Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02378961
Collaborator
(none)
128
34
7
11.3
3.8
0.3
Study Details
Study Description
Brief Summary
The 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) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
128 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 Non-Genotype 1 HCV Infection
Actual Study Start Date
:
Feb 16, 2015
Actual Primary Completion Date
:
Sep 21, 2015
Actual Study Completion Date
:
Jan 26, 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: GS-9857+SOF/VEL 6 wk, TN, with cirrhosis GS-9857 + 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 GS-9857 + 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 8 wk,TE, without cirrhosis GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), 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, TE, without cirrhosis VOX + SOF/VEL for 12 weeks (treatment 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: GS-9857+SOF/VEL 8 wk, TE, with cirrhosis GS-9857 + SOF/VEL for 8 weeks (treatment 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, TE, with cirrhosis VOX + SOF/VEL for 12 weeks (treatment 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:
|
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 treatment, 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 genotypes 2, 3, 4, 5, or 6
-
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 | Aurora | 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 School of Medicine | 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 | Seattle | Washington | United States | |
| 32 | Christchurch Clinical Studies Trust | Christchurch | New Zealand | ||
| 33 | Auckland Clinical Studies | Grafton | 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:
NCT02378961
Other Study ID Numbers:
- GS-US-367-1169
First Posted:
Mar 4, 2015
Last Update Posted:
Mar 3, 2020
Last Verified:
Oct 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 16 February 2015. The last study visit occurred on 26 January 2016. |
|---|---|
| Pre-assignment Detail | 171 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, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic |
|---|---|---|---|---|
| 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 with cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
| Period Title: Overall Study | ||||
| STARTED | 33 | 30 | 36 | 29 |
| COMPLETED | 29 | 28 | 35 | 28 |
| NOT COMPLETED | 4 | 2 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment-Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | 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 tablet 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 treatment experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis | Total of all reporting groups |
| Overall Participants | 33 | 30 | 36 | 29 | 128 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
53
(12.0)
|
56
(8.3)
|
57
(8.3)
|
58
(7.0)
|
56
(9.3)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
21
63.6%
|
9
30%
|
10
27.8%
|
8
27.6%
|
48
37.5%
|
| Male |
12
36.4%
|
21
70%
|
26
72.2%
|
21
72.4%
|
80
62.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| Black or African American |
2
6.1%
|
1
3.3%
|
2
5.6%
|
2
6.9%
|
7
5.5%
|
| White |
27
81.8%
|
24
80%
|
29
80.6%
|
23
79.3%
|
103
80.5%
|
| Asian |
3
9.1%
|
4
13.3%
|
3
8.3%
|
2
6.9%
|
12
9.4%
|
| American Indian or Alaska Native |
1
3%
|
0
0%
|
0
0%
|
2
6.9%
|
3
2.3%
|
| Native India or Pacific Islander |
0
0%
|
1
3.3%
|
1
2.8%
|
0
0%
|
2
1.6%
|
| Other |
0
0%
|
0
0%
|
1
2.8%
|
0
0%
|
1
0.8%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| Hispanic or Latino |
4
12.1%
|
6
20%
|
5
13.9%
|
2
6.9%
|
17
13.3%
|
| Not Hispanic or Latino |
29
87.9%
|
24
80%
|
31
86.1%
|
27
93.1%
|
111
86.7%
|
| Region of Enrollment (participants) [Number] | |||||
| New Zealand |
1
3%
|
4
13.3%
|
2
5.6%
|
0
0%
|
7
5.5%
|
| United States |
32
97%
|
26
86.7%
|
34
94.4%
|
29
100%
|
121
94.5%
|
| IL28b Status (Count of Participants) | |||||
| CC |
11
33.3%
|
11
36.7%
|
15
41.7%
|
10
34.5%
|
47
36.7%
|
| CT |
15
45.5%
|
15
50%
|
15
41.7%
|
17
58.6%
|
62
48.4%
|
| TT |
6
18.2%
|
4
13.3%
|
5
13.9%
|
2
6.9%
|
17
13.3%
|
| HCV RNA (log10 IU/mL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [log10 IU/mL] |
6.2
(0.86)
|
6.1
(0.66)
|
6.3
(0.72)
|
6.4
(0.57)
|
6.3
(0.72)
|
| HCV RNA Category (Count of Participants) | |||||
| < 800,000 IU/mL |
14
42.4%
|
11
36.7%
|
12
33.3%
|
7
24.1%
|
44
34.4%
|
| ≥ 800,000 IU/mL |
19
57.6%
|
19
63.3%
|
24
66.7%
|
22
75.9%
|
84
65.6%
|
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, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic |
|---|---|---|---|---|
| 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 tablet 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 treatment experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
| Measure Participants | 33 | 30 | 36 | 29 |
| Number (95% Confidence Interval) [percentage of participants] |
87.9
266.4%
|
93.3
311%
|
100.0
277.8%
|
96.6
333.1%
|
| 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, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic |
|---|---|---|---|---|
| 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 tablet 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 treatment experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
| Measure Participants | 33 | 30 | 36 | 29 |
| Number [percentage of participants] |
0
0%
|
6.7
22.3%
|
0
0%
|
3.4
11.7%
|
| 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 treatment, 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, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic |
|---|---|---|---|---|
| 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 tablet 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 treatment experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
| Measure Participants | 33 | 30 | 36 | 29 |
| SVR4 |
90.9
275.5%
|
96.7
322.3%
|
100.0
277.8%
|
100.0
344.8%
|
| SVR24 |
87.9
266.4%
|
93.3
311%
|
100.0
277.8%
|
96.6
333.1%
|
| 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, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic |
|---|---|---|---|---|
| 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 tablet 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 treatment experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
| Measure Participants | 33 | 30 | 36 | 29 |
| Week 1 |
33.3
100.9%
|
20.0
66.7%
|
33.3
92.5%
|
10.
34.5%
|
| Week 2 |
81.8
247.9%
|
73.3
244.3%
|
72.2
200.6%
|
58.6
202.1%
|
| Week 4 |
100.0
303%
|
100.0
333.3%
|
88.9
246.9%
|
89.7
309.3%
|
| Week 6 |
100.0
303%
|
100.0
333.3%
|
97.2
270%
|
96.6
333.1%
|
| Week 8 |
100.0
303%
|
100.0
333.3%
|
100.0
277.8%
|
|
| Week 10 |
100.0
303%
|
100.0
333.3%
|
||
| Week 12 |
100.0
303%
|
100.0
333.3%
|
| 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, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic |
|---|---|---|---|---|
| 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 tablet 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 treatment experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
| Measure Participants | 33 | 30 | 36 | 29 |
| Change at Week 1 |
-4.51
(0.568)
|
-4.28
(0.546)
|
-4.51
(0.594)
|
-4.24
(0.510)
|
| Change at Week 2 |
-4.91
(0.786)
|
-4.84
(0.648)
|
-4.95
(0.619)
|
-4.96
(0.592)
|
| Change at Week 4 |
-5.01
(0.857)
|
-4.99
(0.661)
|
-5.14
(0.709)
|
-5.25
(0.567)
|
| Change at Week 6 |
-5.01
(0.857)
|
-4.99
(0.661)
|
-5.19
(0.716)
|
-5.29
(0.572)
|
| Change at Week 8 |
-4.98
(0.672)
|
-5.19
(0.718)
|
-5.30
(0.571)
|
|
| Change at Week 10 |
-5.19
(0.718)
|
-5.30
(0.571)
|
||
| Change at Week 12 |
-5.19
(0.718)
|
-5.32
(0.566)
|
| 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, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic |
|---|---|---|---|---|
| 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 tablet 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 treatment experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis |
| Measure Participants | 33 | 30 | 36 | 29 |
| Number [percentage of participants] |
12.1
36.7%
|
6.7
22.3%
|
0
0%
|
3.4
11.7%
|
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, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | ||||
| 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 tablet 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 treatment experienced participants without cirrhosis | VOX 100 mg tablet + SOF/VEL (400/100 mg) FDC tablet administered once daily for 12 weeks in treatment experienced participants with cirrhosis | ||||
All Cause Mortality |
||||||||
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/33 (0%) | 0/30 (0%) | 0/36 (0%) | 1/29 (3.4%) | ||||
| Infections and infestations | ||||||||
| Gastroenteritis | 0/33 (0%) | 0/30 (0%) | 0/36 (0%) | 1/29 (3.4%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| VOX+SOF/VEL 6 Weeks, Treatment Naive, Non Cirrhotic | VOX+SOF/VEL 8 Weeks, Treatment Naive, Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Non Cirrhotic | VOX+SOF/VEL 12 Weeks, Treatment Experienced, Cirrhotic | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/33 (66.7%) | 14/30 (46.7%) | 25/36 (69.4%) | 23/29 (79.3%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain upper | 2/33 (6.1%) | 1/30 (3.3%) | 1/36 (2.8%) | 1/29 (3.4%) | ||||
| Constipation | 1/33 (3%) | 2/30 (6.7%) | 2/36 (5.6%) | 1/29 (3.4%) | ||||
| Diarrhoea | 10/33 (30.3%) | 1/30 (3.3%) | 10/36 (27.8%) | 8/29 (27.6%) | ||||
| Dry mouth | 2/33 (6.1%) | 1/30 (3.3%) | 0/36 (0%) | 3/29 (10.3%) | ||||
| Dyspepsia | 0/33 (0%) | 1/30 (3.3%) | 2/36 (5.6%) | 1/29 (3.4%) | ||||
| Nausea | 9/33 (27.3%) | 3/30 (10%) | 8/36 (22.2%) | 4/29 (13.8%) | ||||
| General disorders | ||||||||
| Fatigue | 7/33 (21.2%) | 3/30 (10%) | 10/36 (27.8%) | 6/29 (20.7%) | ||||
| Infections and infestations | ||||||||
| Nasopharyngitis | 1/33 (3%) | 1/30 (3.3%) | 0/36 (0%) | 3/29 (10.3%) | ||||
| Upper respiratory tract infection | 2/33 (6.1%) | 1/30 (3.3%) | 1/36 (2.8%) | 1/29 (3.4%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Increased appetite | 1/33 (3%) | 0/30 (0%) | 0/36 (0%) | 2/29 (6.9%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Pain in extremity | 0/33 (0%) | 1/30 (3.3%) | 1/36 (2.8%) | 2/29 (6.9%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 3/33 (9.1%) | 0/30 (0%) | 0/36 (0%) | 3/29 (10.3%) | ||||
| Headache | 10/33 (30.3%) | 3/30 (10%) | 11/36 (30.6%) | 8/29 (27.6%) | ||||
| Renal and urinary disorders | ||||||||
| Chromaturia | 0/33 (0%) | 0/30 (0%) | 2/36 (5.6%) | 1/29 (3.4%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 0/33 (0%) | 0/30 (0%) | 2/36 (5.6%) | 1/29 (3.4%) | ||||
| Epistaxis | 0/33 (0%) | 2/30 (6.7%) | 1/36 (2.8%) | 0/29 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Pruritus | 0/33 (0%) | 0/30 (0%) | 1/36 (2.8%) | 2/29 (6.9%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 0/33 (0%) | 0/30 (0%) | 2/36 (5.6%) | 0/29 (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:
NCT02378961
Other Study ID Numbers:
- GS-US-367-1169
First Posted:
Mar 4, 2015
Last Update Posted:
Mar 3, 2020
Last Verified:
Oct 1, 2017