icon-avatar

Empresas

Boehringer Ingelheim to announce pivotal Phase III hepatitis C data for faldaprevir* at AASLD Congress 2013

    For media outside of the U.S.A., UK and Canada only

    Ten abstracts featuring Boehringer Ingelheim’s investigational hepatitis C virus (HCV) protease inhibitor, faldaprevir*and polymerase inhibitor, deleobuvir* will be presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) 2013, 1-5 November, Washington.1

    Faldaprevir* is a second generation protease inhibitor and is the foundation of Boehringer Ingelheim’s interferon-based and interferon-free treatment regimens.

    The accepted abstracts include final results from the Phase III STARTVerso™1 and 2 studies, investigating the treatment regimen of faldaprevir* in combination with pegylated interferon and ribavirin. Also data in difficult-to-treat populations such as treatment-experienced (STARTVerso™3 – final data) and HCV/HIV co-infected (STARTVerso™4 – end of treatment data) patients will be presented at the meeting, adding to the comprehensive portfolio of data for faldaprevir in HCV. The STARTVerso™ trial results form the basis for regulatory submissions of faldaprevir.

    Boehringer Ingelheim’s comprehensive hepatitis C clinical trial programme includes a broad range of the type of patients that clinicians see every day in clinical practice. The company’s goal is to develop effective and well tolerated treatments recognising the unmet need for more patient centric approaches in hepatitis C.

    Boehringer Ingelheim’s abstracts can be accessed on the AASLD website today at www.aasld.org. Details of the poster presentations can be found below.

    Poster Presentations

    Title   Lead Author   Presentation Details  

    Effect of multiple oral doses of
    faldaprevir on the multiple dose
    pharmacokinetics of a combination
    oral tablet of ethinylestradiol and
    levonorgestrel in healthy
    premenopausal female volunteers

    		   J. Sabo  

    ID# 482
    Session: HCV Therapy:
    The Developmental
    Pipeline
    Date: Sat, 2 November
    Time: 2:00 PM – 7:30 PM ET
    Location: Poster Hall

     

    		  

    Mass balance, metabolic profile and
    the role of hepatic and bacterial
    enzymes in the metabolism of the HCV
    polymerase inhibitor,
    deleobuvir (BI 207127)

    		   R. Sane  

    ID# 491
    Session: HCV Therapy:
    The Developmental
    Pipeline
    Date: Sat, 2 November
    Time: 2:00 PM – 7:30 PM ET
    Location: Poster Hall

     

    		  

    Pharmacokinetics, safety, and
    tolerability of faldaprevir in
    patients with different levels of
    renal impairment

    		   F. Huang  

    ID# 466
    Session: HCV Therapy:
    The Developmental
    Pipeline
    Date: Sat, 2 November
    Time: 2:00 PM – 7:30 PM ET
    Location: Poster Hall

     

    		  

    Effect of steady-state faldaprevir on
    the pharmacokinetics of steady-state
    methadone and buprenorphine/naloxone
    in subjects on stable addiction
    management therapy

    		   D. Joseph  

    ID# 483
    Session: HCV Therapy:
    The Developmental
    Pipeline
    Date: Sat, 2 November
    Time: 2:00 PM – 7:30 PM ET
    Location: Poster Hall

     

    		  

    A pooled analysis of two
    randomized, double-blind placebo-
    controlled Phase III trials
    (STARTVerso1&2) of faldaprevir plus
    pegylated interferon alfa-2a and
    ribavirin in treatment-naïve patients
    with chronic hepatitis C genotype-1
    infection

    		   D. Jensen  

    ID# 1088
    Session: HCV
    Therapeutics: New Agents
    Date: Sun, 3 November
    Time: 8:00 AM – 5:30 PM ET
    Location: Poster Hall

     

    		  

    Subgroup analyses and baseline
    predictors of response with
    faldaprevir plus pegylated interferon
    alfa-2a and ribavirin in
    treatment-naïve patients with chronic
    hepatitis C genotype-1 infection: a
    pooled analysis of STARTVerso1 and 2

    		   E.M. Yoshida  

    ID# 1114
    Session: HCV
    Therapeutics: New Agents

    Date: Sun, 3 November
    Time: 8:00 AM – 5:30 PM ET
    Location: Poster Hall

     

    		  

    STARTVerso3: A randomized,
    double-blind, placebo-controlled
    Phase III trial of faldaprevir in
    combination with pegylated
    interferon alfa-2a and ribavirin in
    treatment-experienced patients
    with chronic hepatitis C
    genotype-1 infection            

    		      

    I. Jacobson  

    		      

    ID# 1100
    Session: HCV
    Therapeutics: New Agents
    Date: Sun, 3 November
    Time: 8:00 AM – 5:30 PM ET
    Location: Poster Hall

     

    		  

    Interferon-Free Treatment with
    Faldaprevir, Deleobuvir (BI
    207127) and Ribavirin in
    SOUND-C3: 95% SVR12 in HCV-
    GT1b

    		       J.F. Dufour      

    ID# 1102
    Session: HCV
    Therapeutics: New Agents
    Date: Sun, 3 November
    Time: 8:00 AM – 5:30 PM ET
    Location: Poster Hall

     

    		  

    Pharmacokinetic interactions of
    faldaprevir and deleobuvir (BI
    207127) and their individual and
    combined effect on selected
    cytochrome P450 (CYP) probe
    substrates in genotype 1 hepatitis C
    infected patients

    		       C. Cooper      

    ID# 1083
    Session: HCV
    Therapeutics: New Agents
    Date: Sun, 3 November
    Time: 8:00 AM – 5:30 PM ET
    Location: Poster Hall

     

    		  

    STARTVerso 4 Phase III trial of
    faldaprevir plus peg interferon
    alfa-2a and ribavirin (PR) in
    patients with HIV and HCV
    genotype 1 coinfection: end of
    treatment response               

    		       J. Rockstroh      

    ID# 1099
    Session: HCV
    Therapeutics: New Agents
    Date: Sun, 3 November
    Time: 8:00 AM – 5:30 PM ET
    Location: Poster Hall

     

    		  
                       

    # # #

    NOTES TO EDITORS

    The Boehringer Ingelheim NewsHome: An innovative resource for journalists

    The Boehringer Ingelheim hepatitis C www.NewsHome.com is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for media.

    Boehringer Ingelheim

    The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

    Social responsibility is a central element of Boehringer Ingelheim´s culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

    In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

    For more information please visit www.boehringer-ingelheim.com

    References

    1American Association for the Study of Liver diseases (AASLD). The Liver Meeting® Abstract Central. http://aasld2013.abstractcentral.com/viewer

    [Last accessed 1 October, 2013]

    * Faldaprevir and deleobuvir (BI 207127) are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.

     

    WhatsAppFacebookFacebookTwitterTwitterLinkedinLinkedinBeloudBeloudBluesky