Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
Study Details
Study Description
Brief Summary
The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Velpatasvir 5 mg (GT 1a) Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 25 mg (GT 1a) Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 50 mg (GT 1a) Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 100 mg (GT 1a) Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 150 mg (GT 1a) Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 150 mg (GT 1b) Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 150 mg (GT 2) Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 25 mg (GT 3) Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 50 mg (GT 3) Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 150 mg (GT 3) Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir 150 mg (GT 4) Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Experimental: Velpatasvir up to 400 mg (GT 2) Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions. |
Drug: Velpatasvir
Tablets administered orally
Other Names:
Drug: Placebo
Tablets administered orally
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Experiencing Treatment Emergent Adverse Events [First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)]
Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).
- Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities [First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)]
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose.
- Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline [Baseline; Days 4, 5, 6, 7, 8, 10, and 17]
Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo.
Secondary Outcome Measures
- Absolute HCV RNA Level [Baseline; Days 4, 5, 6, 7, 8, 10, and 17]
- Number of Participants Achieving Reductions From Baseline in HCV RNA [Baseline; Days 4, 5, 6, 7, 8, 10, and 17]
Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to < 2, ≥ 2 to < 3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17.
- Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected [Days 4, 5, 6, 7, and 8]
The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay.
- Plasma HCV RNA Levels by Treatment and IL28B Genotype [Days 4, 5, 6, 7, 8, 10, and 17]
- Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1]
AUCinf is defined as the concentration of drug extrapolated to infinite time.
- PK Parameter of Velpatasvir: AUCtau [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3]
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
- PK Parameter of Velpatasvir: Cmax [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose.]
Cmax is defined as the maximum observed plasma concentration of drug.
- PK Parameter of Velpatasvir: CL/F [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose]
CL/F is defined as the apparent oral clearance following administration of the drug.
- PK Parameter of Velpatasvir: Ctau [0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3]
Ctau is defined as the observed drug concentration at the end of the dosing interval.
- Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints [First dose date up to Day 17]
The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection and plasma HCV RNA ≥ 5 log10 IU/mL at screening
-
Agree to use protocol defined precautions against pregnancy
Key Exclusion Criteria:
-
Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
-
Evidence of cirrhosis
-
Evidence of current drug abuse
-
Screening laboratory results outside the protocol specified requirements
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | West Coast Clinical Trials, LLC | Costa Mesa | California | United States | 92626 |
2 | Avail Clinical Research, LLC | DeLand | Florida | United States | 32720 |
3 | Orlando Clinical Research Center | Orlando | Florida | United States | 32809 |
4 | Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | United States | 64131 |
5 | CRI Worldwide, LLC | Marlton | New Jersey | United States | 08053 |
6 | CRI Worldwide, LLC | Philadelphia | Pennsylvania | United States | 19139 |
7 | New Orleans Center for Clinical Research-Knoxville | Knoxville | Tennessee | United States | 37920 |
8 | Alamo Medical Research | San Antonio | Texas | United States | 78215 |
9 | Charles River Clinical Services Northwest, Inc. | Tacoma | Washington | United States | 98418 |
10 | Fundacion De Investigacion De Diego | San Juan | Puerto Rico | 00927 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GS-US-281-0102
Study Results
Participant Flow
Recruitment Details | Participants were enrolled at study sites in United States. The first participant was screened on 06 November 2012. The last study visit occurred on 24 January 2014. |
---|---|
Pre-assignment Detail | 163 participants were screened. Participants were not enrolled in 'Velpatasvir up to 400 mg genotype (GT) 2' group. |
Arm/Group Title | Placebo | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Period Title: Overall Study | ||||||
STARTED | 22 | 7 | 17 | 14 | 9 | 34 |
COMPLETED | 10 | 4 | 11 | 7 | 6 | 23 |
NOT COMPLETED | 12 | 3 | 6 | 7 | 3 | 11 |
Baseline Characteristics
Arm/Group Title | Placebo | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg | Total |
---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Total of all reporting groups |
Overall Participants | 17 | 4 | 15 | 12 | 8 | 31 | 87 |
Age (years) [Mean (Standard Deviation) ] | |||||||
Mean (Standard Deviation) [years] |
46.6
(11.46)
|
44.8
(15.65)
|
45.1
(11.56)
|
46.9
(10.13)
|
47.0
(8.40)
|
49.2
(9.12)
|
47.3
(10.26)
|
Sex: Female, Male (Count of Participants) | |||||||
Female |
3
17.6%
|
1
25%
|
3
20%
|
2
16.7%
|
2
25%
|
8
25.8%
|
19
21.8%
|
Male |
14
82.4%
|
3
75%
|
12
80%
|
10
83.3%
|
6
75%
|
23
74.2%
|
68
78.2%
|
Race/Ethnicity, Customized (Count of Participants) | |||||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
1
1.1%
|
Black or African American |
6
35.3%
|
0
0%
|
5
33.3%
|
4
33.3%
|
2
25%
|
10
32.3%
|
27
31%
|
White |
11
64.7%
|
4
100%
|
10
66.7%
|
7
58.3%
|
6
75%
|
21
67.7%
|
59
67.8%
|
Race/Ethnicity, Customized (Count of Participants) | |||||||
Hispanic or Latino |
8
47.1%
|
1
25%
|
3
20%
|
6
50%
|
2
25%
|
8
25.8%
|
28
32.2%
|
Not Hispanic or Latino |
9
52.9%
|
3
75%
|
12
80%
|
6
50%
|
6
75%
|
23
74.2%
|
59
67.8%
|
HCV RNA (log10 IU/mL) (log10 IU/mL) [Mean (Standard Deviation) ] | |||||||
Mean (Standard Deviation) [log10 IU/mL] |
6.52
(0.517)
|
6.64
(0.312)
|
6.32
(0.826)
|
6.39
(0.558)
|
6.46
(0.479)
|
6.41
(0.603)
|
6.43
(0.597)
|
HCV Genotype (Count of Participants) | |||||||
1a |
10
58.8%
|
4
100%
|
8
53.3%
|
8
66.7%
|
8
100%
|
7
22.6%
|
45
51.7%
|
1b |
2
11.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
8
25.8%
|
10
11.5%
|
2b |
2
11.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
8
25.8%
|
10
11.5%
|
3 |
0
0%
|
0
0%
|
1
6.7%
|
0
0%
|
0
0%
|
0
0%
|
1
1.1%
|
3a |
3
17.6%
|
0
0%
|
6
40%
|
4
33.3%
|
0
0%
|
6
19.4%
|
19
21.8%
|
4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.2%
|
1
1.1%
|
4a/4c/4d |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.2%
|
1
1.1%
|
IL28B Genotype (Count of Participants) | |||||||
C/C |
7
41.2%
|
2
50%
|
5
33.3%
|
5
41.7%
|
2
25%
|
5
16.1%
|
26
29.9%
|
C/T |
5
29.4%
|
2
50%
|
8
53.3%
|
5
41.7%
|
6
75%
|
18
58.1%
|
44
50.6%
|
T/T |
5
29.4%
|
0
0%
|
2
13.3%
|
2
16.7%
|
0
0%
|
8
25.8%
|
17
19.5%
|
Outcome Measures
Title | Percentage of Participants Experiencing Treatment Emergent Adverse Events |
---|---|
Description | Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing). |
Time Frame | First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing) |
Outcome Measure Data
Analysis Population Description |
---|
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (velpatasvir or placebo). Data were summarized by velpatasvir or placebo. |
Arm/Group Title | Placebo | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 17 | 4 | 15 | 12 | 8 | 31 |
Number [percentage of participants] |
17.6
103.5%
|
25.0
625%
|
26.7
178%
|
8.3
69.2%
|
37.5
468.8%
|
29.0
93.5%
|
Title | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities |
---|---|
Description | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose. |
Time Frame | First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing) |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Safety Analysis Set were analyzed. Data were summarized by dose. |
Arm/Group Title | Placebo | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg |
---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 17 | 4 | 15 | 12 | 8 | 31 |
Grade 1 |
41.2
242.4%
|
25.0
625%
|
40.0
266.7%
|
58.3
485.8%
|
62.5
781.3%
|
33.3
107.4%
|
Grade 2 |
17.6
103.5%
|
0
0%
|
33.3
222%
|
8.3
69.2%
|
25.0
312.5%
|
33.3
107.4%
|
Grade 3 |
11.8
69.4%
|
0
0%
|
13.3
88.7%
|
16.7
139.2%
|
0
0%
|
6.7
21.6%
|
Title | Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline |
---|---|
Description | Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo. |
Time Frame | Baseline; Days 4, 5, 6, 7, 8, 10, and 17 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Efficacy Analysis Set (all randomized participants with appropriate genotype who received at least one dose of the study drug (velpatasvir or placebo) and with at least one on-treatment HCV RNA assessment) with available data were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo. |
Arm/Group Title | Placebo | Velpatasvir 5 mg (GT 1a) | Velpatasvir 25 mg (GT 1a) | Velpatasvir 50 mg (GT 1a) | Velpatasvir 100 mg (GT 1a) | Velpatasvir 150 mg (GT 1a) | Velpatasvir 150 mg (GT 1b) | Velpatasvir 150 mg (GT 2) | Velpatasvir 25 mg (GT 3) | Velpatasvir 50 mg (GT 3) | Velpatasvir 150 mg (GT 3) | Velpatasvir 150 mg (GT 4) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with genotype (GT) 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 17 | 4 | 8 | 8 | 8 | 7 | 8 | 8 | 7 | 4 | 6 | 2 |
Change at Day 4 |
-0.005
(0.3343)
|
-3.104
(0.7348)
|
-3.638
(0.4350)
|
-3.338
(1.3088)
|
-3.154
(1.0089)
|
-3.648
(0.9270)
|
-3.848
(0.4834)
|
-4.044
(0.3671)
|
-2.796
(1.4313)
|
-2.382
(1.5028)
|
-2.834
(0.7608)
|
-3.269
(0.6080)
|
Change at Day 5 |
-0.018
(0.2346)
|
-1.998
(0.8305)
|
-3.538
(0.7566)
|
-3.123
(1.5009)
|
-3.060
(1.1098)
|
-3.636
(1.0023)
|
-3.955
(0.3519)
|
-4.148
(0.5841)
|
-2.617
(1.3034)
|
-2.130
(1.4385)
|
-2.259
(1.1488)
|
-2.827
(0.5506)
|
Change at Day 6 |
-0.037
(0.2119)
|
-1.244
(0.6135)
|
-3.140
(0.9786)
|
-2.704
(1.5100)
|
-2.713
(1.1206)
|
-3.221
(1.2323)
|
-4.021
(0.3681)
|
-4.109
(0.6408)
|
-2.193
(1.1060)
|
-1.737
(1.3854)
|
-1.869
(1.3270)
|
-2.243
(0.5919)
|
Change at Day 7 |
-0.003
(0.1923)
|
-1.031
(0.6112)
|
-2.424
(0.7292)
|
-2.184
(1.5527)
|
-2.273
(1.1753)
|
-2.481
(1.3542)
|
-4.205
(0.4393)
|
-3.850
(0.9630)
|
-1.586
(1.0710)
|
-1.742
(1.3842)
|
-1.380
(1.6686)
|
-1.892
(1.0143)
|
Change at Day 8 |
0.027
(0.2740)
|
-0.941
(0.5345)
|
-2.074
(0.7701)
|
-1.702
(1.6152)
|
-1.780
(0.9987)
|
-2.544
(1.5460)
|
-4.026
(0.3155)
|
-3.559
(0.9866)
|
-1.025
(1.1864)
|
-1.542
(1.0593)
|
-1.062
(1.5998)
|
-1.478
(1.1542)
|
Change at Day 10 |
0.142
(0.3813)
|
-0.679
(0.4352)
|
-1.304
(1.0374)
|
-1.472
(1.4315)
|
-1.143
(1.2137)
|
-2.032
(1.4388)
|
-3.348
(0.6201)
|
-2.918
(1.1566)
|
-0.844
(0.6967)
|
-1.051
(1.4338)
|
-1.198
(1.0991)
|
-0.494
(0.8933)
|
Change at Day 17 |
-0.025
(0.2719)
|
-0.135
(0.3747)
|
-0.223
(0.4236)
|
-1.110
(1.3584)
|
-0.801
(0.7679)
|
-0.879
(0.9231)
|
-1.532
(1.2059)
|
-0.886
(1.3190)
|
-0.672
(0.5003)
|
-0.085
(0.6910)
|
-0.225
(0.4210)
|
-0.351
(0.5914)
|
Title | Absolute HCV RNA Level |
---|---|
Description | |
Time Frame | Baseline; Days 4, 5, 6, 7, 8, 10, and 17 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Efficacy Analysis Set with available data were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo. |
Arm/Group Title | Placebo | Velpatasvir 5 mg (GT 1a) | Velpatasvir 25 mg (GT 1a) | Velpatasvir 50 mg (GT 1a) | Velpatasvir 100 mg (GT 1a) | Velpatasvir 150 mg (GT 1a) | Velpatasvir 150 mg (GT 1b) | Velpatasvir 150 mg (GT 2) | Velpatasvir 25 mg (GT 3) | Velpatasvir 50 mg (GT 3) | Velpatasvir 150 mg (GT 3) | Velpatasvir 150 mg (GT 4) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 17 | 4 | 8 | 8 | 8 | 7 | 8 | 8 | 7 | 4 | 6 | 2 |
Baseline |
6.523
(0.5173)
|
6.639
(0.3123)
|
6.461
(0.6623)
|
6.459
(0.5726)
|
6.458
(0.4785)
|
6.335
(0.5710)
|
6.379
(0.4187)
|
6.753
(0.5857)
|
6.150
(1.0108)
|
6.240
(0.5796)
|
6.318
(0.8151)
|
5.734
(0.2345)
|
Day 4 |
6.518
(0.4840)
|
3.535
(0.7588)
|
2.823
(0.7866)
|
3.121
(1.6969)
|
3.304
(1.2823)
|
2.687
(0.8776)
|
2.574
(0.3526)
|
2.708
(0.5823)
|
3.151
(2.0090)
|
3.858
(1.9120)
|
3.484
(0.6784)
|
2.465
(0.8425)
|
Day 5 |
6.512
(0.5715)
|
4.642
(0.9016)
|
2.922
(1.0852)
|
3.336
(1.8716)
|
3.398
(1.3325)
|
2.699
(1.0083)
|
2.466
(0.3511)
|
2.681
(0.3893)
|
3.329
(1.8305)
|
4.110
(1.8964)
|
4.059
(1.0186)
|
2.907
(0.7850)
|
Day 6 |
6.493
(0.5373)
|
5.395
(0.6898)
|
3.321
(1.3322)
|
3.755
(1.9323)
|
3.745
(1.3213)
|
3.104
(1.2373)
|
2.400
(0.3365)
|
2.644
(0.6568)
|
3.753
(1.6214)
|
4.503
(1.9383)
|
4.450
(1.1943)
|
3.491
(0.8264)
|
Day 7 |
6.527
(0.6190)
|
5.608
(0.6929)
|
4.036
(1.1305)
|
4.275
(1.9196)
|
4.185
(1.4107)
|
3.862
(1.4141)
|
2.217
(0.5807)
|
2.903
(0.7639)
|
4.361
(1.4130)
|
4.498
(1.9226)
|
4.938
(1.4707)
|
3.842
(1.2488)
|
Day 8 |
6.555
(0.4880)
|
5.699
(0.6305)
|
4.387
(1.1089)
|
4.756
(1.9494)
|
4.678
(1.3233)
|
3.791
(1.5984)
|
2.396
(0.6092)
|
3.194
(0.8402)
|
4.922
(1.3395)
|
4.698
(1.6047)
|
5.256
(1.3141)
|
4.256
(1.3887)
|
Day 10 |
6.659
(0.4583)
|
5.960
(0.6104)
|
5.156
(1.3456)
|
4.986
(1.7558)
|
5.315
(1.5130)
|
4.319
(1.6357)
|
3.074
(0.8660)
|
3.834
(1.1710)
|
5.103
(1.1273)
|
5.190
(2.0061)
|
5.120
(0.6140)
|
5.240
(1.1278)
|
Day 17 |
6.503
(0.5432)
|
6.505
(0.5615)
|
6.237
(0.6709)
|
5.468
(1.6269)
|
5.657
(1.0148)
|
5.455
(1.2889)
|
4.890
(1.5438)
|
5.867
(1.5443)
|
5.275
(1.1421)
|
6.007
(0.9524)
|
6.093
(0.6451)
|
5.383
(0.8259)
|
Title | Number of Participants Achieving Reductions From Baseline in HCV RNA |
---|---|
Description | Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to < 2, ≥ 2 to < 3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17. |
Time Frame | Baseline; Days 4, 5, 6, 7, 8, 10, and 17 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Efficacy Analysis Set were analyzed. |
Arm/Group Title | Placebo | Velpatasvir 5 mg (GT 1a) | Velpatasvir 25 mg (GT 1a) | Velpatasvir 50 mg (GT 1a) | Velpatasvir 100 mg (GT 1a) | Velpatasvir 150 mg (GT 1a) | Velpatasvir 150 mg (GT 1b) | Velpatasvir 150 mg (GT 2) | Velpatasvir 25 mg (GT 3) | Velpatasvir 50 mg (GT 3) | Velpatasvir 150 mg (GT 3) | Velpatasvir 150 mg (GT 4) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 17 | 4 | 8 | 8 | 8 | 7 | 8 | 8 | 7 | 4 | 6 | 2 |
Missing HCV RNA |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.1%
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
< 1 log10 IU/mL decrease in HCV RNA |
17
100%
|
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
≥1 and <2 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
1
3.2%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
≥2 and <3 log10 IU/mL decrease in HCV RNA |
0
0%
|
1
25%
|
1
6.7%
|
2
16.7%
|
3
37.5%
|
1
3.2%
|
0
0%
|
0
NaN
|
1
NaN
|
1
NaN
|
3
NaN
|
1
NaN
|
≥3 log10 IU/mL decrease in HCV RNA |
0
0%
|
3
75%
|
7
46.7%
|
5
41.7%
|
4
50%
|
5
16.1%
|
7
8%
|
8
NaN
|
4
NaN
|
2
NaN
|
2
NaN
|
1
NaN
|
Missing HCV RNA |
2
11.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.1%
|
2
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
< 1 log10 IU/mL decrease in HCV RNA |
15
88.2%
|
1
25%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1
NaN
|
1
NaN
|
1
NaN
|
0
NaN
|
≥1 and <2 log10 IU/mL decrease in HCV RNA |
0
0%
|
1
25%
|
1
6.7%
|
1
8.3%
|
2
25%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
1
NaN
|
0
NaN
|
≥2 and <3 log10 IU/mL decrease in HCV RNA |
0
0%
|
2
50%
|
0
0%
|
1
8.3%
|
2
25%
|
2
6.5%
|
0
0%
|
0
NaN
|
2
NaN
|
2
NaN
|
2
NaN
|
1
NaN
|
≥3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
7
46.7%
|
5
41.7%
|
4
50%
|
5
16.1%
|
7
8%
|
6
NaN
|
3
NaN
|
1
NaN
|
2
NaN
|
1
NaN
|
Missing HCV RNA |
2
11.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.2%
|
1
1.1%
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
< 1 log10 IU/mL decrease in HCV RNA |
15
88.2%
|
1
25%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1
NaN
|
1
NaN
|
3
NaN
|
0
NaN
|
≥1 and <2 log10 IU/mL decrease in HCV RNA |
0
0%
|
3
75%
|
1
6.7%
|
2
16.7%
|
2
25%
|
2
6.5%
|
0
0%
|
0
NaN
|
2
NaN
|
1
NaN
|
0
NaN
|
1
NaN
|
≥2 and <3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
0
0%
|
0
0%
|
1
NaN
|
1
NaN
|
2
NaN
|
1
NaN
|
1
NaN
|
≥3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
7
46.7%
|
5
41.7%
|
4
50%
|
4
12.9%
|
7
8%
|
7
NaN
|
2
NaN
|
0
NaN
|
2
NaN
|
0
NaN
|
Missing HCV RNA |
2
11.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
6.5%
|
1
1.1%
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
< 1 log10 IU/mL decrease in HCV RNA |
15
88.2%
|
1
25%
|
1
6.7%
|
3
25%
|
2
25%
|
0
0%
|
0
0%
|
0
NaN
|
2
NaN
|
1
NaN
|
3
NaN
|
0
NaN
|
≥1 and <2 log10 IU/mL decrease in HCV RNA |
0
0%
|
3
75%
|
0
0%
|
0
0%
|
0
0%
|
2
6.5%
|
0
0%
|
0
NaN
|
1
NaN
|
1
NaN
|
1
NaN
|
1
NaN
|
≥2 and <3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
5
33.3%
|
3
25%
|
3
37.5%
|
0
0%
|
0
0%
|
3
NaN
|
3
NaN
|
2
NaN
|
0
NaN
|
1
NaN
|
≥3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
2
13.3%
|
2
16.7%
|
3
37.5%
|
3
9.7%
|
7
8%
|
5
NaN
|
0
NaN
|
0
NaN
|
2
NaN
|
0
NaN
|
Missing HCV RNA |
1
5.9%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.1%
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
< 1 log10 IU/mL decrease in HCV RNA |
16
94.1%
|
2
50%
|
1
6.7%
|
3
25%
|
2
25%
|
2
6.5%
|
0
0%
|
0
NaN
|
3
NaN
|
1
NaN
|
4
NaN
|
1
NaN
|
≥1 and <2 log10 IU/mL decrease in HCV RNA |
0
0%
|
2
50%
|
2
13.3%
|
2
16.7%
|
2
25%
|
0
0%
|
0
0%
|
0
NaN
|
1
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
≥2 and <3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
5
33.3%
|
1
8.3%
|
3
37.5%
|
2
6.5%
|
0
0%
|
3
NaN
|
2
NaN
|
2
NaN
|
2
NaN
|
1
NaN
|
≥3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
0
0%
|
2
16.7%
|
1
12.5%
|
3
9.7%
|
7
8%
|
5
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
Missing HCV RNA |
2
11.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.2%
|
1
1.1%
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
< 1 log10 IU/mL decrease in HCV RNA |
15
88.2%
|
3
75%
|
3
20%
|
4
33.3%
|
3
37.5%
|
1
3.2%
|
0
0%
|
0
NaN
|
4
NaN
|
2
NaN
|
3
NaN
|
1
NaN
|
≥1 and <2 log10 IU/mL decrease in HCV RNA |
0
0%
|
1
25%
|
4
26.7%
|
2
16.7%
|
3
37.5%
|
2
6.5%
|
0
0%
|
2
NaN
|
2
NaN
|
0
NaN
|
1
NaN
|
1
NaN
|
≥2 and <3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
1
6.7%
|
0
0%
|
2
25%
|
2
6.5%
|
3
3.4%
|
2
NaN
|
0
NaN
|
2
NaN
|
2
NaN
|
0
NaN
|
≥3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
0
0%
|
2
16.7%
|
0
0%
|
1
3.2%
|
4
4.6%
|
4
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
Missing HCV RNA |
1
5.9%
|
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
1
1.1%
|
0
NaN
|
1
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
< 1 log10 IU/mL decrease in HCV RNA |
16
94.1%
|
4
100%
|
8
53.3%
|
5
41.7%
|
5
62.5%
|
6
19.4%
|
3
3.4%
|
6
NaN
|
5
NaN
|
3
NaN
|
6
NaN
|
2
NaN
|
≥1 and <2 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
0
0%
|
2
2.3%
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
≥2 and <3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
0
0%
|
1
8.3%
|
1
12.5%
|
1
3.2%
|
1
1.1%
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
≥3 log10 IU/mL decrease in HCV RNA |
0
0%
|
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
1
1.1%
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
Title | Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected |
---|---|
Description | The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. |
Time Frame | Days 4, 5, 6, 7, and 8 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Efficacy Analysis Set were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo. |
Arm/Group Title | Placebo | Velpatasvir 5 mg (GT 1a) | Velpatasvir 25 mg (GT 1a) | Velpatasvir 50 mg (GT 1a) | Velpatasvir 100 mg (GT 1a) | Velpatasvir 150 mg (GT 1a) | Velpatasvir 150 mg (GT 1b) | Velpatasvir 150 mg (GT 2) | Velpatasvir 25 mg (GT 3) | Velpatasvir 50 mg (GT 3) | Velpatasvir 150 mg (GT 3) | Velpatasvir 150 mg (GT 4) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 17 | 4 | 8 | 8 | 8 | 7 | 8 | 8 | 7 | 4 | 6 | 2 |
Day 4 < LLOQ detected |
0
0%
|
0
0%
|
0
0%
|
2
16.7%
|
0
0%
|
1
3.2%
|
0
0%
|
1
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
Day 5 < LLOQ detected |
0
0%
|
0
0%
|
1
6.7%
|
1
8.3%
|
0
0%
|
1
3.2%
|
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
Day 6 < LLOQ detected |
0
0%
|
0
0%
|
1
6.7%
|
0
0%
|
0
0%
|
1
3.2%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
Day 7 < LLOQ detected |
0
0%
|
0
0%
|
0
0%
|
1
8.3%
|
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
Day 8 < LLOQ detected |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.2%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
Title | Plasma HCV RNA Levels by Treatment and IL28B Genotype |
---|---|
Description | |
Time Frame | Days 4, 5, 6, 7, 8, 10, and 17 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Efficacy Analysis Set with available data were analyzed. Data are were summarized by treatment (velpatasvir dose/HCV genotype and placebo) and IL28B genotype (CC and non-CC). Due to the small number of participants in each treatment group, no conclusions can be made on the effect of IL28B genotype on HCV RNA decline. |
Arm/Group Title | Placebo (IL28B Genotype CC) | Velpatasvir 5 mg (GT 1a) (IL28B Genotype CC) | Velpatasvir 25 mg (GT 1a) (IL28B Genotype CC) | Velpatasvir 50 mg (GT 1a) (IL28B Genotype CC) | Velpatasvir 100 mg (GT 1a) (IL28B Genotype CC) | Velpatasvir 150 mg (GT 1a) (IL28B Genotype CC) | Velpatasvir 150 mg (GT 1b) (IL28B Genotype CC) | Velpatasvir 150 mg (GT 2) (IL28B Genotype CC) | Velpatasvir 25 mg (GT 3) (IL28B Genotype CC) | Velpatasvir 50 mg (GT 3) (IL28B Genotype CC) | Velpatasvir 150 mg (GT 3) (IL28B Genotype CC) | Velpatasvir 150 mg (GT 4) (IL28B Genotype CC) | Placebo (IL28B Genotype Non-CC) | Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC) | Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC) | Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC) | Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC) | Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC) | Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC) | Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC) | Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC) | Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC) | Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC) | Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC) |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 7 | 2 | 3 | 2 | 2 | 0 | 1 | 3 | 2 | 3 | 1 | 0 | 10 | 2 | 5 | 6 | 6 | 7 | 7 | 5 | 5 | 1 | 5 | 2 |
Day 4 |
6.473
(0.4869)
|
3.410
(0.4007)
|
2.603
(0.5255)
|
1.762
(0.5394)
|
2.891
(0.4237)
|
2.539
|
2.758
(0.3416)
|
2.976
|
4.304
(2.0716)
|
3.590
|
6.549
(0.5057)
|
3.660
(1.2265)
|
2.955
(0.9418)
|
3.574
(1.7284)
|
3.442
(1.4747)
|
2.687
(0.8776)
|
2.579
(0.3859)
|
2.678
(0.7295)
|
3.186
(2.2441)
|
2.521
|
3.463
(0.7562)
|
2.465
(0.8425)
|
||
Day 5 |
6.604
(0.4842)
|
4.578
(0.6202)
|
2.581
(1.0972)
|
1.748
(0.0110)
|
2.996
(0.4644)
|
2.605
|
2.689
(0.5473)
|
3.117
|
4.620
(1.9568)
|
3.742
|
6.450
(0.6437)
|
4.705
(1.4275)
|
3.127
(1.1484)
|
3.865
(1.8868)
|
3.532
(1.5350)
|
2.699
(1.0083)
|
2.443
(0.3787)
|
2.673
(0.2813)
|
3.372
(2.0433)
|
2.577
|
4.123
(1.1255)
|
2.907
(0.7850)
|
||
Day 6 |
6.595
(0.3266)
|
5.388
(0.5909)
|
2.740
(1.2380)
|
2.134
(0.3192)
|
3.138
(0.5754)
|
2.801
|
2.668
(0.7974)
|
3.813
|
5.035
(1.9842)
|
3.653
|
6.426
(0.6525)
|
5.403
(1.0383)
|
3.669
(1.3910)
|
4.295
(1.9510)
|
3.947
(1.4771)
|
3.104
(1.2373)
|
2.334
(0.3139)
|
2.629
(0.6604)
|
3.741
(1.8125)
|
2.907
|
4.609
(1.2620)
|
3.491
(0.8264)
|
||
Day 7 |
6.563
(0.3311)
|
5.612
(0.4912)
|
3.637
(0.7489)
|
2.988
(0.7310)
|
3.390
(0.1908)
|
3.312
|
2.684
(1.0300)
|
4.196
|
5.038
(1.9476)
|
3.713
|
6.504
(0.7748)
|
5.604
(1.0949)
|
4.276
(1.3284)
|
4.704
(2.0419)
|
4.449
(1.5628)
|
3.862
(1.4141)
|
2.034
(0.3534)
|
3.034
(0.6583)
|
4.394
(1.5772)
|
2.877
|
5.183
(1.5012)
|
3.842
(1.2488)
|
||
Day 8 |
6.643
(0.4611)
|
5.744
(0.7194)
|
3.875
(0.5026)
|
3.053
(1.1852)
|
3.867
(0.3347)
|
3.441
|
2.913
(1.0913)
|
4.553
|
5.123
(1.6669)
|
4.114
|
6.503
(0.5202)
|
5.653
(0.8166)
|
4.694
(1.3082)
|
5.324
(1.8687)
|
4.949
(1.4416)
|
3.791
(1.5984)
|
2.222
(0.4366)
|
3.362
(0.7384)
|
4.996
(1.4838)
|
3.423
|
5.485
(1.3293)
|
4.256
(1.3887)
|
||
Day 10 |
6.817
(0.3336)
|
6.171
(0.8102)
|
4.369
(0.3684)
|
3.488
(1.1964)
|
4.059
(0.0027)
|
3.948
|
3.438
(1.2872)
|
5.061
|
5.724
(2.0787)
|
4.754
|
6.580
(0.5065)
|
5.750
(0.5333)
|
5.629
(1.5354)
|
5.485
(1.6832)
|
5.733
(1.5375)
|
4.319
(1.6357)
|
2.928
(0.8495)
|
4.073
(1.1757)
|
5.111
(1.2601)
|
3.585
|
5.193
(0.6566)
|
5.240
(1.1278)
|
||
Day 17 |
6.601
(0.3466)
|
6.713
(0.6714)
|
6.147
(1.0166)
|
2.949
|
4.572
(0.1838)
|
6.953
|
5.127
(1.8225)
|
6.744
|
5.881
(1.3108)
|
6.621
|
6.444
(0.6440)
|
6.297
(0.5676)
|
6.292
(0.5110)
|
5.888
(1.3019)
|
6.019
(0.8985)
|
5.455
(1.2889)
|
4.546
(1.3663)
|
6.311
(1.3623)
|
4.981
(0.9912)
|
6.260
|
5.987
(0.6606)
|
5.383
(0.8259)
|
Title | Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf |
---|---|
Description | AUCinf is defined as the concentration of drug extrapolated to infinite time. |
Time Frame | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
The PK analysis set included all randomized and treated participants who have evaluable PK profiles for velpatasvir. |
Arm/Group Title | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 4 | 15 | 12 | 8 | 30 |
Mean (Standard Deviation) [h*ng/mL] |
113.8
(71.61)
|
857.9
(612.23)
|
2054.3
(806.69)
|
2727.3
(1619.74)
|
4546.6
(1757.10)
|
Title | PK Parameter of Velpatasvir: AUCtau |
---|---|
Description | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). |
Time Frame | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the PK Analysis Set were analyzed. |
Arm/Group Title | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 4 | 15 | 12 | 8 | 30 |
Mean (Standard Deviation) [h*ng/mL] |
86.4
(14.32)
|
857.5
(467.74)
|
1950.5
(486.87)
|
2745.3
(1480.47)
|
5003.0
(2371.91)
|
Title | PK Parameter of Velpatasvir: Cmax |
---|---|
Description | Cmax is defined as the maximum observed plasma concentration of drug. |
Time Frame | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose. |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the PK Analysis Set were analyzed. |
Arm/Group Title | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 4 | 15 | 12 | 8 | 30 |
Day 1 (Single-Dose) |
20.1
(14.62)
|
110.8
(55.97)
|
272.3
(95.46)
|
372.8
(222.74)
|
583.3
(257.90)
|
Day 3 (Multiple-Dose) |
16.2
(2.34)
|
122.9
(61.38)
|
292.4
(88.77)
|
413.9
(243.66)
|
690.1
(307.04)
|
Title | PK Parameter of Velpatasvir: CL/F |
---|---|
Description | CL/F is defined as the apparent oral clearance following administration of the drug. |
Time Frame | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the PK Analysis Set were analyzed. |
Arm/Group Title | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 4 | 15 | 12 | 8 | 30 |
Day 1 |
61312.2
(42726.76)
|
37170.7
(16570.51)
|
27930.6
(10689.18)
|
49237.5
(25550.98)
|
38011.7
(14392.55)
|
Day 3 |
59173.6
(10490.08)
|
34,820.1
(13217.45)
|
27,263.0
(7367.47)
|
53,194.3
(39618.97)
|
37,362.8
(18382.06)
|
Title | PK Parameter of Velpatasvir: Ctau |
---|---|
Description | Ctau is defined as the observed drug concentration at the end of the dosing interval. |
Time Frame | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the PK Analysis Set were analyzed. |
Arm/Group Title | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg |
---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 4 | 15 | 12 | 8 | 30 |
Mean (Standard Deviation) [ng/mL] |
0.6
(0.70)
|
10.8
(8.50)
|
22.4
(4.66)
|
30.8
(15.03)
|
60.6
(33.24)
|
Title | Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints |
---|---|
Description | The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs. |
Time Frame | First dose date up to Day 17 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the efficacy analysis set who were sequenced at pre-treatment or post baseline treatment were analyzed. |
Arm/Group Title | Placebo | Velpatasvir 5 mg (GT 1a) | Velpatasvir 25 mg (GT 1a) | Velpatasvir 50 mg (GT 1a) | Velpatasvir 100 mg (GT 1a) | Velpatasvir 150 mg (GT 1a) | Velpatasvir 150 mg (GT 1b) | Velpatasvir 150 mg (GT 2) | Velpatasvir 25 mg (GT 3) | Velpatasvir 50 mg (GT 3) | Velpatasvir 150 mg (GT 3) | Velpatasvir 150 mg (GT 4) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
Measure Participants | 8 | 4 | 8 | 8 | 8 | 7 | 8 | 8 | 7 | 4 | 6 | 2 |
Number of participants sequenced pretreatment |
8
47.1%
|
4
100%
|
8
53.3%
|
8
66.7%
|
8
100%
|
7
22.6%
|
8
9.2%
|
8
NaN
|
7
NaN
|
4
NaN
|
6
NaN
|
2
NaN
|
Number of participants with RAVs at pretreatment |
2
11.8%
|
0
0%
|
2
13.3%
|
3
25%
|
3
37.5%
|
2
6.5%
|
1
1.1%
|
4
NaN
|
2
NaN
|
1
NaN
|
2
NaN
|
2
NaN
|
Number of participants sequenced at postbaseline |
2
11.8%
|
4
100%
|
8
53.3%
|
7
58.3%
|
8
100%
|
6
19.4%
|
6
6.9%
|
8
NaN
|
6
NaN
|
4
NaN
|
6
NaN
|
2
NaN
|
Number of participants with RAVs at postbaseline |
0
0%
|
4
100%
|
7
46.7%
|
6
50%
|
8
100%
|
6
19.4%
|
6
6.9%
|
7
NaN
|
6
NaN
|
4
NaN
|
6
NaN
|
2
NaN
|
Adverse Events
Time Frame | Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); All-Cause Mortality: First dose date up to Week 48 | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (velpatasvir or placebo). Data were summarized by velpatasvir and placebo. | |||||||||||
Arm/Group Title | Placebo | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg | ||||||
Arm/Group Description | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | ||||||
All Cause Mortality |
||||||||||||
Placebo | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg | |||||||
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 | 0/17 (0%) | 0/4 (0%) | 0/15 (0%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Serious Adverse Events |
||||||||||||
Placebo | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg | |||||||
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 | 0/17 (0%) | 0/4 (0%) | 0/15 (0%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
Placebo | Velpatasvir 5 mg | Velpatasvir 25 mg | Velpatasvir 50 mg | Velpatasvir 100 mg | Velpatasvir 150 mg | |||||||
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 | 3/17 (17.6%) | 1/4 (25%) | 4/15 (26.7%) | 1/12 (8.3%) | 3/8 (37.5%) | 6/31 (19.4%) | ||||||
Eye disorders | ||||||||||||
Dry eye | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Eye irritation | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Gastrointestinal disorders | ||||||||||||
Abdominal pain upper | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Constipation | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 0/12 (0%) | 1/8 (12.5%) | 0/31 (0%) | ||||||
Diarrhoea | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 1/12 (8.3%) | 0/8 (0%) | 0/31 (0%) | ||||||
Faeces discoloured | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Flatulence | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Gingival bleeding | 1/17 (5.9%) | 0/4 (0%) | 0/15 (0%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Nausea | 0/17 (0%) | 0/4 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/8 (0%) | 2/31 (6.5%) | ||||||
Vomiting | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 1/12 (8.3%) | 0/8 (0%) | 1/31 (3.2%) | ||||||
Infections and infestations | ||||||||||||
Gastroenteritis | 0/17 (0%) | 0/4 (0%) | 0/15 (0%) | 0/12 (0%) | 1/8 (12.5%) | 0/31 (0%) | ||||||
Injury, poisoning and procedural complications | ||||||||||||
Contusion | 1/17 (5.9%) | 0/4 (0%) | 0/15 (0%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Fibula fracture | 1/17 (5.9%) | 0/4 (0%) | 0/15 (0%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Nervous system disorders | ||||||||||||
Headache | 0/17 (0%) | 1/4 (25%) | 0/15 (0%) | 0/12 (0%) | 1/8 (12.5%) | 4/31 (12.9%) | ||||||
Syncope | 1/17 (5.9%) | 0/4 (0%) | 0/15 (0%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||
Asthma | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Cough | 0/17 (0%) | 0/4 (0%) | 0/15 (0%) | 0/12 (0%) | 1/8 (12.5%) | 1/31 (3.2%) | ||||||
Skin and subcutaneous tissue disorders | ||||||||||||
Dermatitis contact | 0/17 (0%) | 0/4 (0%) | 1/15 (6.7%) | 0/12 (0%) | 0/8 (0%) | 0/31 (0%) | ||||||
Rash pruritic | 0/17 (0%) | 0/4 (0%) | 0/15 (0%) | 1/12 (8.3%) | 0/8 (0%) | 0/31 (0%) | ||||||
Vascular disorders | ||||||||||||
Hypertension | 1/17 (5.9%) | 0/4 (0%) | 0/15 (0%) | 0/12 (0%) | 0/8 (0%) | 1/31 (3.2%) |
Limitations/Caveats
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 | Gilead Clinical Study Information Center |
---|---|
Organization | Gilead Sciences |
Phone | 1-833-445-3230 (GILEAD-0) |
GileadClinicalTrials@gilead.com |
- GS-US-281-0102