Trial Outcomes & Findings for An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease (NCT NCT02262728)
NCT ID: NCT02262728
Last Updated: 2025-02-04
Results Overview
Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable at 12 weeks after the end of study drug treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Week 24
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Panel 1 SMV 150mg/DCV 60mg/SOF 400mg
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeters of mercury \[mm Hg\]) received simeprevir (150 milligram \[mg\] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
Panel 2 SMV 150mg/DCV 60mg/SOF 400mg
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (150 mg capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Treatment Period (12 Weeks)
STARTED
|
19
|
21
|
|
Treatment Period (12 Weeks)
COMPLETED
|
19
|
21
|
|
Treatment Period (12 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Follow-up Phase (3 Years)
STARTED
|
19
|
21
|
|
Follow-up Phase (3 Years)
COMPLETED
|
15
|
18
|
|
Follow-up Phase (3 Years)
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Panel 1 SMV 150mg/DCV 60mg/SOF 400mg
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeters of mercury \[mm Hg\]) received simeprevir (150 milligram \[mg\] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
Panel 2 SMV 150mg/DCV 60mg/SOF 400mg
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (150 mg capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Follow-up Phase (3 Years)
Death
|
0
|
1
|
|
Follow-up Phase (3 Years)
Lost to Follow-up
|
4
|
1
|
|
Follow-up Phase (3 Years)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
Baseline characteristics by cohort
| Measure |
Panel 1 SMV 150mg/DCV 60mg/SOF 400mg
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeters of mercury \[mm Hg\]) received simeprevir (150 milligram \[mg\] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
Panel 2 SMV 150mg/DCV 60mg/SOF 400mg
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (150 mg capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=99 Participants
|
61 years
n=107 Participants
|
58.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.
Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable at 12 weeks after the end of study drug treatment.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)
|
100 Percentage of Participants
Interval 82.4 to 100.0
|
100 Percentage of Participants
Interval 83.9 to 100.0
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 10, 12Population: The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.
On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point: \<LLOQ undetectable, \<LLOQ detectable, and \<LLOQ undetectable or detectable. The LLOQ value was 15 IU/mL. Very rapid virologic response (vRVR) is undetectable HCV RNA at Week 2 while on treatment and Rapid virologic response (RVR) is undetectable HCV RNA at Week 4 while on treatment.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With On-Treatment Virologic Response
Week 1: < 15 IU/mL undetect/detectable
|
27.8 Percentage of Participants
|
23.8 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 8 : < 15 IU/mL undetectable
|
100.0 Percentage of Participants
|
95.2 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 10 : < 15 IU/mL undetectable
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 12 : >= 15 IU/mL
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 12: < 15 IU/mL undetect/detectable
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 6: < 15 IU/mL undetect/detectable
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 6 : < 15 IU/mL detectable
|
5.3 Percentage of Participants
|
20.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 6 : < 15 IU/mL undetectable
|
94.7 Percentage of Participants
|
80.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 8 : >= 15 IU/mL
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 8 : < 100 IU/mL
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 8: < 15 IU/mL undetect/detectable
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 8 : < 15 IU/mL detectable
|
0 Percentage of Participants
|
4.8 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 10 : >= 15 IU/mL
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 10 : < 100 IU/mL
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 10: < 15 IU/mL undetect/detectable
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 10 : < 15 IU/mL detectable
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 12 :< 100 IU/mL
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 12 : < 15 IU/mL detectable
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 12 : < 15 IU/mL undetectable
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 1 : >= 15 IU/mL
|
72.2 Percentage of Participants
|
76.2 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 1 : < 100 IU/mL
|
61.1 Percentage of Participants
|
38.1 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 1 : < 15 IU/mL detectable
|
11.1 Percentage of Participants
|
19.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 1 : < 15 IU/mL Undetectable
|
16.7 Percentage of Participants
|
4.8 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 2 : >= 15 IU/mL
|
10.5 Percentage of Participants
|
47.6 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 2 : < 100 IU/mL
|
94.7 Percentage of Participants
|
71.4 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 2: < 15 IU/mL undetect/detectable
|
89.5 Percentage of Participants
|
52.4 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 2 : < 15 IU/mL detectable
|
36.8 Percentage of Participants
|
19.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 2: < 15 IU/mL undetectable (vRVR)
|
52.6 Percentage of Participants
|
33.3 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 4 : >= 15 IU/mL
|
0 Percentage of Participants
|
9.5 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 4 : < 100 IU/mL
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 4: < 15 IU/mL undetect/detectable
|
100.0 Percentage of Participants
|
90.5 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 4 : < 15 IU/mL detectable
|
5.6 Percentage of Participants
|
28.6 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 4 : < 15 IU/mL undetectable (RVR)
|
94.4 Percentage of Participants
|
61.9 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 6 : >= 15 IU/mL
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With On-Treatment Virologic Response
Week 6 : < 100 IU/mL
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16 and Week 36Population: The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here , 'n' signifies number of participants evaluable for this outcome measure at specific time point.
Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was \<LLOQ detectable or undetectable at 4 weeks and 24 weeks respectively after the end of study drug treatment. The LLOQ value was 15 IU/mL.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)
SVR 4
|
100 Percentage of Participants
Interval 82.4 to 100.0
|
100 Percentage of Participants
Interval 83.9 to 100.0
|
|
Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)
SVR 24
|
100 Percentage of Participants
Interval 82.4 to 100.0
|
100 Percentage of Participants
95% Confidence Interval was not calculated since less than 10 participants were evaluable for the specific arm group.
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Week 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and Year 1, 1.5, 2, 2.5, 3 after end of treatmentPopulation: The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint analysis was zero.
Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. All participants in this study achieved SVR12. Therefore, reasons for not achieving SVR12 are not applicable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Follow-up Week 24 (Week 36)Population: The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)
Follow-Up Week 24 : ALT
|
34.8 Units per Liter (U/L)
Standard Deviation 11.30
|
32.3 Units per Liter (U/L)
Standard Deviation 9.75
|
|
Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)
Baseline : ALT
|
137.8 Units per Liter (U/L)
Standard Deviation 101.90
|
60.9 Units per Liter (U/L)
Standard Deviation 29.52
|
|
Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)
Baseline : AST
|
119.1 Units per Liter (U/L)
Standard Deviation 80.57
|
83.5 Units per Liter (U/L)
Standard Deviation 35.68
|
|
Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)
Follow-Up Week 24 : AST
|
39.2 Units per Liter (U/L)
Standard Deviation 21.86
|
35.0 Units per Liter (U/L)
Standard Deviation 10.31
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8Population: Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.
Tmax is the time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir: Week 2
|
6.00 Hours
Interval 4.0 to 12.0
|
8.00 Hours
Interval 2.0 to 24.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir: Week 8
|
6.00 Hours
Interval 3.0 to 12.0
|
8.00 Hours
Interval 0.5 to 24.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir: Week 2
|
3.00 Hours
Interval 0.5 to 6.0
|
4.00 Hours
Interval 1.0 to 8.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir: Week 8
|
2.50 Hours
Interval 0.0 to 8.0
|
4.00 Hours
Interval 0.0 to 12.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir: Week 2
|
1.00 Hours
Interval 0.5 to 4.0
|
2.00 Hours
Interval 0.5 to 4.08
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir: Week 8
|
1.75 Hours
Interval 0.5 to 12.0
|
2.00 Hours
Interval 1.0 to 6.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007: Week 2
|
4.00 Hours
Interval 1.5 to 4.17
|
4.00 Hours
Interval 1.5 to 8.0
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007: Week 8
|
4.00 Hours
Interval 2.0 to 12.0
|
4.00 Hours
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8Population: Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.
The AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after dosing.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir : Week 2
|
113835 ng.h/mL
Standard Deviation 91598
|
142162 ng.h/mL
Standard Deviation 80217
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir : Week 8
|
98568 ng.h/mL
Standard Deviation 80037
|
207221 ng.h/mL
Standard Deviation 162168
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir : Week 2
|
16487 ng.h/mL
Standard Deviation 6323
|
17858 ng.h/mL
Standard Deviation 7726
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir : Week 8
|
15574 ng.h/mL
Standard Deviation 5347
|
20787 ng.h/mL
Standard Deviation 10741
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir : Week 2
|
2870 ng.h/mL
Standard Deviation 978
|
3915 ng.h/mL
Standard Deviation 1258
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir : Week 8
|
2746 ng.h/mL
Standard Deviation 963
|
3933 ng.h/mL
Standard Deviation 1315
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007 : Week 2
|
17900 ng.h/mL
Standard Deviation 6320
|
21118 ng.h/mL
Standard Deviation 11301
|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007 : Week 8
|
18132 ng.h/mL
Standard Deviation 7469
|
22829 ng.h/mL
Standard Deviation 15394
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8Population: Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.
The Cmax is the maximum observed plasma concentration.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir : Week 2 (reference)
|
6976 nanogram per milliliter (ng/mL)
Standard Deviation 4439
|
7726 nanogram per milliliter (ng/mL)
Standard Deviation 3946
|
|
Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir : Week 8 (test)
|
6029 nanogram per milliliter (ng/mL)
Standard Deviation 3936
|
10498 nanogram per milliliter (ng/mL)
Standard Deviation 7492
|
|
Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir : Week 2
|
1187 nanogram per milliliter (ng/mL)
Standard Deviation 397
|
1145 nanogram per milliliter (ng/mL)
Standard Deviation 440
|
|
Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir : Week 8
|
1072 nanogram per milliliter (ng/mL)
Standard Deviation 313
|
1210 nanogram per milliliter (ng/mL)
Standard Deviation 543
|
|
Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir : Week 2
|
1571 nanogram per milliliter (ng/mL)
Standard Deviation 738
|
1615 nanogram per milliliter (ng/mL)
Standard Deviation 986
|
|
Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir : Week 8
|
1276 nanogram per milliliter (ng/mL)
Standard Deviation 856
|
1527 nanogram per milliliter (ng/mL)
Standard Deviation 993
|
|
Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007 : Week 2
|
1403 nanogram per milliliter (ng/mL)
Standard Deviation 369
|
1561 nanogram per milliliter (ng/mL)
Standard Deviation 720
|
|
Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007 : Week 8
|
1404 nanogram per milliliter (ng/mL)
Standard Deviation 361
|
1594 nanogram per milliliter (ng/mL)
Standard Deviation 952
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8Population: PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.
The Cmin is the minimum observed plasma concentration.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir : Week 2
|
3133 ng/mL
Standard Deviation 3410
|
4363 ng/mL
Standard Deviation 3081
|
|
Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir : Week 8
|
2639 ng/mL
Standard Deviation 2725
|
6955 ng/mL
Standard Deviation 6035
|
|
Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir : Week 2
|
414 ng/mL
Standard Deviation 230
|
519 ng/mL
Standard Deviation 275
|
|
Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir : Week 8
|
442 ng/mL
Standard Deviation 192
|
660 ng/mL
Standard Deviation 416
|
|
Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir : Week 2
|
NA ng/mL
Standard Deviation NA
Data was not reported as participants had concentration below the limit of quantification (less than \[\<\]5.00 nanogram/millilter \[ng/mL\])
|
NA ng/mL
Standard Deviation NA
Data was not reported as participants had concentration below the limit of quantification (less than \[\<\]5.00 nanogram/millilter \[ng/mL\])
|
|
Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir : Week 8
|
NA ng/mL
Standard Deviation NA
Data was not reported as participants had concentration below the limit of quantification (less than \[\<\]5.00 nanogram/millilter \[ng/mL\])
|
NA ng/mL
Standard Deviation NA
Data was not reported as participants had concentration below the limit of quantification (less than \[\<\]5.00 nanogram/milliliter\[ng/mL\])
|
|
Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007 : Week 2
|
419 ng/mL
Standard Deviation 198
|
441 ng/mL
Standard Deviation 254
|
|
Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007 : Week 8
|
443 ng/mL
Standard Deviation 213
|
523 ng/mL
Standard Deviation 392
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8Population: PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.
The C0h is the pre-dose plasma concentration.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir : Week 2
|
3577 nanogram/milliliter (ng/mL)
Standard Deviation 3685
|
5218 nanogram/milliliter (ng/mL)
Standard Deviation 3461
|
|
Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Simeprevir : Week 8
|
3160 nanogram/milliliter (ng/mL)
Standard Deviation 3725
|
8577 nanogram/milliliter (ng/mL)
Standard Deviation 7398
|
|
Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir : Week 2
|
494 nanogram/milliliter (ng/mL)
Standard Deviation 279
|
646 nanogram/milliliter (ng/mL)
Standard Deviation 384
|
|
Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Daclatasvir : Week 8
|
492 nanogram/milliliter (ng/mL)
Standard Deviation 232
|
824 nanogram/milliliter (ng/mL)
Standard Deviation 476
|
|
Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir : Week 2
|
NA nanogram/milliliter (ng/mL)
Standard Deviation NA
Data was not reported as participants had concentration below the limit of quantification (less than \[\<\]5.00 nanogram/millilter \[ng/mL\])
|
NA nanogram/milliliter (ng/mL)
Standard Deviation NA
Data was not reported as participants had concentration below the limit of quantification (less than \[\<\]5.00 nanogram/millilter \[ng/mL\])
|
|
Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
Sofosbuvir : Week 8
|
NA nanogram/milliliter (ng/mL)
Standard Deviation NA
Data was not reported as participants had concentration below the limit of quantification (less than \[\<\]5.00 nanogram/millilter \[ng/mL\])
|
NA nanogram/milliliter (ng/mL)
Standard Deviation NA
Data was not reported as participants had concentration below the limit of quantification (less than \[\<\]5.00 nanogram/millilter \[ng/mL\])
|
|
Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007 : Week 2
|
484 nanogram/milliliter (ng/mL)
Standard Deviation 236
|
490 nanogram/milliliter (ng/mL)
Standard Deviation 282
|
|
Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)
GS-331007 : Week 8
|
478 nanogram/milliliter (ng/mL)
Standard Deviation 262
|
572 nanogram/milliliter (ng/mL)
Standard Deviation 450
|
SECONDARY outcome
Timeframe: Week 12Population: The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With On-treatment Failure
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 16, 24 and 36Population: The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint (viral relapse) analysis was zero.
Viral relapse is defined as participants who do not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (\>=) LLOQ (15 IU/mL) at Week 16, 24 or 36.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24 post treatment until the end of 3-year follow-upPopulation: The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.
Percentage of participants with SVR12 who maintained to have HCV RNA \<LLOQ (15 IU/mL) until the end of 3 years follow up were reported.
Outcome measures
| Measure |
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A
n=19 Participants
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeter of mercury \[mm Hg\]) received simeprevir (SMV) (150 milligram \[mg\] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B
n=21 Participants
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With SVR12 Who Maintained to Have HCV RNA <LLOQ Until the End of 3 Years Follow up
|
78.9 Percentage of participants
|
85.7 Percentage of participants
|
Adverse Events
Panel 1 SMV 150mg/DCV 60mg/SOF 400mg
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Panel 2 SMV 150mg/DCV 60mg/SOF 400mg
Serious events: 10 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panel 1 SMV 150mg/DCV 60mg/SOF 400mg
n=19 participants at risk
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeters of mercury \[mm Hg\]) received simeprevir (150 milligram \[mg\] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
Panel 2 SMV 150mg/DCV 60mg/SOF 400mg
n=21 participants at risk
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (150 mg capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/19
|
4.8%
1/21
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.00%
0/19
|
4.8%
1/21
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/19
|
9.5%
2/21
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/19
|
4.8%
1/21
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/19
|
9.5%
2/21
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.00%
0/19
|
4.8%
1/21
|
|
General disorders
Death
|
0.00%
0/19
|
4.8%
1/21
|
|
Hepatobiliary disorders
Biliary Dyskinesia
|
0.00%
0/19
|
4.8%
1/21
|
|
Hepatobiliary disorders
Hepatic Lesion
|
5.3%
1/19
|
4.8%
1/21
|
|
Infections and infestations
Appendicitis
|
0.00%
0/19
|
4.8%
1/21
|
|
Infections and infestations
Diverticulitis
|
5.3%
1/19
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/19
|
4.8%
1/21
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumour
|
5.3%
1/19
|
0.00%
0/21
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
|
0.00%
0/19
|
19.0%
4/21
|
|
Nervous system disorders
Cerebrovascular Accident
|
5.3%
1/19
|
0.00%
0/21
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/19
|
4.8%
1/21
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.00%
0/19
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
5.3%
1/19
|
0.00%
0/21
|
Other adverse events
| Measure |
Panel 1 SMV 150mg/DCV 60mg/SOF 400mg
n=19 participants at risk
Participants with Child-Pugh score \<7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient \[HVPG\] greater than or equal to 10 millimeters of mercury \[mm Hg\]) received simeprevir (150 milligram \[mg\] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
Panel 2 SMV 150mg/DCV 60mg/SOF 400mg
n=21 participants at risk
Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (150 mg capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19
|
4.8%
1/21
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.3%
1/19
|
0.00%
0/21
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19
|
9.5%
2/21
|
|
Gastrointestinal disorders
Umbilical hernia
|
5.3%
1/19
|
0.00%
0/21
|
|
Infections and infestations
Staphylococcal infection
|
5.3%
1/19
|
0.00%
0/21
|
|
Infections and infestations
Tooth infection
|
5.3%
1/19
|
0.00%
0/21
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19
|
9.5%
2/21
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.3%
1/19
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Patella fracture
|
5.3%
1/19
|
0.00%
0/21
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/19
|
9.5%
2/21
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19
|
0.00%
0/21
|
|
Nervous system disorders
Headache
|
10.5%
2/19
|
0.00%
0/21
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/19
|
9.5%
2/21
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19
|
9.5%
2/21
|
|
Psychiatric disorders
Irritability
|
5.3%
1/19
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
10.5%
2/19
|
4.8%
1/21
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19
|
9.5%
2/21
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
5.3%
1/19
|
0.00%
0/21
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.3%
1/19
|
4.8%
1/21
|
|
Gastrointestinal disorders
Gingival Bleeding
|
5.3%
1/19
|
0.00%
0/21
|
|
Gastrointestinal disorders
Stomatitis
|
5.3%
1/19
|
0.00%
0/21
|
|
Gastrointestinal disorders
Umbilical Hernia
|
5.3%
1/19
|
0.00%
0/21
|
|
General disorders
Influenza Like Illness
|
5.3%
1/19
|
4.8%
1/21
|
|
General disorders
Oedema Peripheral
|
0.00%
0/19
|
9.5%
2/21
|
|
Infections and infestations
Diverticulitis
|
5.3%
1/19
|
0.00%
0/21
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19
|
4.8%
1/21
|
|
Infections and infestations
Sepsis
|
5.3%
1/19
|
0.00%
0/21
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19
|
0.00%
0/21
|
|
Infections and infestations
Staphylococcal Infection
|
5.3%
1/19
|
0.00%
0/21
|
|
Infections and infestations
Tooth Infection
|
5.3%
1/19
|
0.00%
0/21
|
|
Infections and infestations
Urinary Tract Infection
|
10.5%
2/19
|
14.3%
3/21
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
5.3%
1/19
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
5.3%
1/19
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
1/19
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.3%
1/19
|
0.00%
0/21
|
|
Nervous system disorders
Hepatic Encephalopathy
|
5.3%
1/19
|
19.0%
4/21
|
|
Nervous system disorders
Restless Legs Syndrome
|
5.3%
1/19
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
10.5%
2/19
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
5.3%
1/19
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
5.3%
1/19
|
0.00%
0/21
|
|
Vascular disorders
Hypertension
|
5.3%
1/19
|
4.8%
1/21
|
Additional Information
Medical Leader Hepatitis C, GCO ED&CP
Janssen Research & Development, a division of Janssen Pharmaceutica NV
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER