Phase 2
Completed N=386
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
Source: ClinicalTrials.gov NCT00882908 ↗Enrolled (actual)
386
Serious AEs
7.8%
Results posted
Jun 2014
Primary outcomePrimary: The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72) — 80.8; 70.7; 77.9; 84.8 Percentage of participants — p=0.051
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72) |
80.8; 70.7; 77.9; 84.8; 64.9 | 0.051 |
| 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 |
39.7; 30.7; 23.4; 39.2; 2.6; 75.6 | — |
| 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 |
65.4; 66.7; 75.3; 78.5; 5.2; 85.9 | — |
| 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 |
93.6; 98.7; 97.4; 98.7; 40.3; 94.9 | — |
| SECONDARY The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) |
82.1; 74.7; 80.5; 86.1; 64.9 | — |
| SECONDARY The Percentage of Participants Achieving a Rapid Virologic Response (RVR) |
75.6; 68.0; 75.3; 74.7; 5.2 | — |
| SECONDARY The Percentage of Participants Achieving an Early Virologic Response (EVR) |
97.4; 96.0; 96.1; 96.2; 89.6 | — |
| SECONDARY The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR) |
91.0; 93.3; 93.5; 94.9; 55.8 | — |
| SECONDARY The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) |
83.3; 76.0; 80.5; 86.1; 66.2 | — |
| SECONDARY Number of Participants With Viral Breakthrough |
5; 2; 6; 2; 4 | — |
| SECONDARY The Number of Participants With Viral Relapse |
8; 14; 6; 6; 11 | — |
| SECONDARY The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT) |
39; 37; 39; 35; 150 | — |
| SECONDARY Plasma Concentrations of TMC435 |
240.9; 213.6; 1123.3; 1176.7; 413.6; 374.0 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435 |
9926.4; 8976.8; 39884.0; 36038.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00882908). 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.