Navigation Links
Tibotec to Present Final Safety and Efficacy Results From Phase 2b PILLAR Study of Once-Daily TMC435 in Late-Breaker at AASLD
Date:11/5/2011

SAN FRANCISCO, Nov. 5, 2011 /PRNewswire/ -- Tibotec Pharmaceuticals (Tibotec), one of the Janssen (Janssen) Pharmaceutical Companies, today will present results of the final analysis of PILLAR, a phase 2b study of the investigational hepatitis C virus (HCV) NS3/4A protease inhibitor TMC435 in treatment-naive patients with chronic genotype 1 HCV, as part of a late-breaker oral presentation at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, CA, USA.  

Results from the final PILLAR analysis showed that TMC435 administered in combination with peginterferon alpha-2a and ribavirin (PR) resulted in significantly higher sustained virologic response (SVR) rates compared to placebo plus PR. In the two TMC435 treatment groups who received TMC435 75mg, between 75 and 82 percent of patients achieved SVR24, and in the two TMC435 treatment groups who received TMC435 150mg, between 81 and 86 percent of patients achieved SVR24. This is compared to 65 percent of patients in the placebo arm who achieved SVR24. In addition, 79 to 86 percent of patients in the TMC435 treatment arms had a shortened treatment duration of 24 weeks, compared to a 48 weeks treatment duration for patients who received placebo plus P/R. In TMC435 arms, 68 to 76 percent of patients achieved rapid virologic response [RVR; HCV RNA<25 (undetectable)], of whom 88 to 95 percent achieved SVR24. There were no significant differences for adverse events between TMC435 treatment groups and placebo. TMC435 150mg administered once daily (q.d.) is being investigated in phase 3 trials in treatment-naive patients and in patients who experienced a viral relapse after being treated with interferon-based therapy. TMC435 is being developed by Tibotec Pharmaceuticals. Medivir AB has commercialization rights for TMC435 for the Nordic countries, Janssen has commercialization rights for TMC435 in the rest of the world.

The PILLAR study [Protease Inhibitor TMC435 trial assessing the optimaL dose and duration as once daiLy Anti-viral Regimen] (TMC435-C205; NCT00882908) was a five-arm, global phase 2b randomized, double-blind, placebo controlled study in 386 treatment-naive patients. TMC435 was administered in doses of 75mg or 150mg q.d. for either 12 weeks or 24 weeks in combination with 24 or 48 weeks of peg-interferon and ribavirin (PR). Patients in the placebo arm receive 24 weeks of placebo plus peg-interferon and ribavirin followed by 24 additional weeks of peg-interferon and ribavirin treatment. The primary endpoint of the study was sustained virologic response at Week-72 (SVR week 72). The PILLAR study was conducted in 13 countries in Europe, North America, and Australasia.

Patients receiving TMC435 were allowed to stop all treatment at week 24 if they met both response-guided criteria: a) detectable or undetectable HCV RNA levels (< 25 IU/mL) at week 4 and b) undetectable HCV RNA at weeks 12, 16 and 20. Patients who did not meet the above response-guided criteria continued with peg-interferon and ribavirin until Week-48.

"HCV is a devastating problem worldwide and remains a leading cause of cirrhosis, liver cancer, and liver transplantation," said Dr. Michael W. Fried M.D., lead clinical investigator and Professor of Medicine, Director, UNC Liver Center, University of North Carolina at Chapel Hill. "We are extremely encouraged by the success of once-daily TMC435 in achieving significantly higher SVR compared to control group and look forward to furthering its development in recently launched phase 3 trials."

The goal of HCV treatment is to achieve SVR24, which means the virus is undetectable in patients' blood six months after they have finished treatment. Patients who achieve SVR are considered cured.

The most common adverse events (AEs) in the PILLAR study were headache and fatigue, 46 percent and 42 percent in the TMC435 groups and 51 percent and 47 percent in the placebo group respectively. There were no clinically significant differences in frequency of rash, anemia or gastrointestinal events between the TMC435 groups and placebo. Most AEs were mild to moderate in severity. AEs leading to treatment discontinuation of TMC435/placebo were reported in 7.1 percent of patients in TMC435 arms and 7.8 percent in placebo arm.

"Tibotec is pleased to present the final results of the phase 2b PILLAR study at AASLD. The continued development of TMC435, which is currently being investigated in registrational phase 3 studies, reinforces our strong commitment to the development of new therapies that may reduce treatment duration and improve the lives of those impacted by HCV," said Maria Beumont, M.D., Global Medical Leader TMC435 at Tibotec.

In conjunction with the final sustained virologic response (SVR) results from PILLAR, Tibotec is presenting virology analysis data from PILLAR and two sets of early study results on the effects of co-administering TMC435 and methadone and its interaction with the antidepressant escitalopram, to be featured in 3 posters at AASLD:

  • "TMC435 in combination with peginterferon alpha-2a/ribavirin in treatment-naive patients infected with HCV genotype 1: virology analysis of the PILLAR study." O. Lenz.
  • "The pharmacokinetic interaction between the investigational NS3-4A HCV protease inhibitor TMC435 and methadone." M. Beumont-Mauviel.
  • "The pharmacokinetic interaction between the investigational HCV NS3/4A protease inhibitor TMC435 and escitalopram." M. Beumont-Mauviel.

  • Tibotec is currently conducting two global, phase 3 registrational trials to examine TMC435 in treatment-naive adults with chronic genotype 1 hepatitis C virus (HCV). A third global, phase 3 trial is being conducted in genotype 1 HCV patients who have experienced a viral relapse after prior interferon-based treatment. All three studies are fully randomized.

    About HCV
    HCV is a blood-borne infectious disease that affects the liver. With an estimated 170 million people infected worldwide and three to four million people newly infected each year, HCV puts a significant burden on patients and society. Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases, and is the most common cause of liver transplant worldwide.  Pegylated interferon combined with ribavirin causes serious side effects and only cures 40 to 50 percent of genotype 1 patients. The development of new therapies, particularly direct antivirals with different modes of action, may allow HCV patients to undergo a shorter and more effective treatment regimen.

    About Tibotec Pharmaceuticals
    Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global pharmaceutical and research development company. The Company's main research and development facilities are in Beerse, Belgium with offices in Titusville, NJ and Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.Contacts: Media

    Investor RelationsKaren Manson: Cell + 32 (479) 89 47 99Louise Mehrotra:  +1 732 524 6491Stan Panasewicz:  +1 732 524 2524
    '/>"/>

    SOURCE Tibotec Pharmaceuticals
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. AHF Criticizes Tibotec Over Steep Price for Newest AIDS Drug, Etravirine
    2. Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adults with HIV
    3. Ninety-Six Week Data on Tibotec Investigational NNRTI, TMC278, Presented at AIDS 2008
    4. Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Meeting 2008
    5. Tibotec Data Presented at ICAAC and HIV9 Follow Key Regulatory Approvals for Anti-HIV Compounds
    6. Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences
    7. Tibotec Therapeutics Launches GRACE Campaign for Women and People of Color Living With HIV/AIDS
    8. Tibotec Therapeutics Debuts Innovative Web Portal for HIV/AIDS Front-Line Service Providers
    9. Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
    10. Medivir Notes That Partner Tibotec Announced Week 24 Interim Results From Phase 2b TMC435 PILLAR Study to be Presented as a Late-Breaker at AASLD
    11. Tibotec Signs Multiple Agreements With Generic Manufacturers to Provide Access to New HIV Treatment
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:4/19/2017)... DIEGO , April 19, 2017  Sorrento ... an antibody-centric, clinical-stage biopharmaceutical company developing new treatments ... announced the closing of its previously announced underwritten ... stock at a public offering price of $2.00 ... and estimated offering expenses payable by Sorrento.  The ...
    (Date:4/19/2017)... HANOVER, N.J. , April 19, 2017 /PRNewswire/ ... conducted by the National Heart, Lung, and Blood ... (NIH) demonstrating that 58% of patients with treatment-naïve ... six months when treated with eltrombopag at the ... 1 . The study evaluated three sequential treatment ...
    (Date:4/18/2017)... Cogentix Medical, Inc. (NASDAQ: CGNT), a global medical device ... markets with innovative and proprietary products, will release financial ... after the market close on Tuesday, May 2, 2017. ... call and webcast to discuss its financial results the ... p.m. Eastern Time (3:30 p.m. Central Time). Darin ...
    Breaking Medicine Technology:
    (Date:4/21/2017)... West Palm Beach, FL (PRWEB) , ... April 21, 2017 , ... The staff at ... FACS , will be taking part in the 2017 London Marathon. Set to take place ... variety of charitable organizations. This year, Dr. Schwartz will run as part of team EMPOWER, ...
    (Date:4/21/2017)... , ... April 21, 2017 , ... Brady ... that its B-595 and B-7569 vinyl label materials received certification ... warning labels are tested to remain intact and legible, for use on chemical drums ...
    (Date:4/21/2017)... , ... April 21, 2017 , ... The Patient Advocacy ... Health System, with the 2017 Ruth Ravich Patient Advocacy Award in recognition ... advocates. DeVaro was honored with the award at The Beryl Institute’s annual Patient ...
    (Date:4/21/2017)... ... April 21, 2017 , ... ... campaign, AWARE: A Week of Addiction and Recovery Education, from April 24 to ... and preventing substance use disorders. , The mission of AWARE is to ...
    (Date:4/21/2017)... ... 21, 2017 , ... Metrasens is honoured to have won ... most prestigious award for business success. The company has been recognized for ... grown by a total of 400% over the last six years. , Metrasens ...
    Breaking Medicine News(10 mins):