Trial Outcomes & Findings for Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus (NCT NCT01628692)
NCT ID: NCT01628692
Last Updated: 2017-02-23
Results Overview
SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be \<lower limit of quantitation, target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
230 participants
Primary outcome timeframe
Post Treatment Week 12 (Follow-up period)
Results posted on
2017-02-23
Participant Flow
The study was conducted at 25 centers in 6 countries.
Of the 230 participants enrolled, 168 received treatment.
Participant milestones
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
23
|
51
|
20
|
12
|
9
|
|
Overall Study
COMPLETED
|
46
|
17
|
43
|
19
|
8
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
8
|
1
|
4
|
9
|
Reasons for withdrawal
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
4
|
5
|
1
|
4
|
7
|
|
Overall Study
Adverse Event
|
2
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Poor compliance/noncompliance
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Administrative reason by sponsor
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Completed 12 Week only
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
Baseline characteristics by cohort
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
n=53 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
n=23 Participants
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=51 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
n=20 Participants
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=12 Participants
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
n=9 Participants
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<21 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
1 participants
n=31 Participants
|
0 participants
n=30 Participants
|
2 participants
n=3 Participants
|
|
Age, Customized
21-<65 years
|
41 participants
n=99 Participants
|
19 participants
n=107 Participants
|
42 participants
n=206 Participants
|
11 participants
n=7 Participants
|
11 participants
n=31 Participants
|
9 participants
n=30 Participants
|
133 participants
n=3 Participants
|
|
Age, Customized
>=65 years
|
12 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
8 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
33 participants
n=3 Participants
|
|
Gender
Female
|
31 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
86 Participants
n=3 Participants
|
|
Gender
Male
|
22 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
82 Participants
n=3 Participants
|
|
Hepatitis C Virus RNA Distribution
<800,000 IU/mL
|
12 participants
n=99 Participants
|
3 participants
n=107 Participants
|
11 participants
n=206 Participants
|
4 participants
n=7 Participants
|
5 participants
n=31 Participants
|
0 participants
n=30 Participants
|
35 participants
n=3 Participants
|
|
Hepatitis C Virus RNA Distribution
≥800,000 IU/mL
|
41 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
16 participants
n=7 Participants
|
7 participants
n=31 Participants
|
9 participants
n=30 Participants
|
133 participants
n=3 Participants
|
|
Randomization Stratum
Hepatitis C Virus Genotype 1b
|
53 participants
n=99 Participants
|
23 participants
n=107 Participants
|
51 participants
n=206 Participants
|
20 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
147 participants
n=3 Participants
|
|
Randomization Stratum
Hepatitis C Virus Genotype 1a
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
12 participants
n=31 Participants
|
9 participants
n=30 Participants
|
21 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Post Treatment Week 12 (Follow-up period)Population: All participants who were randomized and received at least 1 dose of active study therapy (daclatasvir, simeprevir, ribavirin).
SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be \<lower limit of quantitation, target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
n=53 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
n=23 Participants
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=51 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
n=20 Participants
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=12 Participants
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
n=9 Participants
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)
|
84.9 Percentage of participants
Interval 78.6 to 91.2
|
69.6 Percentage of participants
Interval 57.3 to 81.9
|
74.5 Percentage of participants
Interval 66.7 to 82.3
|
95 Percentage of participants
Interval 88.8 to 100.0
|
66.7 Percentage of participants
Interval 49.2 to 84.1
|
0 Percentage of participants
As none of the participants responded to SVR12, 80% confidence interval value is not available.
|
SECONDARY outcome
Timeframe: Week 4Population: All treated participants.
RVR was defined as hepatitis C virus (HCV) RNA levels to be \<lower limit of quantitation, target not detected at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
n=53 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
n=23 Participants
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=51 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
n=20 Participants
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=12 Participants
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
n=9 Participants
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
|
79.2 Percentage of participants
Interval 72.1 to 86.4
|
69.6 Percentage of participants
Interval 57.3 to 81.9
|
68.6 Percentage of participants
Interval 60.3 to 77.0
|
85 Percentage of participants
Interval 74.8 to 95.2
|
75 Percentage of participants
Interval 59.0 to 91.0
|
33.3 Percentage of participants
Interval 13.2 to 53.5
|
SECONDARY outcome
Timeframe: Week 12Population: All treated participants.
cEVR was defined as hepatitis C virus (HCV) RNA levels to be \<lower limit of quantitation, target not detected at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
n=53 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
n=23 Participants
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=51 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
n=20 Participants
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=12 Participants
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
n=9 Participants
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Early Virologic Response (cEVR)
|
84.9 Percentage of participants
Interval 78.6 to 91.2
|
73.9 Percentage of participants
Interval 62.2 to 85.6
|
82.4 Percentage of participants
Interval 75.5 to 89.2
|
90 Percentage of participants
Interval 81.4 to 98.6
|
66.7 Percentage of participants
Interval 49.2 to 84.1
|
11.1 Percentage of participants
Interval 0.0 to 24.5
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: All treated participants.
eRVR were defined as hepatitis C virus (HCV) RNA levels to be \<lower limit of quantitation, target not detected at both Week 4 and Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
n=53 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
n=23 Participants
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=51 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
n=20 Participants
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=12 Participants
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
n=9 Participants
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
|
71.7 Percentage of participants
Interval 63.8 to 79.6
|
60.9 Percentage of participants
Interval 47.8 to 73.9
|
62.7 Percentage of participants
Interval 54.1 to 71.4
|
75 Percentage of participants
Interval 62.6 to 87.4
|
58.3 Percentage of participants
Interval 40.1 to 76.6
|
11.1 Percentage of participants
Interval 0.0 to 24.5
|
SECONDARY outcome
Timeframe: End of treatment (Week 24)Population: All treated participants.
EOTR were defined as hepatitis C virus (HCV) RNA levels \<lower limit of quantitation, target not detected at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
n=53 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
n=23 Participants
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=51 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
n=20 Participants
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=12 Participants
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
n=9 Participants
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With End of Treatment Response (EOTR)
|
88.7 Percentage of participants
Interval 83.1 to 94.3
|
78.3 Percentage of participants
Interval 67.2 to 89.3
|
78.4 Percentage of participants
Interval 71.1 to 85.8
|
95 Percentage of participants
Interval 88.8 to 100.0
|
66.7 Percentage of participants
Interval 49.2 to 84.1
|
0 Percentage of participants
As none of the participants responded at EOT, hence 80% confidence interval value is not available.
|
SECONDARY outcome
Timeframe: Baseline, post-treatment Week 12 (Follow-up period)Population: All treated participants. Here 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
n=53 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
n=23 Participants
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=51 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
n=20 Participants
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=12 Participants
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
n=9 Participants
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories
IL28B Genotype CC type (n= 16,1,13,1,3,0)
|
87.5 Percentage of participants
|
100 Percentage of participants
|
84.6 Percentage of participants
|
100 Percentage of participants
|
66.7 Percentage of participants
|
NA Percentage of participants
As no participant was evaluable for assessment, hence value is not available.
|
|
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories
IL28B Genotype CT type (n= 22,15, 28,10,9,8)
|
95.5 Percentage of participants
|
60 Percentage of participants
|
82.1 Percentage of participants
|
90 Percentage of participants
|
66.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories
IL28B Genotype TT type (n= 12,6,10,7,0,1)
|
66.7 Percentage of participants
|
83.3 Percentage of participants
|
40 Percentage of participants
|
100 Percentage of participants
|
NA Percentage of participants
No participants were available for assessment
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)Population: All treated participants.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Outcome measures
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive)
n=76 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype 1b: Daclatasvir + Simeprevir (Null)
n=71 Participants
Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)
n=21 Participants
Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)
Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)
Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)
Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died
SAEs
|
7 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died
AEs Leading to Discontinuation
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died
Death
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)
Serious events: 7 serious events
Other events: 49 other events
Deaths: 0 deaths
Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)
Serious events: 3 serious events
Other events: 63 other events
Deaths: 0 deaths
Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)
n=76 participants at risk
Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)
n=71 participants at risk
Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)
n=21 participants at risk
Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Intracranial haematoma
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Nervous system disorders
Hypoaesthesia
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Nervous system disorders
Ischaemic stroke
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Nervous system disorders
Neurotoxicity
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Infections and infestations
Pneumonia
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Psychiatric disorders
Depression
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
4.8%
1/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
Other adverse events
| Measure |
Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)
n=76 participants at risk
Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
|
Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)
n=71 participants at risk
Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
|
Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)
n=21 participants at risk
Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \<75/\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
4/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
16.9%
12/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
4.8%
1/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.6%
5/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
7.0%
5/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
19.0%
4/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Vascular disorders
Hot flush
|
0.00%
0/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
General disorders
Irritability
|
3.9%
3/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Psychiatric disorders
Sleep disorder
|
6.6%
5/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
7.0%
5/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
14.3%
3/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
4/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
2.8%
2/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
23.8%
5/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
General disorders
Fatigue
|
7.9%
6/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
15.5%
11/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
33.3%
7/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
16.9%
12/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
14.3%
3/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Psychiatric disorders
Insomnia
|
5.3%
4/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.9%
7/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
4.8%
1/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Nausea
|
18.4%
14/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
15.5%
11/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
19.0%
4/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.9%
3/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
5.6%
4/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
4/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
15.5%
11/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
2.8%
2/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.6%
5/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
21.1%
15/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
23.8%
5/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
2/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.9%
7/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
19.0%
4/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.9%
3/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
19.0%
4/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
2/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
7.0%
5/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.9%
3/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
5.6%
4/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.9%
3/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Infections and infestations
Nasopharyngitis
|
13.2%
10/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
12.7%
9/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
General disorders
Asthenia
|
19.7%
15/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
22.5%
16/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
23.8%
5/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Eye disorders
Dry eye
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Nervous system disorders
Headache
|
21.1%
16/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
14.1%
10/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
28.6%
6/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Vascular disorders
Hypertension
|
6.6%
5/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
2.8%
2/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
4.8%
1/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Nervous system disorders
Disturbance in attention
|
2.6%
2/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
General disorders
Influenza like illness
|
6.6%
5/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
14.3%
3/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Hepatobiliary disorders
Jaundice
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
5.6%
4/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
7.9%
6/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
4.2%
3/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
4.8%
1/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.9%
3/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
12.7%
9/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
14.3%
3/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.9%
3/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
7.0%
5/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
General disorders
Chills
|
1.3%
1/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
2.8%
2/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Constipation
|
7.9%
6/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
7.0%
5/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
19.0%
4/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
General disorders
Pain
|
3.9%
3/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
1.4%
1/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Nervous system disorders
Paraesthesia
|
2.6%
2/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
2.8%
2/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
14.3%
3/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
4/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
0.00%
0/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
4.8%
1/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
5/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
2.8%
2/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/76 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
4.2%
3/71 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
9.5%
2/21 • From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)
On-Treatment Period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER