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

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

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)

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

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

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

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

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

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

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               

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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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.