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A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard 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 PegIFNa-2a and Ribavirin in HCV Genotype 1 Infected Subjects Who Failed Previous Standard Therapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00980330
Acronym
ASPIRE
Enrollment
463
Registered
2009-09-21
Start date
2009-10-31
Completion date
2011-08-31
Last updated
2014-06-09

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, Peginterferon alpha-2a, PegIFNalpha-2a, RBV, Ribavirin, Placebo, TMC435-TIDP16-C206, TMC435-C206, TMC435, HCV

Brief summary

The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).

Detailed description

The study is a randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled Phase IIb trial with TMC435 in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who have failed standard treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV). The study will compare the efficacy, tolerability and safety of different regimens with TMC435 combined with standard treatment (Peg-INF-alfa-2a and RBV) versus standard treatment alone. The trial will consist of a screening period of maximum 6 weeks, a 48-week treatment period, and a 24-week follow-up period. Participants will be eligible to enroll in the trial if they failed to respond to a prior course of standard treatment or relapsed following standard treatment. Participants will be randomly assigned to receive TMC435 with standard treatment for 12 weeks followed by standard treatment (plus placebo) for 36 weeks, TMC435 (100 mg or 150 mg once a day) with standard treatment for 24 weeks followed by standard treatment (plus placebo) for 24 weeks, TMC435 (100 mg or 150 mg once a day) with standard treatment for 48 weeks, or a placebo with standard treatment for 48 weeks.

Interventions

DRUGPeg-IFN-alfa-2a (P)

180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.

DRUGTMC435

One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.

DRUGPlacebo

One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.

DRUGRibavirin (R)

1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken 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

* Must have chronic hepatitis C infection as evidenced by liver biopsy, anti-hepatitis C virus (HCV) and HCV RNA positive * Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater than10000 IU/mL * Patient must have failed at least 1 prior course of peg interferon (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment) * Must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion criteria

* Has an evidence of decompensated liver disease * Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV) * Has a medical condition which is a contraindication to Peg-INF or RBV therapy * Have had 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 the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)Week 72The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.

Secondary

MeasureTime frameDescription
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)The table below shows the percentage of participants in each treatment who achieved plasma HCV RNA levels of \<25 IU/mL undetectable at selected time points during treatment and follow-up and at the end of treatment (EOT).
The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (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 an undetectable plasma Hepatitis C virus ribonucleic acid level after receiving 4 weeks of treatment.
The Percentage of Participants Achieving an Early Virologic Response (EVR)Week 12The table below shows the percentage of participants who achieved an EVR, defined as having a greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline 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 levels of Hepatitis C virus ribonucleic acid at Week 12.
The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeeks, 2, 4, 8, and 12The table below shows the percentage of participants in each treatment group who achieved a greater than 2 log10 drop in plasma levels of HCV RNA at selected time points during treatment.
The Percentage of Participants With Viral BreakthroughEOT (up to Week 48)The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of \> 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable).
The Percentage of Participants With Viral RelapseUp to Week 72The table below shows the percentage of participants in the overall population who had viral relapse, defined as confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with HCV RNA less than 25 IU/mL undetectable at end of treatment.
The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)EOT (up to Week 48)The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48).
Plasma Concentrations of TMC4350 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for TMC435 for participants in each of the 6 TMC435 treatment groups.
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC4350 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48The table below shows the median (range) AUC24h values for TMC435 for participants in each TMC435 treatment group.
The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)Week 60The table below shows the percentage of participants in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT.

Countries

Australia, Austria, Belgium, Canada, France, Germany, Israel, New Zealand, Norway, Poland, Portugal, Russia, United Kingdom, United States

Participant flow

Recruitment details

The study was conducted at 89 sites in 14 countries.

Pre-assignment details

A total of 618 participants were screened. Of these, 463 participants were randomized of whom 462 participants started treatment. One participant in the placebo group was 'randomized in error,' did not receive treatment, and was withdrawn from the study due to non-compliance (did not come for visit).

Participants by arm

ArmCount
TMC435 100mg 12 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
66
TMC435 100mg 24 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
65
TMC435 100mg 48 Wks + PR48
Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
66
TMC435 150mg 12 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
66
TMC435 150mg 24 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
68
TMC435 150mg 48 Wks + PR48
Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
65
Placebo 48Wks + PR48
Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
66
Total462

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Overall StudyAdverse Event0001000
Overall StudyLost to Follow-up1142112
Overall Study(not specified)2001110
Overall StudyWithdrawal by Subject2441325

Baseline characteristics

CharacteristicTotalPlacebo 48Wks + PR48TMC435 150mg 48 Wks + PR48TMC435 150mg 24 Wks + PR48TMC435 100mg 12 Wks + PR48TMC435 150mg 12 Wks + PR48TMC435 100mg 48 Wks + PR48TMC435 100mg 24 Wks + PR48
Age, Continuous50 years50.5 years50 years51.5 years51.5 years48 years50 years50 years
Metavir Score
Not reported
7 participants2 participants1 participants1 participants1 participants0 participants0 participants2 participants
Metavir Score
Score F0
39 participants7 participants1 participants11 participants6 participants5 participants6 participants3 participants
Metavir Score
Score F1
129 participants18 participants27 participants11 participants17 participants19 participants23 participants14 participants
Metavir Score
Score F2
118 participants16 participants16 participants21 participants21 participants18 participants9 participants17 participants
Metavir Score
Score F3
86 participants13 participants7 participants11 participants14 participants11 participants14 participants16 participants
Metavir Score
Score F4
83 participants10 participants13 participants13 participants7 participants13 participants14 participants13 participants
Prior PR response
Null responder
117 participants16 participants17 participants17 participants16 participants17 participants18 participants16 participants
Prior PR response
Partial responder
160 participants23 participants22 participants24 participants23 participants23 participants22 participants23 participants
Prior PR response
Relapser
185 participants27 participants26 participants27 participants27 participants26 participants26 participants26 participants
Region of Enrollment
Asia Pacific
29 participants7 participants4 participants1 participants4 participants4 participants4 participants5 participants
Region of Enrollment
Europe and Israel
313 participants46 participants43 participants49 participants34 participants49 participants46 participants46 participants
Region of Enrollment
North-America
120 participants13 participants18 participants18 participants28 participants13 participants16 participants14 participants
Sex: Female, Male
Female
151 Participants24 Participants17 Participants25 Participants22 Participants21 Participants21 Participants21 Participants
Sex: Female, Male
Male
311 Participants42 Participants48 Participants43 Participants44 Participants45 Participants45 Participants44 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
63 / 6661 / 6565 / 6663 / 6665 / 6863 / 6563 / 66
serious
Total, serious adverse events
3 / 665 / 653 / 667 / 665 / 688 / 654 / 66

Outcome results

Primary

The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)

The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.

Time frame: Week 72

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)69.7 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)66.2 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)60.6 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)66.7 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)72.1 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)80.0 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)22.7 Percentage of participants
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 TMC435 treatment group.

Time frame: 0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48

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 100mg 12 Wks + PR48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC43516587.0 ng.h/mL
TMC435 100mg 24 Wks + PR48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC43518492.5 ng.h/mL
TMC435 100mg 48 Wks + PR48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC43521409.0 ng.h/mL
TMC435 150mg 12 Wks + PR48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC43547061.8 ng.h/mL
TMC435 150mg 24 Wks + PR48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC43543015.0 ng.h/mL
TMC435 150mg 48 Wks + PR48Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC43538564.5 ng.h/mL
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 TMC435 for participants in each of the 6 TMC435 treatment groups.

Time frame: 0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48

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 100mg 12 Wks + PR48Plasma Concentrations of TMC435Css,av691.1 ng/mL
TMC435 100mg 12 Wks + PR48Plasma Concentrations of TMC435C0h380.5 ng/mL
TMC435 100mg 24 Wks + PR48Plasma Concentrations of TMC435C0h411.3 ng/mL
TMC435 100mg 24 Wks + PR48Plasma Concentrations of TMC435Css,av770.5 ng/mL
TMC435 100mg 48 Wks + PR48Plasma Concentrations of TMC435C0h529.8 ng/mL
TMC435 100mg 48 Wks + PR48Plasma Concentrations of TMC435Css,av892.0 ng/mL
TMC435 150mg 12 Wks + PR48Plasma Concentrations of TMC435C0h1323.5 ng/mL
TMC435 150mg 12 Wks + PR48Plasma Concentrations of TMC435Css,av1960.9 ng/mL
TMC435 150mg 24 Wks + PR48Plasma Concentrations of TMC435C0h1074.0 ng/mL
TMC435 150mg 24 Wks + PR48Plasma Concentrations of TMC435Css,av1792.3 ng/mL
TMC435 150mg 48 Wks + PR48Plasma Concentrations of TMC435Css,av1606.9 ng/mL
TMC435 150mg 48 Wks + PR48Plasma Concentrations of TMC435C0h886.1 ng/mL
Secondary

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

The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48).

Time frame: EOT (up to Week 48)

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)26 Percentage of participants
TMC435 100mg 24 Wks + PR48The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)37 Percentage of participants
TMC435 100mg 48 Wks + PR48The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)31 Percentage of participants
TMC435 150mg 12 Wks + PR48The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)23 Percentage of participants
TMC435 150mg 24 Wks + PR48The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)31 Percentage of participants
TMC435 150mg 48 Wks + PR48The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)33 Percentage of participants
Placebo 48Wks + PR48The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)181 Percentage of 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 levels of Hepatitis C virus ribonucleic acid at Week 12.

Time frame: Week 12

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)81.8 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)73.8 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)72.7 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)80.3 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)85.3 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)83.1 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)19.7 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 greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline at Week 12.

Time frame: Week 12

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving an Early Virologic Response (EVR)90.9 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving an Early Virologic Response (EVR)87.7 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving an Early Virologic Response (EVR)84.8 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving an Early Virologic Response (EVR)92.4 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving an Early Virologic Response (EVR)91.2 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving an Early Virologic Response (EVR)92.3 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving an Early Virologic Response (EVR)60.6 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 an undetectable plasma Hepatitis C virus ribonucleic acid level after receiving 4 weeks of treatment.

Time frame: Week 4

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)66.7 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)58.5 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)53.0 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)62.1 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)67.6 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)66.2 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving a Rapid Virologic Response (RVR)1.5 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 in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT.

Time frame: Week 60

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)69.7 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)67.7 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)60.6 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)66.7 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)72.1 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)80.0 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)22.7 Percentage of participants
Secondary

The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <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 HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (EOT).

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

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureGroupValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7269.7 Percentage of Participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 478.8 Percentage of Participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1287.9 Percentage of Participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6071.2 Percentage of Participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2484.8 Percentage of Participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4883.3 Percentage of Participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 48)86.4 Percentage of Participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3681.8 Percentage of Participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 887.9 Percentage of Participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 260.6 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 881.5 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7266.2 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 255.4 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1281.5 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2478.5 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3673.8 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6067.7 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 48)81.5 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 472.3 Percentage of Participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4873.8 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3678.8 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 254.5 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 48)81.8 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 481.8 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4874.2 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 884.8 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7260.6 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1283.3 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2480.3 Percentage of Participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6060.6 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 48)89.4 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 887.9 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 486.4 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 263.6 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3681.8 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2486.4 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4878.8 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6066.7 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1289.4 Percentage of Participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7266.7 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7273.5 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 260.3 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 482.4 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 889.7 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1288.2 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2486.8 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3686.8 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4882.4 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6072.1 Percentage of Participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 48)89.7 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 887.7 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6078.5 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7280.0 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 486.2 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3684.6 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 266.2 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2489.2 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1289.2 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4881.5 Percentage of Participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 48)89.2 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 4840.9 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 2450.0 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 6022.7 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 1234.8 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 812.1 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 43.0 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 23.0 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 7222.7 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upEOT (up to Week 48)47.0 Percentage of Participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-upWeek 3643.9 Percentage of Participants
Secondary

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

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

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

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureGroupValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 48)80.3 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 222.7 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 6069.7 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 7269.7 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 877.3 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 466.7 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 4881.8 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 1281.8 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 3678.8 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 2481.8 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 2475.4 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 1273.8 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 48)78.5 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 7266.2 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 458.5 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 218.5 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 6067.7 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 4873.8 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 875.4 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 3673.8 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 877.3 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 215.2 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 453.0 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 1272.7 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 2478.8 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 3678.8 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 4874.2 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 6059.1 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 7260.6 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 48)80.3 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 224.2 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 2483.3 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 884.8 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 3680.3 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 48)80.3 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 4875.8 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 462.1 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 6066.7 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 7266.7 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 1280.3 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 3683.8 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 48)83.8 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 2486.8 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 6072.1 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 1285.3 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 7273.5 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 4880.9 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 467.6 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 883.8 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 232.4 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 3681.5 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 883.1 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 4881.5 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 466.2 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 1283.1 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 6076.9 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 227.7 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 48)86.2 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 7280.0 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 2486.2 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 6022.7 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 41.5 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 1219.7 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 3639.4 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 2442.4 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 4837.9 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 20.0 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 7222.7 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upEOT (up to Week 48)40.9 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-upWeek 87.6 Percentage of participants
Secondary

The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment

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

Time frame: Weeks, 2, 4, 8, and 12

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureGroupValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 297.0 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 492.4 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 892.4 Percentage of participants
TMC435 100mg 12 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 1290.9 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 1287.7 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 889.2 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 293.8 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 493.8 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 889.4 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 492.4 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 297.0 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 1284.8 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 2100.0 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 497.0 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 893.9 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 1292.4 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 295.6 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 1291.2 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 491.2 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 891.2 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 496.9 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 296.9 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 895.4 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 1292.3 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 857.6 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 224.2 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 436.4 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During TreatmentWeek 1260.6 Percentage of participants
Secondary

The Percentage of Participants With Viral Breakthrough

The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of \> 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable).

Time frame: EOT (up to Week 48)

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants With Viral Breakthrough10.6 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants With Viral Breakthrough13.8 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants With Viral Breakthrough13.6 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants With Viral Breakthrough9.1 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants With Viral Breakthrough10.3 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants With Viral Breakthrough7.7 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants With Viral Breakthrough1.5 Percentage of participants
Secondary

The Percentage of Participants With Viral Relapse

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

Time frame: Up to Week 72

Population: Intent-to-treat: Participants who received at least 1 dose of study medication were included.

ArmMeasureValue (NUMBER)
TMC435 100mg 12 Wks + PR48The Percentage of Participants With Viral Relapse9.3 Percentage of participants
TMC435 100mg 24 Wks + PR48The Percentage of Participants With Viral Relapse13.7 Percentage of participants
TMC435 100mg 48 Wks + PR48The Percentage of Participants With Viral Relapse18.0 Percentage of participants
TMC435 150mg 12 Wks + PR48The Percentage of Participants With Viral Relapse11.8 Percentage of participants
TMC435 150mg 24 Wks + PR48The Percentage of Participants With Viral Relapse14.0 Percentage of participants
TMC435 150mg 48 Wks + PR48The Percentage of Participants With Viral Relapse5.5 Percentage of participants
Placebo 48Wks + PR48The Percentage of Participants With Viral Relapse44.4 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026