Trial Outcomes & Findings for Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease (NCT NCT03036852)
NCT ID: NCT03036852
Last Updated: 2020-03-06
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2020-03-06
Participant Flow
Participants were enrolled at study sites in Canada, the United Kingdom, Spain, Israel, New Zealand, and Australia. The first participant was screened on 22 March 2017. The last study visit occurred on 07 November 2018.
78 participants were screened.
Participant milestones
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
Baseline characteristics by cohort
| Measure |
SOF/VEL (GT-1)
n=25 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
n=16 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
n=4 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
n=2 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
67 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
55 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
58 years
STANDARD_DEVIATION 15.5 • n=4 Participants
|
69 years
STANDARD_DEVIATION 3.5 • n=21 Participants
|
52 years
STANDARD_DEVIATION 13.0 • n=10 Participants
|
60 years
STANDARD_DEVIATION 12.1 • n=115 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
IL28b Status
CC
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
IL28b Status
CT
|
14 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
IL28b Status
TT
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
HCV RNA
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.70 • n=5 Participants
|
5.2 log10 IU/mL
STANDARD_DEVIATION 1.04 • n=7 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.55 • n=5 Participants
|
5.6 log10 IU/mL
STANDARD_DEVIATION 1.55 • n=4 Participants
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.27 • n=21 Participants
|
4.4 log10 IU/mL
STANDARD_DEVIATION 1.69 • n=10 Participants
|
5.8 log10 IU/mL
STANDARD_DEVIATION 1.02 • n=115 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: The Full Analysis Set included participants who are enrolled into the study and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
n=25 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
n=16 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
n=4 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
n=2 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
94.9 percentage of participants
Interval 85.9 to 98.9
|
92.0 percentage of participants
Interval 74.0 to 99.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
PRIMARY outcome
Timeframe: First dose date up to Week 12Population: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Participants in the Full Analysis Set were analyzed.
SVR4 was defined as HCV RNA \< LLOQ 4 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
n=25 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
n=16 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
n=4 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
n=2 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
|
96.6 percentage of participants
Interval 88.3 to 99.6
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
SVR24 was defined as HCV RNA \< LLOQ 24 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
n=25 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
n=16 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
n=4 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
n=2 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
|
94.9 percentage of participants
Interval 85.9 to 98.9
|
92.0 percentage of participants
Interval 74.0 to 99.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 6, 8, and 12Population: Participants in the Full Analysis Set with available date were analyzed.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
n=25 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
n=16 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
n=4 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
n=2 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in HCV RNA
Change at Week 2
|
-4.54 log10 IU/mL
Standard Deviation 1.017
|
-4.69 log10 IU/mL
Standard Deviation 0.797
|
-3.78 log10 IU/mL
Standard Deviation 0.840
|
-5.07 log10 IU/mL
Standard Deviation 0.493
|
-4.23 log10 IU/mL
Standard Deviation 1.333
|
-5.29 log10 IU/mL
Standard Deviation 0.269
|
-3.24 log10 IU/mL
Standard Deviation 1.668
|
|
Change From Baseline in HCV RNA
Change at Week 4
|
-4.69 log10 IU/mL
Standard Deviation 1.020
|
-4.81 log10 IU/mL
Standard Deviation 0.704
|
-4.05 log10 IU/mL
Standard Deviation 1.041
|
-5.20 log10 IU/mL
Standard Deviation 0.551
|
-4.48 log10 IU/mL
Standard Deviation 1.547
|
-5.29 log10 IU/mL
Standard Deviation 0.269
|
-3.26 log10 IU/mL
Standard Deviation 1.692
|
|
Change From Baseline in HCV RNA
Change at Week 6
|
-4.69 log10 IU/mL
Standard Deviation 1.020
|
-4.81 log10 IU/mL
Standard Deviation 0.704
|
-4.05 log10 IU/mL
Standard Deviation 1.041
|
-5.20 log10 IU/mL
Standard Deviation 0.551
|
-4.48 log10 IU/mL
Standard Deviation 1.547
|
-5.29 log10 IU/mL
Standard Deviation 0.269
|
-3.26 log10 IU/mL
Standard Deviation 1.692
|
|
Change From Baseline in HCV RNA
Change at Week 8
|
-4.69 log10 IU/mL
Standard Deviation 1.020
|
-4.81 log10 IU/mL
Standard Deviation 0.704
|
-4.05 log10 IU/mL
Standard Deviation 1.041
|
-5.20 log10 IU/mL
Standard Deviation 0.551
|
-4.48 log10 IU/mL
Standard Deviation 1.547
|
-5.29 log10 IU/mL
Standard Deviation 0.269
|
-3.26 log10 IU/mL
Standard Deviation 1.692
|
|
Change From Baseline in HCV RNA
Change at Week 12
|
-4.69 log10 IU/mL
Standard Deviation 1.020
|
-4.81 log10 IU/mL
Standard Deviation 0.704
|
-4.05 log10 IU/mL
Standard Deviation 1.041
|
-5.20 log10 IU/mL
Standard Deviation 0.551
|
-4.48 log10 IU/mL
Standard Deviation 1.547
|
-5.29 log10 IU/mL
Standard Deviation 0.269
|
-3.26 log10 IU/mL
Standard Deviation 1.692
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, and 12Population: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
n=25 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
n=16 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
n=4 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
n=2 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2
|
67.8 percentage of participants
Interval 54.4 to 79.4
|
76.0 percentage of participants
Interval 54.9 to 90.6
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
43.8 percentage of participants
Interval 19.8 to 70.1
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 6
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12
|
100.0 percentage of participants
Interval 93.9 to 100.0
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 24Population: Participants in the Full Analysis Set were analyzed.
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
n=25 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
n=7 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
n=16 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
n=4 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
n=2 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
n=5 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
3.4 percentage of participants
|
4.0 percentage of participants
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to Posttreatment Week 24Population: Participants in the Resistance Analysis Population Set included all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. All data are reported at a 15% assay cutoff.
Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was \> 1000 IU/mL.
Outcome measures
| Measure |
SOF/VEL (Total)
n=58 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))Population: Participants in the PK Analysis Set (all participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma) with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of SOF.
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Outcome measures
| Measure |
SOF/VEL (Total)
n=21 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: AUCtau of SOF
|
2381.9 h*ng/mL
Standard Deviation 567.63
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))Population: Participants in the PK analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of GS-331007 .
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
|
230989.2 h*ng/mL
Standard Deviation 81453.30
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))Population: Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of VEL.
AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
PK Parameter: AUCtau of VEL
|
4279.4 h*ng/mL
Standard Deviation 2198.77
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))Population: Participants in the PK Analysis set with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of SOF.
Cmax is defined as the population PK derived maximum concentration of the drug.
Outcome measures
| Measure |
SOF/VEL (Total)
n=21 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of SOF
|
1041.0 ng/mL
Standard Deviation 176.96
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))Population: Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of GS-331007.
Cmax is defined as the population PK derived maximum concentration of the drug.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
|
9776.2 ng/mL
Standard Deviation 3433.16
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))Population: Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of VEL.
Cmax is defined as the population PK derived maximum concentration of the drug.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of VEL
|
226.9 ng/mL
Standard Deviation 92.80
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))Population: Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Ctau of VEL.
Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.
Outcome measures
| Measure |
SOF/VEL (Total)
n=59 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
SOF/VEL (GT-1)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
|
SOF/VEL (GT-2)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
|
SOF/VEL (GT-3)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
|
SOF/VEL (GT-4)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
|
SOF/VEL (GT-6)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
|
SOF/VEL (Indeterminate)
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
|
|---|---|---|---|---|---|---|---|
|
PK Parameter: Ctau of VEL
|
137.2 ng/mL
Standard Deviation 95.91
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SOF/VEL
Serious events: 11 serious events
Other events: 33 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
SOF/VEL
n=59 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Streptococcal bacteraemia
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma benign
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
1.7%
1/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
SOF/VEL
n=59 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
6.8%
4/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
3/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
3/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
3/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
13.6%
8/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
8/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
13.6%
8/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
3/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
4/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.1%
3/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.5%
5/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
16.9%
10/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
10.2%
6/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
5/59 • Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER