Trial Outcomes & Findings for BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C (NCT NCT01389323)
NCT ID: NCT01389323
Last Updated: 2015-10-12
Results Overview
SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
448 participants
Primary outcome timeframe
Post-treatment Week 12
Results posted on
2015-10-12
Participant Flow
The study was conducted at 33 clinical sites in United States.
A total of 448 participants were enrolled, and 246 entered treatment period. Remaining 202 did not enter treatment period (29: withdrew consent, 17: lost to follow-up, 156: no longer met study criteria). As per protocol, any participant who discontinued the treatment period was still expected to enter the post-treatment follow-up period.
Participant milestones
| Measure |
Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
|
|---|---|
|
Treatment Period (up to 48 Weeks)
STARTED
|
246
|
|
Treatment Period (up to 48 Weeks)
COMPLETED
|
151
|
|
Treatment Period (up to 48 Weeks)
NOT COMPLETED
|
95
|
|
Follow-up Period (up to 48 Weeks)
STARTED
|
221
|
|
Follow-up Period (up to 48 Weeks)
COMPLETED
|
184
|
|
Follow-up Period (up to 48 Weeks)
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
|
|---|---|
|
Treatment Period (up to 48 Weeks)
Lack of Efficacy
|
41
|
|
Treatment Period (up to 48 Weeks)
Adverse Event
|
24
|
|
Treatment Period (up to 48 Weeks)
Participant's request to discontinue
|
6
|
|
Treatment Period (up to 48 Weeks)
Withdrawal by Subject
|
7
|
|
Treatment Period (up to 48 Weeks)
Lost to Follow-up
|
10
|
|
Treatment Period (up to 48 Weeks)
Poor/non-compliance
|
5
|
|
Treatment Period (up to 48 Weeks)
Did not meet study criteria
|
2
|
|
Follow-up Period (up to 48 Weeks)
Withdrawal by Subject
|
10
|
|
Follow-up Period (up to 48 Weeks)
Lost to Follow-up
|
22
|
|
Follow-up Period (up to 48 Weeks)
Follow-up no longer needed per protocol
|
2
|
|
Follow-up Period (up to 48 Weeks)
Other
|
3
|
Baseline Characteristics
BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
Baseline characteristics by cohort
| Measure |
Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
n=246 Participants
Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
|
|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 9.94 • n=99 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
107 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
128 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
118 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black/African American Latino
|
19 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black/African American Non-Latino
|
109 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White Latino
|
88 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian Non-Latino
|
30 participants
n=99 Participants
|
|
Hepatitis C Virus RNA Levels
|
6.21 Log10 IU/mL
STANDARD_DEVIATION 0.684 • n=99 Participants
|
|
Hepatitis C Virus RNA Distribution
<800,000 IU/mL
|
64 participants
n=99 Participants
|
|
Hepatitis C Virus RNA Distribution
≥800,000 IU/mL
|
182 participants
n=99 Participants
|
|
Hepatitis C Virus Genotype
Subtype 1A
|
191 participants
n=99 Participants
|
|
Hepatitis C Virus Genotype
Subtype 1B
|
54 participants
n=99 Participants
|
|
Hepatitis C Virus Genotype
Subtype 1
|
1 participants
n=99 Participants
|
|
rs12979860 Single Nucleotide Polymorphism in the Interleukin-28B Gene
Wild Type (CC)
|
50 participants
n=99 Participants
|
|
rs12979860 Single Nucleotide Polymorphism in the Interleukin-28B Gene
Heterozygous (CT)
|
134 participants
n=99 Participants
|
|
rs12979860 Single Nucleotide Polymorphism in the Interleukin-28B Gene
Minor Homozygous (TT)
|
62 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Post-treatment Week 12Population: All treated participants. Modified intent-to-treat analysis (participants meeting the response criteria / all treated participants) was performed for Black/African American and Latino cohorts.
SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Outcome measures
| Measure |
Black/African American Cohort
n=128 Participants
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
|
Latino Cohort
n=107 Participants
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
White Non-Latino Cohort
n=30 Participants
Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
Non-Latino Cohort
Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
Overall Population
Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)
|
50.8 percentage of participants
Interval 42.1 to 59.4
|
57.0 percentage of participants
Interval 47.6 to 66.4
|
66.7 percentage of participants
Interval 49.8 to 83.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-treatment Week 12Population: All treated participants. Here, 'n' signifies the number of participants evaluable in the specified category.
SVR12 was defined as Hepatitis C Virus (HCV) RNA levels \<lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Outcome measures
| Measure |
Black/African American Cohort
n=128 Participants
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
|
Latino Cohort
n=107 Participants
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
White Non-Latino Cohort
n=30 Participants
Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
Non-Latino Cohort
Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
Overall Population
Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene
Wild Type (CC) (n=20, 24, 10)
|
80.0 percentage of participants
Interval 62.5 to 97.5
|
70.8 percentage of participants
Interval 52.6 to 89.0
|
80.0 percentage of participants
Interval 55.2 to 100.0
|
—
|
—
|
|
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene
Heterozygous (CT) (n=58, 69, 17)
|
53.4 percentage of participants
Interval 40.6 to 66.3
|
50.7 percentage of participants
Interval 38.9 to 62.5
|
58.8 percentage of participants
Interval 35.4 to 82.2
|
—
|
—
|
|
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene
Minor Homozygous (TT) (n=50, 14, 3)
|
36.0 percentage of participants
Interval 22.7 to 49.3
|
64.3 percentage of participants
Interval 39.2 to 89.4
|
66.7 percentage of participants
Interval 13.3 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24Population: All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.
The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels \<LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Outcome measures
| Measure |
Black/African American Cohort
n=128 Participants
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
|
Latino Cohort
n=107 Participants
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
White Non-Latino Cohort
n=30 Participants
Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
Non-Latino Cohort
Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
Overall Population
Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Week 6
|
76.6 percentage of participants
Interval 69.2 to 83.9
|
81.3 percentage of participants
Interval 73.9 to 88.7
|
80.0 percentage of participants
Interval 65.7 to 94.3
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Week 8
|
76.6 percentage of participants
Interval 69.2 to 83.9
|
81.3 percentage of participants
Interval 73.9 to 88.7
|
76.7 percentage of participants
Interval 61.5 to 91.8
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Week 12
|
71.1 percentage of participants
Interval 63.2 to 78.9
|
80.4 percentage of participants
Interval 72.8 to 87.9
|
76.7 percentage of participants
Interval 61.5 to 91.8
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Both Weeks 4 and 12
|
68.0 percentage of participants
Interval 59.9 to 76.1
|
77.6 percentage of participants
Interval 69.7 to 85.5
|
56.7 percentage of participants
Interval 38.9 to 74.4
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
EOT
|
73.4 percentage of participants
Interval 65.8 to 81.1
|
79.4 percentage of participants
Interval 71.8 to 87.1
|
93.3 percentage of participants
Interval 84.4 to 100.0
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Post-treatment Week 24
|
46.9 percentage of participants
Interval 38.2 to 55.5
|
57.0 percentage of participants
Interval 47.6 to 66.4
|
63.3 percentage of participants
Interval 46.1 to 80.6
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Week 1
|
32.8 percentage of participants
Interval 24.7 to 40.9
|
44.9 percentage of participants
Interval 35.4 to 54.3
|
33.3 percentage of participants
Interval 16.5 to 50.2
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Week 2
|
64.1 percentage of participants
Interval 55.8 to 72.4
|
72.0 percentage of participants
Interval 63.5 to 80.5
|
60.0 percentage of participants
Interval 42.5 to 77.5
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Week 4
|
77.3 percentage of participants
Interval 70.1 to 84.6
|
85.0 percentage of participants
Interval 78.3 to 91.8
|
66.7 percentage of participants
Interval 49.8 to 83.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24Population: All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.
The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Outcome measures
| Measure |
Black/African American Cohort
n=128 Participants
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
|
Latino Cohort
n=107 Participants
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
White Non-Latino Cohort
n=30 Participants
Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
Non-Latino Cohort
Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
Overall Population
Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Week 1
|
6.3 percentage of participants
Interval 2.1 to 10.4
|
12.1 percentage of participants
Interval 6.0 to 18.3
|
6.7 percentage of participants
Interval 0.0 to 15.6
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Week 2
|
28.1 percentage of participants
Interval 20.3 to 35.9
|
27.1 percentage of participants
Interval 18.7 to 35.5
|
30.0 percentage of participants
Interval 13.6 to 46.4
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Week 4
|
64.1 percentage of participants
Interval 55.8 to 72.4
|
68.2 percentage of participants
Interval 59.4 to 77.0
|
50.0 percentage of participants
Interval 32.1 to 67.9
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Week 6
|
68.8 percentage of participants
Interval 60.7 to 76.8
|
75.7 percentage of participants
Interval 67.6 to 83.8
|
66.7 percentage of participants
Interval 49.8 to 83.5
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Week 8
|
70.3 percentage of participants
Interval 62.4 to 78.2
|
73.8 percentage of participants
Interval 65.5 to 82.2
|
66.7 percentage of participants
Interval 49.8 to 83.5
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Week 12
|
64.1 percentage of participants
Interval 55.8 to 72.4
|
74.8 percentage of participants
Interval 66.5 to 83.0
|
66.7 percentage of participants
Interval 49.8 to 83.5
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Both Weeks 4 and 12
|
55.5 percentage of participants
Interval 46.9 to 64.1
|
58.9 percentage of participants
Interval 49.6 to 68.2
|
43.3 percentage of participants
Interval 25.6 to 61.1
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
EOT
|
71.1 percentage of participants
Interval 63.2 to 78.9
|
78.5 percentage of participants
Interval 70.7 to 86.3
|
93.3 percentage of participants
Interval 84.4 to 100.0
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Post-treatment Week 12
|
50.8 percentage of participants
Interval 42.1 to 59.4
|
55.1 percentage of participants
Interval 45.7 to 64.6
|
63.3 percentage of participants
Interval 46.1 to 80.6
|
—
|
—
|
|
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Post-treatment Week 24
|
46.9 percentage of participants
Interval 38.2 to 55.5
|
55.1 percentage of participants
Interval 45.7 to 64.6
|
63.3 percentage of participants
Interval 46.1 to 80.6
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])Population: All treated participants for TP and all follow-up participants for FUP. Here, "n" signifies the number of participants evaluable in their respective study periods.
An 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 hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Outcome measures
| Measure |
Black/African American Cohort
n=128 Participants
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
|
Latino Cohort
n=118 Participants
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
White Non-Latino Cohort
n=107 Participants
Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
Non-Latino Cohort
n=139 Participants
Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
|
Overall Population
n=246 Participants
Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing \<75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
Deaths: TP (n=128,118,107,139,246)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
Discontinued due to AE: TP (n=128,118,107,139,246)
|
9 participants
|
15 participants
|
6 participants
|
18 participants
|
24 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
Treatment-related AEs: TP (n=128,118,107,139,246)
|
111 participants
|
108 participants
|
93 participants
|
126 participants
|
219 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
SAEs: TP (n=128,118,107,139,246)
|
12 participants
|
9 participants
|
5 participants
|
16 participants
|
21 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
SAEs: FUP (n=117,104,96,125,221)
|
3 participants
|
0 participants
|
1 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
Deaths: FUP (n=117,104,96,125,221)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
Serious events: 21 serious events
Other events: 227 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
n=246 participants at risk
Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
General disorders
Chest pain
|
2.0%
5/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Psychiatric disorders
Drug abuse
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Infections and infestations
Gangrene
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Infections and infestations
Pneumonia
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Infections and infestations
Osteomyelitis
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Psychiatric disorders
Substance abuse
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Nervous system disorders
Cerebrovascular accident
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Nervous system disorders
Intracranial aneurysm
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Gastrointestinal disorders
Melaena
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Nervous system disorders
Syncope
|
0.81%
2/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Nervous system disorders
Headache
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Cardiac disorders
Acute coronary syndrome
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
3/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Infections and infestations
Gastroenteritis
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Nervous system disorders
Paraesthesia
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Renal and urinary disorders
Renal failure acute
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Infections and infestations
Cellulitis
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Injury, poisoning and procedural complications
Overdose
|
0.41%
1/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
Other adverse events
| Measure |
Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
n=246 participants at risk
Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing \<75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
|
|---|---|
|
Psychiatric disorders
Anxiety
|
5.3%
13/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Nervous system disorders
Dizziness
|
10.2%
25/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.6%
31/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
General disorders
Influenza like illness
|
19.1%
47/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Psychiatric disorders
Insomnia
|
18.7%
46/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.5%
43/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
16/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.8%
34/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Psychiatric disorders
Depression
|
9.8%
24/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.3%
23/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
General disorders
Injection site reaction
|
5.3%
13/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.2%
57/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.9%
17/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Investigations
Weight decreased
|
6.1%
15/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
General disorders
Chills
|
14.2%
35/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
General disorders
Fatigue
|
43.5%
107/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Nervous system disorders
Headache
|
31.3%
77/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
General disorders
Pain
|
8.5%
21/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
15/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
19/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Gastrointestinal disorders
Nausea
|
24.8%
61/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Blood and lymphatic system disorders
Anaemia
|
29.7%
73/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Gastrointestinal disorders
Diarrhoea
|
12.2%
30/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Psychiatric disorders
Irritability
|
10.6%
26/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
18/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.4%
28/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.8%
24/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
General disorders
Pyrexia
|
9.3%
23/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.6%
58/246 • From first dose to 7 days post last dose of study treatment
On-treatment Period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER