Hepatitis C, Chronic
Conditions
Keywords
VX-950, INCIVEK, INCIVO
Brief summary
The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.
Interventions
DRUGTelaprevir
Tablet
DRUGPegylated Interferon Alfa-2a
Subcutaneous Injection
DRUGRibavirin
Tablet
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects, 18 to 70 years of age, inclusive * Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration * Subjects have IL28B CC genotype determined during screening * Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required
Exclusion criteria
* Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C * Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment * Subjects have evidence of hepatic decompensation * Subjects have evidence of cirrhosis * Subjects have diagnosed or suspected hepatocellular carcinoma * Subjects have any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. Steatosis is allowed if clinically asymptomatic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | 12 weeks after last planned dose of study drug (up to Week 36) | SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | 24 weeks after last planned dose of study drug (up to Week 48) | SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups. |
| Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72) | Week 72 | SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups. |
| Percentage of Subjects With Viral Relapse | After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up | Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (\<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups. |
| Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4) | 4 weeks after last planned dose of study drug (up to Week 28) | SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups. |
| Number of Subjects With Rapid Viral Response (RVR) | Week 4 | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups. |
| Number of Subjects With Extended Rapid Viral Response (eRVR) | Week 4 and Week 12 | The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups. |
| Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 48 | AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study. |
| Percentage of Subjects With On-Treatment Virologic Failure | Baseline up to Week 48 | On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well. |
Countries
Austria, Canada, Germany, Israel, Poland, United States
Participant flow
Pre-assignment details
Subjects received telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a)/ ribavirin (RBV). Planned duration of telaprevir treatment was 12 weeks. Minimum planned duration of Peg-IFN-alfa-2a/RBV treatment was 12 weeks; however, was dependent on virologic response during initial 12 weeks of telaprevir plus Peg-IFN-alfa-2a/RBV.
Participants by arm
| Arm | Count |
|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment. | 106 |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. | 52 |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. | 19 |
| Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned. | 61 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 3 |
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Did Not Meet Inclusion Criteria | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 4 | 1 | 8 |
| Overall Study | Non- Compliance | 0 | 0 | 0 | 3 |
| Overall Study | Other | 0 | 0 | 3 | 1 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 |
| Overall Study | Study Terminated by Sponsor | 30 | 15 | 9 | 11 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) | Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 12.82 | 44.8 years STANDARD_DEVIATION 12.89 | 54.4 years STANDARD_DEVIATION 8.7 | 49.8 years STANDARD_DEVIATION 10.56 | 47.4 years STANDARD_DEVIATION 12.26 |
| Sex: Female, Male Female | 39 Participants | 16 Participants | 11 Participants | 29 Participants | 95 Participants |
| Sex: Female, Male Male | 67 Participants | 36 Participants | 8 Participants | 32 Participants | 143 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 | 104 / 106 | 51 / 52 | 19 / 19 | 61 / 62 |
| serious Total, serious adverse events | 5 / 106 | 4 / 52 | 3 / 19 | 13 / 62 |
Outcome results
Primary
Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups.
Time frame: 12 weeks after last planned dose of study drug (up to Week 36)
Population: Full Analysis (FA) Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | 88.7 percentage of participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | 96.2 percentage of participants |
Secondary
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study.
Time frame: Baseline up to Week 48
Population: Safety set included all subjects who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 104 participants |
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 5 participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 51 participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 19 participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 participants |
| Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 61 participants |
| Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) | Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 13 participants |
Secondary
Number of Subjects With Extended Rapid Viral Response (eRVR)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups.
Time frame: Week 4 and Week 12
Population: FA Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Number of Subjects With Extended Rapid Viral Response (eRVR) | 105 participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Number of Subjects With Extended Rapid Viral Response (eRVR) | 51 participants |
Secondary
Number of Subjects With Rapid Viral Response (RVR)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups.
Time frame: Week 4
Population: FA Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Number of Subjects With Rapid Viral Response (RVR) | 106 participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Number of Subjects With Rapid Viral Response (RVR) | 52 participants |
Secondary
Percentage of Subjects With On-Treatment Virologic Failure
On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.
Time frame: Baseline up to Week 48
Population: FA Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Percentage of Subjects With On-Treatment Virologic Failure | 0 percentage of participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Percentage of Subjects With On-Treatment Virologic Failure | 0 percentage of participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) | Percentage of Subjects With On-Treatment Virologic Failure | 0 percentage of participants |
| Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) | Percentage of Subjects With On-Treatment Virologic Failure | 3.3 percentage of participants |
| Telaprevir+Peg-IFN-alfa-2a, RBV (Total) | Percentage of Subjects With On-Treatment Virologic Failure | 0.8 percentage of participants |
Secondary
Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups.
Time frame: 24 weeks after last planned dose of study drug (up to Week 48)
Population: FA Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | 85.8 percentage of participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | 92.3 percentage of participants |
Secondary
Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups.
Time frame: 4 weeks after last planned dose of study drug (up to Week 28)
Population: FA Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4) | 89.6 percentage of participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4) | 98.1 percentage of participants |
Secondary
Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups.
Time frame: Week 72
Population: FA Set. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to 'Study Terminated by the Sponsor' are excluded from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72) | 72.4 percentage of participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72) | 86.5 percentage of participants |
Secondary
Percentage of Subjects With Viral Relapse
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (\<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups.
Time frame: After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up
Population: FA Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Percentage of Subjects With Viral Relapse | 4 Weeks | 1.9 percentage of participants |
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Percentage of Subjects With Viral Relapse | 12 Weeks | 7.5 percentage of participants |
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Percentage of Subjects With Viral Relapse | 24 Weeks | 10.4 percentage of participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Percentage of Subjects With Viral Relapse | 4 Weeks | 0.0 percentage of participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Percentage of Subjects With Viral Relapse | 12 Weeks | 0.0 percentage of participants |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Percentage of Subjects With Viral Relapse | 24 Weeks | 0.0 percentage of participants |