Hepatitis C
Conditions
Keywords
hepatitis C virus
Brief summary
The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).
Interventions
DRUGBMS-790052 (NS5A Replication Complex Inhibitor)
DRUGPlacebo matching BMS-790052
DRUGPegylated-interferon alfa 2a
DRUGRibavirin
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants chronically infected with HCV Genotype 4 * HCV RNA viral load of ≥ 10,000 IU/mL * No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent * Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted
Exclusion criteria
* Evidence of decompensated liver disease * Documented or suspected Hepatocellular carcinoma (HCC) * Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 12 Week Sustained Virologic Response (SVR12) | Week 12 (Follow-up period) | Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels \< lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48 | Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. |
| Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48 | Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. |
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | Post Treatment Weeks 12, 24 | Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively. |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | From Day 1 (start of study treatment) up to Follow-up Week 4 | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation. |
Countries
France, Greece, Italy, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 152 participants were enrolled in the study, of which 125 were randomized and 27 participants were not randomized due to 23 no longer met criteria, 1 withdrew consent, 1 due to administrative reason, and 2 other reasons. Of 125 randomized, 124 were treated and 1 was not treated due to withdrawal of consent.
Participants by arm
| Arm | Count |
|---|---|
| Daclatasvir + PegIFNα2a + Ribavirin Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response. | 82 |
| Placebo + PegIFNα2a + Ribavirin Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants \<75 kg) or 600 mg (3 tablets for participants \>=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks. | 42 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow Up Period | Lost to Follow-up | 6 | 2 |
| Follow Up Period | Other | 5 | 11 |
| Follow Up Period | Withdrawal by Subject | 1 | 1 |
| Treatment Period | Adverse Event | 4 | 3 |
| Treatment Period | Completed 24 weeks treatment period only | 8 | 0 |
| Treatment Period | Lack of Efficacy | 5 | 12 |
| Treatment Period | Lost to Follow-up | 2 | 1 |
| Treatment Period | Other reason | 2 | 0 |
| Treatment Period | Participant does not meet study criteria | 1 | 0 |
| Treatment Period | Subject requested discontinue study drug | 1 | 0 |
Baseline characteristics
| Characteristic | Daclatasvir + PegIFNα2a + Ribavirin | Placebo + PegIFNα2a + Ribavirin | Total |
|---|---|---|---|
| Age, Continuous | 47.7 years STANDARD_DEVIATION 10.23 | 48.4 years STANDARD_DEVIATION 8.09 | 48.0 years STANDARD_DEVIATION 9.53 |
| Age, Customized 21 to < 65 years | 78 participants | 42 participants | 120 participants |
| Age, Customized < 21 years | 1 participants | 0 participants | 1 participants |
| Age, Customized >= 65 years | 3 participants | 0 participants | 3 participants |
| Sex: Female, Male Female | 21 Participants | 13 Participants | 34 Participants |
| Sex: Female, Male Male | 61 Participants | 29 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 80 / 82 | 39 / 42 |
| serious Total, serious adverse events | 8 / 82 | 2 / 42 |
Outcome results
Primary
Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)
Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels \< lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.
Time frame: Week 12 (Follow-up period)
Population: The analysis was performed in modified Intent to treat population (ITT), defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. Missing values were imputed using backward imputation technique.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With 12 Week Sustained Virologic Response (SVR12) | 81.7 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With 12 Week Sustained Virologic Response (SVR12) | 42.9 Percentage of participants |
p-value: <0.000195% CI: [21.703, 55.997]Cochran-Mantel-Haenszel
Secondary
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 pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.
Time frame: From Day 1 (start of study treatment) up to Follow-up Week 4
Population: Analysis was performed on all treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + PegIFNα2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | AEs leading to discontinuation of study drug | 4 participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | SAEs | 8 participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | Death | 0 participants |
| Placebo + PegIFNα2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | AEs leading to discontinuation of study drug | 3 participants |
| Placebo + PegIFNα2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | SAEs | 2 participants |
| Placebo + PegIFNα2a + Ribavirin | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | Death | 0 participants |
Secondary
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
Time frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48
Population: The analysis was performed in modified ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 1 | 53.7 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 2 | 89.0 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 4 | 91.5 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 6 | 84.1 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 8 | 87.8 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 12 | 85.4 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Weeks 4 and 12 | 84.1 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | End of Treatment | 92.7 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Post treatment Week 24 | 80.5 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Post treatment Week 48 | 83.6 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | End of Treatment | 64.3 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 1 | 4.8 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 12 | 59.5 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 2 | 11.9 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Post treatment Week 48 | NA Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 4 | 19.0 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Weeks 4 and 12 | 19.0 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 6 | 40.5 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Post treatment Week 24 | 40.5 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Week 8 | 47.6 Percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.
Time frame: Post Treatment Weeks 12, 24
Population: For SVR12; analysis was performed by backward imputation method, For SVR24: analysis was performed in Modified ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype CC (SVR12) (n=22, 9) | 95.5 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype TT (SVR12) (n=20, 6) | 80.0 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype CT (SVR12) (n=40, 27) | 75.0 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype CC (SVR24) (n=22, 9) | 95.5 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype CT (SVR24) (n=40, 27) | 72.5 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype TT (SVR24) (n=20, 6) | 80.0 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype CT (SVR24) (n=40, 27) | 33.3 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype CC (SVR12) (n=22, 9) | 100.0 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype CC (SVR24) (n=22, 9) | 88.9 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype TT (SVR24) (n=20, 6) | 0.0 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype CT (SVR12) (n=40, 27) | 33.3 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | IL28B Genotype TT (SVR12) (n=20, 6) | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
Time frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48
Population: The analysis was performed in modified ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 1 | 14.6 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 12 | 84.1 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 6 | 80.5 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Weeks 4 and 12 (VR 4 & 12) | 79.3 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | EOT | 90.2 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 2 | 45.1 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Post treatment Week 24 | 78.0 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 8 | 87.8 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Post treatment Week 48 | 81.8 Percentage of participants |
| Daclatasvir + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 4 | 85.4 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Post treatment Week 48 | NA Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 4 | 11.9 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Weeks 4 and 12 (VR 4 & 12) | 11.9 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 1 | 0.0 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 2 | 9.5 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 6 | 16.7 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 8 | 38.1 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Week 12 | 47.6 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | EOT | 64.3 Percentage of participants |
| Placebo + PegIFNα2a + Ribavirin | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Post treatment Week 24 | 40.5 Percentage of participants |