Phase 3
Completed N=106
A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01288209 ↗
Enrolled (actual)
106
Serious AEs
4.7%
Results posted
Jan 2014
Primary outcomePrimary: The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12) — 52.8; 35.8 Percentage of participants
Summary
The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12) |
52.8; 35.8 | — |
| SECONDARY The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24) |
50.9; 35.8 | — |
| SECONDARY The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up |
96.2; 96.2; 100; 100; 100; 96.2 | — |
| SECONDARY The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT) |
58.5; 50.9; 84.9; 79.2; 79.2; 71.7 | — |
| SECONDARY The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During Treatment for Participants Who Did Not Achieve Undetectable Plasma HCV RNA Levels at Week 12 |
0.0; 0.0; 0.0; 0.0; NA; NA | — |
| SECONDARY The Number of Participants With Viral Breakthrough During the Study |
7; 6 | — |
| SECONDARY The Number of Participants Demonstrating Viral Relapse During the Study |
17; 23 | — |
| SECONDARY The Number Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT) |
20; 28 | — |
| SECONDARY The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFNα-2a) and Ribavirin (RBV) at Week 24 |
81.1; 73.6 | — |
| SECONDARY Plasma Concentrations of TMC435 |
1844; 910; NA; 866; 1784; 906 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435 |
62993; 39867; NA; 38931; 62313; 40014 | — |
Eligibility Criteria
Inclusion Criteria
- Participant must have chronic genotype 1 HCV infection with HCV RNA level >= 5.0 log10 IU/mL
- Participant failed to respond to previous IFN-based therapy
- Participant must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication.
Exclusion Criteria
- Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)
- Diagnosed with hepatic cirrhosis or hepatic failure
- A medical condition which is a contraindication to PegIFNα-2a or ribavirin therapy
- History of, or any current medical condition which could impact the safety of the patient in the study
Data sourced from ClinicalTrials.gov (NCT01288209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.