Trial Outcomes & Findings for Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study (NCT NCT01987453)
NCT ID: NCT01987453
Last Updated: 2018-11-19
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Post-treatment Week 12
Results posted on
2018-11-19
Participant Flow
Participants were enrolled at study sites in the US, Australia, and Spain. The first participant was screened on 30 July 2014. The last study visit occurred on 12 November 2015.
101 participants were screened.
Participant milestones
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks (Group 2)
Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Weeks (Group 3)
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
41
|
8
|
|
Overall Study
COMPLETED
|
50
|
29
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
12
|
1
|
Reasons for withdrawal
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks (Group 2)
Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Weeks (Group 3)
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
12
|
0
|
Baseline Characteristics
Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Baseline characteristics by cohort
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
n=51 Participants
Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks (Group 2)
n=41 Participants
Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Weeks (Group 3)
n=8 Participants
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 Years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
58 Years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
61 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
57 Years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
41 participants
n=7 Participants
|
4 participants
n=5 Participants
|
96 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Prior HCV Treatment Experience
SOF+PEG+RBV
|
25 Particiapants
n=5 Participants
|
0 Particiapants
n=7 Participants
|
0 Particiapants
n=5 Participants
|
25 Particiapants
n=4 Participants
|
|
Prior HCV Treatment Experience
SOF+RBV
|
20 Particiapants
n=5 Participants
|
0 Particiapants
n=7 Participants
|
8 Particiapants
n=5 Participants
|
28 Particiapants
n=4 Participants
|
|
Prior HCV Treatment Experience
LDV/SOF
|
0 Particiapants
n=5 Participants
|
18 Particiapants
n=7 Participants
|
0 Particiapants
n=5 Participants
|
18 Particiapants
n=4 Participants
|
|
Prior HCV Treatment Experience
LDV/SOF+RBV
|
0 Particiapants
n=5 Participants
|
15 Particiapants
n=7 Participants
|
0 Particiapants
n=5 Participants
|
15 Particiapants
n=4 Participants
|
|
Prior HCV Treatment Experience
LDV/SOF+GS-9669
|
0 Particiapants
n=5 Participants
|
8 Particiapants
n=7 Participants
|
0 Particiapants
n=5 Participants
|
8 Particiapants
n=4 Participants
|
|
Prior HCV Treatment Experience
Without SOF
|
6 Particiapants
n=5 Participants
|
0 Particiapants
n=7 Participants
|
0 Particiapants
n=5 Participants
|
6 Particiapants
n=4 Participants
|
|
IL28B
CC
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
IL28B
CT
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
IL28B
TT
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
HCV RNA
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.58 • n=5 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.62 • n=7 Participants
|
5.6 log10 IU/mL
STANDARD_DEVIATION 0.44 • n=5 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.61 • n=4 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
HCV RNA Category
>= 800,000 IU/mL
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Post-treatment Week 12Population: Full Analysis Set: participants 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 treatment.
Outcome measures
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
n=51 Participants
Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks (Group 2)
n=41 Participants
Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Weeks (Group 3)
n=8 Participants
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
98.0 Percentage of participants
|
70.7 Percentage of participants
|
100.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 WeeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
n=51 Participants
Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks (Group 2)
n=41 Participants
Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Weeks (Group 3)
n=8 Participants
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
5.9 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 treatment, respectively.
Outcome measures
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
n=51 Participants
Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks (Group 2)
n=41 Participants
Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Weeks (Group 3)
n=8 Participants
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
98.0 Percentage of participants
|
70.7 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
98.0 Percentage of participants
|
73.2 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
n=51 Participants
Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks (Group 2)
n=41 Participants
Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Weeks (Group 3)
n=8 Participants
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 1
|
23.5 Percentage of participants
|
31.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 24
|
NA Percentage of participants
Treatment for this group was 12 weeks only.
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 4
|
98.0 Percentage of participants
|
95.1 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 8
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 12
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 16
|
NA Percentage of participants
Treatment for this group was 12 weeks only.
|
97.6 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ While on Treatment
Week 20
|
NA Percentage of participants
Treatment for this group was 12 weeks only.
|
97.6 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Full Analysis Set
Outcome measures
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
n=51 Participants
Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks (Group 2)
n=41 Participants
Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Weeks (Group 3)
n=8 Participants
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Change in HCV RNA From Baseline
Week 1
|
-4.47 log10 IU/mL
Standard Deviation 0.500
|
-4.40 log10 IU/mL
Standard Deviation 0.535
|
-3.75 log10 IU/mL
Standard Deviation 0.878
|
|
Change in HCV RNA From Baseline
Week 4
|
-5.07 log10 IU/mL
Standard Deviation 0.565
|
-5.06 log10 IU/mL
Standard Deviation 0.600
|
-4.47 log10 IU/mL
Standard Deviation 0.441
|
|
Change in HCV RNA From Baseline
Week 8
|
-5.09 log10 IU/mL
Standard Deviation 0.583
|
-5.08 log10 IU/mL
Standard Deviation 0.617
|
-4.47 log10 IU/mL
Standard Deviation 0.441
|
SECONDARY outcome
Timeframe: Up to posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit confirmed with 2 consecutive values or last available posttreatment measurement
Outcome measures
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
n=51 Participants
Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Weeks (Group 2)
n=41 Participants
Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Weeks (Group 3)
n=8 Participants
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Percentage of Participants With Virologic Failure
Relapse
|
2.0 Percentage of participants
|
27.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Virologic Failure
On treatment Virologic Failure
|
0 Percentage of participants
|
2.4 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
LDV/SOF + RBV 12 Weeks (Group 1)
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
LDV/SOF 24 Week (Group 2)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
LDV/SOF + RBV 24 Week (Group 3)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
n=51 participants at risk
Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Week (Group 2)
n=41 participants at risk
Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Week (Group 3)
n=8 participants at risk
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Chest pain
|
2.0%
1/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Anal abscess
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Cholecystitis infective
|
2.0%
1/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Bipolar disorder
|
2.0%
1/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
LDV/SOF + RBV 12 Weeks (Group 1)
n=51 participants at risk
Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
|
LDV/SOF 24 Week (Group 2)
n=41 participants at risk
Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
|
LDV/SOF + RBV 24 Week (Group 3)
n=8 participants at risk
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Constipation
|
7.8%
4/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
7/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
9.8%
5/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
3/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
25.5%
13/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
9.8%
4/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
37.5%
3/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Oedema
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Oedema peripheral
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Pyrexia
|
2.0%
1/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Anal abscess
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
5.9%
3/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Sinusitis
|
5.9%
3/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Viral infection
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Investigations
Haemoglobin decreased
|
3.9%
2/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
3/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
21.6%
11/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
14.6%
6/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Depression
|
5.9%
3/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
11.8%
6/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.3%
3/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
25.0%
2/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Irritability
|
5.9%
3/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
4.9%
2/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
3/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
6/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
2.4%
1/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/8 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/51 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/41 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
12.5%
1/8 • 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