Welcome!

News Feed Item

Phase 2b Data of Boehringer Ingelheim's Interferon-Free Hepatitis C Treatment Show Viral Cure Achieved in Up to 85% of Treatment-Naive Patients

Results to be presented at American Association for the Study of Liver Diseases (AASLD) Annual Meeting

BOSTON and RIDGEFIELD, Conn., Nov. 10, 2012 /PRNewswire/ -- Final Phase 2b data from Boehringer Ingelheim's interferon (IFN)-free Phase 2b SOUND-C2 study showed that up to 85 percent of genotype 1b (GT1b) hepatitis C (HCV) patients achieved sustained virologic response (SVR or viral cure) 12 and 24 weeks after the end of treatment with the investigational treatment regimen of faldaprevir (BI 201335) and BI 207127, in combination with ribavirin (RBV). A viral cure was achieved for 69 percent of all patients included in the study (both GT1a and GT1b HCV infections), and includes patients with advanced liver disease that are more challenging to cure.

Pivotal Phase 3 trials evaluating an IFN-free regimen of faldaprevir, BI 207127 and ribavirin are now being initiated.

"Final results from this Phase 2b study show potential for an interferon-free HCV cure for patients with chronic HCV that historically have been among the most difficult to cure," said Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Goethe University Hospital in Frankfurt, Germany, and lead investigator of the study. "The SOUND-C2 trial provides valuable information regarding the types of patients that are more likely to respond to treatment with faldaprevir and BI 207127, which may be useful for attaining optimal antiviral outcomes in the clinical setting."

Comprehensive results from SOUND-C2 will be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), in Boston, MA.

  • An oral presentation of final results from the SOUND-C2 study, including an analysis of predictors of treatment response, will be presented on Tuesday, November 13 (ID# 232)
  • An oral presentation of results from a sub-analysis of patients with compensated liver cirrhosis from the SOUND-C2 study will be presented on Sunday, November 11 (ID# 84)
  • A poster presentation of a comparison of SVR4, SVR12 and SVR24 results from SOUND-C2 will be presented on Sunday, November 11 (ID# 778)

The SOUND-C2 study, which includes compounds each of which targets HCV in a different way (polymodal therapy*), is the largest Phase 2 IFN-free HCV trial to date, enrolling 362 HCV GT1 patients, the most difficult genotype to treat successfully and the most common genotype found in the US. Nine percent of patients in the SOUND-C2 study had compensated liver cirrhosis due to HCV (damaged or scarred liver tissue). As part of the study, investigators performed a detailed analysis of patient and virus characteristics to explore the likelihood of a patient's response to treatment with faldaprevir and BI 207127 in combination with RBV (regression analysis). HCV GT1 subtype, patient IL-28b genome type and patient gender were identified as significant predictors of treatment success.

*Polymodal therapy involves treatment that combines compounds that each work with different modes of action to inhibit viral replication, as seen with faldaprevir + BI 207127 + ribavirin.

"We are looking forward to continuing development of our HCVerso program and are now initiating Phase 3 clinical trials investigating interferon-free HCV treatment with faldaprevir and BI 207127," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.  "Through HCVerso Boehringer Ingelheim is striving to deliver new solutions that consider real-world challenges faced by patients and clinicians."

Final Results from SOUND-C2 and Predictors of Response
SOUND-C2 was an open-label, randomized, Phase 2b study that enrolled 362 treatment-naive HCV GT1 patients into five different treatment arms evaluating polymodal, IFN-free HCV treatment with Boehringer Ingelheim's investigational compounds faldaprevir and BI 207127, with and without RBV, for up to 40 weeks.

SOUND-C2 Trial Design and Results – SVR12 and 24


SVR

Group

 

Faldaprevir

BI 207127

RBV

Duration
(wks)

All
Patients

GT1a

GT1b

A

N=81

120 mg QD

600 mg TID

Y

16

48 (59%)

13/34 (38%)

35/47 (75%)

B

N=80

120 mg QD

600 mg TID

Y

28

47 (59%)

14/32 (44%)

33/48 (69%)

C

N=77

120 mg QD

600 mg TID

Y

40

40 (52%)

16/34 (47%)

24/43 (56%)

D

N=78

120 mg QD

600 mg BID

Y

28

54 (69%)

13/30 (43%)

41/48 (85%)

E

N=46

120 mg QD

600 mg TID

N

28

18 (39%)

2/18 (11%)

16/28 (57%)

In SOUND-C2, regression analysis identified HCV GT1 subtype, patient IL-28b genome type and gender as significant predictors of treatment response. Patients with GT1b were shown to be six times more likely to achieve SVR as compared to patients with HCV GT1a (95 percent CI; p<0.0001). Patients with the CC subtype of the IL-28b genome were more than four times as likely to achieve SVR compared to the CT and TT subtype of the genome.

The most common adverse events (AEs) in SOUND-C2 were skin changes (photosensitivity, rash), gastrointestinal (GI) disorders (vomiting, diarrhea), and jaundice due to transient benign bilirubin elevation (unconjugated hyperbilirubinemia). Treatment discontinuation due to AEs correlated with increased treatment duration, with discontinuations ranging from 4.9 percent in Arm A (16 weeks) to 24.7 percent in Arm C (40 weeks), which was the longest treatment duration evaluation in the study.

Results from SOUND-C2 Sub-analysis of Patients with Compensated Liver Cirrhosis due to HCV
Data from the SOUND-C2 study are the first data for an IFN-free regimen in HCV patients with compensated liver cirrhosis. This sub-analysis included 33 patients (nine percent of the study population) with compensated liver cirrhosis, as confirmed by either biopsy or Fibroscan. Investigators noted that data from this analysis support the continued development of this investigational IFN-free treatment regimen in Phase 3 trials for patients with compensated liver cirrhosis.

SOUND-C2 Sub-Analysis in Patients with Compensated Liver Cirrhosis


1335QD/7127TID/RBV

16, 28 or 40 weeks

Pooled (n=21)

1335QD/7127BID/RBV

28 weeks (n=9)

1335QD/7127TID
28 weeks (n=3)


GT1a

(n=7)

GT1b

(n=14)

GT1a

(n=4)

GT1b

(n=5)

GT1a

(n=0)

GT1b

(n=3)

SVR12 / 24, n (%)

3 (43%)

8 (57%)

2 (50%)

4 (80%)

N/A

1 (33%)

DCs due to AEs,
n (%)

6* (29%)

1 (11%)

0

DCs due to rash,
n (%)

3* (14%)

0

0

DCs due to
photosensitivity,
n (%)

2 (10%)

0

0

DCs due to
vomiting, n (%)

1 (5%)

0

0

*No cases of erythema multiforme, Stevens-Johnson Syndrome (SJS), toxic epidermal necrosis, or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Comparison of SVR4, SVR12 and SVR24 Results from SOUND-C2
A comparison of results from the SOUND-C2 study shows that almost all patients (98 percent) in the study who achieved SVR4 continued to maintain undetectable virus levels and achieve SVR24. All of the patients who achieved SVR12 in the SOUND-C2 study maintained their undetectable virus levels and achieved SVR24.

Of the patients with undetectable hepatitis C virus levels at the end of treatment (EOT), and who received the treatment per the pre-specified protocol, 15 experienced documented relapse (7 percent). Relapse occurred within 12 weeks post-treatment for 14/15 patients. One patient in the 16 week study arm relapsed between 24-48 weeks post-treatment.

It should be noted that rare late relapses have been observed following both IFN-based and IFN-free treatment. It is unclear why these patients relapsed so late in the follow up period.  These results emphasize the importance of monitoring patients for at least one year following the end of treatment regardless of whether they were treated with an IFN-based or IFN-free regimen.

Pivotal Phase 3 Program Now Beginning
Based on the results of SOUND-C2, Boehringer Ingelheim is now initiating a pivotal Phase 3 program. Three clinical trials will enroll approximately 1,200 treatment-naive HCV patients, including patients with compensated cirrhosis and those who are ineligible for IFN treatment.

Other BI HCV data being presented at the AASLD Annual Meeting include:

Title

Lead Author

Presentation Details

HCV NS3 and NS5B variants that emerged in patients with virologic breakthrough and relapse from the Phase II SOUND-C2 trial investigating interferon-free BI 201335 and BI 207127 therapy +/- ribavirin

A. Cote-Martin

ID# 788

 

Session: Clinical HCV 1

 

Date: Sun, Nov. 11

Time: 8:00 AM – 5:30 PM ET

Location: Poster Hall

Pharmacokinetics of the interferon-free combination of BI 207127 and BI 201335 plus ribavirin in treatment naive patients with genotype (GT) 1 HCV: Results from the SOUND-C1 study

J. Sabo

ID# 777

 

Session: Clinical HCV 1

 

Date: Sun, Nov. 11

Time: 8:00 AM – 5:30 PM ET

Location: Poster Hall

Analysis of baseline polymorphisms and persistence of emergent variants from Phase Ib and II trials evaluating the HCV NS3 protease inhibitor BI 201335

K. Berger

ID# 785

 

Session: Clinical HCV 1

 

Date: Sun, Nov. 11

Time: 8:00 AM – 5:30 PM ET

Location: Poster Hall

Addition of the NS5B polymerase inhibitor BI 207127 to pegylated interferon and ribavirin (PegIFN/RBV) for 4 weeks followed by PegIFN/RBV for 44 weeks improves SVR24 rates in treatment-naive patients with HCV genotype (GT) 1 and is well tolerated

A. Lohse 

ID# 767

 

Session: Clinical HCV 1

 

Date: Sun, Nov. 11

Time: 8:00 AM – 5:30 PM ET

Location: Poster Hall

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial program, HCVerso, is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to treat.

Faldaprevir, also known as BI 201335, is an investigational, oral HCV NS3/4A protease inhibitor that may improve viral cure rates as compared to PegIFN/RBV therapy alone, and has completed clinical trials through Phase 2b (SILEN-C studies). Faldaprevir is designed to target the hepatitis C viral reservoir in the liver and inhibit viral replication. The ongoing multi-study Phase 3 STARTVerso trial program, evaluating faldaprevir combined with PegIFN/RBV in treatment-naive, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV, is near clinical completion. BI 207127 is an investigational NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined in a polymodal regimen with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVerso trials investigating this regimen are now being initiated.

Faldaprevir and BI 207127 are investigational compounds and not yet approved by the FDA. Their safety and efficacy have not yet been fully established.

HCV is an infectious disease of the liver, which acts as a viral reservoir. It is a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, an estimated 4.1 million Americans have been infected with HCV, of which approximately 3.2 million have chronic HCV infection. Since 1999 there has been a significant increase in deaths due to chronic HCV, accounting for 15,000 deaths in the United States in 2007.  

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. 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.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In his session at 18th Cloud Expo, Andrew Cole, Director of Solutions Engineering at Peak 10, will discuss how the newest technology advances are reducing the cost and complexity of traditional business continuity and disaster recovery solutions. Attendees will: Learn why having a full disaster recovery strategy is more important now than ever before Explore the key drivers of a successful disaster recovery solution Achieve measurable operational and business value from a disaster recovery ...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
As organizations shift towards IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. Commvault can ensure protection, access and E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his general session at 18th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Part...
SYS-CON Events announced today that Hanu Software will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Leveraging best-in-class people, processes, and technologies, Hanu provides high-quality, high-value software development and business process outsourcing services to independent software vendors (ISVs) and enterprises.
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
What a difference a year makes. Organizations aren’t just talking about IoT possibilities, it is now baked into their core business strategy. With IoT, billions of devices generating data from different companies on different networks around the globe need to interact. From efficiency to better customer insights to completely new business models, IoT will turn traditional business models upside down. In the new customer-centric age, the key to success is delivering critical services and apps wit...
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in Embedded and IoT solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and ...
SYS-CON Events announced today that MobiDev will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex software systems for startups and enterprises. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobile software company with over 200 develope...
In the rush to compete in the digital age, a successful digital transformation is essential, but many organizations are setting themselves up for failure. There’s a common misconception that the process is just about technology, but it’s not. It’s about your business. It shouldn’t be treated as an isolated IT project; it should be driven by business needs with the committed involvement of a range of stakeholders.
SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer's modular architecture, full-featured API, and sophisticated automation provide unparalleled performance and control. Its flexible unified platform seamlessly spans physical and virtual devices linked via a world...
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
How will your company move to the cloud while ensuring a solid security posture? Organizations from small to large are increasingly adopting cloud solutions to deliver essential business services at a much lower cost. According to cyber security experts, the frequency and severity of cyber-attacks are on the rise, causing alarm to businesses and customers across a variety of industries. To defend against exploits like these, a company must adopt a comprehensive security defense strategy that is ...