Trial Outcomes & Findings for Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia (NCT NCT01741545)
NCT ID: NCT01741545
Last Updated: 2020-08-11
Results Overview
SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
71 participants
Primary outcome timeframe
Follow-up Week 12
Results posted on
2020-08-11
Participant Flow
A total of 71 participants were enrolled, of which 51 subjects were randomized and treated.
Participant milestones
| Measure |
Cohort A
Participants with hepatitis C virus (HCV) genotype (GT)-2 or GT-3 infection (Cohort A) were treated with peginterferon lambda-1a (pegIFNλ-1a referred to as Lambda)/Ribavirin (RBV)/Daclatasvir (DCV). Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Treatment Period
STARTED
|
12
|
39
|
|
Treatment Period
COMPLETED
|
11
|
35
|
|
Treatment Period
NOT COMPLETED
|
1
|
4
|
|
Follow-up Period (24 Weeks)
STARTED
|
12
|
39
|
|
Follow-up Period (24 Weeks)
COMPLETED
|
11
|
37
|
|
Follow-up Period (24 Weeks)
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort A
Participants with hepatitis C virus (HCV) genotype (GT)-2 or GT-3 infection (Cohort A) were treated with peginterferon lambda-1a (pegIFNλ-1a referred to as Lambda)/Ribavirin (RBV)/Daclatasvir (DCV). Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Treatment Period
Lack of Efficacy
|
0
|
1
|
|
Treatment Period
Adverse event, non-fatal
|
1
|
3
|
|
Follow-up Period (24 Weeks)
Other than specified
|
0
|
1
|
|
Follow-up Period (24 Weeks)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
Baseline characteristics by cohort
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 12.04 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 11.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 1A
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 1B
|
0 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 2
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 3
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
HCV Genotype
Genotype 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Follow-up Week 12Population: The analysis was performed in modified intent to treat (mITT) population defined as participants meeting the response criteria over all treated participants.
SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
Outcome measures
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
89.7 Percentage of participants
Interval 75.8 to 97.1
|
SECONDARY outcome
Timeframe: Treatment Week 4Population: mITT population.
RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.
Outcome measures
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR)
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
76.9 Percentage of participants
Interval 60.7 to 88.9
|
SECONDARY outcome
Timeframe: Treatment Week 12Population: mITT population.
cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.
Outcome measures
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Percentage of Participants With Complete Early Virologic Response (cEVR)
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
92.3 Percentage of participants
Interval 79.1 to 98.4
|
SECONDARY outcome
Timeframe: End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)Population: mITT population.
EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.
Outcome measures
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Percentage of Participants With End of the Treatment Response (EOTR)
|
100 Percentage of participants
Interval 73.5 to 100.0
|
100 Percentage of participants
Interval 91.0 to 100.0
|
SECONDARY outcome
Timeframe: Follow-up Week 24Population: mITT population.
SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.
Outcome measures
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
30.8 Percentage of participants
Interval 17.0 to 47.6
|
SECONDARY outcome
Timeframe: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)Population: mITT population.
Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) \<10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) \<750 mm\^3, and/or thrombocytopenia: platelets \<50,000 mm\^3.
Outcome measures
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment
|
0 Percentage of participants
Interval 0.0 to 26.5
|
0 Percentage of participants
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)Population: mITT population.
Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.
Outcome measures
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment
Flu-like symptoms
|
8.3 Percentage of participants
Interval 0.2 to 38.5
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
|
Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment
Musculoskeletal symptoms
|
0 Percentage of participants
Interval 0.0 to 26.5
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
SECONDARY outcome
Timeframe: From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)Population: All treated participants.
AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.
Outcome measures
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
AEs on treatment
|
10 Percentage of participants
|
38 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
SAEs
|
0 Percentage of participants
|
4 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
Death
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
AE leading to discontinuation
|
1 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
Dose reduction - Lambda
|
0 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
Dose reduction - RBV
|
0 Percentage of participants
|
2 Percentage of participants
|
SECONDARY outcome
Timeframe: After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)Population: All treated participants.
Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): \>2.0\*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : \>5\*ULN; Aspartate aminotransferase (AST): \>5\*ULN; Prothrombin Time (PT): \>1.50\*ULN; Bilirubin (Total): \>2.5\*ULN; Triglycerides (fasting): \>750 mg/dL.
Outcome measures
| Measure |
Cohort A
n=12 Participants
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 Participants
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
INR
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
ALT
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
AST
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
PT
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
Bilirubin
|
2 Participants
|
7 Participants
|
|
Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
Triglycerides
|
0 Participants
|
1 Participants
|
Adverse Events
Cohort A
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort B
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A
n=12 participants at risk
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 participants at risk
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
2.6%
1/39 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
2.6%
1/39 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
2.6%
1/39 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
2.6%
1/39 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
Other adverse events
| Measure |
Cohort A
n=12 participants at risk
Participants with HCV GT-2 or GT-3 infection (Cohort A) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily; peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively (treatment period= 12 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
Cohort B
n=39 participants at risk
Participants with HCV GT-1b or GT-4 infection (Cohort B) were treated with Lambda/Ribavirin/Daclatasvir. Participants were administered daclatasvir 60 mg orally, once daily, peginterferon lambda-1a 180 microgram subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (participants weighing \<75 kg = 1000 mg and participants weighing \>=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively (treatment period= 24 Weeks). Participants were followed up for 24 weeks after administration of last treatment (follow-up period= 24 Weeks).
|
|---|---|---|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
7.7%
3/39 • Number of events 3 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
General disorders
Asthenia
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
30.8%
12/39 • Number of events 12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
General disorders
Fatigue
|
25.0%
3/12 • Number of events 3 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
23.1%
9/39 • Number of events 9 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
12.8%
5/39 • Number of events 5 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
0.00%
0/39 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
General disorders
Pain
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
0.00%
0/39 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • Number of events 3 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
33.3%
13/39 • Number of events 13 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Psychiatric disorders
Sleep disorder
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
12.8%
5/39 • Number of events 5 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Psychiatric disorders
Anger
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Psychiatric disorders
Irritability
|
16.7%
2/12 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
0.00%
0/39 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Psychiatric disorders
Initial insomnia
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
0.00%
0/39 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Investigations
Blood bilirubin increased
|
16.7%
2/12 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Investigations
Weight decreased
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
2.6%
1/39 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Investigations
Lipase increased
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
2.6%
1/39 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Investigations
Blood bicarbonate decreased
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
0.00%
0/39 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
0.00%
0/39 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
7.7%
3/39 • Number of events 3 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
0.00%
0/39 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
0.00%
0/39 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
17.9%
7/39 • Number of events 7 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
7.7%
3/39 • Number of events 3 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
20.5%
8/39 • Number of events 8 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
15.4%
6/39 • Number of events 6 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
7.7%
3/39 • Number of events 3 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
7.7%
3/39 • Number of events 3 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Renal and urinary disorders
Chromaturia
|
16.7%
2/12 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
10.3%
4/39 • Number of events 4 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
17.9%
7/39 • Number of events 7 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
10.3%
4/39 • Number of events 4 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
2.6%
1/39 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
10.3%
4/39 • Number of events 4 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
5.1%
2/39 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
1/12 • Number of events 1 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
0.00%
0/39 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
2/12 • Number of events 2 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
12.8%
5/39 • Number of events 5 • From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
|
Additional Information
Bristol Myers Squibb Study Director
Bristol Myers Squibb
Phone: Please email
Email: [email protected]
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 submitting 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