Phase 3
Completed N=106
A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1
Hepatitis C Virus Genotype-1
Source: ClinicalTrials.gov NCT01479868 ↗
Enrolled (actual)
106
Serious AEs
10.4%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12) — 73.6 percentage of participants
Summary
The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12) |
73.6 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24) |
72.6 | — |
| SECONDARY Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable |
65.7; 88.6; 94.8; 97.9; 90.0; 93.3 | — |
| SECONDARY Percentage of Participants With On-treatment Failure |
17 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
11.4 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
10.3 | — |
| SECONDARY Percentage of Participants With Normalized Alanine Aminotransferase Levels |
81.5 | — |
| SECONDARY Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure |
5.4; 2.2 | — |
| SECONDARY Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load |
1.3726; -0.0724; -0.0704; -0.0442; -0.0655; -0.0829 | — |
| SECONDARY Mean Change From Baseline in CD4+ Cell Count |
640.3; -95.0; -171.5; -244.2; -271.7; -275.5 | — |
| SECONDARY Change From Baseline in CD4+ Cell Count in Percentage |
31.65; 0.42; 2.50; 3.85; 3.93; 5.47 | — |
| SECONDARY Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
102; 6 | — |
Eligibility Criteria
Inclusion Criteria
- A liver biopsy required within 3 years prior to screening unless the patient has a contraindication for a liver biopsy
- Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within 2 years prior screening must have an ultrasound taken within 2 months prior to the screening visit or during screening with no findings suspicious for hepatocellular carcinoma (HCC)
- Genotype-1 hepatitis C virus (HCV) infection
- Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
- Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months prior to screening
Exclusion Criteria
- Patient showing evidence of hepatic decompensation (ie, history or current evidence of ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less than 3.3 gm per dL, prolonged prothrombin time [PT] expressed as international normalized ratio [INR] more than 1.5)
- Any liver disease of non-HCV etiology
- Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
- An acute HIV-1 infection; or HIV-2 infection
- Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening
Data sourced from ClinicalTrials.gov (NCT01479868). 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.