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

NCT01479868 | Completed Phase 3 Results

• 2 other identifiers: CR018334TMC435-TiDP16-C212
• Study Type: interventional
• Target: 109
• Locations: 8 countries
• Sites: 32

Brief 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.

Conditions

Hepatitis C Virus Genotype-1

Keywords

Hepatitis C virus genotype-1; Human immunodeficiency virus-type 1; HCV-1; HIV-1; TMC435; Pegylated interferon alpha-2a; PegIFNα-2a; Pegasys; Ribavirin; RBV; Copegus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)

  The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (\<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable at 12 Weeks after end of treatment.

  12 weeks after end of treatment (Week 24 or 48)

Secondary Outcomes (11)

• Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)

  24 weeks after end of treatment (Week 24 or 48)

• Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable

  Week 4, 12, 24, 36, and 48

• Percentage of Participants With On-treatment Failure

  Week 1 to 48

• Percentage of Participants With Viral Breakthrough

  Week 1 to 48

• Percentage of Participants With Viral Relapse

  Week 1 to 72

Study Arms (1)

TMC435 + pegylated interferon alpha-2a + ribavirin

EXPERIMENTAL

Patients will be administered TMC435 150 mg along with pegylated interferon alpha-2a 180 microgram and ribavirin 1000 or 1200 mg for 12 weeks. Pegylated interferon alpha-2a and ribavirin will only be continued until 24 to 48 weeks.

Drug: TMC435; Drug: Pegylated interferon alpha-2a; Drug: Ribavirin

Interventions

TMC435 DRUG

TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.

TMC435 + pegylated interferon alpha-2a + ribavirin

Pegylated interferon alpha-2a DRUG

Pegylated interferon alpha-2a 180 microgram will be administered as subcutaneous injection of 0.5 mL until 24 to 48 weeks.

TMC435 + pegylated interferon alpha-2a + ribavirin

Ribavirin DRUG

Ribavirin 1000 or 1200 mg twice daily will be administered each day until 24 to 48 weeks.

TMC435 + pegylated interferon alpha-2a + ribavirin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (32)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Newark, New Jersey, United States

Location

Unknown Facility

Albany, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Nantes, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Freiburg im Breisgau, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Amadora, Portugal

Location

Unknown Facility

Lisbon, Portugal

Location

Unknown Facility

Porto, Portugal

Location

Unknown Facility

San Juan, Puerto Rico

Location

Unknown Facility

Badalona, Spain

Location

Unknown Facility

Elche, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Brighton, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (3)

• Andersohn F, Claes AK, Kulp W, Mahlich J, Rockstroh JK. Simeprevir with pegylated interferon alfa 2a plus ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a meta-analysis and historical comparison. BMC Infect Dis. 2016 Jan 11;16:10. doi: 10.1186/s12879-015-1311-3.

  PMID: 26753774 DERIVED

• Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.

  PMID: 26743093 DERIVED

• Dieterich D, Rockstroh JK, Orkin C, Gutierrez F, Klein MB, Reynes J, Shukla U, Jenkins A, Lenz O, Ouwerkerk-Mahadevan S, Peeters M, De La Rosa G, Tambuyzer L, Jessner W. Simeprevir (TMC435) with pegylated interferon/ribavirin in patients coinfected with HCV genotype 1 and HIV-1: a phase 3 study. Clin Infect Dis. 2014 Dec 1;59(11):1579-87. doi: 10.1093/cid/ciu675. Epub 2014 Sep 5.

  PMID: 25192745 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Simeprevir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Director & Study Responsible Scientist
• Organization: Janssen Research & Development

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: November 28, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 29, 2014
• Results First Posted: October 29, 2014

Record last verified: 2014-10

Locations

US (10); CA (2); ES (3); GB (2); PT (3); FR (4); DE (7); PR (1)