Welcome!

Web 2.0 Authors: AppDynamics Blog, Noel Wurst, David H Deans, Aria Blog, Gilad Parann-Nissany

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.

@ThingsExpo Stories
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, discussed the underlying factors that are driving the economics of intelligent systems. Discover how hardware commoditization, the ubiquitous nature of connectivity, and the emergence of Big Data a...
"BSQUARE is in the business of selling software solutions for smart connected devices. It's obvious that IoT has moved from being a technology to being a fundamental part of business, and in the last 18 months people have said let's figure out how to do it and let's put some focus on it, " explained Dave Wagstaff, VP & Chief Architect, at BSQUARE Corporation, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud strategy and programs. In this Power Panel at 15th Cloud Expo (http://www.CloudComputingExpo.com), moderated by Ashar Baig, Research Director, Cloud, at Gigaom Research, Nate Gordon, Director of T...
SYS-CON Events announced today that IDenticard will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada. Our partner network encompasses some 300 of the world's leading systems integrators and security s...
SYS-CON Events announced today that Windstream, a leading provider of advanced network and cloud communications, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Windstream (Nasdaq: WIN), a FORTUNE 500 and S&P 500 company, is a leading provider of advanced network communications, including cloud computing and managed services, to businesses nationwide. The company also offers broadband, phone and digital TV services to consumers primarily in rural areas.

ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ --  IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's platform-as-a-service. The new platform enables developers to build ap...

The BPM world is going through some evolution or changes where traditional business process management solutions really have nowhere to go in terms of development of the road map. In this demo at 15th Cloud Expo, Kyle Hansen, Director of Professional Services at AgilePoint, shows AgilePoint’s unique approach to dealing with this market circumstance by developing a rapid application composition or development framework.
“In the past year we've seen a lot of stabilization of WebRTC. You can now use it in production with a far greater degree of certainty. A lot of the real developments in the past year have been in things like the data channel, which will enable a whole new type of application," explained Peter Dunkley, Technical Director at Acision, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete at launch. DevOps may be disruptive, but it is essential.
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nigeria has the largest economy in Africa, at more than US$500 billion, and ranks 23rd in the world. A recent re-evaluation of Nigeria's true economic size doubled the previous estimate, and brought it well ahead of South Africa, which is a member (unlike Nigeria) of the G20 club for political as well as economic reasons. Nigeria's economy can be said to be quite diverse from one point of view, but heavily dependent on oil and gas at the same time. Oil and natural gas account for about 15% of Nigera's overall economy, but traditionally represent more than 90% of the country's exports and as...
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tracker. The mesh of things that we manage must be segmented into zones of trust for sensing data, transmitting data, receiving command and control administrative changes, and peer-to-peer mesh messaging. In his session at @ThingsExpo, Ryan Bagnulo, Solution Architect / Software Engineer at SOA Software, focused on desi...
"At our booth we are showing how to provide trust in the Internet of Things. Trust is where everything starts to become secure and trustworthy. Now with the scaling of the Internet of Things it becomes an interesting question – I've heard numbers from 200 billion devices next year up to a trillion in the next 10 to 15 years," explained Johannes Lintzen, Vice President of Sales at Utimaco, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"For over 25 years we have been working with a lot of enterprise customers and we have seen how companies create applications. And now that we have moved to cloud computing, mobile, social and the Internet of Things, we see that the market needs a new way of creating applications," stated Jesse Shiah, CEO, President and Co-Founder of AgilePoint Inc., in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the industry’s first all flash version of HyperConverged Appliances that include both compute and storag...
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile devices as well as laptops and desktops using a visual drag-and-drop application – and eForms-buildi...
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
Code Halos - aka "digital fingerprints" - are the key organizing principle to understand a) how dumb things become smart and b) how to monetize this dynamic. In his session at @ThingsExpo, Robert Brown, AVP, Center for the Future of Work at Cognizant Technology Solutions, outlined research, analysis and recommendations from his recently published book on this phenomena on the way leading edge organizations like GE and Disney are unlocking the Internet of Things opportunity and what steps your organization should be taking to position itself for the next platform of digital competition.
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
As the Internet of Things unfolds, mobile and wearable devices are blurring the line between physical and digital, integrating ever more closely with our interests, our routines, our daily lives. Contextual computing and smart, sensor-equipped spaces bring the potential to walk through a world that recognizes us and responds accordingly. We become continuous transmitters and receivers of data. In his session at @ThingsExpo, Andrew Bolwell, Director of Innovation for HP's Printing and Personal Systems Group, discussed how key attributes of mobile technology – touch input, sensors, social, and ...