Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01858766
Collaborator
(none)
379
51
14
16
7.4
0.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
379 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date
:
Apr 1, 2013
Actual Primary Completion Date
:
May 1, 2014
Actual Study Completion Date
:
Aug 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SOF+VEL 25 mg 12 Weeks (GT1) Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 100 mg 12 Weeks (GT1) Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 25 mg 12 Weeks (GT2/4/5/6) Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 100 mg 12 Weeks (GT2/4/5/6) Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 25 mg 12 Weeks (GT3) Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 100 mg 12 Weeks (GT3) Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 25 mg 8 Weeks (GT1) Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 25 mg + RBV 8 Weeks (GT1) Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
Drug: RBV
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)
Other Names:
|
| Experimental: SOF+VEL 100 mg 8 Weeks (GT1) Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 100 mg + RBV 8 Weeks (GT1) Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
Drug: RBV
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)
Other Names:
|
| Experimental: SOF+VEL 25 mg 8 Weeks (GT2) Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 25 mg + RBV 8 Weeks (GT2) Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
Drug: RBV
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)
Other Names:
|
| Experimental: SOF+VEL 100 mg 8 Weeks (GT2) Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
|
| Experimental: SOF+VEL 100 mg + RBV 8 Weeks (GT2) Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. |
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: VEL
Tablet administered orally once daily
Other Names:
Drug: RBV
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)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [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 [Up to 12 weeks]
Secondary Outcome Measures
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [Posttreatment Weeks 4 and 24]
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
- Percentage of Participants With Virologic Failure [Up to Posttreatment Week 24]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSD | La Jolla | California | United States | 92037 |
| 2 | University of California San Diego Medical Center | La Jolla | California | United States | 92093 |
| 3 | VA Long Beach Healthcare System | Long Beach | California | United States | 90822 |
| 4 | Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 5 | Ruane Peter J MD Incorporated | Los Angeles | California | United States | 90036 |
| 6 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 7 | National Research Institute | Los Angeles | California | United States | 90057 |
| 8 | Huntington Medical Research Institutes Liver Center | Pasadena | California | United States | 91105 |
| 9 | Kaiser Permanente Medical Grp | San Diego | California | United States | 92120 |
| 10 | Medical Associates Research Group, Inc. | San Diego | California | United States | 92123 |
| 11 | Kaiser Permante | San Francisco | California | United States | 94080 |
| 12 | University of Colorado | Denver | Colorado | United States | 80220 |
| 13 | University of Florida Center for Clinical Trials Research | Gainesville | Florida | United States | 32610 |
| 14 | Borland-Groover Clinic | Jacksonville | Florida | United States | 32216 |
| 15 | University of Miami | Miami | Florida | United States | 33136 |
| 16 | Orlando Immunology Center | Orlando | Florida | United States | 32803 |
| 17 | Tampa General Hospital | Tampa | Florida | United States | 33606 |
| 18 | South Florida Center of Gastroenterology, P.A | Wellington | Florida | United States | 33414 |
| 19 | Center For Hepatitis C/Atlanta Medical Center | Atlanta | Georgia | United States | 30344 |
| 20 | Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | United States | 30060 |
| 21 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 22 | Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
| 23 | Indianapolis Gastroenterology & Hepatology, Inc.- ARC | Indianapolis | Indiana | United States | 46237 |
| 24 | Mercy Medical Ctr | Baltimore | Maryland | United States | 21202 |
| 25 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
| 26 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 27 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 28 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 29 | ID Care | Hillsborough | New Jersey | United States | 08844 |
| 30 | Southwest C.A.R.E. Center | Santa Fe | New Mexico | United States | 87505 |
| 31 | North Shore/Long Island Jewish PRIME | Lake Success | New York | United States | 11041 |
| 32 | Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | United States | 10021 |
| 33 | Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | United States | 28801 |
| 34 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 35 | Cumberland Research Associates, LLC | Fayetteville | North Carolina | United States | 28303 |
| 36 | Digestive Health Specialists, PA | Winston-Salem | North Carolina | United States | 27103 |
| 37 | University of Pennsylvania Health System | Philadelphia | Pennsylvania | United States | 19104 |
| 38 | UPMC Center For Liver Diseases | Pittsburgh | Pennsylvania | United States | 15213 |
| 39 | VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | United States | 15240 |
| 40 | University Gastroenterology | Providence | Rhode Island | United States | 02905 |
| 41 | Gastro One | Germantown | Tennessee | United States | 38138 |
| 42 | Nashville Gastrointestinal Specialists Inc. | Nashville | Tennessee | United States | 37211 |
| 43 | Texas Clinical Research Institute, LLC | Arlington | Texas | United States | 76012 |
| 44 | Methodist Transplant Physicians | Dallas | Texas | United States | 75203 |
| 45 | Alamo Medical Research, LTD d/b/a American Research Corporation | San Antonio | Texas | United States | 78215 |
| 46 | Metropolitan Research | Fairfax | Virginia | United States | 22031 |
| 47 | INOVA Institute of Research & Education | Falls Church | Virginia | United States | 22042 |
| 48 | The Liver Institute of Virginia | Newport News | Virginia | United States | 23602 |
| 49 | Digestive and Liver Disease Specialists, Ltd. | Norfolk | Virginia | United States | 23502 |
| 50 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 51 | Fundacion de Investigacion de Diego | Santurce | Puerto Rico | 00909 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: John McNally, PhD, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01858766
Other Study ID Numbers:
- GS-US-342-0102
First Posted:
May 21, 2013
Last Update Posted:
Nov 14, 2018
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Gilead Sciences
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 469 participants were screened. |
| Arm/Group Title | SOF+VEL 25 mg 12 Weeks (GT1) | SOF+VEL 100 mg 12 Weeks (GT1) | SOF+VEL 25 mg 12 Weeks (GT2) | SOF+VEL 100 mg 12 Weeks (GT2) | SOF+VEL 25 mg 12 Weeks (GT3) | SOF+VEL 100 mg 12 Weeks (GT3) | SOF+VEL 25 mg 12 Weeks (GT4) | SOF+VEL 100 mg 12 Weeks (GT4) | SOF+VEL 25 mg 12 Weeks (GT5) | SOF+VEL 25 mg 12 Weeks (GT6) | SOF+VEL 100 mg 12 Weeks (GT6) | SOF+VEL 25 mg 8 Weeks (GT1) | SOF+VEL 25 mg + RBV 8 Weeks (GT1) | SOF+VEL 100 mg 8 Weeks (GT1) | SOF+VEL 100 mg + RBV 8 Weeks (GT1) | SOF+VEL 25 mg 8 Weeks (GT2) | SOF+VEL 25 mg + RBV 8 Weeks (GT2) | SOF+VEL 100 mg 8 Weeks (GT2) | SOF+VEL 100 mg + RBV 8 Weeks (GT2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Sofosbuvir (SOF) 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 1) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) |
| Period Title: Overall Study | |||||||||||||||||||
| STARTED | 27 | 28 | 11 | 10 | 27 | 28 | 7 | 7 | 1 | 4 | 5 | 30 | 30 | 29 | 31 | 26 | 25 | 27 | 26 |
| COMPLETED | 26 | 28 | 10 | 10 | 26 | 24 | 7 | 5 | 1 | 4 | 5 | 25 | 25 | 26 | 23 | 20 | 22 | 23 | 22 |
| NOT COMPLETED | 1 | 0 | 1 | 0 | 1 | 4 | 0 | 2 | 0 | 0 | 0 | 5 | 5 | 3 | 8 | 6 | 3 | 4 | 4 |
Baseline Characteristics
| Arm/Group Title | SOF+VEL 25 mg 12 Weeks (GT1) | SOF+VEL 100 mg 12 Weeks (GT1) | SOF+VEL 25 mg 12 Weeks (GT2) | SOF+VEL 100 mg 12 Weeks (GT2) | SOF+VEL 25 mg 12 Weeks (GT3) | SOF+VEL 100 mg 12 Weeks (GT3) | SOF+VEL 25 mg 12 Weeks (GT4) | SOF+VEL 100 mg 12 Weeks (GT4) | SOF+VEL 25 mg 12 Weeks (GT5) | SOF+VEL 25 mg 12 Weeks (GT6) | SOF+VEL 100 mg 12 Weeks (GT6) | SOF+VEL 25 mg 8 Weeks (GT1) | SOF+VEL 25 mg + RBV 8 Weeks (GT1) | SOF+VEL 100 mg 8 Weeks (GT1) | SOF+VEL 100 mg + RBV 8 Weeks (GT1) | SOF+VEL 25 mg 8 Weeks (GT2) | SOF+VEL 25 mg + RBV 8 Weeks (GT2) | SOF+VEL 100 mg 8 Weeks (GT2) | SOF+VEL 100 mg + RBV 8 Weeks (GT2) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) | Total of all reporting groups |
| Overall Participants | 27 | 28 | 11 | 10 | 27 | 27 | 7 | 7 | 1 | 4 | 5 | 30 | 30 | 29 | 31 | 26 | 25 | 26 | 26 | 377 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||||||||||||
| Mean (Standard Deviation) [years] |
49
(11.4)
|
49
(12.2)
|
42
(14.6)
|
53
(12.6)
|
52
(10.8)
|
50
(12.7)
|
51
(16.1)
|
56
(5.5)
|
53
(NA)
|
57
(4.8)
|
54
(9.3)
|
50
(10.7)
|
53
(8.5)
|
55
(9.6)
|
52
(13.8)
|
52
(10.8)
|
54
(11.5)
|
54
(10.8)
|
51
(9.4)
|
52
(11.3)
|
| Sex: Female, Male (Count of Participants) | ||||||||||||||||||||
| Female |
13
48.1%
|
11
39.3%
|
5
45.5%
|
3
30%
|
9
33.3%
|
10
37%
|
1
14.3%
|
3
42.9%
|
0
0%
|
0
0%
|
1
20%
|
14
46.7%
|
12
40%
|
13
44.8%
|
15
48.4%
|
11
42.3%
|
8
32%
|
14
53.8%
|
16
61.5%
|
159
42.2%
|
| Male |
14
51.9%
|
17
60.7%
|
6
54.5%
|
7
70%
|
18
66.7%
|
17
63%
|
6
85.7%
|
4
57.1%
|
1
100%
|
4
100%
|
4
80%
|
16
53.3%
|
18
60%
|
16
55.2%
|
16
51.6%
|
15
57.7%
|
17
68%
|
12
46.2%
|
10
38.5%
|
218
57.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||||||||||||||
| Hispanic or Latino |
4
14.8%
|
5
17.9%
|
1
9.1%
|
0
0%
|
2
7.4%
|
1
3.7%
|
0
0%
|
1
14.3%
|
0
0%
|
0
0%
|
0
0%
|
4
13.3%
|
1
3.3%
|
2
6.9%
|
1
3.2%
|
3
11.5%
|
2
8%
|
7
26.9%
|
5
19.2%
|
39
10.3%
|
| Not Hispanic or Latino |
23
85.2%
|
23
82.1%
|
10
90.9%
|
10
100%
|
25
92.6%
|
26
96.3%
|
7
100%
|
6
85.7%
|
1
100%
|
4
100%
|
5
100%
|
26
86.7%
|
29
96.7%
|
27
93.1%
|
30
96.8%
|
23
88.5%
|
23
92%
|
19
73.1%
|
21
80.8%
|
338
89.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||||||||||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.7%
|
1
3.7%
|
0
0%
|
1
14.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
7.7%
|
0
0%
|
0
0%
|
1
3.8%
|
6
1.6%
|
| Asian |
0
0%
|
1
3.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
50%
|
4
80%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
7
1.9%
|
| Black or African American |
4
14.8%
|
1
3.6%
|
0
0%
|
0
0%
|
4
14.8%
|
0
0%
|
2
28.6%
|
1
14.3%
|
0
0%
|
0
0%
|
0
0%
|
4
13.3%
|
3
10%
|
5
17.2%
|
5
16.1%
|
2
7.7%
|
2
8%
|
2
7.7%
|
0
0%
|
35
9.3%
|
| White |
23
85.2%
|
25
89.3%
|
11
100%
|
10
100%
|
22
81.5%
|
26
96.3%
|
5
71.4%
|
5
71.4%
|
1
100%
|
2
50%
|
1
20%
|
26
86.7%
|
27
90%
|
24
82.8%
|
24
77.4%
|
22
84.6%
|
23
92%
|
24
92.3%
|
25
96.2%
|
326
86.5%
|
| Other |
0
0%
|
1
3.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
6.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3
0.8%
|
| HCV Genotype (participants) [Number] | ||||||||||||||||||||
| Genotype 1a |
22
81.5%
|
21
75%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
25
83.3%
|
25
83.3%
|
24
82.8%
|
25
80.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
142
37.7%
|
| Genotype 1b |
5
18.5%
|
6
21.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
16.7%
|
5
16.7%
|
5
17.2%
|
6
19.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
32
8.5%
|
| Genotype 1g |
0
0%
|
1
3.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| Genotype 2 |
0
0%
|
0
0%
|
11
100%
|
10
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
26
100%
|
25
100%
|
26
100%
|
26
100%
|
124
32.9%
|
| Genotype 3 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
27
100%
|
27
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
54
14.3%
|
| Genotype 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
7
100%
|
7
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
14
3.7%
|
| Genotype 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| Genotype 6 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
4
100%
|
5
100%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
9
2.4%
|
| IL28b Status (participants) [Number] | ||||||||||||||||||||
| CC |
8
29.6%
|
9
32.1%
|
1
9.1%
|
2
20%
|
12
44.4%
|
13
48.1%
|
2
28.6%
|
2
28.6%
|
1
100%
|
1
25%
|
5
100%
|
9
30%
|
10
33.3%
|
13
44.8%
|
9
29%
|
9
34.6%
|
13
52%
|
9
34.6%
|
7
26.9%
|
135
35.8%
|
| CT |
16
59.3%
|
17
60.7%
|
8
72.7%
|
8
80%
|
13
48.1%
|
12
44.4%
|
5
71.4%
|
2
28.6%
|
0
0%
|
3
75%
|
0
0%
|
14
46.7%
|
16
53.3%
|
13
44.8%
|
18
58.1%
|
14
53.8%
|
9
36%
|
14
53.8%
|
14
53.8%
|
196
52%
|
| TT |
3
11.1%
|
2
7.1%
|
2
18.2%
|
0
0%
|
2
7.4%
|
1
3.7%
|
0
0%
|
3
42.9%
|
0
0%
|
0
0%
|
0
0%
|
7
23.3%
|
4
13.3%
|
3
10.3%
|
4
12.9%
|
3
11.5%
|
3
12%
|
3
11.5%
|
3
11.5%
|
43
11.4%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
7.7%
|
3
0.8%
|
| HCV RNA (log10 IU/mL) [Mean (Standard Deviation) ] | ||||||||||||||||||||
| Mean (Standard Deviation) [log10 IU/mL] |
6.4
(0.60)
|
6.4
(0.74)
|
6.5
(0.74)
|
6.7
(0.78)
|
6.4
(1.09)
|
6.2
(0.74)
|
6.2
(0.58)
|
5.8
(0.55)
|
7.0
(NA)
|
6.1
(0.89)
|
6.7
(0.88)
|
6.5
(0.69)
|
6.5
(0.63)
|
6.3
(0.85)
|
6.6
(0.55)
|
6.4
(0.87)
|
6.6
(0.80)
|
6.5
(0.74)
|
6.7
(0.57)
|
6.5
(0.75)
|
| HCV RNA Category (participants) [Number] | ||||||||||||||||||||
| < 800,000 IU/mL |
4
14.8%
|
6
21.4%
|
2
18.2%
|
1
10%
|
9
33.3%
|
6
22.2%
|
2
28.6%
|
4
57.1%
|
0
0%
|
1
25%
|
1
20%
|
5
16.7%
|
5
16.7%
|
8
27.6%
|
3
9.7%
|
6
23.1%
|
4
16%
|
5
19.2%
|
2
7.7%
|
74
19.6%
|
| ≥ 800,000 IU/mL |
23
85.2%
|
22
78.6%
|
9
81.8%
|
9
90%
|
18
66.7%
|
21
77.8%
|
5
71.4%
|
3
42.9%
|
1
100%
|
3
75%
|
4
80%
|
25
83.3%
|
25
83.3%
|
21
72.4%
|
28
90.3%
|
20
76.9%
|
21
84%
|
21
80.8%
|
24
92.3%
|
303
80.4%
|
Outcome Measures
| 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; ie, 15 IU/mL) at 12 weeks after stopping study treatment. |
| Time Frame | Posttreatment Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug. |
| Arm/Group Title | SOF+VEL 25 mg 12 Weeks (GT1) | SOF+VEL 100 mg 12 Weeks (GT1) | SOF+VEL 25 mg 12 Weeks (GT2) | SOF+VEL 100 mg 12 Weeks (GT2) | SOF+VEL 25 mg 12 Weeks (GT3) | SOF+VEL 100 mg 12 Weeks (GT3) | SOF+VEL 25 mg 12 Weeks (GT4) | SOF+VEL 100 mg 12 Weeks (GT4) | SOF+VEL 25 mg 12 Weeks (GT5) | SOF+VEL 25 mg 12 Weeks (GT6) | SOF+VEL 100 mg 12 Weeks (GT6) | SOF+VEL 25 mg 8 Weeks (GT1) | SOF+VEL 25 mg + RBV 8 Weeks (GT1) | SOF+VEL 100 mg 8 Weeks (GT1) | SOF+VEL 100 mg + RBV 8 Weeks (GT1) | SOF+VEL 25 mg 8 Weeks (GT2) | SOF+VEL 25 mg + RBV 8 Weeks (GT2) | SOF+VEL 100 mg 8 Weeks (GT2) | SOF+VEL 100 mg + RBV 8 Weeks (GT2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) |
| Measure Participants | 27 | 28 | 11 | 10 | 27 | 27 | 7 | 7 | 1 | 4 | 5 | 30 | 30 | 29 | 31 | 26 | 25 | 26 | 26 |
| Number (95% Confidence Interval) [percentage of participants] |
96.3
356.7%
|
100.0
357.1%
|
90.9
826.4%
|
100.0
1000%
|
92.6
343%
|
92.6
343%
|
100.0
1428.6%
|
85.7
1224.3%
|
100.0
10000%
|
100.0
2500%
|
100.0
2000%
|
86.7
289%
|
83.3
277.7%
|
89.7
309.3%
|
80.6
260%
|
76.9
295.8%
|
88.0
352%
|
88.5
340.4%
|
88.5
340.4%
|
| Title | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
|---|---|
| Description | |
| Time Frame | Up to 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set |
| Arm/Group Title | SOF+VEL 25 mg 12 Weeks | SOF+VEL 100 mg 12 Weeks | SOF+VEL 25 mg 8 Weeks | SOF+VEL 25 mg + RBV 8 Weeks | SOF+VEL 100 mg 8 Weeks | SOF+VEL 100 mg + RBV 8 Weeks |
|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes) | 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) |
| Measure Participants | 77 | 77 | 56 | 55 | 55 | 57 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
1.8
16.4%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
|---|---|
| Description | SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. |
| Time Frame | Posttreatment Weeks 4 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | SOF+VEL 25 mg 12 Weeks (GT1) | SOF+VEL 100 mg 12 Weeks (GT1) | SOF+VEL 25 mg 12 Weeks (GT2) | SOF+VEL 100 mg 12 Weeks (GT2) | SOF+VEL 25 mg 12 Weeks (GT3) | SOF+VEL 100 mg 12 Weeks (GT3) | SOF+VEL 25 mg 12 Weeks (GT4) | SOF+VEL 100 mg 12 Weeks (GT4) | SOF+VEL 25 mg 12 Weeks (GT5) | SOF+VEL 25 mg 12 Weeks (GT6) | SOF+VEL 100 mg 12 Weeks (GT6) | SOF+VEL 25 mg 8 Weeks (GT1) | SOF+VEL 25 mg + RBV 8 Weeks (GT1) | SOF+VEL 100 mg 8 Weeks (GT1) | SOF+VEL 100 mg + RBV 8 Weeks (GT1) | SOF+VEL 25 mg 8 Weeks (GT2) | SOF+VEL 25 mg + RBV 8 Weeks (GT2) | SOF+VEL 100 mg 8 Weeks (GT2) | SOF+VEL 100 mg + RBV 8 Weeks (GT2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) |
| Measure Participants | 27 | 28 | 11 | 10 | 27 | 27 | 7 | 7 | 1 | 4 | 5 | 30 | 30 | 29 | 31 | 26 | 25 | 26 | 26 |
| SVR4 |
96.3
356.7%
|
100.0
357.1%
|
90.9
826.4%
|
100.0
1000%
|
92.6
343%
|
100.0
370.4%
|
100.0
1428.6%
|
85.7
1224.3%
|
100.0
10000%
|
100.0
2500%
|
100.0
2000%
|
86.7
289%
|
83.3
277.7%
|
93.1
321%
|
87.1
281%
|
88.5
340.4%
|
88.0
352%
|
92.3
355%
|
88.5
340.4%
|
| SVR24 |
92.6
343%
|
100.0
357.1%
|
90.9
826.4%
|
100.0
1000%
|
92.6
343%
|
92.6
343%
|
100.0
1428.6%
|
85.7
1224.3%
|
100.0
10000%
|
100.0
2500%
|
100.0
2000%
|
86.7
289%
|
83.3
277.7%
|
89.7
309.3%
|
80.6
260%
|
76.9
295.8%
|
88.0
352%
|
88.5
340.4%
|
88.5
340.4%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | SOF+VEL 25 mg 12 Weeks (GT1) | SOF+VEL 100 mg 12 Weeks (GT1) | SOF+VEL 25 mg 12 Weeks (GT2) | SOF+VEL 100 mg 12 Weeks (GT2) | SOF+VEL 25 mg 12 Weeks (GT3) | SOF+VEL 100 mg 12 Weeks (GT3) | SOF+VEL 25 mg 12 Weeks (GT4) | SOF+VEL 100 mg 12 Weeks (GT4) | SOF+VEL 25 mg 12 Weeks (GT5) | SOF+VEL 25 mg 12 Weeks (GT6) | SOF+VEL 100 mg 12 Weeks (GT6) | SOF+VEL 25 mg 8 Weeks (GT1) | SOF+VEL 25 mg + RBV 8 Weeks (GT1) | SOF+VEL 100 mg 8 Weeks (GT1) | SOF+VEL 100 mg + RBV 8 Weeks (GT1) | SOF+VEL 25 mg 8 Weeks (GT2) | SOF+VEL 25 mg + RBV 8 Weeks (GT2) | SOF+VEL 100 mg 8 Weeks (GT2) | SOF+VEL 100 mg + RBV 8 Weeks (GT2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1) | 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) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2) | 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) |
| Measure Participants | 27 | 28 | 11 | 10 | 27 | 27 | 7 | 7 | 1 | 4 | 5 | 30 | 30 | 29 | 31 | 26 | 25 | 26 | 26 |
| Number [percentage of participants] |
3.7
13.7%
|
0
0%
|
0
0%
|
0
0%
|
7.4
27.4%
|
7.4
27.4%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
10.0
33.3%
|
16.7
55.7%
|
10.3
35.5%
|
16.1
51.9%
|
23.1
88.8%
|
8.0
32%
|
11.5
44.2%
|
11.5
44.2%
|
Adverse Events
| Time Frame | Up to 12 weeks plus 30 days | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Analysis Set | |||||||||||
| Arm/Group Title | SOF+VEL 25 mg 12 Weeks | SOF+VEL 100 mg 12 Weeks | SOF+VEL 25 mg 8 Weeks | SOF+VEL 25 mg + RBV 8 Weeks | SOF+VEL 100 mg 8 Weeks | SOF+VEL 100 mg + RBV 8 Weeks | ||||||
| Arm/Group Description | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes) | SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes) | 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) | SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes) | 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) | ||||||
All Cause Mortality |
||||||||||||
| SOF+VEL 25 mg 12 Weeks | SOF+VEL 100 mg 12 Weeks | SOF+VEL 25 mg 8 Weeks | SOF+VEL 25 mg + RBV 8 Weeks | SOF+VEL 100 mg 8 Weeks | SOF+VEL 100 mg + RBV 8 Weeks | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| SOF+VEL 25 mg 12 Weeks | SOF+VEL 100 mg 12 Weeks | SOF+VEL 25 mg 8 Weeks | SOF+VEL 25 mg + RBV 8 Weeks | SOF+VEL 100 mg 8 Weeks | SOF+VEL 100 mg + RBV 8 Weeks | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/77 (2.6%) | 1/77 (1.3%) | 3/56 (5.4%) | 1/55 (1.8%) | 0/55 (0%) | 0/57 (0%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Cholecystitis acute | 0/77 (0%) | 1/77 (1.3%) | 0/56 (0%) | 0/55 (0%) | 0/55 (0%) | 0/57 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Appendicitis | 0/77 (0%) | 0/77 (0%) | 1/56 (1.8%) | 0/55 (0%) | 0/55 (0%) | 0/57 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Rib fracture | 1/77 (1.3%) | 0/77 (0%) | 0/56 (0%) | 0/55 (0%) | 0/55 (0%) | 0/57 (0%) | ||||||
| Traumatic liver injury | 1/77 (1.3%) | 0/77 (0%) | 0/56 (0%) | 0/55 (0%) | 0/55 (0%) | 0/57 (0%) | ||||||
| Investigations | ||||||||||||
| Electrocardiogram ST segment elevation | 0/77 (0%) | 0/77 (0%) | 1/56 (1.8%) | 0/55 (0%) | 0/55 (0%) | 0/57 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| Completed suicide | 1/77 (1.3%) | 0/77 (0%) | 0/56 (0%) | 0/55 (0%) | 0/55 (0%) | 0/57 (0%) | ||||||
| Major depression | 0/77 (0%) | 0/77 (0%) | 1/56 (1.8%) | 0/55 (0%) | 0/55 (0%) | 0/57 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Calculus urinary | 0/77 (0%) | 0/77 (0%) | 0/56 (0%) | 1/55 (1.8%) | 0/55 (0%) | 0/57 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| SOF+VEL 25 mg 12 Weeks | SOF+VEL 100 mg 12 Weeks | SOF+VEL 25 mg 8 Weeks | SOF+VEL 25 mg + RBV 8 Weeks | SOF+VEL 100 mg 8 Weeks | SOF+VEL 100 mg + RBV 8 Weeks | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/77 (49.4%) | 45/77 (58.4%) | 27/56 (48.2%) | 43/55 (78.2%) | 22/55 (40%) | 36/57 (63.2%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 1/77 (1.3%) | 1/77 (1.3%) | 0/56 (0%) | 4/55 (7.3%) | 0/55 (0%) | 2/57 (3.5%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Abdominal pain upper | 1/77 (1.3%) | 4/77 (5.2%) | 1/56 (1.8%) | 1/55 (1.8%) | 1/55 (1.8%) | 1/57 (1.8%) | ||||||
| Constipation | 9/77 (11.7%) | 6/77 (7.8%) | 1/56 (1.8%) | 3/55 (5.5%) | 3/55 (5.5%) | 1/57 (1.8%) | ||||||
| Diarrhoea | 5/77 (6.5%) | 7/77 (9.1%) | 3/56 (5.4%) | 5/55 (9.1%) | 2/55 (3.6%) | 6/57 (10.5%) | ||||||
| Dyspepsia | 4/77 (5.2%) | 4/77 (5.2%) | 0/56 (0%) | 4/55 (7.3%) | 1/55 (1.8%) | 4/57 (7%) | ||||||
| Nausea | 10/77 (13%) | 8/77 (10.4%) | 4/56 (7.1%) | 7/55 (12.7%) | 7/55 (12.7%) | 8/57 (14%) | ||||||
| Vomiting | 5/77 (6.5%) | 1/77 (1.3%) | 0/56 (0%) | 0/55 (0%) | 0/55 (0%) | 4/57 (7%) | ||||||
| General disorders | ||||||||||||
| Fatigue | 19/77 (24.7%) | 14/77 (18.2%) | 7/56 (12.5%) | 17/55 (30.9%) | 2/55 (3.6%) | 21/57 (36.8%) | ||||||
| Infections and infestations | ||||||||||||
| Bronchitis | 0/77 (0%) | 0/77 (0%) | 3/56 (5.4%) | 1/55 (1.8%) | 1/55 (1.8%) | 0/57 (0%) | ||||||
| Influenza | 0/77 (0%) | 0/77 (0%) | 2/56 (3.6%) | 2/55 (3.6%) | 1/55 (1.8%) | 3/57 (5.3%) | ||||||
| Nasopharyngitis | 2/77 (2.6%) | 5/77 (6.5%) | 6/56 (10.7%) | 4/55 (7.3%) | 0/55 (0%) | 3/57 (5.3%) | ||||||
| Sinusitis | 0/77 (0%) | 1/77 (1.3%) | 1/56 (1.8%) | 1/55 (1.8%) | 3/55 (5.5%) | 0/57 (0%) | ||||||
| Upper respiratory tract infection | 1/77 (1.3%) | 3/77 (3.9%) | 0/56 (0%) | 2/55 (3.6%) | 3/55 (5.5%) | 4/57 (7%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 3/77 (3.9%) | 2/77 (2.6%) | 3/56 (5.4%) | 4/55 (7.3%) | 1/55 (1.8%) | 1/57 (1.8%) | ||||||
| Back pain | 3/77 (3.9%) | 4/77 (5.2%) | 1/56 (1.8%) | 0/55 (0%) | 2/55 (3.6%) | 1/57 (1.8%) | ||||||
| Nervous system disorders | ||||||||||||
| Dizziness | 2/77 (2.6%) | 3/77 (3.9%) | 2/56 (3.6%) | 2/55 (3.6%) | 0/55 (0%) | 3/57 (5.3%) | ||||||
| Headache | 16/77 (20.8%) | 14/77 (18.2%) | 7/56 (12.5%) | 21/55 (38.2%) | 9/55 (16.4%) | 10/57 (17.5%) | ||||||
| Psychiatric disorders | ||||||||||||
| Anxiety | 6/77 (7.8%) | 1/77 (1.3%) | 2/56 (3.6%) | 0/55 (0%) | 0/55 (0%) | 2/57 (3.5%) | ||||||
| Insomnia | 3/77 (3.9%) | 3/77 (3.9%) | 3/56 (5.4%) | 9/55 (16.4%) | 1/55 (1.8%) | 5/57 (8.8%) | ||||||
| Irritability | 4/77 (5.2%) | 1/77 (1.3%) | 1/56 (1.8%) | 5/55 (9.1%) | 0/55 (0%) | 2/57 (3.5%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| Dysmenorrhoea | 0/77 (0%) | 4/77 (5.2%) | 0/56 (0%) | 0/55 (0%) | 0/55 (0%) | 0/57 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 1/77 (1.3%) | 1/77 (1.3%) | 1/56 (1.8%) | 4/55 (7.3%) | 1/55 (1.8%) | 2/57 (3.5%) | ||||||
| Dyspnoea exertional | 0/77 (0%) | 0/77 (0%) | 1/56 (1.8%) | 3/55 (5.5%) | 0/55 (0%) | 2/57 (3.5%) | ||||||
| Oropharyngeal pain | 1/77 (1.3%) | 5/77 (6.5%) | 2/56 (3.6%) | 3/55 (5.5%) | 2/55 (3.6%) | 3/57 (5.3%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Pruritus | 2/77 (2.6%) | 3/77 (3.9%) | 2/56 (3.6%) | 3/55 (5.5%) | 0/55 (0%) | 5/57 (8.8%) | ||||||
| Rash | 4/77 (5.2%) | 4/77 (5.2%) | 1/56 (1.8%) | 7/55 (12.7%) | 0/55 (0%) | 3/57 (5.3%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | Clinical Trial Disclosures |
|---|---|
| Organization | Gilead Sciences |
| Phone | |
| ClinicalTrialDisclosures@gilead.com |
Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01858766
Other Study ID Numbers:
- GS-US-342-0102
First Posted:
May 21, 2013
Last Update Posted:
Nov 14, 2018
Last Verified:
Jul 1, 2016