Hepatitis C Infection
Conditions
Brief summary
The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care
Interventions
DRUGBMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
DRUGPlacebo
Tablets, Oral, 0 mg, daily, 48 weeks
DRUGPeginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
DRUGRibavirin
Capsules, 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: * Patients chronically infected with hepatitis C virus (HCV) genotype 1 * HCV RNA viral load ≥10\*5\* IU/mL at screening * Naïve or nonresponsive to the current standard of care Key
Exclusion criteria
* Cirrhosis * Hepatocellular carcinoma * Coinfection with hepatitis B virus, HIV-1 or HIV-2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) | At Weeks 4 and 12 on treatment | eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | Follow-up Weeks 4, 12, and 24 | SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory . |
| Percentage of Participants With Rapid Virologic Response (RVR) | At Week 4 on treatment | RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory . |
| Percentage of Participants With Complete Early Virologic Response (cEVR) | At Week 12 on treatment | cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory |
| Percentage of Participants With Virologic Failure | From on-treatment Week 1 to Follow-up Week 24 | Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed \>1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as \<2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | From baseline 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. |
| Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | From baseline to 30 days after last dose of study drug | Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= \<7.0 to 8.9 g/dL, Grade 4= \<7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm\^3, Grade 4= \<350 cells/mm\^3. Neutrophils: Grade 3= 500-999 cells/mm\^3, Grade 4= \<500 cells/mm\^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm\^3, Grade 4= \<1000 cells/mm\^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10\*upper limit of normal (ULN), Grade 4= \>10.0\*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10\*ULN, Grade 4= \>10.0\*ULN. Total bilirubin: Grade 3= 2.6-5\*ULN, Grade 4= \>5.0\*ULN. |
Countries
Japan
Participant flow
Recruitment details
The study was conducted at 6 sites in Japan.
Pre-assignment details
A total of 51 participants were enrolled, of which 45 were randomized to receive treatment and 6 were discontinued for no longer meeting study criteria.
Participants by arm
| Arm | Count |
|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. | 8 |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. | 9 |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. | 10 |
| Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders) Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. | 9 |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders) Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin. | 9 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| End of Treatment Period | Adverse Event | 0 | 1 | 1 | 0 | 0 |
| End of Treatment Period | Completed double-blind period only | 0 | 1 | 0 | 0 | 0 |
| End of Treatment Period | Lack of Efficacy | 0 | 1 | 0 | 4 | 4 |
| Follow-up Period | Other reason | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo + pegIFNα + Ribavirin (Treatment-naive) | Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Daclatasvir 10- mg + pegIFNα + Ribavirin (Nonresponders) | Daclatasvir 60- mg + pegIFNα + Ribavirin (Nonresponders) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 52.6 years STANDARD_DEVIATION 8.78 | 49.1 years STANDARD_DEVIATION 15.09 | 53.2 years STANDARD_DEVIATION 9.96 | 57.4 years STANDARD_DEVIATION 6.11 | 58.8 years STANDARD_DEVIATION 9.46 | 54.2 years STANDARD_DEVIATION 10.46 |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 4 Participants | 6 Participants | 6 Participants | 27 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants | 3 Participants | 3 Participants | 18 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 | 10 / 10 | 9 / 9 | 9 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 | 0 / 10 | 1 / 9 | 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, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.
Time frame: At Weeks 4 and 12 on treatment
Population: All participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 0 percentage of participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 66.7 percentage of participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 80.0 percentage of participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 55.6 percentage of participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Percentage of Participants With Extended Rapid Virologic Response (eRVR) | 22.2 percentage of participants |
Secondary
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .
Time frame: Follow-up Weeks 4, 12, and 24
Population: All participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR12: Follow-up Week 12 | 62.5 percentage of participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR4: Follow-up Week 4 | 75.0 percentage of participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR24: Follow-up Week 24 | 62.5 percentage of participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR24: Follow-up Week 24 | 66.7 percentage of participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR4: Follow-up Week 4 | 66.7 percentage of participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR12: Follow-up Week 12 | 66.7 percentage of participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR4: Follow-up Week 4 | 90.0 percentage of participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR24: Follow-up Week 24 | 90.0 percentage of participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR12: Follow-up Week 12 | 90.0 percentage of participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR12: Follow-up Week 12 | 22.2 percentage of participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR24: Follow-up Week 24 | 22.2 percentage of participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR4: Follow-up Week 4 | 22.2 percentage of participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR24: Follow-up Week 24 | 33.3 percentage of participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR4: Follow-up Week 4 | 33.3 percentage of participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24 | SVR12: Follow-up Week 12 | 33.3 percentage of participants |
Secondary
Percentage of Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory
Time frame: At Week 12 on treatment
Population: All participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 62.5 percentage of participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 77.8 percentage of participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 100.0 percentage of participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 55.6 percentage of participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Percentage of Participants With Complete Early Virologic Response (cEVR) | 55.6 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, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .
Time frame: At Week 4 on treatment
Population: All participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Rapid Virologic Response (RVR) | 0 percentage of participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Percentage of Participants With Rapid Virologic Response (RVR) | 77.8 percentage of participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Rapid Virologic Response (RVR) | 80.0 percentage of participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Percentage of Participants With Rapid Virologic Response (RVR) | 55.6 percentage of participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Percentage of Participants With Rapid Virologic Response (RVR) | 33.3 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure
Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed \>1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as \<2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.
Time frame: From on-treatment Week 1 to Follow-up Week 24
Population: All participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Virologic Failure | Virologic failure | 37.5 percentage of participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Virologic Failure | Relapse | 25.0 percentage of participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Virologic Failure | Virologic breakthrough | 12.5 percentage of participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Percentage of Participants With Virologic Failure | Virologic breakthrough | 11.1 percentage of participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Percentage of Participants With Virologic Failure | Virologic failure | 33.3 percentage of participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Percentage of Participants With Virologic Failure | Relapse | 11.1 percentage of participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Virologic Failure | Virologic breakthrough | 0.0 percentage of participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Virologic Failure | Virologic failure | 10.0 percentage of participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Percentage of Participants With Virologic Failure | Relapse | 10.0 percentage of participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Percentage of Participants With Virologic Failure | Virologic failure | 77.8 percentage of participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Percentage of Participants With Virologic Failure | Relapse | 33.3 percentage of participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Percentage of Participants With Virologic Failure | Virologic breakthrough | 44.4 percentage of participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Percentage of Participants With Virologic Failure | Virologic breakthrough | 44.4 percentage of participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Percentage of Participants With Virologic Failure | Virologic failure | 66.7 percentage of participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Percentage of Participants With Virologic Failure | Relapse | 22.2 percentage of participants |
Other Pre-specified
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= \<7.0 to 8.9 g/dL, Grade 4= \<7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm\^3, Grade 4= \<350 cells/mm\^3. Neutrophils: Grade 3= 500-999 cells/mm\^3, Grade 4= \<500 cells/mm\^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm\^3, Grade 4= \<1000 cells/mm\^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10\*upper limit of normal (ULN), Grade 4= \>10.0\*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10\*ULN, Grade 4= \>10.0\*ULN. Total bilirubin: Grade 3= 2.6-5\*ULN, Grade 4= \>5.0\*ULN.
Time frame: From baseline to 30 days after last dose of study drug
Population: All participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Hemoglobin | 1 participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Total bilirubin | 0 participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | AST | 0 participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Neutrophils | 2 participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Lymphocytes | 2 participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | WBC | 1 participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | ALT | 0 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | ALT | 1 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | WBC | 1 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Lymphocytes | 2 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Hemoglobin | 0 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | AST | 1 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Neutrophils | 4 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Total bilirubin | 1 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | WBC | 0 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Hemoglobin | 1 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Lymphocytes | 3 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Neutrophils | 2 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | ALT | 0 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | AST | 0 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Total bilirubin | 0 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Neutrophils | 2 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | ALT | 0 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Lymphocytes | 3 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Total bilirubin | 0 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | AST | 0 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Hemoglobin | 3 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | WBC | 2 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Neutrophils | 0 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Total bilirubin | 0 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | AST | 1 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | ALT | 1 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Lymphocytes | 2 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | Hemoglobin | 0 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results | WBC | 0 participants |
Other Pre-specified
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
Time frame: From baseline to 30 days after last dose of study drug
Population: All participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | SAEs | 0 participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Discontinuation due to AEs | 0 participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Treatment-related AEs | 8 participants |
| Placebo + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Death | 0 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | SAEs | 0 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Death | 0 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Discontinuation due to AEs | 1 participants |
| Daclatasvir 10- mg + pegIFNα- + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Treatment-related AEs | 9 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Death | 0 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Discontinuation due to AEs | 1 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Treatment-related AEs | 10 participants |
| Daclatasvir 60- mg + pegIFNα + Ribavirin (Treatment-naive) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | SAEs | 0 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | SAEs | 1 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Discontinuation due to AEs | 0 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Death | 0 participants |
| Daclatasvir 10- mg+ pegIFNα + Ribavirin (Nonresponders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Treatment-related AEs | 9 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Death | 0 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Treatment-related AEs | 9 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | Discontinuation due to AEs | 0 participants |
| Daclatasvir 60- mg + pegIFNα- + Ribavirin (Nonresponders) | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome | SAEs | 0 participants |