Hepatitis C, Chronic
Conditions
Keywords
Hepatitis C, Chronic, Telaprevir, Roll-over study
Brief summary
The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.
Detailed description
This is an open-label (i.e all people involved know the identity of the intervention), single-arm, roll-over trial of telaprevir in combination with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV). The purpose of the trial is to provide access to telaprevir for patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred to as C216 trial hereafter) and who failed therapy for virologic reasons. The efficacy, safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV will be evaluated. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein associated with the hepatitis C virus) protease domain will be evaluated. The trial will consist of a screening period of approximately 28 days, a 48-week treatment period, and a 24-week follow-up period. It is expected that approximately 120 patients could be eligible for enrollment. Since the C216 trial is blinded until all patients reach Week 72 (or have discontinued earlier), patients can only enter the current trial upon invitation. The investigator will receive an invitation sent by the unblinded independent virology monitor of the C216 trial for those patients of the C216 trial who were randomized to the control group and who failed therapy for virologic reasons. Next to this invitation, the patient will need to fulfill the inclusion and exclusion criteria of the current trial in order to be eligible to participate. The screening visit for the current trial can only occur after the patient completes all assessments in the C216 trial, including the Safety Follow-up Visit. Patients must not enter this trial later than 80 weeks after their first dose in the C216 trial. In the current trial, all patients will receive 12 weeks of telaprevir 750 mg every 8 hours (q8h) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly and 1,000 or 1,200 mg/day (weight based), respectively, followed by 36 weeks of Peg IFN alfa 2a and RBV at standard doses. Patients with hepatitis C virus RNA levels \< 25 IU/mL undetectable at the end of treatment (Week 48 or having discontinued earlier) will be followed for 24 weeks after the last dose of study medication to assess sustained virologic response (SVR). Safety/tolerability assessments will be performed and adverse events (AEs), regardless of severity, will be collected continuously until the Safety Follow-up Visit, scheduled 4 weeks after the last dose of study medication. Thereafter, only serious adverse events (SAEs) will be reported. All patients will receive 12 weeks of telaprevir 750 mg q8h (orally) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly (injection) and 1,000 or 1,200 mg/day (weight-based) (orally), respectively, followed by 36 weeks of Peg IFN alfa-2a and RBV at standard doses.
Interventions
DRUGTelaprevir
750 mg orally every 8 hours (q8h) for 12 weeks
180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.
DRUGribavirin (RBV)
1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.
Sponsors
Vertex Pharmaceuticals Incorporated
Janssen Infectious Diseases BVBA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient from the control group of the C216 study who failed therapy for virologic reasons * Patient must have completed all assessments in the C216 trial * Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion criteria
* Patient received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial * Patient has history of decompensated liver disease * Patient has history of acute or chronic pancreatitis * Patient has condition that requires use of systemic corticosteroids * Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment * Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) | End of trial (24 weeks after last dose, administerd at 48 weeks) | The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \< 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of \< 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8 | Week 4, Week 8 | The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value \>100 IU/mL. |
| Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 12 or Weeks 24 or 36 | The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of \>100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of \>=25 IU/mL. |
| Percentage of Participants Achieving Rapid Virologic Response (RVR) | Week 4 | The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA values of \<25 IU/mL, target not detected at Week 4 of treatment). |
| Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) | Weeks 4 and 12 | The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA values of \<25 IU/mL, target not detected at at Weeks 4 and 12 of treatment). |
| The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation) | The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values. |
| Percentage of Participants Who Relapsed During Follow-Up | During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks) | The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] during the 24-week follow-up period after previous HCV RNA \<25 IU/mL, target not detected, at end of treatment). |
| Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Baseline, Weeks 4, 8, 12, 24, 36, 48 | The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time. |
| Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Baseline, Weeks 4, 8, 12, 24, 36, and 48 | The table below shows change from baseline in log 10 plasma HCV RNA values measured over time. |
| Percentage of Participants With Viral Breakthrough | Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase) | The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase \>1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is \> 25 IU/mL, or a confirmed value of HCV RNA \>100 IU/mL in participants whose HCV RNA had previously become \<25 IU/mL (detected or target not detected) during the considered treatment phase. |
Countries
Australia, Belgium, Brazil, Canada, France, Germany, Israel, Netherlands, Poland, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
A total of 90 participants were enrolled and received treatment in the study: 9 participants from Phase 1 studies VX04-950-101 or Study VX05-950-103 and 81 participants from the Phase 3 study VX-950-TiDP24-C216 (NCT00703118) (referred to as the parent studies). The current study was conducted in 16 countries including the United States.
Pre-assignment details
This study provided participants with access to telaprevir who were randomized to the control group in a previous Phase 3 study and failed therapy with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV) or to participants who received telaprevir as monotherapy or in combination with Peg-IFN-alfa-2a in 2 previous Phase 1 studies.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: T12(Q8h)/PR T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. | 9 |
| Phase 3: T12(Q8h)/PR - Prior Null Responder T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. | 32 |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. | 22 |
| Phase 3: T12(Q8h)/PR - Prior Relapser T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. | 27 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Phase 1: T12(Q8h)/PR | Phase 3: T12(Q8h)/PR - Prior Null Responder | Phase 3: T12(Q8h)/PR - Prior Partial Responder | Phase 3: T12(Q8h)/PR - Prior Relapser | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 0 Participants | 7 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 30 Participants | 22 Participants | 20 Participants | 80 Participants |
| Age Continuous | 52 years | 51.5 years | 50.5 years | 55 years | 53 years |
| Region of Enrollment Europe | 9 participants | 18 participants | 10 participants | 14 participants | 51 participants |
| Region of Enrollment North America | 0 participants | 12 participants | 7 participants | 4 participants | 23 participants |
| Region of Enrollment Other | 0 participants | 2 participants | 5 participants | 9 participants | 16 participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 7 Participants | 8 Participants | 28 Participants |
| Sex: Female, Male Male | 5 Participants | 23 Participants | 15 Participants | 19 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 9 | 77 / 81 |
| serious Total, serious adverse events | 0 / 9 | 5 / 81 |
Outcome results
Primary
The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)
The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \< 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of \< 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.
Time frame: End of trial (24 weeks after last dose, administerd at 48 weeks)
Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) | 34.4 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) | 72.7 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Relapser | The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) | 81.5 Percentage of participants with response |
| Phase 1: T12(Q8h)/PR | The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) | 44.4 Percentage of participants with response |
Secondary
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
The table below shows change from baseline in log 10 plasma HCV RNA values measured over time.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 4 (n=32, 22, 26, and 9) | -5.39 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 8 (n=32, 22, 26, and 9) | -5.51 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 12 (n=31, 22, 26, 9) | -5.40 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 24 (n=23, 20, 24, and 8) | -5.89 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 36 (n=18, 19, 23, and 7) | -5.95 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 48 (n=15, 16, 21, and 7) | -6.03 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 48 (n=15, 16, 21, and 7) | -5.88 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 24 (n=23, 20, 24, and 8) | -5.72 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 4 (n=32, 22, 26, and 9) | -5.83 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 12 (n=31, 22, 26, 9) | -5.88 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 8 (n=32, 22, 26, and 9) | -5.88 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 36 (n=18, 19, 23, and 7) | -5.86 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 8 (n=32, 22, 26, and 9) | -5.62 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 12 (n=31, 22, 26, 9) | -5.62 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 24 (n=23, 20, 24, and 8) | -5.75 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 48 (n=15, 16, 21, and 7) | -5.71 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 36 (n=18, 19, 23, and 7) | -5.78 log 10 IU/ml |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 4 (n=32, 22, 26, and 9) | -5.59 log 10 IU/ml |
| Phase 1: T12(Q8h)/PR | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 36 (n=18, 19, 23, and 7) | -6.07 log 10 IU/ml |
| Phase 1: T12(Q8h)/PR | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 48 (n=15, 16, 21, and 7) | -6.07 log 10 IU/ml |
| Phase 1: T12(Q8h)/PR | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 8 (n=32, 22, 26, and 9) | -5.96 log 10 IU/ml |
| Phase 1: T12(Q8h)/PR | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 24 (n=23, 20, 24, and 8) | -5.87 log 10 IU/ml |
| Phase 1: T12(Q8h)/PR | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 4 (n=32, 22, 26, and 9) | -5.55 log 10 IU/ml |
| Phase 1: T12(Q8h)/PR | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level | Week 12 (n=31, 22, 26, 9) | -5.96 log 10 IU/ml |
Secondary
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, 48
Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Baseline (n=32, 22, 27, and 9) | 6.63 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 4 (n=32, 22, 26, and 9) | 1.24 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 24 (n=23, 20, 26, and 8) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 8 (n=32, 22, 26, and 9) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 36 (n=18, 19, 23, and 7) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 12 (n=31, 22, 26, and 9) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 48 (n=16, 16, 21, and 7) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 12 (n=31, 22, 26, and 9) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 24 (n=23, 20, 26, and 8) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Baseline (n=32, 22, 27, and 9) | 6.72 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 48 (n=16, 16, 21, and 7) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 36 (n=18, 19, 23, and 7) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 4 (n=32, 22, 26, and 9) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 8 (n=32, 22, 26, and 9) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 4 (n=32, 22, 26, and 9) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 8 (n=32, 22, 26, and 9) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Baseline (n=32, 22, 27, and 9) | 6.48 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 12 (n=31, 22, 26, and 9) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 24 (n=23, 20, 26, and 8) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 36 (n=18, 19, 23, and 7) | 0.70 Log 10 IU/mL |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 48 (n=16, 16, 21, and 7) | 0.70 Log 10 IU/mL |
| Phase 1: T12(Q8h)/PR | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Baseline (n=32, 22, 27, and 9) | 6.76 Log 10 IU/mL |
| Phase 1: T12(Q8h)/PR | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 48 (n=16, 16, 21, and 7) | 0.70 Log 10 IU/mL |
| Phase 1: T12(Q8h)/PR | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 36 (n=18, 19, 23, and 7) | 0.70 Log 10 IU/mL |
| Phase 1: T12(Q8h)/PR | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 8 (n=32, 22, 26, and 9) | 0.70 Log 10 IU/mL |
| Phase 1: T12(Q8h)/PR | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 4 (n=32, 22, 26, and 9) | 1.24 Log 10 IU/mL |
| Phase 1: T12(Q8h)/PR | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 24 (n=23, 20, 26, and 8) | 0.70 Log 10 IU/mL |
| Phase 1: T12(Q8h)/PR | Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time | Week 12 (n=31, 22, 26, and 9) | 0.70 Log 10 IU/mL |
Secondary
Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)
The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA values of \<25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).
Time frame: Weeks 4 and 12
Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) | 34.4 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) | 72.7 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) | 85.2 Percentage of participants |
| Phase 1: T12(Q8h)/PR | Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) | 33.3 Percentage of participants |
Secondary
Percentage of Participants Achieving Rapid Virologic Response (RVR)
The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA values of \<25 IU/mL, target not detected at Week 4 of treatment).
Time frame: Week 4
Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Percentage of Participants Achieving Rapid Virologic Response (RVR) | 37.5 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Percentage of Participants Achieving Rapid Virologic Response (RVR) | 77.3 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Percentage of Participants Achieving Rapid Virologic Response (RVR) | 85.2 Percentage of participants |
| Phase 1: T12(Q8h)/PR | Percentage of Participants Achieving Rapid Virologic Response (RVR) | 33.3 Percentage of participants |
Secondary
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of \>100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of \>=25 IU/mL.
Time frame: Week 12 or Weeks 24 or 36
Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 12 | 31.2 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 36 | 9.4 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 24 | 9.4 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 12 | 4.5 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 36 | 0 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 24 | 9.1 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 24 | 3.7 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 12 | 0 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 36 | 0 Percentage of participants |
| Phase 1: T12(Q8h)/PR | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 12 | 11.1 Percentage of participants |
| Phase 1: T12(Q8h)/PR | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 36 | 0 Percentage of participants |
| Phase 1: T12(Q8h)/PR | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 | Week 24 | 11.1 Percentage of participants |
Secondary
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8
The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value \>100 IU/mL.
Time frame: Week 4, Week 8
Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8 | 28.1 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8 | 4.5 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8 | 3.7 Percentage of participants |
| Phase 1: T12(Q8h)/PR | Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8 | 11.1 Percentage of participants |
Secondary
Percentage of Participants Who Relapsed During Follow-Up
The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] during the 24-week follow-up period after previous HCV RNA \<25 IU/mL, target not detected, at end of treatment).
Time frame: During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)
Population: The analysis was performed on the full analysis (FA) set, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Percentage of Participants Who Relapsed During Follow-Up | 21.4 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Percentage of Participants Who Relapsed During Follow-Up | 5.3 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Percentage of Participants Who Relapsed During Follow-Up | 4.0 Percentage of participants |
| Phase 1: T12(Q8h)/PR | Percentage of Participants Who Relapsed During Follow-Up | 28.6 Percentage of participants |
Secondary
Percentage of Participants With Viral Breakthrough
The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase \>1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is \> 25 IU/mL, or a confirmed value of HCV RNA \>100 IU/mL in participants whose HCV RNA had previously become \<25 IU/mL (detected or target not detected) during the considered treatment phase.
Time frame: Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)
Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Percentage of Participants With Viral Breakthrough | Week 12 (Telaprevir Treatment Phase) | 15.6 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | Percentage of Participants With Viral Breakthrough | Week 48 (Period After Telaprevir Intake) | 25.0 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Percentage of Participants With Viral Breakthrough | Week 12 (Telaprevir Treatment Phase) | 4.5 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | Percentage of Participants With Viral Breakthrough | Week 48 (Period After Telaprevir Intake) | 9.1 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Percentage of Participants With Viral Breakthrough | Week 48 (Period After Telaprevir Intake) | 3.7 Percentage of participants |
| Phase 3: T12(Q8h)/PR - Prior Relapser | Percentage of Participants With Viral Breakthrough | Week 12 (Telaprevir Treatment Phase) | 0.0 Percentage of participants |
| Phase 1: T12(Q8h)/PR | Percentage of Participants With Viral Breakthrough | Week 48 (Period After Telaprevir Intake) | 11.1 Percentage of participants |
| Phase 1: T12(Q8h)/PR | Percentage of Participants With Viral Breakthrough | Week 12 (Telaprevir Treatment Phase) | 11.1 Percentage of participants |
Secondary
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)
Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 3: T12(Q8h)/PR - Prior Null Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 24 | 50.0 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 4 | 37.5 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 36 | 43.8 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | End of Treatment | 43.8 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 8 | 56.3 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Basline | 0 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 12 | 59.4 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Null Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 48 | 43.8 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 12 | 90.9 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 24 | 77.3 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Basline | 0 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 8 | 86.4 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | End of Treatment | 86.4 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 4 | 77.3 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 48 | 72.7 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Partial Responder | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 36 | 81.8 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Relapser | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | End of Treatment | 92.6 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Relapser | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 8 | 92.6 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Relapser | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Basline | 0 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Relapser | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 4 | 85.2 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Relapser | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 12 | 92.6 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Relapser | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 24 | 85.2 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Relapser | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 36 | 85.2 Percentage of participants with response |
| Phase 3: T12(Q8h)/PR - Prior Relapser | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 48 | 85.2 Percentage of participants with response |
| Phase 1: T12(Q8h)/PR | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 36 | 77.8 Percentage of participants with response |
| Phase 1: T12(Q8h)/PR | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 12 | 66.7 Percentage of participants with response |
| Phase 1: T12(Q8h)/PR | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 8 | 66.7 Percentage of participants with response |
| Phase 1: T12(Q8h)/PR | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | End of Treatment | 77.8 Percentage of participants with response |
| Phase 1: T12(Q8h)/PR | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 48 | 77.8 Percentage of participants with response |
| Phase 1: T12(Q8h)/PR | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 4 | 33.3 Percentage of participants with response |
| Phase 1: T12(Q8h)/PR | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Week 24 | 66.7 Percentage of participants with response |
| Phase 1: T12(Q8h)/PR | The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points | Basline | 0 Percentage of participants with response |