Hepatitis C
Conditions
Keywords
Hepatitis C, Telaprevir, Pegylated-interferon-alfa-2a, Pegasys, Ribavirin, Copegus
Brief summary
The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.
Detailed description
This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4. The study consists of 4 parts: Screening period (6-week); Investigational Treatment period (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo); Standard Treatment period (consists of 46 or 48-week standard treatment); and Follow-up period (24-week). The activity of telaprevir will be evaluated by early viral kinetic parameters along with viral response and pharmacokinetic assessments during the investigational treatment phase. Participants' safety will be monitored throughout the study.
Interventions
DRUGTelaprevir
Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.
Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.
DRUGPlacebo
Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.
DRUGRibavirin
Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.
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
- Participant has chronic Genotype 4 Hepatitis C infection * Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level greater than 10,000 International unit per milliliter (IU/mL) at Screening * Participant never received treatment for HCV * Participant was to be in good health (besides HCV infection), in the opinion of the Investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram \[ECG\]), with any chronic medical conditions under stable medical control * Participant had to be willing to refrain from the concomitant use of any medications or substances
Exclusion criteria
- Participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the Investigator's opinion would compromise the participant's safety and/or compliance with study procedures * Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection * Female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding * Participant has hypersensitivity to tartrazine * Participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 | Baseline and Day 15 | The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification \[LLOQ=25 IU/mL\] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to First Viral Response (Undetectable HCV RNA) | Up to Week 48/50 | Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected. |
| Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 8, Day 12, Day 15, Week 24/26 and Week 36/38 | Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable \[less than 25 IU/mL\]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group. |
| Percentage of Participants With Sustained Viral Response (SVR) | Week 12 and 24 after the last dose of study medication | Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication. |
| Percentage of Participants With Relapse | Week 24 after EOT (Week 48/50 or early discontinuation) | Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse. |
| Area Under the Serum Concentration-Time Curve (AUC) | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 | The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method. |
| Percentage of Participants With Viral Response (Undetectable HCV RNA) | Day 15 up to EOT (Week 48/50 or early discontinuation) | Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group. |
| Pre-Dose Serum Concentration (C[0h]) of Telaprevir | 0 hour (pre-dose) at Day 15 | The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). |
| Minimum Serum Concentration (Cmin) of Telaprevir on Day 15 | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15 | The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here. |
| Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 | The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test). |
| Average Steady-State Serum Concentration (Css,av) of Telaprevir | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 | The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). |
| Maximum Serum Concentration (Cmax) of Telaprevir | Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15 | The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50. | 8 |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. | 8 |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48. | 8 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 0 |
| Overall Study | Participant non-compliant | 0 | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Reached a virologic endpoint | 0 | 1 | 2 |
| Overall Study | Travel | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 8 Participants | 24 Participants |
| Age Continuous | 41 Years | 46 Years | 43 Years | 45.5 Years |
| Region of Enrollment France | 8 Participants | 8 Participants | 8 Participants | 24 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 5 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 8 / 8 | 8 / 8 |
| serious Total, serious adverse events | 1 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15
The plasma HCV RNA levels were used to assess the antiviral activity which included viral response as either undetectable HCV RNA (that is no HCV target was detected in the plasma sample) or less than 25 International unit per milliliter (IU/mL) of HCV RNA (that is Plasma sample contained HCV RNA at a concentration below the limit of quantification \[LLOQ=25 IU/mL\] of the viral load assay). Plasma HCV RNA levels were measured using the COBAS TaqMan HCV test Version 2.0. This assay used real-time reverse transcription-polymerase chain reaction (RT-PCR) methodology.
Time frame: Baseline and Day 15
Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 | HCV RNA levels: Change at Day 15 (n=7,8,8) | -0.77 log 10 IU/mL |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 | HCV RNA levels: Baseline (n=8,8,8) | 5.83 log 10 IU/mL |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 | HCV RNA levels: Baseline (n=8,8,8) | 6.16 log 10 IU/mL |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 | HCV RNA levels: Change at Day 15 (n=7,8,8) | -4.32 log 10 IU/mL |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 | HCV RNA levels: Change at Day 15 (n=7,8,8) | -1.58 log 10 IU/mL |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15 | HCV RNA levels: Baseline (n=8,8,8) | 5.88 log 10 IU/mL |
Secondary
Area Under the Serum Concentration-Time Curve (AUC)
The AUC is a measure of the serum concentration-time curve, calculated by the lin-up/log-down method.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
Population: Intent-to-treat (ITT) population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Area Under the Serum Concentration-Time Curve (AUC) | AUC : Day 1 (n=8, 7) | 6702 nanogram*hour/milliliter (ng*h/mL) | Standard Deviation 3284 |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Area Under the Serum Concentration-Time Curve (AUC) | AUC : Day 15 (n=7, 7) | 17120 nanogram*hour/milliliter (ng*h/mL) | Standard Deviation 3599 |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Area Under the Serum Concentration-Time Curve (AUC) | AUC : Day 1 (n=8, 7) | 7467 nanogram*hour/milliliter (ng*h/mL) | Standard Deviation 4684 |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Area Under the Serum Concentration-Time Curve (AUC) | AUC : Day 15 (n=7, 7) | 23320 nanogram*hour/milliliter (ng*h/mL) | Standard Deviation 7065 |
90% CI: [0.54, 1.78]
90% CI: [1.03, 1.72]
Secondary
Average Steady-State Serum Concentration (Css,av) of Telaprevir
The Average steady-state serum concentration (Css,av) was calculated by AUC/τ at steady-state (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Average Steady-State Serum Concentration (Css,av) of Telaprevir | 2141 Nanogram/milliliter (ng/mL) | Standard Deviation 438.5 |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Average Steady-State Serum Concentration (Css,av) of Telaprevir | 2896 Nanogram/milliliter (ng/mL) | Standard Deviation 842 |
Secondary
Maximum Serum Concentration (Cmax) of Telaprevir
The Cmax is the maximum observed serum concentration, which was measured at Day 1 and 15 for telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Maximum Serum Concentration (Cmax) of Telaprevir | Cmax: Day 1 (n=8, 8) | 1598 Nanogram/milliliter (ng/mL) | Standard Deviation 803.1 |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Maximum Serum Concentration (Cmax) of Telaprevir | Cmax: Day 15 (n=7, 7) | 2733 Nanogram/milliliter (ng/mL) | Standard Deviation 554.9 |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Maximum Serum Concentration (Cmax) of Telaprevir | Cmax: Day 1 (n=8, 8) | 1709 Nanogram/milliliter (ng/mL) | Standard Deviation 1017 |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Maximum Serum Concentration (Cmax) of Telaprevir | Cmax: Day 15 (n=7, 7) | 3669 Nanogram/milliliter (ng/mL) | Standard Deviation 1017 |
90% CI: [0.58, 1.72]
90% CI: [1.05, 1.66]
Secondary
Median Time to First Viral Response (Undetectable HCV RNA)
Time to first viral response (Undetectable HCV RNA) is defined as the number of days since the start of study medication until first time negative HCV RNA level that is less than 25 IU/mL was detected.
Time frame: Up to Week 48/50
Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Median Time to First Viral Response (Undetectable HCV RNA) | 93 Days |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Median Time to First Viral Response (Undetectable HCV RNA) | 85.50 Days |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Median Time to First Viral Response (Undetectable HCV RNA) | 128 Days |
Secondary
Minimum Serum Concentration (Cmin) of Telaprevir on Day 15
The Cmin is the minimum serum concentration between 0 hour and τ (τ=dosing interval) of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test). Cmin on Day 15 is reported here.
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15
Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Minimum Serum Concentration (Cmin) of Telaprevir on Day 15 | 1639 Nanogram/milliliter (ng/mL) | Standard Deviation 447.7 |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Minimum Serum Concentration (Cmin) of Telaprevir on Day 15 | 2100 Nanogram/milliliter (ng/mL) | Standard Deviation 796.3 |
90% CI: [0.88, 1.74]
Secondary
Number of Participants With Viral Breakthrough (Detectable HCV RNA)
Viral breakthrough was defined as having a confirmed increase greater than 1 log 10 in HCV RNA level from the lowest level reached, or a confirmed level of HCV RNA greater than 100 IU/mL in participants whose HCV RNA had previously become undetectable \[less than 25 IU/mL\]). In Week x/y, where, x represents time frame for Telaprevir+pegylated-interferon-alfa-2a+Ribavirin and Placebo+pegylated-interferon-alfa-2a+Ribavirin and y represents time frame for Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin treatment group.
Time frame: Day 8, Day 12, Day 15, Week 24/26 and Week 36/38
Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 12 | 3 Participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 15 | 5 Participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Week 24/26 | 5 Participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 8 | 1 Participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Week 36/38 | 5 Participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 12 | 0 Participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Week 36/38 | 2 Participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Week 24/26 | 0 Participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 15 | 0 Participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 8 | 0 Participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Week 36/38 | 1 Participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 15 | 0 Participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 8 | 0 Participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Day 12 | 0 Participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Number of Participants With Viral Breakthrough (Detectable HCV RNA) | Week 24/26 | 1 Participants |
Secondary
Percentage of Participants With Relapse
Relapse was defined as having confirmed detectable HCV RNA during the 24-week follow-up period in participants who had undetectable HCV RNA at EOT (Week 48/50 or early discontinuation). Participants who dropped out between 24-week follow-up after EOT were not evaluated for relapse.
Time frame: Week 24 after EOT (Week 48/50 or early discontinuation)
Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. N signifies those participants who were evaluated for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Relapse | 14.3 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Relapse | 33.3 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Relapse | 16.7 Percentage of participants |
Secondary
Percentage of Participants With Sustained Viral Response (SVR)
Sustained viral response was defined as having undetectable HCV RNA at EOT (Week 48/50 or early discontinuation) and no confirmed detectable HCV RNA levels between EOT and 12 weeks (SVR12) and 24 weeks (SVR24) after the last dose of study medication.
Time frame: Week 12 and 24 after the last dose of study medication
Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Sustained Viral Response (SVR) | SVR12 | 75.0 Percentage of participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Sustained Viral Response (SVR) | SVR24 | 62.5 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Sustained Viral Response (SVR) | SVR12 | 50.0 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Sustained Viral Response (SVR) | SVR24 | 50.0 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Sustained Viral Response (SVR) | SVR12 | 62.5 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Sustained Viral Response (SVR) | SVR24 | 62.5 Percentage of participants |
Secondary
Percentage of Participants With Viral Response (Undetectable HCV RNA)
Viral response was either defined as having undetectable HCV RNA (that is, no HCV RNA was detected in the participants' plasma samples) or less than 25 IU/mL HCV RNA from Day 15 up to end of treatment (EOT), that is Week 48/50 or early discontinuation. In Week x/y, where, x represents time frame for Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin and Placebo+Pegylated-interferon-alfa-2a+Ribavirin and; y represents time frame for Telaprevir and Pegylated-interferon-alfa-2a+Ribavirin treatment group.
Time frame: Day 15 up to EOT (Week 48/50 or early discontinuation)
Population: Full analysis included all randomized participants who received at least one dose of the telaprevir or placebo. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 36/38 (n=6, 8, 5) | 100 Percentage of participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Day 15 (n=7, 8, 8) | 0 Percentage of participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 4/6 (n=7, 8, 8) | 42.9 Percentage of participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 24/26 (n=6, 8, 8) | 100 Percentage of participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | EOT (n=8, 8, 8) | 87.5 Percentage of participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 48/50 (n=4, 7, 5) | 100 Percentage of participants |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 12/14 (n=7, 8, 7) | 85.7 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | EOT (n=8, 8, 8) | 75.0 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 48/50 (n=4, 7, 5) | 85.7 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Day 15 (n=7, 8, 8) | 12.5 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 4/6 (n=7, 8, 8) | 37.5 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 12/14 (n=7, 8, 7) | 75.0 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 24/26 (n=6, 8, 8) | 87.5 Percentage of participants |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 36/38 (n=6, 8, 5) | 75.0 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 36/38 (n=6, 8, 5) | 100 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 24/26 (n=6, 8, 8) | 62.5 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | EOT (n=8, 8, 8) | 75.0 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Day 15 (n=7, 8, 8) | 0 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 12/14 (n=7, 8, 7) | 57.1 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 4/6 (n=7, 8, 8) | 12.5 Percentage of participants |
| Placebo+Pegylated-interferon-alfa-2a+Ribavirin | Percentage of Participants With Viral Response (Undetectable HCV RNA) | Week 48/50 (n=4, 7, 5) | 100 Percentage of participants |
Secondary
Pre-Dose Serum Concentration (C[0h]) of Telaprevir
The C(0h) is the pre-dose serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and telaprevir+pegylated-interferon-alfa-2a+Ribavirin (test).
Time frame: 0 hour (pre-dose) at Day 15
Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. N signifies those participants who were evaluated for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Pre-Dose Serum Concentration (C[0h]) of Telaprevir | 1873 Nanogram/milliliter (ng/mL) | Standard Deviation 376.6 |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Pre-Dose Serum Concentration (C[0h]) of Telaprevir | 2806 Nanogram/milliliter (ng/mL) | Standard Deviation 1056 |
90% CI: [1.02, 2.02]
Secondary
Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir
The tmax is the time to reach maximum observed serum concentration of telaprevir and then pegylated-interferon-alfa-2a+Ribavirin (reference) and pegylated-interferon-alfa-2a+Ribavirin (test).
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
Population: ITT population included any randomized participant who received at least 1 dose of telaprevir/placebo. n signifies number of participants with data for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir | tmax: Day 1 (n=8, 8) | 4.02 Hours | Full Range 447.7 |
| Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin | Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir | tmax: Day 15 (n=7, 7) | 2.92 Hours | — |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir | tmax: Day 1 (n=8, 8) | 4.00 Hours | Full Range 796.3 |
| Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin | Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir | tmax: Day 15 (n=7, 7) | 3.00 Hours | — |