Trial Outcomes & Findings for Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection (NCT NCT02487030)
NCT ID: NCT02487030
Last Updated: 2018-11-16
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
255 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled in 4 sites in Egypt. The first participant was screened on 07 September 2015 and the last study visit was on 04 February 2017.
289 participants were screened.
Participant milestones
| Measure |
LDV/SOF 8 wk TN (Cohort 1, Group 1)
Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed dose combination (FDC) tablet administered orally once daily for 8 weeks (wk) in treatment-naive (TN) participants
|
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + Ribavirin (RBV) tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
|
LDV/SOF 12 wk TN (Cohort 1, Group 3)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
|
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
|
LDV/SOF 12 wk TE (Cohort 3, Group 1)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in treatment-experienced (TE) participants
|
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
|
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were in enrolled into Cohort 2.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
43
|
42
|
36
|
38
|
11
|
|
Overall Study
COMPLETED
|
41
|
38
|
41
|
40
|
34
|
37
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
2
|
2
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
LDV/SOF 8 wk TN (Cohort 1, Group 1)
Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed dose combination (FDC) tablet administered orally once daily for 8 weeks (wk) in treatment-naive (TN) participants
|
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + Ribavirin (RBV) tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
|
LDV/SOF 12 wk TN (Cohort 1, Group 3)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
|
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
|
LDV/SOF 12 wk TE (Cohort 3, Group 1)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in treatment-experienced (TE) participants
|
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
|
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were in enrolled into Cohort 2.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
4
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Baseline characteristics by cohort
| Measure |
LDV/SOF 8 wk TN (Cohort 1, Group 1)
n=43 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
|
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)
n=42 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
|
LDV/SOF 12 wk TN (Cohort 1, Group 3)
n=43 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
|
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)
n=42 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
|
LDV/SOF 12 wk TE (Cohort 3, Group 1)
n=36 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
|
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)
n=38 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
|
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
n=11 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
49 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
49 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
46 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
49 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
51 years
STANDARD_DEVIATION 10.1 • n=8 Participants
|
48 years
STANDARD_DEVIATION 16.3 • n=8 Participants
|
50.0 years
STANDARD_DEVIATION 12.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
99 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
156 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
255 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
255 Participants
n=24 Participants
|
|
IL28b Status
CC
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
53 Participants
n=24 Participants
|
|
IL28b Status
CT
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
158 Participants
n=24 Participants
|
|
IL28b Status
TT
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
47 Participants
n=24 Participants
|
|
HCV RNA
|
6.0 log10 IU/mL)
STANDARD_DEVIATION 0.64 • n=5 Participants
|
5.6 log10 IU/mL)
STANDARD_DEVIATION 0.63 • n=7 Participants
|
5.7 log10 IU/mL)
STANDARD_DEVIATION 0.69 • n=5 Participants
|
5.8 log10 IU/mL)
STANDARD_DEVIATION 0.66 • n=4 Participants
|
5.8 log10 IU/mL)
STANDARD_DEVIATION 1.10 • n=21 Participants
|
5.8 log10 IU/mL)
STANDARD_DEVIATION 1.04 • n=8 Participants
|
6.2 log10 IU/mL)
STANDARD_DEVIATION 0.59 • n=8 Participants
|
5.8 log10 IU/mL)
STANDARD_DEVIATION 0.79 • n=24 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
17 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
134 Participants
n=24 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
121 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: all randomized or enrolled participants who had genotype 4 HCV infection and who took 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 |
LDV/SOF 8 wk TN (Cohort 1, Group 1)
n=43 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
|
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)
n=42 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
|
LDV/SOF 12 wk TN (Cohort 1, Group 3)
n=43 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
|
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)
n=42 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
|
LDV/SOF 12 wk TE (Cohort 3, Group 1)
n=36 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
|
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)
n=38 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
|
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
n=11 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
95.3 percentage of participants
Interval 84.2 to 99.4
|
90.5 percentage of participants
Interval 77.4 to 97.3
|
97.7 percentage of participants
Interval 87.7 to 99.9
|
97.6 percentage of participants
Interval 87.4 to 99.9
|
94.4 percentage of participants
Interval 81.3 to 99.3
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Safety analysis Set
Outcome measures
| Measure |
LDV/SOF 8 wk TN (Cohort 1, Group 1)
n=43 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
|
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)
n=42 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
|
LDV/SOF 12 wk TN (Cohort 1, Group 3)
n=79 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
|
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)
n=91 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
|
LDV/SOF 12 wk TE (Cohort 3, Group 1)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
|
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
|
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.1 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 were defined as HCV RNA \< LLOQ 4 and 24 weeks after the last dose of study drug, respectively.
Outcome measures
| Measure |
LDV/SOF 8 wk TN (Cohort 1, Group 1)
n=43 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
|
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)
n=42 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
|
LDV/SOF 12 wk TN (Cohort 1, Group 3)
n=43 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
|
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)
n=42 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
|
LDV/SOF 12 wk TE (Cohort 3, Group 1)
n=36 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
|
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)
n=38 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
|
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
n=11 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
95.3 percentage of participants
Interval 84.2 to 99.4
|
95.2 percentage of participants
Interval 83.8 to 99.4
|
97.7 percentage of participants
Interval 87.7 to 99.9
|
97.6 percentage of participants
Interval 87.4 to 99.9
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
|
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
95.3 percentage of participants
Interval 84.2 to 99.4
|
90.5 percentage of participants
Interval 77.4 to 97.3
|
97.7 percentage of participants
Interval 87.7 to 99.9
|
97.6 percentage of participants
Interval 87.4 to 99.9
|
94.4 percentage of participants
Interval 81.3 to 99.3
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as * On-treatment virologic failure * confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment (ie, breakthrough), * confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), * 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 |
LDV/SOF 8 wk TN (Cohort 1, Group 1)
n=43 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
|
LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2)
n=42 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
|
LDV/SOF 12 wk TN (Cohort 1, Group 3)
n=43 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
|
LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4)
n=42 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
|
LDV/SOF 12 wk TE (Cohort 3, Group 1)
n=36 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
|
LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2)
n=38 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
|
LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
n=11 Participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Overall Virologic Failure
|
4.7 percentage of participants
|
9.5 percentage of participants
|
2.3 percentage of participants
|
0.0 percentage of participants
|
2.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
LDV/SOF 8 Weeks
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
LDV/SOF + RBV 8 Weeks
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
LDV/SOF 12 Weeks
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
LDV/SOF + RBV 12 Weeks
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF 8 Weeks
n=43 participants at risk
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks
|
LDV/SOF + RBV 8 Weeks
n=42 participants at risk
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
|
LDV/SOF 12 Weeks
n=79 participants at risk
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks
|
LDV/SOF + RBV 12 Weeks
n=91 participants at risk
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
|
|---|---|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/43 • Up to 12 weeks + 30 days
|
0.00%
0/42 • Up to 12 weeks + 30 days
|
0.00%
0/79 • Up to 12 weeks + 30 days
|
1.1%
1/91 • Up to 12 weeks + 30 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/43 • Up to 12 weeks + 30 days
|
0.00%
0/42 • Up to 12 weeks + 30 days
|
0.00%
0/79 • Up to 12 weeks + 30 days
|
2.2%
2/91 • Up to 12 weeks + 30 days
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/43 • Up to 12 weeks + 30 days
|
0.00%
0/42 • Up to 12 weeks + 30 days
|
0.00%
0/79 • Up to 12 weeks + 30 days
|
1.1%
1/91 • Up to 12 weeks + 30 days
|
Other adverse events
| Measure |
LDV/SOF 8 Weeks
n=43 participants at risk
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks
|
LDV/SOF + RBV 8 Weeks
n=42 participants at risk
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
|
LDV/SOF 12 Weeks
n=79 participants at risk
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks
|
LDV/SOF + RBV 12 Weeks
n=91 participants at risk
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/43 • Up to 12 weeks + 30 days
|
4.8%
2/42 • Up to 12 weeks + 30 days
|
0.00%
0/79 • Up to 12 weeks + 30 days
|
7.7%
7/91 • Up to 12 weeks + 30 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/43 • Up to 12 weeks + 30 days
|
4.8%
2/42 • Up to 12 weeks + 30 days
|
0.00%
0/79 • Up to 12 weeks + 30 days
|
6.6%
6/91 • Up to 12 weeks + 30 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/43 • Up to 12 weeks + 30 days
|
7.1%
3/42 • Up to 12 weeks + 30 days
|
0.00%
0/79 • Up to 12 weeks + 30 days
|
3.3%
3/91 • Up to 12 weeks + 30 days
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
3/43 • Up to 12 weeks + 30 days
|
2.4%
1/42 • Up to 12 weeks + 30 days
|
6.3%
5/79 • Up to 12 weeks + 30 days
|
6.6%
6/91 • Up to 12 weeks + 30 days
|
|
General disorders
Fatigue
|
9.3%
4/43 • Up to 12 weeks + 30 days
|
11.9%
5/42 • Up to 12 weeks + 30 days
|
10.1%
8/79 • Up to 12 weeks + 30 days
|
15.4%
14/91 • Up to 12 weeks + 30 days
|
|
General disorders
Pyrexia
|
2.3%
1/43 • Up to 12 weeks + 30 days
|
2.4%
1/42 • Up to 12 weeks + 30 days
|
1.3%
1/79 • Up to 12 weeks + 30 days
|
5.5%
5/91 • Up to 12 weeks + 30 days
|
|
Infections and infestations
Bronchitis
|
7.0%
3/43 • Up to 12 weeks + 30 days
|
2.4%
1/42 • Up to 12 weeks + 30 days
|
3.8%
3/79 • Up to 12 weeks + 30 days
|
2.2%
2/91 • Up to 12 weeks + 30 days
|
|
Nervous system disorders
Headache
|
9.3%
4/43 • Up to 12 weeks + 30 days
|
31.0%
13/42 • Up to 12 weeks + 30 days
|
16.5%
13/79 • Up to 12 weeks + 30 days
|
22.0%
20/91 • Up to 12 weeks + 30 days
|
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