Trial Outcomes & Findings for Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection (NCT NCT02472886)
NCT ID: NCT02472886
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
153 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2018-11-16
Participant Flow
Participants were enrolled at study sites in Russia and Estonia. The first participant was screened on 17 June 2015. The last study visit occurred on 30 June 2016.
169 participants were screened.
Participant milestones
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
Ledipasvir/sofosbuvir (LDV/SOF; Harvoni®) (90/400 mg) fixed dose combination (FDC) tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir (SOF) study
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
59
|
27
|
|
Overall Study
COMPLETED
|
67
|
57
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
Ledipasvir/sofosbuvir (LDV/SOF; Harvoni®) (90/400 mg) fixed dose combination (FDC) tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir (SOF) study
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
1
|
Baseline Characteristics
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
n=67 Participants
LDV/SOF(90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
n=59 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
n=27 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
34 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
47 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
40 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
66 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
61 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Region of Enrollment
Estonia
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
IL28b Status
CC
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
IL28b Status
CT
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
IL28b Status
TT
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
HCV RNA
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=5 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.54 • n=7 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.67 • n=5 Participants
|
6.0 log10 IU/mL
STANDARD_DEVIATION 0.66 • n=4 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Cirrhosis Status
No
|
67 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Cirrhosis Status
Yes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set (FAS) included participants who were 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) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
n=67 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
n=59 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
n=27 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
100.0 percentage of participants
Interval 94.6 to 100.0
|
96.6 percentage of participants
Interval 88.3 to 99.6
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
n=67 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
n=59 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
n=27 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)
|
0 percentage of participants
|
0 percentage of participants
|
0 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 |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
n=67 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
n=59 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
n=27 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
100.0 percentage of participants
Interval 94.6 to 100.0
|
96.6 percentage of participants
Interval 88.3 to 99.6
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
100.0 percentage of participants
Interval 94.6 to 100.0
|
96.6 percentage of participants
Interval 88.3 to 99.6
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
n=67 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
n=59 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
n=27 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 1
|
20.9 percentage of participants
Interval 11.9 to 32.6
|
39.0 percentage of participants
Interval 26.5 to 52.6
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 2
|
65.7 percentage of participants
Interval 53.1 to 76.8
|
69.5 percentage of participants
Interval 56.1 to 80.8
|
59.3 percentage of participants
Interval 38.8 to 77.6
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 4
|
100.0 percentage of participants
Interval 94.6 to 100.0
|
96.6 percentage of participants
Interval 88.3 to 99.6
|
88.9 percentage of participants
Interval 70.8 to 97.6
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 8
|
100.0 percentage of participants
Interval 94.6 to 100.0
|
98.3 percentage of participants
Interval 90.9 to 100.0
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
|
Percentage of Participants With HCV RNA < LLOQ on Treatment
Week 12
|
NA percentage of participants
Treatment for this group was 8 weeks only.
|
NA percentage of participants
Treatment for this group was 8 weeks only.
|
100.0 percentage of participants
Interval 87.2 to 100.0
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Participants in Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
n=67 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
n=59 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
n=27 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
|---|---|---|---|
|
HCV RNA Change From Day 1
Week 1
|
-3.97 log10 IU/mL
Standard Deviation 0.675
|
-4.34 log10 IU/mL
Standard Deviation 0.626
|
-4.12 log10 IU/mL
Standard Deviation 0.582
|
|
HCV RNA Change From Day 1
Week 2
|
-4.50 log10 IU/mL
Standard Deviation 0.687
|
-4.76 log10 IU/mL
Standard Deviation 0.522
|
-4.83 log10 IU/mL
Standard Deviation 0.630
|
|
HCV RNA Change From Day 1
Week 12
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was 8 weeks only.
|
NA log10 IU/mL
Standard Deviation NA
Treatment for this group was 8 weeks only.
|
-5.11 log10 IU/mL
Standard Deviation 0.671
|
|
HCV RNA Change From Day 1
Week 4
|
-4.74 log10 IU/mL
Standard Deviation 0.723
|
-4.89 log10 IU/mL
Standard Deviation 0.534
|
-5.08 log10 IU/mL
Standard Deviation 0.642
|
|
HCV RNA Change From Day 1
Week 8
|
-4.74 log10 IU/mL
Standard Deviation 0.723
|
-4.91 log10 IU/mL
Standard Deviation 0.536
|
-5.11 log10 IU/mL
Standard Deviation 0.671
|
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 Weeks (TN, HCV-monoinfected)
n=67 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
n=59 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
n=27 Participants
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
|---|---|---|---|
|
Percentage of Participants With Virologic Failure
|
0 percentage of participants
|
3.4 percentage of participants
|
3.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 4Population: Participants in the Safety Analysis Set (who had HIV RNA \< 50 Copies/mL at baseline) with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
n=45 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
|---|---|---|---|
|
Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
Week 4
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
Week 8
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
Posttreatment Week 4
|
97.2 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 4Population: Participant in the Safety analysis set (with or without prior antiretroviral (ARV) treatment) with available data were analyzed.
Outcome measures
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
n=44 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
n=9 Participants
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
|---|---|---|---|
|
For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4
Change at Week 4
|
47 cells/µL
Standard Deviation 120.5
|
159 cells/µL
Standard Deviation 114.9
|
—
|
|
For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4
Change at Week 8
|
45 cells/µL
Standard Deviation 122.7
|
202 cells/µL
Standard Deviation 178.1
|
—
|
|
For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4
Change at Posttreatment Week 4
|
74 cells/µL
Standard Deviation 117.8
|
172 cells/µL
Standard Deviation 114.1
|
—
|
Adverse Events
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LDV/SOF 8 Weeks (TN, HCV-monoinfected)
n=67 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
|
LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)
n=59 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
|
LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)
n=27 participants at risk
LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
1/67 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.7%
1/59 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/67 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/59 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
11.1%
3/27 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Asthenia
|
1.5%
1/67 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/59 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/67 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/59 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
6.0%
4/67 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/59 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
14.8%
4/27 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
0.00%
0/67 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
1.7%
1/59 • Up to 12 weeks plus 30 days
Safety Analysis Set
|
7.4%
2/27 • Up to 12 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