Hepatitis C, Chronic
Conditions
Keywords
Hepatitis C, Chronic, Genotype 2, Genotype 3, Telaprevir
Brief summary
The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.
Detailed description
This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.
Interventions
DRUGTelaprevir
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
DRUGPeg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
DRUGPlacebo
Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
Sponsors
Tibotec BVBA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants chronically infected with genotype 2 or 3 hepatitis C virus (HCV) with amount of virus in the blood greater than 10,000 international units per milliliter (IU/ml) * Participants who were never treated for hepatitis C virus infection * Participants without any significant lab abnormalities * Participants who agree to the use of two effective methods of contraception * Participant who were judged to be in good health
Exclusion criteria
* Participants who had contraindications for starting anti-HCV therapy * Participants who had history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease or hepatocellular carcinoma (type of cancer) * Participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis B virus * Females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding * Participants who have hypersensitivity to tartrazine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr) | The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax. |
| Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Baseline, Pre-dose (Day 15) | Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology. |
| Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr]) | The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml). |
| Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr) | The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation) | Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable). |
| Median Time to Virological Response (HCV RNA Level < 10 IU/ml) | Baseline up to EOT | Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) | The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. |
| Percentage of Participants Who Achieved Sustained Virological Response (SVR) | Week 12, 24 after EOT | The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Percentage of Participants Who Demonstrated Virological Relapse | 24 weeks after EOT | Relapse was defined as confirmed detectable HCV RNA (\>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (\< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (\>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (\< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (\< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Percentage of Participants With Viral Breakthrough | Baseline, Day 12, 15 and Week 24/26 | Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA \> 100 IU/ml in participants whose HCV RNA had previously become undetectable (\< 10 IU/ml) or unquantifiable (\< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 | Baseline and Week 24/26 | Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) | The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml. |
| Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) | The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml. |
Countries
France, Sweden, United Kingdom
Participant flow
Pre-assignment details
Out of 26 participants infected with genotype 2 hepatitis C virus (HCV) who were randomly assigned to treatment, only 23 participants received treatment. 2 participants withdrew and 1 participant was infected with HCV genotype 4. All the 26 participants infected with genotype 3 HCV received treatment.
Participants by arm
| Arm | Count |
|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | 9 |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | 5 |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | 9 |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | 8 |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | 9 |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | 9 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 0 | 1 | 0 | 3 |
| Overall Study | Participant non-compliance | 2 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 5 Participants | 9 Participants | 8 Participants | 9 Participants | 9 Participants | 49 Participants |
| Age Continuous | 42.3 years STANDARD_DEVIATION 10.63 | 56.6 years STANDARD_DEVIATION 5.13 | 49.8 years STANDARD_DEVIATION 10.33 | 43.4 years STANDARD_DEVIATION 9.62 | 42.4 years STANDARD_DEVIATION 7.75 | 39.8 years STANDARD_DEVIATION 13.76 | 44.9 years STANDARD_DEVIATION 10.97 |
| Region of Enrollment France | 7 participants | 5 participants | 6 participants | 3 participants | 4 participants | 3 participants | 28 participants |
| Region of Enrollment Italy | 1 participants | 0 participants | 2 participants | 0 participants | 0 participants | 1 participants | 4 participants |
| Region of Enrollment Sweden | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment United Kingdom | 1 participants | 0 participants | 0 participants | 5 participants | 5 participants | 5 participants | 16 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 4 Participants | 3 Participants | 1 Participants | 0 Participants | 14 Participants |
| Sex: Female, Male Male | 7 Participants | 1 Participants | 5 Participants | 5 Participants | 8 Participants | 9 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 9 | 4 / 5 | 8 / 9 | 7 / 8 | 9 / 9 | 8 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 5 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1
The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.
Time frame: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 | 7980 ng*hr/ml | Standard Deviation 4658 |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 | 11248 ng*hr/ml | Standard Deviation 3810 |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 | 6938 ng*hr/ml | Standard Deviation 1828 |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 | 6979 ng*hr/ml | Standard Deviation 5011 |
Primary
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15
Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology.
Time frame: Baseline, Pre-dose (Day 15)
Population: Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of TVR or placebo.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Baseline | 6.61 log10 IU/ml |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Change at Day 15 | -3.66 log10 IU/ml |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Baseline | 6.21 log10 IU/ml |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Change at Day 15 | -5.51 log10 IU/ml |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Baseline | 6.15 log10 IU/ml |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Change at Day 15 | -4.83 log10 IU/ml |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Baseline | 6.65 log10 IU/ml |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Change at Day 15 | -0.54 log10 IU/ml |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Baseline | 6.79 log10 IU/ml |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Change at Day 15 | -4.85 log10 IU/ml |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Baseline | 6.92 log10 IU/ml |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 | Change at Day 15 | -4.72 log10 IU/ml |
Primary
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1
The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).
Time frame: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 | 1886 ng/ml | Standard Deviation 1043 |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 | 2462 ng/ml | Standard Deviation 761 |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 | 1497 ng/ml | Standard Deviation 435 |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 | 1588 ng/ml | Standard Deviation 1090 |
Primary
Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1
The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax.
Time frame: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 | 3.0 hr |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 | 4.0 hr |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 | 4.0 hr |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 | 4.0 hr |
Secondary
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15
The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.
Time frame: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 | 20144 ng*hr/ml | Standard Deviation 11129 |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 | 26588 ng*hr/ml | Standard Deviation 10908 |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 | 18480 ng*hr/ml | Standard Deviation 3011 |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 | 20895 ng*hr/ml | Standard Deviation 6242 |
Secondary
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26
Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Time frame: Baseline and Week 24/26
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 | -5.91 log10 IU/ml |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 | -5.51 log10 IU/ml |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 | -5.45 log10 IU/ml |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 | -5.71 log10 IU/ml |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 | -5.50 log10 IU/ml |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 | -6.22 log10 IU/ml |
Secondary
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15
The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml.
Time frame: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 | 3261 ng/ml | Standard Deviation 1818 |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 | 4318 ng/ml | Standard Deviation 1518 |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 | 2898 ng/ml | Standard Deviation 423 |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 | 3358 ng/ml | Standard Deviation 377 |
Secondary
Median Time to Virological Response (HCV RNA Level < 10 IU/ml)
Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Time frame: Baseline up to EOT
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Median Time to Virological Response (HCV RNA Level < 10 IU/ml) | 31.0 days |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Median Time to Virological Response (HCV RNA Level < 10 IU/ml) | 12.0 days |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Median Time to Virological Response (HCV RNA Level < 10 IU/ml) | 43.0 days |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Median Time to Virological Response (HCV RNA Level < 10 IU/ml) | 99.0 days |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Median Time to Virological Response (HCV RNA Level < 10 IU/ml) | 43.0 days |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Median Time to Virological Response (HCV RNA Level < 10 IU/ml) | 29.0 days |
Secondary
Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15
The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml.
Time frame: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 | 1605 ng/ml | Standard Deviation 1106 |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 | 2164 ng/ml | Standard Deviation 1398 |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 | 1800 ng/ml | Standard Deviation 375 |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 | 2002 ng/ml | Standard Deviation 659 |
Secondary
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)
Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable).
Time frame: Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'n' included those participants who were evaluable for this measure at specific time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | EOT (n=9,5,9,8,9,9) | 88.9 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 12 (n=8,5,9,8,9,9) | 0.00 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 14 (n=7,5,9,8,9,9) | 100 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 4 (n=7,5,9,8,9,9) | 71.4 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 24/ Week 26 (n=7,5,9,8,7,9) | 100 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 15 (n=9,5,9,8,9,9) | 0.00 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 6 (n=7,5,9,8,9,9) | 71.4 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 14 (n=7,5,9,8,9,9) | 100.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 6 (n=7,5,9,8,9,9) | 100.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | EOT (n=9,5,9,8,9,9) | 100.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 12 (n=8,5,9,8,9,9) | 60.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 24/ Week 26 (n=7,5,9,8,7,9) | 100.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 15 (n=9,5,9,8,9,9) | 40.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 4 (n=7,5,9,8,9,9) | 80.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | EOT (n=9,5,9,8,9,9) | 88.9 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 4 (n=7,5,9,8,9,9) | 44.4 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 15 (n=9,5,9,8,9,9) | 22.2 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 6 (n=7,5,9,8,9,9) | 77.8 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 12 (n=8,5,9,8,9,9) | 0.00 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 24/ Week 26 (n=7,5,9,8,7,9) | 88.9 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 14 (n=7,5,9,8,9,9) | 88.9 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 14 (n=7,5,9,8,9,9) | 75.0 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 12 (n=8,5,9,8,9,9) | 0.00 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 15 (n=9,5,9,8,9,9) | 0.00 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 4 (n=7,5,9,8,9,9) | 0.00 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 6 (n=7,5,9,8,9,9) | 37.5 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 24/ Week 26 (n=7,5,9,8,7,9) | 75.0 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | EOT (n=9,5,9,8,9,9) | 75.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 15 (n=9,5,9,8,9,9) | 22.2 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 4 (n=7,5,9,8,9,9) | 33.3 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 14 (n=7,5,9,8,9,9) | 100 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 12 (n=8,5,9,8,9,9) | 11.1 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | EOT (n=9,5,9,8,9,9) | 100 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 6 (n=7,5,9,8,9,9) | 66.7 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 24/ Week 26 (n=7,5,9,8,7,9) | 100 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 6 (n=7,5,9,8,9,9) | 100 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 12 (n=8,5,9,8,9,9) | 22.2 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 24/ Week 26 (n=7,5,9,8,7,9) | 100 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 14 (n=7,5,9,8,9,9) | 100 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Day 15 (n=9,5,9,8,9,9) | 11.1 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | EOT (n=9,5,9,8,9,9) | 100 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) | Week 4 (n=7,5,9,8,9,9) | 66.7 percentage of participants |
Secondary
Percentage of Participants Who Achieved Sustained Virological Response (SVR)
The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Time frame: Week 12, 24 after EOT
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 12 | 66.7 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 24 | 55.6 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 12 | 100 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 24 | 100 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 24 | 88.9 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 12 | 88.9 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 12 | 50.0 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 24 | 50.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 24 | 66.7 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 12 | 66.7 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 12 | 44.4 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Who Achieved Sustained Virological Response (SVR) | SVR 24 | 44.4 percentage of participants |
Secondary
Percentage of Participants Who Demonstrated Virological Relapse
Relapse was defined as confirmed detectable HCV RNA (\>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (\< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (\>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (\< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (\< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Time frame: 24 weeks after EOT
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Who Demonstrated Virological Relapse | Missing follow-up | 0.0 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants Who Demonstrated Virological Relapse | 24 weeks after EOT | 12.5 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Who Demonstrated Virological Relapse | Missing follow-up | 0.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants Who Demonstrated Virological Relapse | 24 weeks after EOT | 0.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Who Demonstrated Virological Relapse | Missing follow-up | 0.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants Who Demonstrated Virological Relapse | 24 weeks after EOT | 0.0 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Who Demonstrated Virological Relapse | Missing follow-up | 0.0 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants Who Demonstrated Virological Relapse | 24 weeks after EOT | 33.3 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Who Demonstrated Virological Relapse | 24 weeks after EOT | 33.3 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants Who Demonstrated Virological Relapse | Missing follow-up | 0.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Who Demonstrated Virological Relapse | Missing follow-up | 11.1 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants Who Demonstrated Virological Relapse | 24 weeks after EOT | 22.2 percentage of participants |
Secondary
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA \> 100 IU/ml in participants whose HCV RNA had previously become undetectable (\< 10 IU/ml) or unquantifiable (\< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Time frame: Baseline, Day 12, 15 and Week 24/26
Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants With Viral Breakthrough | Day 15 | 66.7 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants With Viral Breakthrough | Week 24/ Week 26 | 66.7 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | Percentage of Participants With Viral Breakthrough | Day 12 | 11.1 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants With Viral Breakthrough | Week 24/ Week 26 | 0.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants With Viral Breakthrough | Day 15 | 0.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Percentage of Participants With Viral Breakthrough | Day 12 | 0.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants With Viral Breakthrough | Day 15 | 0.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants With Viral Breakthrough | Day 12 | 0.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | Percentage of Participants With Viral Breakthrough | Week 24/ Week 26 | 11.1 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants With Viral Breakthrough | Day 12 | 37.5 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants With Viral Breakthrough | Week 24/ Week 26 | 37.5 percentage of participants |
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | Percentage of Participants With Viral Breakthrough | Day 15 | 37.5 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants With Viral Breakthrough | Day 12 | 0.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants With Viral Breakthrough | Day 15 | 0.0 percentage of participants |
| TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Percentage of Participants With Viral Breakthrough | Week 24/ Week 26 | 0.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants With Viral Breakthrough | Day 15 | 0.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants With Viral Breakthrough | Week 24/ Week 26 | 0.0 percentage of participants |
| Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Percentage of Participants With Viral Breakthrough | Day 12 | 0.0 percentage of participants |