Welcome!

News Feed Item

Efficacy and Safety Data from Phase 2B Trials of Janssen's Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual Meeting of the American Association for the Study of Liver Diseases

- Data from Post Hoc Analyses of the ASPIRE and PILLAR Studies in Patients with Metavir Scores of F3 and F4 Show Sustained Viral Response Compared to Placebo -

BOSTON, Nov. 10, 2012 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) today announced that the use of one once-daily pill of the investigational protease inhibitor simeprevir (TMC435) administered with pegylated interferon and ribavirin led to higher rates of sustained viral response at 24 weeks (SVR24) compared to placebo in patients with Metavir scores of F3 and F4 who were treatment naive and treatment experienced with genotype 1 hepatitis C. Simeprevir was also generally well tolerated and the overall incidence of serious adverse events (AEs) was similar across all treatment arms. The data from the Phase 2b PILLAR and ASPIRE trials were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

In treatment-naive patients with a Metavir score of F3 (PILLAR), the primary endpoint of SVR24 was achieved in 79 percent of patients in the simeprevir group compared to 72 percent in the control group (pegylated interferon and ribavirin alone). In treatment-experienced patients with a Metavir score of F3 (ASPIRE), SVR24 was achieved in 48 percent of patients in the simeprevir group compared to 8 percent in the control group. In treatment-experienced patients with a Metavir score of F4 (ASPIRE), SVR was achieved in 62 percent of patients in the simeprevir group compared to 0 percent in the control group. In both the PILLAR and ASPIRE trials, serious AEs occurred in 7.6 percent of patients receiving simeprevir plus pegylated interferon and ribavirin compared to 9.8 percent of patients receiving pegylated interferon and ribavirin alone.

"Hepatitis C patients with Metavir scores of F3 and F4 have advanced fibrosis of the liver and are harder to cure than those with limited fibrosis," said Fred Poordad, M.D., chief medical officer of Alamo Medical Research Center and investigator in the ASPIRE and PILLAR studies. "The results presented at AASLD suggest that simeprevir could represent an important new treatment option for people living with advanced hepatitis C if proven in advanced trials."

Simeprevir, an investigational NS3/4A protease inhibitor jointly developed by Janssen and Medivir, is currently in Phase 3 studies as a once-daily treatment taken in combination with pegylated interferon and ribavirin for the treatment of genotypes 1 and 4 chronic hepatitis C. It is also being studied in separate Phase 2 trials with other direct-acting antiviral agents as part of interferon-free regimens, with and without ribavirin. This includes a recently initiated Phase 2a trial of an interferon-free regimen with simeprevir and TMC647055, Janssen's non-nucleoside polymerase inhibitor (NNI) currently in development for hepatitis C.

"We are encouraged by these data, which show sustained viral response and tolerability in both treatment-naive and more challenging-to-cure patients," said Maria Beumont, M.D., Medical Leader for simeprevir, Janssen Research & Development. "We look forward to further evaluating the utility of simeprevir in combination with other agents for the treatment of hepatitis C."

About the PILLAR & ASPIRE Trials  
In the two international, Phase 2b, randomized, double-blind, placebo-controlled studies, patients were either treatment naive (PILLAR) or treatment experienced (ASPIRE), and received pegylated interferon and ribavirin alone or in combination with once-daily simeprevir. In PILLAR, 309 treatment-naive hepatitis C patients received either 75 or 150 mg of once-daily simeprevir for 12 or 24 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks depending on their response to treatment. In ASPIRE, 396 treatment-experienced patients received either 100 or 150 mg of once-daily simeprevir for 12, 24 or 48 weeks plus pegylated interferon and ribavirin for 48 weeks.

The post hoc analyses of PILLAR and ASPIRE presented at AASLD (abstracts 83 and 769) evaluated only patients receiving 150 mg of simeprevir and reporting a Metavir score of F3 (PILLAR), or F3 and F4 (ASPIRE). The Metavir score is used to quantify the degree of inflammation and fibrosis of the liver and patients are scored on a four-point scale. An F3 score means the patient has numerous septa (fibrous tissue bands that can decrease the flow of blood through the liver) without cirrhosis, while an F4 score means the patient has cirrhosis.

About Simeprevir   
Simeprevir (TMC435) is a NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB to treat chronic hepatitis C (HCV). Simeprevir is being studied in combination with pegylated interferon and ribavirin, and in combination with direct-acting antiviral agents in all-oral interferon-free regimens, with and without ribavirin.

Global Phase 3 studies of simeprevir include QUEST-1 and QUEST-2 in treatment-naive patients, PROMISE in patients who have relapsed after prior interferon-based treatment and ATTAIN in null-responder patients.  In parallel to these trials, Phase 3 studies for simeprevir are ongoing in both treatment-naive and treatment-experienced HIV-HCV co-infected patients, HCV genotype 4 patients and in Japanese HCV genotype 1 patients.

Simeprevir is also being studied in Phase 2 interferon-free trials with and without ribavirin in combination with:

  • Janssen's TMC647055 and ritonavir in treatment-naive, relapser or null-responder HCV genotype 1 patients;
  • Gilead Sciences, Inc.'s sofosbuvir (GS-7977) in null-responder HCV genotype 1 patients; and
  • Bristol-Myers Squibb's daclatasvir (BMS-790052) in treatment-naive or previous null-responder HCV genotype 1 patients.

In addition, Janssen recently announced that it has entered into a non-exclusive collaboration with Vertex Pharmaceuticals Incorporated to evaluate in a Phase 2 study the safety and efficacy of an all-oral regimen of simeprevir and Vertex's investigational nucleotide analogue polymerase inhibitor VX-135 for the treatment of HCV. As a first step, Janssen will conduct a drug-drug interaction (DDI) study with simeprevir and VX-135.

For additional information about simeprevir, please visit www.clinicaltrials.gov.

About Hepatitis C  
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 170 to 210 million people are infected with hepatitis C worldwide, with three to four million people newly infected each year.

About Janssen   
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Pharmaceuticals, Inc. is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents or other intellectual property rights; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

SOURCE Janssen 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
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
What does it look like when you have access to cloud infrastructure and platform under the same roof? Let’s talk about the different layers of Technology as a Service: who cares, what runs where, and how does it all fit together. In his session at 18th Cloud Expo, Phil Jackson, Lead Technology Evangelist at SoftLayer, an IBM company, spoke about the picture being painted by IBM Cloud and how the tools being crafted can help fill the gaps in your IT infrastructure.
SYS-CON Events announced today that Niagara Networks will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lea...
SYS-CON Events announced today that Interface Masters Technologies, a leader in Network Visibility and Uptime Solutions, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Interface Masters Technologies is a leading vendor in the network monitoring and high speed networking markets. Based in the heart of Silicon Valley, Interface Masters' expertise lies in Gigabit, 10 Gigabit and 40 Gigabit Eth...
SYS-CON Events announced today that Sheng Liang to Keynote at SYS-CON's 19th Cloud Expo, which will take place on November 1-3, 2016 at the Santa Clara Convention Center in Santa Clara, California.
In his session at @ThingsExpo, Kausik Sridharabalan, founder and CTO of Pulzze Systems, Inc., will focus on key challenges in building an Internet of Things solution infrastructure. He will shed light on efficient ways of defining interactions within IoT solutions, leading to cost and time reduction. He will also introduce ways to handle data and how one can develop IoT solutions that are lean, flexible and configurable, thus making IoT infrastructure agile and scalable.
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, showed how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningful f...
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, provided tips on how to be successful in large scale machine learning...
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, will discuss recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model f...