Trial Outcomes & Findings for Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C (NCT NCT01448044)
NCT ID: NCT01448044
Last Updated: 2015-10-12
Results Overview
Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels \< lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
152 participants
Primary outcome timeframe
Week 12 (Follow-up period)
Results posted on
2015-10-12
Participant Flow
A total of 152 participants were enrolled in the study, of which 125 were randomized and 27 participants were not randomized due to 23 no longer met criteria, 1 withdrew consent, 1 due to administrative reason, and 2 other reasons. Of 125 randomized, 124 were treated and 1 was not treated due to withdrawal of consent.
Participant milestones
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
|---|---|---|
|
Treatment Period
STARTED
|
82
|
42
|
|
Treatment Period
COMPLETED
|
59
|
26
|
|
Treatment Period
NOT COMPLETED
|
23
|
16
|
|
Follow Up Period
STARTED
|
77
|
40
|
|
Follow Up Period
COMPLETED
|
65
|
26
|
|
Follow Up Period
NOT COMPLETED
|
12
|
14
|
Reasons for withdrawal
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
|---|---|---|
|
Treatment Period
Adverse Event
|
4
|
3
|
|
Treatment Period
Lack of Efficacy
|
5
|
12
|
|
Treatment Period
Subject requested discontinue study drug
|
1
|
0
|
|
Treatment Period
Completed 24 weeks treatment period only
|
8
|
0
|
|
Treatment Period
Participant does not meet study criteria
|
1
|
0
|
|
Treatment Period
Lost to Follow-up
|
2
|
1
|
|
Treatment Period
Other reason
|
2
|
0
|
|
Follow Up Period
Withdrawal by Subject
|
1
|
1
|
|
Follow Up Period
Lost to Follow-up
|
6
|
2
|
|
Follow Up Period
Other
|
5
|
11
|
Baseline Characteristics
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
Baseline characteristics by cohort
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
n=82 Participants
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
n=42 Participants
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 8.09 • n=7 Participants
|
48.0 years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
|
Age, Customized
< 21 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
21 to < 65 years
|
78 participants
n=5 Participants
|
42 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 (Follow-up period)Population: The analysis was performed in modified Intent to treat population (ITT), defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. Missing values were imputed using backward imputation technique.
Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels \< lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.
Outcome measures
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
n=82 Participants
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
n=42 Participants
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)
|
81.7 Percentage of participants
Interval 73.3 to 90.1
|
42.9 Percentage of participants
Interval 27.9 to 57.8
|
SECONDARY outcome
Timeframe: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48Population: The analysis was performed in modified ITT population.
Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
Outcome measures
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
n=82 Participants
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
n=42 Participants
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Week 1
|
53.7 Percentage of participants
Interval 42.9 to 64.5
|
4.8 Percentage of participants
Interval 0.0 to 11.2
|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Week 2
|
89.0 Percentage of participants
Interval 82.3 to 95.8
|
11.9 Percentage of participants
Interval 2.1 to 21.7
|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Week 4
|
91.5 Percentage of participants
Interval 85.4 to 97.5
|
19.0 Percentage of participants
Interval 7.2 to 30.9
|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Week 6
|
84.1 Percentage of participants
Interval 76.2 to 92.1
|
40.5 Percentage of participants
Interval 25.6 to 55.3
|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Week 8
|
87.8 Percentage of participants
Interval 80.7 to 94.9
|
47.6 Percentage of participants
Interval 32.5 to 62.7
|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Week 12
|
85.4 Percentage of participants
Interval 77.7 to 93.0
|
59.5 Percentage of participants
Interval 44.7 to 74.4
|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Weeks 4 and 12
|
84.1 Percentage of participants
Interval 76.2 to 92.1
|
19.0 Percentage of participants
Interval 7.2 to 30.9
|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
End of Treatment
|
92.7 Percentage of participants
Interval 87.0 to 98.3
|
64.3 Percentage of participants
Interval 49.8 to 78.8
|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Post treatment Week 24
|
80.5 Percentage of participants
Interval 71.9 to 89.1
|
40.5 Percentage of participants
Interval 25.6 to 55.3
|
|
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Post treatment Week 48
|
83.6 Percentage of participants
Interval 73.9 to 93.4
|
NA Percentage of participants
No visit on post treatment Week 48 was planned for this arm.
|
SECONDARY outcome
Timeframe: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48Population: The analysis was performed in modified ITT population.
Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
Outcome measures
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
n=82 Participants
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
n=42 Participants
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Week 1
|
14.6 Percentage of participants
Interval 7.0 to 22.3
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Week 2
|
45.1 Percentage of participants
Interval 34.4 to 55.9
|
9.5 Percentage of participants
Interval 0.6 to 18.4
|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Week 4
|
85.4 Percentage of participants
Interval 77.7 to 93.0
|
11.9 Percentage of participants
Interval 2.1 to 21.7
|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Week 6
|
80.5 Percentage of participants
Interval 71.9 to 89.1
|
16.7 Percentage of participants
Interval 5.4 to 27.9
|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Post treatment Week 24
|
78.0 Percentage of participants
Interval 69.1 to 87.0
|
40.5 Percentage of participants
Interval 25.6 to 55.3
|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Post treatment Week 48
|
81.8 Percentage of participants
Interval 71.6 to 92.0
|
NA Percentage of participants
No visits planned for post treatment Week 48 for this arm.
|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Week 8
|
87.8 Percentage of participants
Interval 80.7 to 94.9
|
38.1 Percentage of participants
Interval 23.4 to 52.8
|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Week 12
|
84.1 Percentage of participants
Interval 76.2 to 92.1
|
47.6 Percentage of participants
Interval 32.5 to 62.7
|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Weeks 4 and 12 (VR 4 & 12)
|
79.3 Percentage of participants
Interval 70.5 to 88.0
|
11.9 Percentage of participants
Interval 2.1 to 21.7
|
|
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
EOT
|
90.2 Percentage of participants
Interval 83.8 to 96.7
|
64.3 Percentage of participants
Interval 49.8 to 78.8
|
SECONDARY outcome
Timeframe: Post Treatment Weeks 12, 24Population: For SVR12; analysis was performed by backward imputation method, For SVR24: analysis was performed in Modified ITT population.
Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.
Outcome measures
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
n=82 Participants
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
n=42 Participants
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
IL28B Genotype CC (SVR12) (n=22, 9)
|
95.5 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
IL28B Genotype CT (SVR12) (n=40, 27)
|
75.0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
IL28B Genotype TT (SVR12) (n=20, 6)
|
80.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
IL28B Genotype CC (SVR24) (n=22, 9)
|
95.5 Percentage of participants
|
88.9 Percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
IL28B Genotype CT (SVR24) (n=40, 27)
|
72.5 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
IL28B Genotype TT (SVR24) (n=20, 6)
|
80.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 (start of study treatment) up to Follow-up Week 4Population: Analysis was performed on all treated participants.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing 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, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.
Outcome measures
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
n=82 Participants
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
n=42 Participants
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
AEs leading to discontinuation of study drug
|
4 participants
|
3 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
SAEs
|
8 participants
|
2 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
Death
|
0 participants
|
0 participants
|
Adverse Events
Daclatasvir + PegIFNα2a + Ribavirin
Serious events: 8 serious events
Other events: 80 other events
Deaths: 0 deaths
Placebo + PegIFNα2a + Ribavirin
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
n=82 participants at risk
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
n=42 participants at risk
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
1/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
0.00%
0/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
2/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
0.00%
0/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
2.4%
1/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
0.00%
0/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.2%
1/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
0.00%
0/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.2%
1/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
0.00%
0/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.2%
1/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
0.00%
0/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
1.2%
1/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
0.00%
0/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
2.4%
1/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Nervous system disorders
Cluster headache
|
1.2%
1/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
0.00%
0/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
Other adverse events
| Measure |
Daclatasvir + PegIFNα2a + Ribavirin
n=82 participants at risk
Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
|
Placebo + PegIFNα2a + Ribavirin
n=42 participants at risk
Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.6%
12/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
16.7%
7/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.7%
3/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
9.5%
4/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.5%
7/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
11.9%
5/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
10/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
19.0%
8/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
5/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
19.0%
8/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.3%
15/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
19.0%
8/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Blood and lymphatic system disorders
Anaemia
|
24.4%
20/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
28.6%
12/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
3/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
7.1%
3/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.4%
2/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
11.9%
5/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
General disorders
Influenza like illness
|
28.0%
23/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
31.0%
13/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.3%
15/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
26.2%
11/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.4%
20/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
11.9%
5/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
7/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
9.5%
4/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
General disorders
Irritability
|
13.4%
11/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
21.4%
9/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.5%
25/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
31.0%
13/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Eye disorders
Dry eye
|
3.7%
3/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
9.5%
4/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
3/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
7.1%
3/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.6%
12/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
26.2%
11/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
General disorders
Pyrexia
|
15.9%
13/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
19.0%
8/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Psychiatric disorders
Anxiety
|
3.7%
3/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
9.5%
4/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
General disorders
Asthenia
|
57.3%
47/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
59.5%
25/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.4%
11/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
14.3%
6/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Gastrointestinal disorders
Constipation
|
2.4%
2/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
7.1%
3/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
General disorders
Fatigue
|
7.3%
6/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
16.7%
7/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Psychiatric disorders
Insomnia
|
22.0%
18/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
14.3%
6/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Gastrointestinal disorders
Nausea
|
12.2%
10/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
11.9%
5/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
6.1%
5/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
2.4%
1/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.0%
9/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
14.3%
6/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.5%
7/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
4.8%
2/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Psychiatric disorders
Depression
|
3.7%
3/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
7.1%
3/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
|
Nervous system disorders
Headache
|
34.1%
28/82 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
26.2%
11/42 • From first dose to last dose plus 7 days (baseline up to 49 weeks)
on-treatment
|
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