Hepatitis C
Conditions
Brief summary
The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
Interventions
DRUGPF-00868554
500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.
DRUGPlacebo
Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Treatment naive (no prior treatment with IFN-a +/- RBV regimens. * Subjects who have discontinued IFN-a containing regimens after \<2 weeks of therapy due to tolerability issues are considered treatment naive. * HCV RNA \> 100,000 IU/mL at screening. * Genotype 1. * A diagnosis of chronic HCV infection for at least 6 months.
Exclusion criteria
* Evidence of acute or chronic infection with HIV or HBV. * Exposure within the previous three months to an investigational anti-HCV agent. * Evidence of severe or decompensated liver disease. * Subjects with liver disease unrelated to HCV infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set | Baseline, Week 4 | Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter \[IU/mL\]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements. |
| Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set | Baseline, Week 4 | Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 4, 12, 48, 60, 72 | Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA \<25 IU/mL. |
| Alanine Aminotransferase (ALT) Levels | Week 4, 12, 48, 72 | — |
| Population Pharmacokinetics (PK) of PF-00868554 | 1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28 | Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (\<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (\>) 75 kg. | 10 |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing \<=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing \>75 kg. | 9 |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing \<=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing \>75 kg. | 8 |
| Placebo + pegIFN Alfa-2a/RBV Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing \<=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing \>75 kg. | 8 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-Blind Period (Week 1-4) | Withdrawal by Subject | 0 | 1 | 0 | 0 |
| Open-Label Period (Week 5-72) | Adverse Event | 0 | 0 | 0 | 2 |
| Open-Label Period (Week 5-72) | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Open-Label Period (Week 5-72) | Other | 4 | 3 | 3 | 2 |
| Open-Label Period (Week 5-72) | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | PF-00868554 200 mg + pegIFN Alfa-2a/RBV | PF-00868554 300 mg + pegIFN Alfa-2a/RBV | PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Placebo + pegIFN Alfa-2a/RBV | Total |
|---|---|---|---|---|---|
| Age, Customized 18 to 44 years | 5 participants | 3 participants | 3 participants | 1 participants | 12 participants |
| Age, Customized 45 to 64 years | 5 participants | 6 participants | 5 participants | 7 participants | 23 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 2 Participants | 5 Participants | 17 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 6 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 |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 10 | 9 / 9 | 8 / 8 | 8 / 8 |
| serious Total, serious adverse events | 0 / 10 | 2 / 9 | 1 / 8 | 2 / 8 |
Outcome results
Primary
Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set
Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter \[IU/mL\]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
Time frame: Baseline, Week 4
Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here 'n' signifies participants evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set | Baseline (n=10, 9, 8, 8) | 6.38843 log10 IU/mL | Standard Deviation 0.483283 |
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set | Change at Week 4 (n=10, 8, 8, 8) | -4.45887 log10 IU/mL | Standard Deviation 1.422134 |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set | Change at Week 4 (n=10, 8, 8, 8) | -4.64646 log10 IU/mL | Standard Deviation 1.982243 |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set | Baseline (n=10, 9, 8, 8) | 6.67823 log10 IU/mL | Standard Deviation 0.472198 |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set | Baseline (n=10, 9, 8, 8) | 6.66254 log10 IU/mL | Standard Deviation 0.563548 |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set | Change at Week 4 (n=10, 8, 8, 8) | -3.61918 log10 IU/mL | Standard Deviation 2.488935 |
| Placebo + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set | Baseline (n=10, 9, 8, 8) | 6.42047 log10 IU/mL | Standard Deviation 0.499677 |
| Placebo + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set | Change at Week 4 (n=10, 8, 8, 8) | -2.10239 log10 IU/mL | Standard Deviation 1.429056 |
Comparison: An analysis of covariance (ANCOVA) model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95 percentage (%) confidence interval (CI) were calculated.p-value: 0.013195% CI: [-4.19228, -0.53485]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.014295% CI: [-4.44619, -0.5376]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.136895% CI: [-3.41898, 0.49248]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.332195% CI: [-2.76711, 0.96648]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.283995% CI: [-2.95573, 0.89844]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.889195% CI: [-1.73676, 1.99342]ANCOVA
Primary
Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set
Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
Time frame: Baseline, Week 4
Population: Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set | -4.45887 log10 IU/mL | Standard Deviation 1.422134 |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set | -4.64646 log10 IU/mL | Standard Deviation 1.982243 |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set | -3.61918 log10 IU/mL | Standard Deviation 2.488935 |
| Placebo + pegIFN Alfa-2a/RBV | Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set | -2.10239 log10 IU/mL | Standard Deviation 1.429056 |
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.013195% CI: [-4.19228, -0.53485]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.014295% CI: [-4.44619, -0.5376]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.136895% CI: [-3.41898, 0.49248]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.332195% CI: [-2.76711, 0.96648]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.283995% CI: [-2.95573, 0.89844]ANCOVA
Comparison: An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.p-value: 0.889195% CI: [-1.73676, 1.99342]ANCOVA
Secondary
Alanine Aminotransferase (ALT) Levels
Time frame: Week 4, 12, 48, 72
Population: FAS included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here 'n' signifies participants evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 12 (n=10, 7, 8, 8) | 32.9 IU/L | Standard Deviation 15.26 |
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 72 (n=6, 5, 5, 4) | 46.0 IU/L | Standard Deviation 40.54 |
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 48 (n=6, 6, 5, 4) | 35.2 IU/L | Standard Deviation 30.8 |
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 4 (n=10, 8, 8, 8) | 31.1 IU/L | Standard Deviation 12.74 |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 4 (n=10, 8, 8, 8) | 28.5 IU/L | Standard Deviation 13.6 |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 72 (n=6, 5, 5, 4) | 34.0 IU/L | Standard Deviation 27.9 |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 12 (n=10, 7, 8, 8) | 29.4 IU/L | Standard Deviation 11.12 |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 48 (n=6, 6, 5, 4) | 25.7 IU/L | Standard Deviation 12.61 |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 12 (n=10, 7, 8, 8) | 42.5 IU/L | Standard Deviation 15.09 |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 72 (n=6, 5, 5, 4) | 21.8 IU/L | Standard Deviation 14.2 |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 4 (n=10, 8, 8, 8) | 51.6 IU/L | Standard Deviation 19.45 |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 48 (n=6, 6, 5, 4) | 24.4 IU/L | Standard Deviation 19.26 |
| Placebo + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 72 (n=6, 5, 5, 4) | 21.5 IU/L | Standard Deviation 12.77 |
| Placebo + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 4 (n=10, 8, 8, 8) | 47.1 IU/L | Standard Deviation 27.68 |
| Placebo + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 12 (n=10, 7, 8, 8) | 35.6 IU/L | Standard Deviation 19.1 |
| Placebo + pegIFN Alfa-2a/RBV | Alanine Aminotransferase (ALT) Levels | Week 48 (n=6, 6, 5, 4) | 148.8 IU/L | Standard Deviation 248.26 |
Secondary
Population Pharmacokinetics (PK) of PF-00868554
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Time frame: 1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28
Secondary
Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA \<25 IU/mL.
Time frame: Week 4, 12, 48, 60, 72
Population: Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 60 | 0.3000 proportion of participants |
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 12 | 0.8000 proportion of participants |
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 72 | 0.3000 proportion of participants |
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 48 | 0.6000 proportion of participants |
| PF-00868554 200 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 4 | 0.6000 proportion of participants |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 48 | 0.7500 proportion of participants |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 60 | 0.5000 proportion of participants |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 72 | 0.5000 proportion of participants |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 12 | 0.8750 proportion of participants |
| PF-00868554 300 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 4 | 0.7500 proportion of participants |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 48 | 0.6250 proportion of participants |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 4 | 0.6250 proportion of participants |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 12 | 0.6250 proportion of participants |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 60 | 0.5000 proportion of participants |
| PF-00868554 500 mg + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 72 | 0.5000 proportion of participants |
| Placebo + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 60 | 0.5000 proportion of participants |
| Placebo + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 12 | 0.5000 proportion of participants |
| Placebo + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 4 | 0.0000 proportion of participants |
| Placebo + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 48 | 0.5000 proportion of participants |
| Placebo + pegIFN Alfa-2a/RBV | Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) | Week 72 | 0.5000 proportion of participants |
Comparison: Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [0.1565, 0.8785]
Comparison: Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [0.233, 0.969]
Comparison: Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [0.0871, 0.9191]
Comparison: Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.4769, 0.4336]
Comparison: Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.4024, 0.6049]
Comparison: Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.5729, 0.3149]
Comparison: Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.1836, 0.6931]
Comparison: Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.1732, 0.7797]
Comparison: Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.4024, 0.6049]
Comparison: Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.2934, 0.5917]
Comparison: Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.2913, 0.696]
Comparison: Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.5144, 0.388]
Comparison: Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.3728, 0.5414]
Comparison: Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.2913, 0.696]
Comparison: Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.4024, 0.6049]
Comparison: Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.4769, 0.4336]
Comparison: Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.4024, 0.6049]
Comparison: Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.5729, 0.3149]
Comparison: Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.6191, 0.2811]
Comparison: Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.507, 0.507]
Comparison: Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.507, 0.507]
Comparison: Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.6191, 0.2811]
Comparison: Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.507, 0.507]
Comparison: Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.6191, 0.2811]
Comparison: Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.6191, 0.2811]
Comparison: Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.507, 0.507]
Comparison: Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.507, 0.507]
Comparison: Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.6191, 0.2811]
Comparison: Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.507, 0.507]
Comparison: Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.95% CI: [-0.6191, 0.2811]