Trial Outcomes & Findings for Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis (NCT NCT02201901)
NCT ID: NCT02201901
Last Updated: 2018-11-15
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
268 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-15
Participant Flow
Participants were enrolled at a total of 47 study sites in the United States. The first participant was screened on 31 July 2014. The last study visit occurred on 25 November 2015.
438 participants were screened.
Participant milestones
| Measure |
SOF/VEL 12 Weeks (Group 1)
SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
90
|
88
|
90
|
|
Overall Study
COMPLETED
|
75
|
79
|
77
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
13
|
Reasons for withdrawal
| Measure |
SOF/VEL 12 Weeks (Group 1)
SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Overall Study
Randomized but never treated
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
7
|
1
|
6
|
|
Overall Study
Death
|
3
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
2
|
|
Overall Study
Withdrew Consent
|
2
|
0
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
Baseline Characteristics
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
Baseline characteristics by cohort
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=90 Participants
SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=87 Participants
SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks ((Group 3)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
58 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
58 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
58 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
228 Participants
n=4 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
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
79 participants
n=5 Participants
|
79 participants
n=7 Participants
|
81 participants
n=5 Participants
|
239 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
31 participants
n=5 Participants
|
42 participants
n=7 Participants
|
45 participants
n=5 Participants
|
118 participants
n=4 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
59 participants
n=5 Participants
|
45 participants
n=7 Participants
|
45 participants
n=5 Participants
|
149 participants
n=4 Participants
|
|
HCV RNA
|
6.0 log 10 IU/mL
STANDARD_DEVIATION 0.54 • n=5 Participants
|
5.8 log 10 IU/mL
STANDARD_DEVIATION 0.61 • n=7 Participants
|
5.9 log 10 IU/mL
STANDARD_DEVIATION 0.63 • n=5 Participants
|
5.9 log 10 IU/mL
STANDARD_DEVIATION 0.60 • n=4 Participants
|
|
HCV Genotype
Genotype 1
|
68 participants
n=5 Participants
|
68 participants
n=7 Participants
|
71 participants
n=5 Participants
|
207 participants
n=4 Participants
|
|
HCV Genotype
Genotype 2
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
HCV Genotype
Genotype 3
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
12 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
HCV Genotype
Genotype 4
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
HCV Genotype
Genotype 6
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
IL28B
CC
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
20 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
IL28B
CT
|
51 participants
n=5 Participants
|
46 participants
n=7 Participants
|
49 participants
n=5 Participants
|
146 participants
n=4 Participants
|
|
IL28B
TT
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
19 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
IL28B
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: The Full Analysis Set (FAS): participants who were randomized into the study and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=87 Participants
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
83.3 percentage of participants
Interval 74.0 to 90.4
|
94.3 percentage of participants
Interval 87.1 to 98.1
|
87.8 percentage of participants
Interval 79.2 to 93.7
|
PRIMARY outcome
Timeframe: Up to 24 weeks plus 30 daysPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=87 Participants
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
1.1 percentage of participants
|
16.1 percentage of participants
|
4.4 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=87 Participants
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
92.2 percentage of participants
Interval 84.6 to 96.8
|
95.4 percentage of participants
Interval 88.6 to 98.7
|
90.0 percentage of participants
Interval 81.9 to 95.3
|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
83.3 percentage of participants
Interval 74.0 to 90.4
|
94.3 percentage of participants
Interval 87.1 to 98.1
|
87.8 percentage of participants
Interval 79.2 to 93.7
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=87 Participants
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 1(Group 1: N=90; Group 2: N=87; Group 3: N=90)
|
2.2 percentage of participants
|
14.9 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 2 (Group 1: N=90; Group 2: N=87;Group 3: N=89)
|
34.4 percentage of participants
|
49.4 percentage of participants
|
39.3 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 4 (Group 1: N=90; Group 2: N=87; Group 3: N=89)
|
81.1 percentage of participants
|
80.5 percentage of participants
|
91.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88)
|
98.9 percentage of participants
|
97.6 percentage of participants
|
98.9 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 8(Group 1: N=89; Group 2: N=84; Group 3: N=87)
|
98.9 percentage of participants
|
98.8 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 10(Group 1: N=89; Group 2: N=84; Group 3: N=87)
|
100.0 percentage of participants
|
98.8 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 12(Group 1: N=89; Group 2: N=83; Group 3: N=87)
|
100.0 percentage of participants
|
98.8 percentage of participants
|
97.7 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 16(Group 1: N=0; Group 2: N=0; Group 3: N=86)
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
97.7 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 20(Group 1: N=0; Group 2: N=0;Group 3: N=84)
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100.0 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 24(Group 1: N=0; Group 2: N=0; Group 3: N=84)
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
NA percentage of participants
Treatment for this group was only 12 weeks.
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=87 Participants
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 1(Group 1: N=89; Group 2: N=83; Group 3: N=88)
|
-3.51 log10 IU/mL
Standard Deviation 0.652
|
-3.63 log10 IU/mL
Standard Deviation 0.691
|
-3.72 log10 IU/mL
Standard Deviation 0.680
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 2(Group 1: N=89; Group 2: N=87; Group 3: N=88)
|
-4.24 log10 IU/mL
Standard Deviation 0.677
|
-4.17 log10 IU/mL
Standard Deviation 0.647
|
-4.38 log10 IU/mL
Standard Deviation 0.669
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 4(Group 1: N=88; Group 2: N=86; Group 3: N=88)
|
-4.78 log10 IU/mL
Standard Deviation 0.549
|
-4.58 log10 IU/mL
Standard Deviation 0.568
|
-4.70 log10 IU/mL
Standard Deviation 0.613
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88)
|
-4.87 log10 IU/mL
Standard Deviation 0.536
|
-4.68 log10 IU/mL
Standard Deviation 0.607
|
-4.74 log10 IU/mL
Standard Deviation 0.630
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 8(Group 1: N=89; Group 2: N=83; Group 3: N=87)
|
-4.87 log10 IU/mL
Standard Deviation 0.536
|
-4.68 log10 IU/mL
Standard Deviation 0.622
|
-4.76 log10 IU/mL
Standard Deviation 0.613
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 10(Group 1: N=89; Group 2: N=84; Group 3, N=87)
|
-4.87 log10 IU/mL
Standard Deviation 0.536
|
-4.67 log10 IU/mL
Standard Deviation 0.634
|
-4.76 log10 IU/mL
Standard Deviation 0.613
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 12(Group 1: N=89; Group 2: N=82; Group 3: N=86)
|
-4.87 log10 IU/mL
Standard Deviation 0.536
|
-4.68 log10 IU/mL
Standard Deviation 0.624
|
-4.75 log10 IU/mL
Standard Deviation 0.618
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 16 (Group 1: N=0; Group 2: N=0; Group 3: N=85)
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was 12 weeks only.
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was 12 weeks only.
|
-4.76 log10 IU/mL
Standard Deviation 0.617
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 20 (Group 1: N=0; Group 2: N=0; Group 3: N =84)
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was 12 weeks only.
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was 12 weeks only.
|
-4.77 log10 IU/mL
Standard Deviation 0.613
|
|
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Wk 24 (Group 1: N=0; Group 2: N=0; Group 3: N =84)
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was 12 weeks only.
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was 12 weeks only.
|
-4.77 log10 IU/mL
Standard Deviation 0.613
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as * On-treatment virologic failure * HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment, * \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, * HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse) * Relapse * HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Outcome measures
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=87 Participants
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=90 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
12.2 percentage of participants
Interval 6.3 to 20.8
|
3.4 percentage of participants
Interval 0.7 to 9.7
|
8.9 percentage of participants
Interval 3.9 to 16.8
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Outcome measures
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=69 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=75 Participants
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=69 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score
Decrease (Improvement)
|
55.1 percentage of participants
|
49.3 percentage of participants
|
50.7 percentage of participants
|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score
No Change
|
20.3 percentage of participants
|
25.3 percentage of participants
|
21.7 percentage of participants
|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score
Increase (Worsening)
|
24.6 percentage of participants
|
25.3 percentage of participants
|
27.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Posttreatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.
Outcome measures
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=69 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=75 Participants
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=69 Participants
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score
Decrease (Improvement)
|
44.9 percentage of participants
|
53.3 percentage of participants
|
63.8 percentage of participants
|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score
No Change
|
43.5 percentage of participants
|
37.3 percentage of participants
|
27.5 percentage of participants
|
|
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score
Increase (Worsening)
|
11.6 percentage of participants
|
9.3 percentage of participants
|
8.7 percentage of participants
|
Adverse Events
SOF/VEL 12 Weeks (Group 1)
Serious events: 17 serious events
Other events: 65 other events
Deaths: 0 deaths
SOF/VEL+RBV 12 Weeks (Group 2)
Serious events: 14 serious events
Other events: 74 other events
Deaths: 0 deaths
SOF/VEL 24 Weeks (Group 3)
Serious events: 16 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=90 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=87 participants at risk
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=90 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.3%
3/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Hernia
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Bone abscess
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Device related infection
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Localised infection
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Osteomyelitis
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Peritonitis
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Pneumonia
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Sepsis
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
3/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.3%
2/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.3%
2/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.3%
3/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.2%
2/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.3%
2/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Seizure
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Syncope
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Mental status changes
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypotension
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF/VEL 12 Weeks (Group 1)
n=90 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
|
SOF/VEL+RBV 12 Weeks (Group 2)
n=87 participants at risk
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
|
SOF/VEL 24 Weeks (Group 3)
n=90 participants at risk
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.4%
4/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
29.9%
26/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.3%
3/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
1/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.7%
5/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.3%
3/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
7/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
6/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.4%
4/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Ascites
|
5.6%
5/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.6%
4/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
6.7%
6/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
3/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.7%
6/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
6/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.7%
18/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.8%
7/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
2/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.3%
2/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.9%
8/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
22.2%
20/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
25.3%
22/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.0%
18/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
7/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.7%
5/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.7%
6/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
25.6%
23/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
39.1%
34/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
23.3%
21/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Oedema peripheral
|
7.8%
7/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
6/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.8%
7/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Pyrexia
|
6.7%
6/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.6%
4/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.3%
3/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
2/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
3/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.9%
8/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
3/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.3%
2/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
8.9%
8/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.4%
4/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.3%
2/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.6%
5/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
7/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
3/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.2%
2/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
6/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.1%
1/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.4%
4/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.3%
3/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
11.5%
10/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.4%
4/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
25.6%
23/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
20.7%
18/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
18.9%
17/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
10.0%
9/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.8%
12/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.0%
9/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
2/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.3%
9/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.4%
4/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.2%
8/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.2%
2/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
10/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.6%
4/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.4%
4/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
6/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.7%
5/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.8%
7/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Vascular disorders
Hypertension
|
3.3%
3/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.7%
5/87 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/90 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Additional Information
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