 affected55 at risk
EG0040 affected55 at risk
EG0050 affected57 at risk
Appendicitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0010 affected77 at risk
EG0021 affected56 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 affected77 at risk
EG0010 affected77 at risk
EG0020 affected56 at risk
EG003
Traumatic liver injury
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 affected77 at risk
EG0010 affected77 at risk
EG0020 affected56 at risk
EG003
Electrocardiogram ST segment elevation
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0010 affected77 at risk
EG0021 affected56 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected77 at risk
EG0010 affected77 at risk
EG0020 affected56 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0010 affected77 at risk
EG0021 affected56 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0010 affected77 at risk
EG0020 affected56 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected77 at risk
EG0011 affected77 at risk
EG0020 affected56 at risk
EG0034 affected55 at risk
EG0040 affected55 at risk
EG0052 affected57 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected77 at risk
EG0014 affected77 at risk
EG0021 affected56 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0009 affected77 at risk
EG0016 affected77 at risk
EG0021 affected56 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0005 affected77 at risk
EG0017 affected77 at risk
EG0023 affected56 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0004 affected77 at risk
EG0014 affected77 at risk
EG0020 affected56 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG00010 affected77 at risk
EG0018 affected77 at risk
EG0024 affected56 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0005 affected77 at risk
EG0011 affected77 at risk
EG0020 affected56 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG00019 affected77 at risk
EG00114 affected77 at risk
EG0027 affected56 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0010 affected77 at risk
EG0023 affected56 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0010 affected77 at risk
EG0022 affected56 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0002 affected77 at risk
EG0015 affected77 at risk
EG0026 affected56 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0011 affected77 at risk
EG0021 affected56 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 affected77 at risk
EG0013 affected77 at risk
EG0020 affected56 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected77 at risk
EG0012 affected77 at risk
EG0023 affected56 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected77 at risk
EG0014 affected77 at risk
EG0021 affected56 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected77 at risk
EG0013 affected77 at risk
EG0022 affected56 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG00016 affected77 at risk
EG00114 affected77 at risk
EG0027 affected56 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0006 affected77 at risk
EG0011 affected77 at risk
EG0022 affected56 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected77 at risk
EG0013 affected77 at risk
EG0023 affected56 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0004 affected77 at risk
EG0011 affected77 at risk
EG0021 affected56 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0014 affected77 at risk
EG0020 affected56 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected77 at risk
EG0011 affected77 at risk
EG0021 affected56 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected77 at risk
EG0010 affected77 at risk
EG0021 affected56 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected77 at risk
EG0015 affected77 at risk
EG0022 affected56 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected77 at risk
EG0013 affected77 at risk
EG0022 affected56 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0004 affected77 at risk
EG0014 affected77 at risk
EG0021 affected56 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Trial Disclosures
Gilead Sciences
ClinicalTrialDisclosures@gilead.com
ID
Term
D006526
Hepatitis C
D006505
Hepatitis
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D006525
Hepatitis, Viral, Human
D014777
Virus Diseases
D018178
Flaviviridae Infections
D012327
RNA Virus Infections
D008107
Liver Diseases
D004066
Digestive System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069474
Sofosbuvir
C000604171
velpatasvir
D012254
Ribavirin
Ancestor Terms
ID
Term
D014542
Uridine Monophosphate
D014500
Uracil Nucleotides
D011742
Pyrimidine Nucleotides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D009711
Nucleotides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D012265
Ribonucleotides
D012263
Ribonucleosides
D009705
Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
1 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0113 subjects
FG0125 subjects
FG0133 subjects
FG0145 subjects
FG0155 subjects
FG0162 subjects
FG0173 subjects
FG0183 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0143 subjects
FG0151 subjects
FG0161 subjects
FG0170 subjects
FG0181 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
53
± 12.6
BG00452± 10.8
BG00550± 12.7
BG00651± 16.1
BG00756± 5.5
BG00853± NAN/A because there is only 1 participant in this group.
BG00957± 4.8
BG01054± 9.3
BG01150± 10.7
BG01253± 8.5
BG01355± 9.6
BG01452± 13.8
BG01552± 10.8
BG01654± 11.5
BG01754± 10.8
BG01851± 9.4
BG01952± 11.3
5
BG0033
BG0049
BG00510
BG0061
BG0073
BG0080
BG0090
BG0101
BG01114
BG01212
BG01313
BG01415
BG01511
BG0168
BG01714
BG01816
BG019159
Male
BG00014
BG00117
BG0026
BG0037
BG00418
BG00517
BG0066
BG0074
BG0081
BG0094
BG0104
BG01116
BG01218
BG01316
BG01416
BG01515
BG01617
BG01712
BG01810
BG019218
1
BG0030
BG0042
BG0051
BG0060
BG0071
BG0080
BG0090
BG0100
BG0114
BG0121
BG0132
BG0141
BG0153
BG0162
BG0177
BG0185
BG01939
Not Hispanic or Latino
BG00023
BG00123
BG00210
BG00310
BG00425
BG00526
BG0067
BG0076
BG0081
BG0094
BG0105
BG01126
BG01229
BG01327
BG01430
BG01523
BG01623
BG01719
BG01821
BG019338
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
0
BG0030
BG0041
BG0051
BG0060
BG0071
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0152
BG0160
BG0170
BG0181
BG0196
Asian
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0092
BG0104
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0197
Black or African American
Title
Measurements
BG0004
BG0011
BG0020
BG0030
BG0044
BG0050
BG0062
BG0071
BG0080
BG0090
BG0100
BG0114
BG0123
BG0135
BG0145
BG0152
BG0162
BG0172
BG0180
BG01935
White
Title
Measurements
BG00023
BG00125
BG00211
BG00310
BG00422
BG00526
BG0065
BG0075
BG0081
BG0092
BG0101
BG01126
BG01227
BG01324
BG01424
BG01522
BG01623
BG01724
BG01825
BG019326
Other
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0142
BG0150
BG0160
BG0170
BG0180
BG0193
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG01125
BG01225
BG01324
BG01425
BG0150
BG0160
BG0170
BG0180
BG019142
Genotype 1b
Title
Measurements
BG0005
BG0016
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0115
BG0125
BG0135
BG0146
BG0150
BG0160
BG0170
BG0180
BG01932
Genotype 1g
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0191
Genotype 2
Title
Measurements
BG0000
BG0010
BG00211
BG00310
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG01526
BG01625
BG01726
BG01826
BG019124
Genotype 3
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG00427
BG00527
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG01954
Genotype 4
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0067
BG0077
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG01914
Genotype 5
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0191
Genotype 6
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0094
BG0105
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0199
1
BG0032
BG00412
BG00513
BG0062
BG0072
BG0081
BG0091
BG0105
BG0119
BG01210
BG01313
BG0149
BG0159
BG01613
BG0179
BG0187
BG019135
CT
Title
Measurements
BG00016
BG00117
BG0028
BG0038
BG00413
BG00512
BG0065
BG0072
BG0080
BG0093
BG0100
BG01114
BG01216
BG01313
BG01418
BG01514
BG0169
BG01714
BG01814
BG019196
TT
Title
Measurements
BG0003
BG0012
BG0022
BG0030
BG0042
BG0051
BG0060
BG0073
BG0080
BG0090
BG0100
BG0117
BG0124
BG0133
BG0144
BG0153
BG0163
BG0173
BG0183
BG01943
Missing
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0182
BG0193
6.5
± 0.74
BG0036.7± 0.78
BG0046.4± 1.09
BG0056.2± 0.74
BG0066.2± 0.58
BG0075.8± 0.55
BG0087.0± NAN/A because there is only 1 participant in this group.
BG0096.1± 0.89
BG0106.7± 0.88
BG0116.5± 0.69
BG0126.5± 0.63
BG0136.3± 0.85
BG0146.6± 0.55
BG0156.4± 0.87
BG0166.6± 0.80
BG0176.5± 0.74
BG0186.7± 0.57
BG0196.5± 0.75
2
BG0031
BG0049
BG0056
BG0062
BG0074
BG0080
BG0091
BG0101
BG0115
BG0125
BG0138
BG0143
BG0156
BG0164
BG0175
BG0182
BG01974
≥ 800,000 IU/mL
Title
Measurements
BG00023
BG00122
BG0029
BG0039
BG00418
BG00521
BG0065
BG0073
BG0081
BG0093
BG0104
BG01125
BG01225
BG01321
BG01428
BG01520
BG01621
BG01721
BG01824
BG019303
10
OG00427
OG00527
OG0067
OG0077
OG0081
OG0094
OG0105
OG01130
OG01230
OG01329
OG01431
OG01526
OG01625
OG01726
OG01826
100.0
(69.2 to 100.0)
OG00492.6(75.7 to 99.1)
OG00592.6(75.7 to 99.1)
OG006100.0(59.0 to 100.0)
OG00785.7(42.1 to 99.6)
OG008100.0(2.5 to 100.0)
OG009100.0(39.8 to 100.0)
OG010100.0(47.8 to 100.0)
OG01186.7(69.3 to 96.2)
OG01283.3(65.3 to 94.4)
OG01389.7(72.6 to 97.8)
OG01480.6(62.5 to 92.5)
OG01576.9(56.4 to 91.0)
OG01688.0(68.8 to 97.5)
OG01788.5(69.8 to 97.6)
OG01888.5(69.8 to 97.6)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
OG005
SOF+VEL 100 mg + RBV 8 Weeks
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
Units
Counts
Participants
OG00077
OG00177
OG00256
OG00355
OG00455
OG00557
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021.8
OG0030
OG0040
OG0050
OG004
SOF+VEL 25 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
OG005
SOF+VEL 100 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
OG006
SOF+VEL 25 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
OG007
SOF+VEL 100 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
OG008
SOF+VEL 25 mg 12 Weeks (GT5)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
OG009
SOF+VEL 25 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
OG010
SOF+VEL 100 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
OG011
SOF+VEL 25 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
OG012
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
OG013
SOF+VEL 100 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
OG014
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
OG015
SOF+VEL 25 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
OG016
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
OG017
SOF+VEL 100 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
OG018
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
Units
Counts
Participants
OG00027
OG00128
OG00211
OG00310
OG00427
OG00527
OG0067
OG0077
OG0081
OG0094
OG0105
OG01130
OG01230
OG01329
OG01431
OG01526
OG01625
OG01726
OG01826
Title
Denominators
Categories
SVR4
Title
Measurements
OG00096.3(81.0 to 99.9)
OG001100.0(87.7 to 100.0)
OG00290.9(58.7 to 99.8)
OG003100.0(69.2 to 100.0)
OG00492.6(75.7 to 99.1)
OG005100.0(87.2 to 100.0)
OG006100.0(59.0 to 100.0)
OG00785.7(42.1 to 99.6)
OG008100.0(2.5 to 100.0)
OG009100.0(39.8 to 100.0)
OG010100.0(47.8 to 100.0)
OG01186.7(69.3 to 96.2)
OG01283.3(65.3 to 94.4)
OG01393.1(77.2 to 99.2)
OG01487.1(70.2 to 96.4)
OG01588.5(69.8 to 97.6)
OG01688.0(68.8 to 97.5)
OG01792.3(74.9 to 99.1)
OG01888.5(69.8 to 97.6)
SVR24
Title
Measurements
OG00092.6(75.7 to 99.1)
OG001100.0(87.7 to 100.0)
OG00290.9(58.7 to 99.8)
OG003
SOF+VEL 100 mg 12 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
OG004
SOF+VEL 25 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
OG005
SOF+VEL 100 mg 12 Weeks (GT3)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
OG006
SOF+VEL 25 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
OG007
SOF+VEL 100 mg 12 Weeks (GT4)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
OG008
SOF+VEL 25 mg 12 Weeks (GT5)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
OG009
SOF+VEL 25 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
OG010
SOF+VEL 100 mg 12 Weeks (GT6)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
OG011
SOF+VEL 25 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
OG012
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
OG013
SOF+VEL 100 mg 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
OG014
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
OG015
SOF+VEL 25 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
OG016
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
OG017
SOF+VEL 100 mg 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
OG018
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)