Trial Outcomes & Findings for A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (NCT NCT02170727)
NCT ID: NCT02170727
Last Updated: 2020-10-29
Results Overview
Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
199 participants
Primary outcome timeframe
Post treatment Week 12
Results posted on
2020-10-29
Participant Flow
Total of 169 subjects were treated; 138 treatment-naive and 31 treatment-experienced; 3 participants did not complete the treatment period (1 was lost to follow-up and 2 had withdrawn)
Participant milestones
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
138
|
31
|
|
Overall Study
COMPLETED
|
135
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Baseline characteristics by cohort
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 11.78 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 12.64 • n=7 Participants
|
52.2 years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
128 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Asia
|
128 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post treatment Week 12Population: Analysis population included enrolled participants who received at least 1 dose of study therapy. SVR12 was based on Next Value Carried Backwards approach. (Exact binomial confidence interval reported)
Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
|
98.6 Percentage of Participants
Interval 94.9 to 99.8
|
—
|
SECONDARY outcome
Timeframe: Post treatment Week 12Population: Analysis population included enrolled participants who received at least 1 dose of study therapy. SVR12 was based on Next Value Carried Backwards approach.
Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA \< LLOQ target detected or target not detected (LLOQ TD/TND).
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=31 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)Population: Included participants who received 1 dose of study therapy. SVR24 based on Observed Values approach. Participants with missing HCV RNA results at follow-up Week 24 were considered non-responders for SVR24. SVR12 is based on Next Value Carried Backwards approach and modified ITT (intent-to-treat) analysis.
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Week 1
|
44.2 Percentage of Participants
Interval 35.9 to 52.5
|
29.0 Percentage of Participants
Interval 14.2 to 48.0
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Week 2
|
87.7 Percentage of Participants
Interval 82.2 to 93.2
|
80.6 Percentage of Participants
Interval 62.5 to 92.5
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Week 4
|
99.3 Percentage of Participants
Interval 96.0 to 100.0
|
93.5 Percentage of Participants
Interval 78.6 to 99.2
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Week 6
|
100.0 Percentage of Participants
Interval 97.4 to 100.0
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Week 8
|
99.3 Percentage of Participants
Interval 96.0 to 100.0
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Week 12
|
100.0 Percentage of Participants
Interval 97.4 to 100.0
|
96.8 Percentage of Participants
Interval 83.3 to 99.9
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
End of Treatment
|
100.0 Percentage of Participants
Interval 97.4 to 100.0
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Follow-Up Week 4
|
97.8 Percentage of Participants
Interval 93.8 to 99.5
|
96.8 Percentage of Participants
Interval 83.3 to 99.9
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Follow-Up Week 8
|
98.6 Percentage of Participants
Interval 94.9 to 99.8
|
96.8 Percentage of Participants
Interval 83.3 to 99.9
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Follow-Up Week 24
|
96.4 Percentage of Participants
Interval 91.7 to 98.8
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
SECONDARY outcome
Timeframe: On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)Population: Included participants who received 1 dose of study therapy. SVR24 based on Observed Values approach. Participants with missing HCV RNA results at follow-up Week 24 were considered non-responders for SVR24. SVR12 is based on Next Value Carried Backwards approach and modified ITT (intent-to-treat) analysis.
Percentage of treated participants with HCV RNA \< LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Week 1
|
11.6 Percentage of Participants
Interval 6.3 to 16.9
|
0.0 Percentage of Participants
Interval 0.0 to 11.2
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Week 2
|
42.0 Percentage of Participants
Interval 33.8 to 50.3
|
25.8 Percentage of Participants
Interval 11.9 to 44.6
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Week 4
|
93.5 Percentage of Participants
Interval 89.4 to 97.6
|
90.3 Percentage of Participants
Interval 74.2 to 98.0
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Week 6
|
98.6 Percentage of Participants
Interval 94.9 to 99.8
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Week 8
|
99.3 Percentage of Participants
Interval 96.0 to 100.0
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Week 12
|
97.8 Percentage of Participants
Interval 93.8 to 99.5
|
96.8 Percentage of Participants
Interval 83.3 to 99.9
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
End of Treatment
|
97.8 Percentage of Participants
Interval 93.8 to 99.5
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Follow-Up Week 4
|
97.1 Percentage of Participants
Interval 92.7 to 99.2
|
96.8 Percentage of Participants
Interval 83.3 to 99.9
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Follow-Up Week 8
|
98.6 Percentage of Participants
Interval 94.9 to 99.8
|
96.8 Percentage of Participants
Interval 83.3 to 99.9
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Follow-Up Week 12
|
98.6 Percentage of Participants
Interval 94.9 to 99.8
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
|
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Follow-Up Week 24
|
96.4 Percentage of Participants
Interval 91.7 to 98.8
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
SECONDARY outcome
Timeframe: Up to post treatment week 4Population: Safety analysis population included participants who received at least 1 dose of study therapy.
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
Serious Adverse Events
|
2 Participants
|
0 Participants
|
|
Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
AEs Leading to Discontinuation
|
2 Participants
|
2 Participants
|
|
Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
Deaths
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to post treatment week 4Population: Analysis population included enrolled participants who received at least 1 dose of study therapy
Anemia was defined as hemoglobin \< 10 g/dL on-treatment for subjects who had hemoglobin \>= 10 g/dL at baseline.
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline
|
1.4 Percentage of Participants
Interval 0.0 to 3.4
|
0.0 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Post treatment week 12Population: It included enrolled participants who received at least 1 dose of study therapy. Here, N signifies number of participants evaluable for the outcome measure, 'n' signifies number of participants analysed for specific category. SVR12 is based on Next Value Carried Backwards approach
Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=136 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b
Genotype - 1a
|
88.9 Percentage of participants
Interval 51.8 to 99.7
|
100.0 Percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b
Genotype - 1b
|
100.0 Percentage of participants
Interval 97.2 to 100.0
|
100.0 Percentage of participants
Interval 88.1 to 100.0
|
SECONDARY outcome
Timeframe: Post treatment Week 12Population: It included enrolled participants who received at least 1 dose of study therapy. SVR12 is based on Next Value Carried Backwards approach
Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)
CC genotype
|
99.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)
Non-CC Genotype
|
97.4 Percentage of Participants
|
100.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Post treatment Week 12Population: It included enrolled participants who received at least 1 dose of study therapy. SVR12 is based on Next Value Carried Backwards approach.
Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12
Cirrhotic
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12
Noncirrhotic
|
98.4 Percentage of Participants
|
100.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Post treatment week 4Population: Safety analysis population included participants who received at least 1 dose of study therapy.
Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
|
16 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to post treatment week 4Population: Subgroup analysis set included participants who received at least 1 dose of study therapy.
Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=23 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=146 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs
Serious AEs
|
0 Participants
|
2 Participants
|
|
Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs
AEs leading to Discontinuation
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to post treatment week 4Population: Subgroup analysis set included participants who received at least 1 dose of study therapy.
Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.
Outcome measures
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=23 Participants
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=146 Participants
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Aspartate Aminotransferase
|
1 Participants
|
4 Participants
|
|
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Alanine Aminotransferase
|
1 Participants
|
6 Participants
|
|
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Lipase
|
2 Participants
|
2 Participants
|
|
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Lymphocytes
|
0 Participants
|
3 Participants
|
|
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Neutrophils
|
1 Participants
|
1 Participants
|
|
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Hemoglobin
|
0 Participants
|
1 Participants
|
|
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Platelets
|
1 Participants
|
0 Participants
|
|
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
International Normalized Ratio
|
1 Participants
|
0 Participants
|
|
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Serum Glucose
|
0 Participants
|
1 Participants
|
Adverse Events
Treatment-Naive: DCV/ASV/BMS-791325
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
Treatment-Experianced:
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 participants at risk
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 participants at risk
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.72%
1/138 • Number of events 1 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
0.00%
0/31 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.72%
1/138 • Number of events 1 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
0.00%
0/31 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Nervous system disorders
SYNCOPE
|
0.72%
1/138 • Number of events 1 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
0.00%
0/31 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
Other adverse events
| Measure |
Treatment-Naive: DCV/ASV/BMS-791325
n=138 participants at risk
Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
Treatment-Experianced:
n=31 participants at risk
Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
|
|---|---|---|
|
Nervous system disorders
HEADACHE
|
13.0%
18/138 • Number of events 19 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
12.9%
4/31 • Number of events 4 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Nervous system disorders
DIZZINESS
|
7.2%
10/138 • Number of events 11 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
3.2%
1/31 • Number of events 1 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Gastrointestinal disorders
DIARRHOEA
|
7.2%
10/138 • Number of events 10 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
6.5%
2/31 • Number of events 2 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.9%
4/138 • Number of events 4 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
6.5%
2/31 • Number of events 2 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.4%
2/138 • Number of events 2 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
6.5%
2/31 • Number of events 2 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.4%
13/138 • Number of events 14 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
9.7%
3/31 • Number of events 3 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
8.0%
11/138 • Number of events 11 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
12.9%
4/31 • Number of events 4 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.1%
7/138 • Number of events 7 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
6.5%
2/31 • Number of events 2 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.5%
9/138 • Number of events 10 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
9.7%
3/31 • Number of events 3 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
General disorders
FATIGUE
|
4.3%
6/138 • Number of events 6 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
12.9%
4/31 • Number of events 4 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.1%
7/138 • Number of events 9 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
3.2%
1/31 • Number of events 1 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.1%
7/138 • Number of events 7 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
3.2%
1/31 • Number of events 1 • Up to 12 Weeks within 30 days of discontinuation of dosing
|
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