Hepatitis C Infection
Conditions
Brief summary
The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
Interventions
DRUGDaclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
DRUGPlacebo
Tablets, Oral, 0 mg, daily, 48 weeks
DRUGPeginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
DRUGRibavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects chronically infected with hepatitis C virus (HCV) genotype 1 * HCV RNA viral load ≥ 10\*5\* IU/mL (100,000 IU/mL) at screening * The current standard of care naïve or non-responder Key
Exclusion criteria
* Cirrhosis * HCC * Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) | From Week 4 up to Week 12 | eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at both Weeks 4 and 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Rapid Virologic Response (RVR) | Week 4 | RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at Week 4. |
| Percentage of Participants With a Complete Early Virologic Response (cEVR) | Week 12 | cEVR was defined as hepatitis C virus RNA \<15 IU/mL at Week 12. |
| Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | Follow up Week 12, Follow up Week 24 | SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA \<15 IU/mL at follow-up Weeks 12 and 24. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | From Baseline up to 30 days after last dose of study drug | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. |
| Number of Participants With Grade 3 to 4 Laboratory Abnormalities | From screening up to Week 12 (treatment period) | Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as \>5.0 to 10.0\*Upper Limit of Normal (ULN), Grade 4 as \>10.0\*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as \<7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749\*10\^9/L, Grade 4 as \<0.5\*10\^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499\*10\^9/L, Grade 4 as \<0.35\*10\^9/L; Platelets- Grade 3 as 25000 to 49999\*10\^9/L, Grade 4 as \<25000 10\^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499\*10\^9/L, Grade 4 as \<1000\*10\^9/L and Lipase- Grade 3 as 3.1-5.0\*ULN, Grade 4 as \>5.0\*ULN. |
Countries
Japan
Participant flow
Recruitment details
The study was conducted at 6 sites in Japan.
Pre-assignment details
A total of 55 participants were enrolled, of which 43 participants were randomized and 42 were treated. 12 participants were not randomized because 10 no longer met study criteria and 2 withdrew consent; 1 randomized participant was not treated due enlarged lymph node.
Participants by arm
| Arm | Count |
|---|---|
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin. | 8 |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | 9 |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin. | 8 |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | 8 |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin. | 9 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Total |
|---|---|---|---|---|---|---|
| Age, Customized <65 years | 7 participants | 8 participants | 6 participants | 6 participants | 8 participants | 35 participants |
| Age, Customized >=65 years | 1 participants | 1 participants | 2 participants | 2 participants | 1 participants | 7 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 6 Participants | 2 Participants | 4 Participants | 22 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 2 Participants | 6 Participants | 5 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 9 / 9 | 8 / 8 | 8 / 8 | 9 / 9 |
| serious Total, serious adverse events | 0 / 8 | 2 / 9 | 0 / 8 | 0 / 8 | 0 / 9 |
Outcome results
Primary
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at both Weeks 4 and 12.
Time frame: From Week 4 up to Week 12
Population: All treated participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 12.5 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 66.7 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 62.5 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 62.5 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 77.8 percentage of participants |
Secondary
Percentage of Participants With a Complete Early Virologic Response (cEVR)
cEVR was defined as hepatitis C virus RNA \<15 IU/mL at Week 12.
Time frame: Week 12
Population: All treated participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With a Complete Early Virologic Response (cEVR) | 62.5 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With a Complete Early Virologic Response (cEVR) | 88.9 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With a Complete Early Virologic Response (cEVR) | 100 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With a Complete Early Virologic Response (cEVR) | 87.5 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With a Complete Early Virologic Response (cEVR) | 88.9 percentage of participants |
Secondary
Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA \<15 IU/mL at follow-up Weeks 12 and 24.
Time frame: Follow up Week 12, Follow up Week 24
Population: All treated participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR12 | 75 percentage of participants |
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR24 | 75 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR12 | 88.9 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR24 | 88.9 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR12 | 100 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR24 | 100 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR24 | 50 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR12 | 50 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR12 | 77.8 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR24 | 77.8 percentage of participants |
Secondary
Percentage of Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at Week 4.
Time frame: Week 4
Population: All treated participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With Rapid Virologic Response (RVR) | 12.5 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With Rapid Virologic Response (RVR) | 77.8 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Percentage of Participants With Rapid Virologic Response (RVR) | 62.5 percentage of participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With Rapid Virologic Response (RVR) | 62.5 percentage of participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Percentage of Participants With Rapid Virologic Response (RVR) | 88.9 percentage of participants |
Other Pre-specified
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as \>5.0 to 10.0\*Upper Limit of Normal (ULN), Grade 4 as \>10.0\*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as \<7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749\*10\^9/L, Grade 4 as \<0.5\*10\^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499\*10\^9/L, Grade 4 as \<0.35\*10\^9/L; Platelets- Grade 3 as 25000 to 49999\*10\^9/L, Grade 4 as \<25000 10\^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499\*10\^9/L, Grade 4 as \<1000\*10\^9/L and Lipase- Grade 3 as 3.1-5.0\*ULN, Grade 4 as \>5.0\*ULN.
Time frame: From screening up to Week 12 (treatment period)
Population: All treated participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Hemoglobin | 0 Participants |
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lipase | 0 Participants |
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | WBC | 3 Participants |
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | AST | 0 Participants |
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Neutrophils | 4 Participants |
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Platelets | 0 Participants |
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lymphocytes | 5 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lipase | 1 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | AST | 0 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lymphocytes | 2 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Hemoglobin | 2 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | WBC | 1 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Neutrophils | 4 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Platelets | 0 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lymphocytes | 4 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lipase | 0 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | WBC | 2 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Platelets | 0 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Hemoglobin | 1 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | AST | 0 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Neutrophils | 3 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Neutrophils | 3 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Hemoglobin | 0 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lymphocytes | 5 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Platelets | 2 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | WBC | 2 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | AST | 1 Participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lipase | 0 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lipase | 0 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | AST | 0 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Neutrophils | 2 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Lymphocytes | 3 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Hemoglobin | 2 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | WBC | 2 Participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Grade 3 to 4 Laboratory Abnormalities | Platelets | 0 Participants |
Other Pre-specified
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time frame: From Baseline up to 30 days after last dose of study drug
Population: All treated participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | SAEs | 0 participants |
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Death | 0 participants |
| Placebo+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Discontinuations due to AEs | 0 participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Discontinuations due to AEs | 1 participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | SAEs | 2 participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Death | 0 participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Discontinuations due to AEs | 0 participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | SAEs | 0 participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Death | 0 participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | SAEs | 0 participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Death | 0 participants |
| Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Discontinuations due to AEs | 0 participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Discontinuations due to AEs | 2 participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | SAEs | 0 participants |
| Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. | Death | 0 participants |