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.[i]
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
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Title
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Lead Author
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Presentation Details
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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
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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
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ID# 491
Session: HCV Therapy: The Developmental Pipeline
Date: Sat, 2 November
Time: 2:00 PM – 7:30 PM ET
Location: Poster Hall
|
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Pharmacokinetics, safety, and tolerability of faldaprevir in patients with different levels of renal impairment
|
F. Huang
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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
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ID# 483
Session: HCV Therapy: The Developmental Pipeline
Date: Sat, 2 November
Time: 2:00 PM – 7:30 PM ET
Location: Poster Hall
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|
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
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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
|
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Interferon-Free Treatment with Faldaprevir, Deleobuvir (BI 207127) and Ribavirin in SOUND-C3: 95% SVR12 in HCV-GT1b
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J.F. Dufour
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ID# 1102
Session: HCV Therapeutics: New Agents
Date: Sun, 3 November
Time: 8:00 AM – 5:30 PM ET
Location: Poster Hall
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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
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C. Cooper
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ID# 1083
Session: HCV Therapeutics: New Agents
Date: Sun, 3 November
Time: 8:00 AM – 5:30 PM ET
Location: Poster Hall
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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
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J. Rockstroh
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ID# 1099
Session: HCV Therapeutics: New Agents
Date: Sun, 3 November
Time: 8:00 AM – 5:30 PM ET
Location: Poster Hall
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