Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02378935
Collaborator
(none)
205
34
10
13.8
6
0.4
Study Details
Study Description
Brief Summary
This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
205 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection
Actual Study Start Date
:
Feb 17, 2015
Actual Primary Completion Date
:
Feb 1, 2016
Actual Study Completion Date
:
Apr 12, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VOX+SOF/VEL 6 wk, TN, without cirrhosis VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
| Experimental: VOX+SOF/VEL 8 wk, TN, without cirrhosis VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
| Experimental: VOX+SOF/VEL 6 wk, TN, with cirrhosis VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
| Experimental: VOX+SOF/VEL 8 wk, TN, with cirrhosis VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
| Experimental: VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
Drug: RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
| Experimental: VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
| Experimental: VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
| Experimental: VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
| Experimental: VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
| Experimental: VOX+SOF/VEL 12 wk (GS-US-338-1121) VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study) |
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Names:
Drug: SOF/VEL
400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [Posttreatment Week 12]
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of 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 Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [Posttreatment Weeks 4 and 24]
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
- Percentage of Participants With HCV RNA < LLOQ on Treatment [Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)]
- HCV RNA Change From Baseline [Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)]
- Percentage of Participants With Virologic Failure [Up to Posttreatment Week 24]
On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Individuals with chronic HCV infection
-
HCV RNA ≥10^4 IU/mL at screening
-
HCV genotype 1
-
Cirrhosis determination; a liver biopsy may be required
-
Screening laboratory values within defined thresholds
-
Use of two contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria:
-
Pregnant or nursing female
-
Current or prior history of hepatic decompensation
-
Hepatocellular carcinoma (HCC) or other clinically significant malignancy
-
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
-
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars Sinai Medical Center | Los Angeles | California | United States | |
| 2 | Stanford University | Palo Alto | California | United States | |
| 3 | Huntington Memorial Hospital Liver Center | Pasadena | California | United States | |
| 4 | Medical Associates Research Group, Inc. | San Diego | California | United States | |
| 5 | University of Colorado | Denver | Colorado | United States | |
| 6 | Borland-Groover Clinic | Jacksonville | Florida | United States | |
| 7 | University of Miami | Miami | Florida | United States | |
| 8 | Orlando Immunology center | Orlando | Florida | United States | |
| 9 | South Florida Center of Gastroenterology, P.A. | Wellington | Florida | United States | |
| 10 | Center for Hep C/Atlanta Medical Center | Atlanta | Georgia | United States | |
| 11 | Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | United States | |
| 12 | University of Chicago | Chicago | Illinois | United States | |
| 13 | Indiana University | Indianapolis | Indiana | United States | |
| 14 | Indianapolis Gastroenterology & Hepatology, Inc. | Indianapolis | Indiana | United States | |
| 15 | Beth Isreal Deconess Medical Center | Boston | Massachusetts | United States | |
| 16 | Massachusetts General Hospital | Boston | Massachusetts | United States | |
| 17 | Henry Ford Hospital and Health System | Detroit | Michigan | United States | |
| 18 | ID Care | Hillsborough | New Jersey | United States | |
| 19 | Southwest Care Center | Santa Fe | New Mexico | United States | |
| 20 | North Shore/Long Island Jewish PRIME | Manhasset | New York | United States | |
| 21 | Mount Sinai Beth Israel | New York | New York | United States | |
| 22 | Cumberland Research Associates, LLC | Fayetteville | North Carolina | United States | |
| 23 | Digestive Health Specialists, PA | Winston-Salem | North Carolina | United States | |
| 24 | University of Pennsylvania Health Systems | Philadelphia | Pennsylvania | United States | |
| 25 | UPMC Center for Liver Diseases | Pittsburgh | Pennsylvania | United States | |
| 26 | Medical University of South Carolina | Charleston | South Carolina | United States | |
| 27 | Gastro One | Germantown | Tennessee | United States | |
| 28 | Nashville Gastrointestinal Specialists, Inc. | Nashville | Tennessee | United States | |
| 29 | Texas Liver Institute | San Antonio | Texas | United States | |
| 30 | Liver Institute of Virginia | Richmond | Virginia | United States | |
| 31 | Swedish Medical Center | Seattle | Washington | United States | |
| 32 | Auckland Clinical Studies | Auckland | New Zealand | ||
| 33 | Christchurch Clinical Studies Trust | Christchurch | New Zealand | ||
| 34 | Fundacion de Investigacion de Diego | San Juan | Puerto Rico |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02378935
Other Study ID Numbers:
- GS-US-367-1168
First Posted:
Mar 4, 2015
Last Update Posted:
Mar 6, 2020
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 17 February 2015. The last study visit occurred on 12 April 2016. |
|---|---|
| Pre-assignment Detail | 255 participants were screened. Enrollment was sequential, with the longer treatment duration groups enrolled, treated, and evaluated for Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) prior to enrollment of the shorter treatment duration groups, which were not enrolled, at the discretion of the Sponsor. |
| Arm/Group Title | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Voxilaprevir (VOX) 100 mg tablet + sofosbuvir/veltapasvir (Epclusa® ; SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in direct-acting antiviral (DAA) experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 |
| Period Title: Overall Study | |||||||
| STARTED | 34 | 36 | 33 | 31 | 31 | 32 | 8 |
| COMPLETED | 24 | 36 | 30 | 25 | 31 | 32 | 8 |
| NOT COMPLETED | 10 | 0 | 3 | 6 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 | Total of all reporting groups |
| Overall Participants | 34 | 36 | 33 | 31 | 31 | 32 | 8 | 205 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
53
(11.5)
|
51
(14.3)
|
58
(7.2)
|
59
(6.7)
|
57
(7.8)
|
59
(6.5)
|
5.7
(5.9)
|
56
(9.8)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
11
32.4%
|
15
41.7%
|
14
42.4%
|
12
38.7%
|
8
25.8%
|
6
18.8%
|
5
62.5%
|
71
34.6%
|
| Male |
23
67.6%
|
21
58.3%
|
19
57.6%
|
19
61.3%
|
23
74.2%
|
26
81.3%
|
3
37.5%
|
134
65.4%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||||||
| Black or African American |
3
8.8%
|
4
11.1%
|
7
21.2%
|
5
16.1%
|
4
12.9%
|
6
18.8%
|
0
0%
|
29
14.1%
|
| White |
31
91.2%
|
32
88.9%
|
25
75.8%
|
26
83.9%
|
27
87.1%
|
26
81.3%
|
8
100%
|
175
85.4%
|
| Native Hawaiian or Pacific Islander |
0
0%
|
0
0%
|
1
3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.5%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||||||
| Hispanic or Latino |
3
8.8%
|
5
13.9%
|
8
24.2%
|
7
22.6%
|
4
12.9%
|
10
31.3%
|
5
62.5%
|
42
20.5%
|
| Not Hispanic or Latino |
31
91.2%
|
31
86.1%
|
25
75.8%
|
24
77.4%
|
27
87.1%
|
22
68.8%
|
3
37.5%
|
163
79.5%
|
| Region of Enrollment (Count of Participants) | ||||||||
| United States |
32
94.1%
|
36
100%
|
28
84.8%
|
31
100%
|
31
100%
|
32
100%
|
8
100%
|
198
96.6%
|
| New Zealand |
2
5.9%
|
0
0%
|
5
15.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
7
3.4%
|
| IL28b Status (Count of Participants) | ||||||||
| CC |
12
35.3%
|
9
25%
|
7
21.2%
|
12
38.7%
|
4
12.9%
|
4
12.5%
|
3
37.5%
|
51
24.9%
|
| CT |
15
44.1%
|
21
58.3%
|
19
57.6%
|
12
38.7%
|
19
61.3%
|
21
65.6%
|
3
37.5%
|
110
53.7%
|
| TT |
7
20.6%
|
4
11.1%
|
7
21.2%
|
6
19.4%
|
7
22.6%
|
7
21.9%
|
2
25%
|
40
19.5%
|
| Missing |
0
0%
|
2
5.6%
|
0
0%
|
1
3.2%
|
1
3.2%
|
0
0%
|
0
0%
|
4
2%
|
| HCV RNA (log10 IU/mL) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [log10 IU/mL] |
6.2
(0.51)
|
6.2
(0.55)
|
6.0
(0.59)
|
6.3
(0.47)
|
6.4
(0.77)
|
6.0
(0.61)
|
6.5
(0.38)
|
6.2
(0.60)
|
| HCV RNA Category (Count of Participants) | ||||||||
| < 800,000 IU/mL |
6
17.6%
|
10
27.8%
|
14
42.4%
|
6
19.4%
|
6
19.4%
|
16
50%
|
0
0%
|
58
28.3%
|
| ≥ 800,000 IU/mL |
28
82.4%
|
26
72.2%
|
19
57.6%
|
25
80.6%
|
25
80.6%
|
16
50%
|
8
100%
|
147
71.7%
|
Outcome Measures
| Title | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
|---|---|
| Description | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. |
| Time Frame | Posttreatment Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS): participants who received at least 1 dose of study drug |
| Arm/Group Title | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 |
| Measure Participants | 34 | 36 | 33 | 31 | 31 | 32 | 8 |
| Number (95% Confidence Interval) [percentage of participants] |
70.6
207.6%
|
100.0
277.8%
|
93.9
284.5%
|
80.6
260%
|
100
322.6%
|
100.0
312.5%
|
100.0
1250%
|
| 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 | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 |
| Measure Participants | 34 | 36 | 33 | 31 | 31 | 32 | 8 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
0
0%
|
6.5
21%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
|---|---|
| Description | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. |
| Time Frame | Posttreatment Weeks 4 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 |
| Measure Participants | 34 | 36 | 33 | 31 | 31 | 32 | 8 |
| SVR4 |
88.2
259.4%
|
100.0
277.8%
|
93.9
284.5%
|
87.1
281%
|
100.0
322.6%
|
100.0
312.5%
|
100.0
1250%
|
| SVR24 |
70.6
207.6%
|
100.0
277.8%
|
93.9
284.5%
|
80.6
260%
|
100.0
322.6%
|
100.0
312.5%
|
100.0
1250%
|
| Title | Percentage of Participants With HCV RNA < LLOQ on Treatment |
|---|---|
| Description | |
| Time Frame | Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed |
| Arm/Group Title | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 |
| Measure Participants | 34 | 36 | 33 | 31 | 31 | 32 | 8 |
| Week 1 |
23.5
69.1%
|
38.9
108.1%
|
33.3
100.9%
|
16.1
51.9%
|
22.6
72.9%
|
28.1
87.8%
|
12.5
156.3%
|
| Week 2 |
79.4
233.5%
|
75.0
208.3%
|
63.6
192.7%
|
54.8
176.8%
|
58.1
187.4%
|
62.5
195.3%
|
75.0
937.5%
|
| Week 4 |
100.0
294.1%
|
94.4
262.2%
|
90.9
275.5%
|
96.8
312.3%
|
93.5
301.6%
|
96.9
302.8%
|
100.0
1250%
|
| Week 6 |
100.0
294.1%
|
100.0
277.8%
|
97.0
293.9%
|
100.0
322.6%
|
100.0
322.6%
|
100.0
312.5%
|
100.0
1250%
|
| Week 8 |
100.0
294.1%
|
100.0
277.8%
|
100.0
303%
|
100.0
322.6%
|
100.0
322.6%
|
100.0
312.5%
|
|
| Week 10 |
100.0
294.1%
|
100.0
277.8%
|
100.0
303%
|
||||
| Week 12 |
100.0
294.1%
|
100.0
277.8%
|
100.0
303%
|
| Title | HCV RNA Change From Baseline |
|---|---|
| Description | |
| Time Frame | Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed |
| Arm/Group Title | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 |
| Measure Participants | 34 | 36 | 33 | 31 | 31 | 32 | 8 |
| Change at Week 1 |
-4.64
(0.556)
|
-4.60
(0.595)
|
-4.15
(0.733)
|
-4.31
(0.658)
|
-4.40
(0.577)
|
-4.19
(0.504)
|
-4.71
(0.486)
|
| Change at Week 2 |
-5.00
(0.504)
|
-4.98
(0.519)
|
-4.57
(0.662)
|
-4.85
(0.583)
|
-4.97
(0.711)
|
-4.66
(0.520)
|
-5.27
(0.450)
|
| Change at Week 4 |
-5.07
(0.514)
|
-5.06
(0.534)
|
-4.81
(0.576)
|
-5.17
(0.481)
|
-5.22
(0.755)
|
-4.84
(0.601)
|
-5.35
(0.385)
|
| Change at Week 6 |
-5.07
(0.514)
|
-5.08
(0.549)
|
-4.84
(0.586)
|
-5.16
(0.480)
|
-5.24
(0.767)
|
-4.84
(0.611)
|
-5.35
(0.385)
|
| Change at Week 8 |
-5.08
(0.549)
|
-4.85
(0.591)
|
-5.16
(0.480)
|
-5.24
(0.767)
|
-4.84
(0.611)
|
-5.35
(0.385)
|
|
| Change at Week 10 |
-5.24
(0.767)
|
-4.84
(0.611)
|
-5.35
(0.385)
|
||||
| Change at Week 12 |
-5.24
(0.767)
|
-4.84
(0.611)
|
-5.35
(0.385)
|
| Title | Percentage of Participants With Virologic Failure |
|---|---|
| Description | On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. |
| Time Frame | Up to Posttreatment Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 |
| Measure Participants | 34 | 36 | 33 | 31 | 31 | 32 | 8 |
| Number [percentage of participants] |
29.4
86.5%
|
0
0%
|
6.1
18.5%
|
19.4
62.6%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Up to 12 weeks plus 30 days | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Analysis Set | |||||||||||||
| Arm/Group Title | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | |||||||
| Arm/Group Description | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 6 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC administered once daily for 8 weeks in treatment naive participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg daily based on weight) administered once daily for 8 weeks in treatment naive participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in DAA-experienced participants with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in participants who were previously enrolled in Gilead sponsored phase 1b study GS-US-338-1121 | |||||||
All Cause Mortality |
||||||||||||||
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | ||||||||
| Affected / at Risk (%) | # Events | 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 | 0/34 (0%) | 0/36 (0%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | ||||||||
| Affected / at Risk (%) | # Events | 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 | 0/34 (0%) | 0/36 (0%) | 2/33 (6.1%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Cardiac disorders | ||||||||||||||
| Atrial flutter | 0/34 (0%) | 0/36 (0%) | 1/33 (3%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Vertigo | 0/34 (0%) | 0/36 (0%) | 1/33 (3%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL+RBV 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, DAA-Experienced, Cirrhotic | VOX+SOF/VEL 12 Weeks (GS-US-338-1121) | ||||||||
| Affected / at Risk (%) | # Events | 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 | 21/34 (61.8%) | 20/36 (55.6%) | 18/33 (54.5%) | 24/31 (77.4%) | 15/31 (48.4%) | 16/32 (50%) | 6/8 (75%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Anaemia | 0/34 (0%) | 0/36 (0%) | 0/33 (0%) | 7/31 (22.6%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal pain upper | 0/34 (0%) | 2/36 (5.6%) | 2/33 (6.1%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Constipation | 0/34 (0%) | 4/36 (11.1%) | 3/33 (9.1%) | 1/31 (3.2%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Diarrhoea | 4/34 (11.8%) | 6/36 (16.7%) | 2/33 (6.1%) | 3/31 (9.7%) | 3/31 (9.7%) | 3/32 (9.4%) | 2/8 (25%) | |||||||
| Dry mouth | 0/34 (0%) | 0/36 (0%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 2/32 (6.3%) | 0/8 (0%) | |||||||
| Dyspepsia | 1/34 (2.9%) | 0/36 (0%) | 1/33 (3%) | 1/31 (3.2%) | 0/31 (0%) | 2/32 (6.3%) | 0/8 (0%) | |||||||
| Nausea | 2/34 (5.9%) | 10/36 (27.8%) | 7/33 (21.2%) | 9/31 (29%) | 3/31 (9.7%) | 3/32 (9.4%) | 1/8 (12.5%) | |||||||
| Vomiting | 0/34 (0%) | 1/36 (2.8%) | 2/33 (6.1%) | 1/31 (3.2%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| General disorders | ||||||||||||||
| Fatigue | 4/34 (11.8%) | 7/36 (19.4%) | 1/33 (3%) | 10/31 (32.3%) | 7/31 (22.6%) | 3/32 (9.4%) | 2/8 (25%) | |||||||
| Malaise | 2/34 (5.9%) | 0/36 (0%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Oedema peripheral | 0/34 (0%) | 0/36 (0%) | 2/33 (6.1%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Gastroenteritis | 0/34 (0%) | 2/36 (5.6%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Nasopharyngitis | 1/34 (2.9%) | 3/36 (8.3%) | 1/33 (3%) | 0/31 (0%) | 2/31 (6.5%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Pneumonia | 0/34 (0%) | 0/36 (0%) | 0/33 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/32 (0%) | 1/8 (12.5%) | |||||||
| Upper respiratory tract infection | 1/34 (2.9%) | 1/36 (2.8%) | 0/33 (0%) | 2/31 (6.5%) | 1/31 (3.2%) | 0/32 (0%) | 1/8 (12.5%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 2/34 (5.9%) | 0/36 (0%) | 2/33 (6.1%) | 0/31 (0%) | 0/31 (0%) | 1/32 (3.1%) | 0/8 (0%) | |||||||
| Arthritis | 0/34 (0%) | 0/36 (0%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 2/32 (6.3%) | 0/8 (0%) | |||||||
| Muscle spasms | 2/34 (5.9%) | 0/36 (0%) | 0/33 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Musculoskeletal chest pain | 0/34 (0%) | 0/36 (0%) | 2/33 (6.1%) | 1/31 (3.2%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Dizziness | 2/34 (5.9%) | 2/36 (5.6%) | 1/33 (3%) | 1/31 (3.2%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Dysgeusia | 2/34 (5.9%) | 0/36 (0%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Headache | 11/34 (32.4%) | 7/36 (19.4%) | 7/33 (21.2%) | 9/31 (29%) | 4/31 (12.9%) | 5/32 (15.6%) | 1/8 (12.5%) | |||||||
| Paraesthesia | 2/34 (5.9%) | 0/36 (0%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Sciatica | 0/34 (0%) | 0/36 (0%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 1/8 (12.5%) | |||||||
| Sinus headache | 0/34 (0%) | 2/36 (5.6%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Anxiety | 2/34 (5.9%) | 0/36 (0%) | 1/33 (3%) | 0/31 (0%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Depression | 0/34 (0%) | 0/36 (0%) | 0/33 (0%) | 0/31 (0%) | 0/31 (0%) | 2/32 (6.3%) | 0/8 (0%) | |||||||
| Insomnia | 5/34 (14.7%) | 1/36 (2.8%) | 0/33 (0%) | 3/31 (9.7%) | 2/31 (6.5%) | 0/32 (0%) | 2/8 (25%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Cough | 1/34 (2.9%) | 3/36 (8.3%) | 0/33 (0%) | 0/31 (0%) | 1/31 (3.2%) | 1/32 (3.1%) | 0/8 (0%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Rash | 0/34 (0%) | 0/36 (0%) | 0/33 (0%) | 2/31 (6.5%) | 0/31 (0%) | 0/32 (0%) | 0/8 (0%) | |||||||
| Vascular disorders | ||||||||||||||
| Hypertension | 0/34 (0%) | 0/36 (0%) | 0/33 (0%) | 2/31 (6.5%) | 1/31 (3.2%) | 1/32 (3.1%) | 0/8 (0%) | |||||||
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:
NCT02378935
Other Study ID Numbers:
- GS-US-367-1168
First Posted:
Mar 4, 2015
Last Update Posted:
Mar 6, 2020
Last Verified:
Nov 1, 2017