Hepatitis C
Conditions
Brief summary
To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.
Interventions
DRUGTelaprevir
Tablet
DRUGRibavirin
Tablet
DRUGPegylated Interferon Alfa-2a
Subcutaneous Injection
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female participants between the ages of 18 and 65 years * History of orthotopic liver transplantation less than 10 years before the Screening visit but no sooner than 6 months before Day 1 * Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months * Naive to pegylated interferon/ribavirin treatment or experienced with pegylated interferon/ribavirin prior to transplantation with relapse, partial, or null response
Exclusion criteria
* Documented cirrhosis after liver transplantation * Ascites or hepatic encephalopathy within 6 months before Screening * Retransplantation for recurrent hepatitis C * Treatment for hepatitis C post liver transplantation * History within the past 3 months of: rejection within 3 months or greater than (\>) 1 rejection within 12 months * Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (\<5 milligram per day) is permitted * History within 3 months of any bacterial infection requiring \>1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush) * History of post transplant lymphoproliferative disease * Acceptable laboratory values at Screening as specified in the protocol * Positive for human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA) antibody screen or Hepatitis B deoxyribonucleic acid (DNA) or Hepatitis B surface antigen * History of hepatocellular carcinoma with high risk of recurrence * Any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis C * Autoimmune-mediated disease * History of acute pancreatitis within 5 years before the Screening visit * Prior treatment with an hepatitis C virus (HCV) protease inhibitor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants 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 60) | SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants 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 72) | SVR24 was defined as an undetectable HCV 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 IU/mL. |
| Percentage of Participants 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. |
| Percentage of Participants 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. |
| Percentage of Participants With On-Treatment Virologic Failure | Baseline up to Week 48 | On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response. |
| Percentage of Participants With Viral Relapse | 48 weeks | — |
| Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications | 48 weeks | — |
| Percentage of Participants With Biopsy Confirmed and Treated Rejection | 48 weeks | — |
| Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage | 48 weeks | — |
| Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region | 48 weeks | — |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 52 | Any adverse change from the participant'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 (including placebo, if applicable) administered during the course of the study. |
| Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine) | 48 weeks | — |
Other
| Measure | Time frame |
|---|---|
| Percentage of Participants 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 52) |
Countries
Canada, United States
Participant flow
Recruitment details
Study included Treatment-Naïve (no prior hepatitis C virus \[HCV\] therapy); Prior Relapser (prior treatment with pegylated interferon alfa/ribavirin \[Peg-IFN/RBV\] and experienced viral relapse); Prior Null/Partial Responder (prior treatment with Peg-IFN/RBV and had null/partial response); Uncategorized (could not tolerate treatment) participants.
Pre-assignment details
Efficacy analyses were reported separately as per immunosuppressant regimen (reporting arms) and also separately as per prior response (in categories) (Treatment-Naive, Prior Relapser, Prior Null Responder, Prior Partial Responder, Uncategorized as well as for Total Participants), unless otherwise specified.
Participants by arm
| Arm | Count |
|---|---|
| T/PR + Immunosuppressant Regimen (Tacrolimus) Participants who were receiving TAC based immunosuppressant regimen at baseline, received 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. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion. | 51 |
| T/PR + Immunosuppressant Regimen (Cyclosporine) Participants who were receiving CsA based immunosuppressant regimen at baseline, received 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. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion. | 10 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Study Terminated by Sponsor | 28 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | T/PR + Immunosuppressant Regimen (Tacrolimus) | T/PR + Immunosuppressant Regimen (Cyclosporine) | Total |
|---|---|---|---|
| Age, Continuous | 56.8 Years STANDARD_DEVIATION 4.08 | 59.5 Years STANDARD_DEVIATION 2.95 | 57.3 Years STANDARD_DEVIATION 4.02 |
| Sex: Female, Male Female | 12 Participants | 0 Participants | 12 Participants |
| Sex: Female, Male Male | 39 Participants | 10 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 51 / 51 | 10 / 10 |
| serious Total, serious adverse events | 11 / 51 | 3 / 10 |
Outcome results
Primary
Percentage of Participants 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 (\<lower limit of quantification) at 12 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).
Time frame: 12 weeks after last planned dose of study drug (up to Week 60)
Population: Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Naive (n= 16, 2) | 75.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Prior Relapser (n= 10, 2) | 60.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Prior Null Responder (n=16, 4) | 37.5 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Prior Partial Responder (n= 3, 1) | 66.7 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Uncategorized (n= 6, 1) | 50.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Total (n= 51, 10) | 56.9 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Uncategorized (n= 6, 1) | 100.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Naive (n= 16, 2) | 50.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Prior Partial Responder (n= 3, 1) | 100.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Prior Relapser (n= 10, 2) | 100.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Total (n= 51, 10) | 70.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) | Prior Null Responder (n=16, 4) | 50.0 percentage of participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any adverse change from the participant'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 (including placebo, if applicable) administered during the course of the study.
Time frame: Baseline up to Week 52
Population: Safety Set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 51 participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 11 participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 10 participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 participants |
Secondary
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Time frame: 48 weeks
Population: Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.
Secondary
Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications
Time frame: 48 weeks
Population: Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.
Secondary
Percentage of Participants With Biopsy Confirmed and Treated Rejection
Time frame: 48 weeks
Population: Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.
Secondary
Percentage of Participants 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.
Time frame: Week 4 and Week 12
Population: Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Naive (n= 16, 2) | 68.8 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Prior Relapser (n= 10, 2) | 50.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Prior Null Responder (n=16, 4) | 37.5 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Prior Partial Responder (n= 3, 1) | 66.7 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Uncategorized (n= 6, 1) | 33.3 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Total (n= 51, 10) | 51.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Uncategorized (n= 6, 1) | 0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Naive (n= 16, 2) | 0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Prior Partial Responder (n= 3, 1) | 100.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Prior Relapser (n= 10, 2) | 50.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Total (n= 51, 10) | 30.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Extended Rapid Viral Response (eRVR) | Prior Null Responder (n=16, 4) | 25.0 percentage of participants |
Secondary
Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage
Time frame: 48 weeks
Population: Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.
Secondary
Percentage of Participants With On-Treatment Virologic Failure
On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.
Time frame: Baseline up to Week 48
Population: Safety Set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With On-Treatment Virologic Failure | 0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With On-Treatment Virologic Failure | 0 percentage of participants |
Secondary
Percentage of Participants 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.
Time frame: Week 4
Population: Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Rapid Viral Response (RVR) | Prior Partial Responder (n= 3, 1) | 66.7 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Rapid Viral Response (RVR) | Naive (n= 16, 2) | 68.8 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Rapid Viral Response (RVR) | Uncategorized (n= 6, 1) | 33.3 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Rapid Viral Response (RVR) | Prior Null Responder (n=16, 4) | 43.8 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Rapid Viral Response (RVR) | Total (n= 51, 10) | 52.9 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Rapid Viral Response (RVR) | Prior Relapser (n= 10, 2) | 50.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Rapid Viral Response (RVR) | Total (n= 51, 10) | 30.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Rapid Viral Response (RVR) | Prior Relapser (n= 10, 2) | 50.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Rapid Viral Response (RVR) | Prior Null Responder (n=16, 4) | 25.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Rapid Viral Response (RVR) | Prior Partial Responder (n= 3, 1) | 100.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Rapid Viral Response (RVR) | Uncategorized (n= 6, 1) | 0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Rapid Viral Response (RVR) | Naive (n= 16, 2) | 0 percentage of participants |
Secondary
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
SVR24 was defined as an undetectable HCV 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 IU/mL.
Time frame: 24 weeks after last planned dose of study drug (up to Week 72)
Population: Safety Set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified category for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Naive (n= 5,1) | 60.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Prior Relapser (n= 4,1) | 25.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Prior Null Responder (n=10, 4) | 20.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Prior Partial Responder (n= 0, 1) | 0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Uncategorized (n= 5, 0) | 20.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Tacrolimus) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Total (n= 24, 7) | 29.2 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Uncategorized (n= 5, 0) | 0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Naive (n= 5,1) | 0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Prior Partial Responder (n= 0, 1) | 100.0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Prior Relapser (n= 4,1) | 0 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Total (n= 24, 7) | 42.9 percentage of participants |
| T/PR + Immunosuppressant Regimen (Cyclosporine) | Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) | Prior Null Responder (n=10, 4) | 50.0 percentage of participants |
Secondary
Percentage of Participants With Viral Relapse
Time frame: 48 weeks
Population: Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.
Secondary
Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)
Time frame: 48 weeks
Population: Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.
Other Pre-specified
Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
Time frame: 4 weeks after last planned dose of study drug (up to Week 52)
Population: Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.