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Boehringer Ingelheim to Announce Pivotal Phase III Hepatitis C Data for Faldaprevir* at AASLD Congress 2013
INGELHEIM, Germany - Tuesday, October 1st 2013 [ME NewsWire]
(BUSINESS WIRE) 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.
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