FindTrial
Sign In

A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00882908
Acronym
PILLAR
Enrollment
386
Registered
2009-04-17
Start date
2009-06-30
Completion date
2011-04-30
Last updated
2014-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C, TMC435, Peginterferon alpha-2a, PegIFNalpha-2a, RBV, Ribavirin, Placebo

Brief summary

The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less than 25 IU per mL undetectable\] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.

Detailed description

This is a randomized (study medication assigned by chance), 5-arm, double-blind (neither investigator nor the participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study) study to compare the efficacy, tolerability and safety of different TMC435 regimens combined with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) versus PegIFNα-2a plus RBV alone in adult treatment-naive patients with chronic genotype 1 HCV infection. The study mainly consists of 3 phases: screening phase (approximately 6 weeks), treatment phase (up to 48 weeks), and follow up phase (up to 48 weeks). In the treatment phase, patients will be divided in to 5 different arms in a 1:1:1:1:1 randomized ratio. In treatment arms 1 and 2, patients will receive 12 weeks of therapy with TMC435 along with PegIFNα 2a and RBV followed by treatment with PegIFNα 2a, RBV, and TMC435-matched placebo. In treatment arms 3 and 4, patients will receive 24 weeks of therapy with TMC435, PegIFNα 2a, and RBV. In treatment arm 5 (control group), patients will receive PegIFNα 2a and RBV for 48 weeks and TMC435 matched placebo for the first 24 weeks. Collection of blood samples for efficacy evaluations will be done at scheduled visits throughout the study. Safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study. The total duration of the study will be up to approximately 72 weeks after initiation of treatment.

Interventions

DRUGTMC435

TMC435 will be administered as one or two 75 mg capsules orally, once daily, for 12 or 24 weeks.

DRUGRibavirin (R)

Ribavirin (R) will be administered as 200 mg tablets (5 to 6 tablets) orally, twice daily, for 48 weeks.

DRUGPegIFNα-2a (P)

PegIFNα-2a (P) 180 micrograms will be administered as a subcutaneous (under the skin) injection, once weekly for 48 weeks.

DRUGPlacebo

Placebo capsules identical in appearance to TMC435 capsule will be administered orally, once daily, for 48 weeks.

Sponsors

Tibotec Pharmaceuticals, Ireland
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients with documented chronic genotype-1 hepatitis C infection and with plasma HCV RNA of \> 100,000 IU/mL at screening * Patients that have not been treated before for HCV * Patients that are of childbearing potential or have a partner of childbearing potential should agree to use 2 effective methods of contraception

Exclusion criteria

* Patients with cirrhosis or evidence of hepatic decompensation * Co-infection with the human immunodeficiency virus (HIV) * Any contraindication to Pegasys or Copegus therapy * History of, or any current medical condition which could impact the safety of the patient in the study

Design outcomes

Primary

MeasureTime frameDescription
The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)Week 72The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.

Secondary

MeasureTime frameDescription
The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).
The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentBaseline (Day 1) and Weeks, 2, 4, 8, and 12The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment.
The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)Week 48 or 72The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT.
The Percentage of Participants Achieving a Rapid Virologic Response (RVR)Week 4The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.
The Percentage of Participants Achieving an Early Virologic Response (EVR)Baseline (Day 1) and Week 12The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.
The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)Week 12The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.
The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).
Number of Participants With Viral BreakthroughWeek 24 or 48The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable).
The Number of Participants With Viral RelapseUp to Week 72The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.
The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)Baseline (Day 1) up to Week 24 or 48The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT.
Plasma Concentrations of TMC435Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups.
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups. Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure).
The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)Up to Week 36 or 52The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT.

Countries

Australia, Austria, Belgium, Canada, Denmark, France, Germany, New Zealand, Norway, Poland, Russia, Spain, United States

Participant flow

Recruitment details

The study was conducted at 79 sites in 13 countries: Australia, New Zealand, Canada, Austria, Belgium, Germany, Spain, France, Poland, Russia, Norway, Denmark, and the United States. Approximately 68% of participants were enrolled in Europe, 21% in North America, and 11% in Australia/New Zealand.

Pre-assignment details

In total, 506 participants were screened; 388 participants were randomized of whom 386 participants started treatment. Two randomized participants did not start treatment due to withdrawal of consent.

Participants by arm

ArmCount
TMC435 75 mg 12 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
78
TMC435 75 mg 24 Wks + PR 24/48
Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
75
TMC435 150 mg 12 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
77
TMC435 150 mg 24 Wks + PR 24/48
Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
79
Placebo 24 Wks + PR48
Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
77
Total386

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyAdverse Event00101
Overall StudyLost to Follow-up35312
Overall StudyProtocol Violation01000
Overall StudyStudy terminated in error00010
Overall StudySubject reached a virologic endpoint00001
Overall StudyWithdrawal by Subject00352

Baseline characteristics

CharacteristicTMC435 75 mg 12 Wks + PR 24/48TMC435 75 mg 24 Wks + PR 24/48TMC435 150 mg 12 Wks + PR 24/48TMC435 150 mg 24 Wks + PR 24/48Placebo 24 Wks + PR48Total
Age, Continuous47 years46 years47 years47 years45 years46.5 years
Region of Enrollment
Asia Pacific
9 participants9 participants7 participants13 participants4 participants42 participants
Region of Enrollment
Europe
52 participants52 participants56 participants44 participants58 participants262 participants
Region of Enrollment
North-America
17 participants14 participants14 participants22 participants15 participants82 participants
Sex: Female, Male
Female
38 Participants28 Participants34 Participants35 Participants38 Participants173 Participants
Sex: Female, Male
Male
40 Participants47 Participants43 Participants44 Participants39 Participants213 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —
other
Total, other adverse events
76 / 7875 / 7574 / 7777 / 7975 / 77
serious
Total, serious adverse events
9 / 784 / 754 / 773 / 7910 / 77

Outcome results

Primary

The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)

The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.

Time frame: Week 72

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)80.8 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)70.7 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)77.9 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)84.8 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)64.9 Percentage of participants
Comparison: TMC435 75 mg 12 and 24 week treatment groups were pooled and the percentage of participants acheiving SVRW72 were compared with the percentage of participants acheiving SVRW72 in the placebo treatment group.p-value: 0.05197.5% CI: [-1.9, 28]Regression, Logistic
Comparison: TMC/PR 150 mg 12 and 24 week treatment groups were pooled and the percentage of participants achieving SVRW72 was compared the percentage of participants achieving SVRW72 in the placebo treatment group.p-value: 0.00497.5% CI: [4.4, 33.5]Regression, Logistic
Secondary

Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435

The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups. Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure).

Time frame: Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24

Population: Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.

ArmMeasureValue (MEDIAN)
TMC435 75 mg 12 Wks + PR 24/48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC4359926.4 ng*h/mL
TMC435 75 mg 24 Wks + PR 24/48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC4358976.8 ng*h/mL
TMC435 150 mg 12 Wks + PR 24/48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC43539884.0 ng*h/mL
TMC435 150 mg 24 Wks + PR 24/48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC43536038.8 ng*h/mL
Secondary

Number of Participants With Viral Breakthrough

The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable).

Time frame: Week 24 or 48

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48Number of Participants With Viral Breakthrough5 Participants
TMC435 75 mg 24 Wks + PR 24/48Number of Participants With Viral Breakthrough2 Participants
TMC435 150 mg 12 Wks + PR 24/48Number of Participants With Viral Breakthrough6 Participants
TMC435 150 mg 24 Wks + PR 24/48Number of Participants With Viral Breakthrough2 Participants
Placebo 24 Wks + PR48Number of Participants With Viral Breakthrough4 Participants
Secondary

Plasma Concentrations of TMC435

The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups.

Time frame: Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24

Population: Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.

ArmMeasureGroupValue (MEDIAN)
TMC435 75 mg 12 Wks + PR 24/48Plasma Concentrations of TMC435Coh240.9 ng/mL
TMC435 75 mg 12 Wks + PR 24/48Plasma Concentrations of TMC435Css, av413.6 ng/mL
TMC435 75 mg 24 Wks + PR 24/48Plasma Concentrations of TMC435Css, av374.0 ng/mL
TMC435 75 mg 24 Wks + PR 24/48Plasma Concentrations of TMC435Coh213.6 ng/mL
TMC435 150 mg 12 Wks + PR 24/48Plasma Concentrations of TMC435Coh1123.3 ng/mL
TMC435 150 mg 12 Wks + PR 24/48Plasma Concentrations of TMC435Css, av1661.8 ng/mL
TMC435 150 mg 24 Wks + PR 24/48Plasma Concentrations of TMC435Coh1176.7 ng/mL
TMC435 150 mg 24 Wks + PR 24/48Plasma Concentrations of TMC435Css, av1501.6 ng/mL
Secondary

The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)

The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT.

Time frame: Baseline (Day 1) up to Week 24 or 48

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)39 Participants
TMC435 75 mg 24 Wks + PR 24/48The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)37 Participants
TMC435 150 mg 12 Wks + PR 24/48The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)39 Participants
TMC435 150 mg 24 Wks + PR 24/48The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)35 Participants
Placebo 24 Wks + PR48The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)150 Participants
Secondary

The Number of Participants With Viral Relapse

The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.

Time frame: Up to Week 72

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Number of Participants With Viral Relapse8 Participants
TMC435 75 mg 24 Wks + PR 24/48The Number of Participants With Viral Relapse14 Participants
TMC435 150 mg 12 Wks + PR 24/48The Number of Participants With Viral Relapse6 Participants
TMC435 150 mg 24 Wks + PR 24/48The Number of Participants With Viral Relapse6 Participants
Placebo 24 Wks + PR48The Number of Participants With Viral Relapse11 Participants
Secondary

The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)

The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.

Time frame: Week 12

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)91.0 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)93.3 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)93.5 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)94.9 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)55.8 Percentage of participants
Secondary

The Percentage of Participants Achieving an Early Virologic Response (EVR)

The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.

Time frame: Baseline (Day 1) and Week 12

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving an Early Virologic Response (EVR)97.4 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving an Early Virologic Response (EVR)96.0 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving an Early Virologic Response (EVR)96.1 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving an Early Virologic Response (EVR)96.2 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving an Early Virologic Response (EVR)89.6 Percentage of participants
Secondary

The Percentage of Participants Achieving a Rapid Virologic Response (RVR)

The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.

Time frame: Week 4

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)75.6 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)68.0 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)75.3 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)74.7 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)5.2 Percentage of participants
Secondary

The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)

The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT.

Time frame: Up to Week 36 or 52

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)83.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)76.0 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)80.5 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)86.1 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)66.2 Percentage of participants
Secondary

The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment

The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment.

Time frame: Baseline (Day 1) and Weeks, 2, 4, 8, and 12

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureGroupValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 293.6 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 494.9 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 897.4 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 1297.4 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 298.7 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 1296.0 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 498.7 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 897.3 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 1296.1 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 497.4 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 897.4 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 297.4 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 298.7 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 493.7 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 1296.2 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 894.9 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 1289.6 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 884.4 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 471.4 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During TreatmentWeek 240.3 Percentage of participants
Secondary

The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up

The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).

Time frame: Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureGroupValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 887.2 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)92.3 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 1291.0 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 7279.5 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 6079.5 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 475.6 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 239.7 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 4879.5 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 3685.9 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 2492.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 468.0 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 230.7 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 890.7 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 1293.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 2493.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 3681.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 4877.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 6068.0 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 7270.7 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)97.3 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 3681.8 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 7277.9 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 892.2 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 1293.5 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 475.3 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 2484.4 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 4879.2 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 223.4 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)92.2 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 6075.3 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 474.7 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)93.7 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 239.2 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 893.7 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 3684.8 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 6083.5 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 7282.3 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 4882.3 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 1294.9 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 2487.3 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 1255.8 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 7264.9 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 2477.9 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 3676.6 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)79.2 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 4874.0 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 22.6 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 6063.6 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 826.0 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-upWeek 45.2 Percentage of participants
Secondary

The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)

The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT.

Time frame: Week 48 or 72

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)82.1 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)74.7 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)80.5 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)86.1 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)64.9 Percentage of participants
Secondary

The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up

The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).

Time frame: Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)

Population: The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.

ArmMeasureGroupValue (NUMBER)
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 893.6 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)93.6 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1293.6 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7279.5 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6079.5 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 485.9 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 265.4 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4879.5 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3685.9 Percentage of participants
TMC435 75 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2492.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 488.0 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 266.7 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 894.7 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1294.7 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2493.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3681.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4877.3 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6068.0 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7270.7 Percentage of participants
TMC435 75 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)97.3 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3681.8 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7277.9 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 893.5 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1296.1 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 490.9 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2484.4 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4879.2 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 275.3 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)92.2 Percentage of participants
TMC435 150 mg 12 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6075.3 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 491.1 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)96.2 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 278.5 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 893.7 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3684.8 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6083.5 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7283.5 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4882.3 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1294.9 Percentage of participants
TMC435 150 mg 24 Wks + PR 24/48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2489.9 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1266.2 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7264.9 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2480.5 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3679.2 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 24 or 48)83.1 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4875.3 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 25.2 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6064.9 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 849.4 Percentage of participants
Placebo 24 Wks + PR48The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 415.6 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026