Welcome!

Web 2.0 Authors: Liz McMillan, Carmen Gonzalez, Pat Romanski, Rick Delgado, Elizabeth White

News Feed Item

FDA Approves Prescribing Information Update for EDURANT® (rilpivirine) to Include 96-Week Data in HIV-1-Infected Treatment-Naive Adult Patients

TITUSVILLE, N.J., Dec. 10, 2012 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a prescribing information update for EDURANT® (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies, which evaluated the efficacy and safety of EDURANT® for the treatment of human immunodeficiency virus type 1 (HIV-1) in antiretroviral treatment-naive adults.

In addition to the inclusion of the 96-week data in the prescribing information, the Indications and Usage section was revised to read: EDURANT®, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.

This indication is based on safety and efficacy analyses through 96 weeks from two randomized, double-blind, active-controlled Phase 3 trials in treatment-naive subjects.

The following points should be considered when initiating therapy with EDURANT®:

  • More EDURANT® treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA greater than or equal to 50 copies/mL) compared to EDURANT® treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL.
  • Regardless of HIV-1 RNA at the start of therapy, more EDURANT® treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to EDURANT® treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3.
  • The observed virologic failure rate in EDURANT® treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz.
  • More subjects treated with EDURANT® developed tenofovir- and lamivudine/emtricitabine-associated resistance compared to efavirenz.

EDURANT® is not recommended for patients less than 18 years of age.

The Warnings and Precautions section was updated with information on hepatotoxicity (liver damage). This section now states that patients with underlying hepatic (liver) disease, including hepatitis B or C, or marked elevations in transaminases (liver enzymes) before treatment may be at increased risk for worsening or development of liver enzyme elevations. Monitor liver function tests (LFTs) before and during treatment. A few liver damage cases occurred in patients with no pre-existing hepatic disease or other identifiable risk factors, therefore, monitoring of LFTs should be considered in all patients.

The full revised EDURANT® label is available at:
http://www.edurant.com/sites/default/files/EDURANT-PI.pdf

"EDURANT® is an important option for adult patients who are starting HIV therapy for the first time," said David Anderson, MD, Senior Medical Director, Janssen Therapeutics. "We are committed to continuing to provide information to help physicians and people living with HIV make the most appropriate treatment decisions."

The updated 96-week data in the prescribing information is based on results from pooled analyses of data from the Phase 3 trials ECHO and THRIVE, which were randomized, double-blind, and active-controlled studies in treatment-naive adult patients with HIV-1.

ECHO and THRIVE 96-Week Study Results
The ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and efavirenz, or TMC278-C209) and THRIVE (TMC278 against HIV, in a once-daily RegImen Versus Efavirenz, or TMC278-C215) studies evaluated EDURANT® (25 mg once daily) in antiretroviral treatment-naive adults. A pooled analysis showed that at 96 weeks:

  • 76 percent of patients in the EDURANT® arm reached an undetectable viral load (the amount of virus in the blood, defined as less than 50 HIV-1 RNA copies/mL) vs. 77 percent of patients in the efavirenz arm.
  • Patients taking EDURANT® had a virologic failure rate of 16 percent compared to 10 percent experienced by patients taking efavirenz. Upon virologic failure, the emergence of resistance and cross-resistance to the NNRTI class was higher in the EDURANT® arm compared to the efavirenz arm.
  • Adverse events or deaths leading to discontinuation in the EDURANT® arm were 4 percent compared to 8 percent in the efavirenz arm.
  • The most common adverse drug reactions (ADRs) to EDURANT® (incidence > 2 percent) of at least moderate-to-severe intensity (greater than or equal to Grade 2) were depressive disorders (5 percent), headache (3 percent), insomnia (3 percent), and rash (3 percent). The proportion of patients who discontinued treatment with EDURANT® or efavirenz due to ADRs, regardless of severity, was 2 percent and 4 percent, respectively.

Additional Information About the ECHO and THRIVE Studies

ECHO and THRIVE evaluated the efficacy and safety of EDURANT® in 1,368 antiretroviral treatment-naive HIV-1-infected adults with plasma HIV-1 RNA greater than or equal to 5000 copies/mL. The studies were identical in design, with the exception of the background regimen (BR). Patients were randomized to receive either EDURANT® (25 mg once daily) plus BR (n=686), or efavirenz (600 mg once daily) plus BR (n=682).

  • In ECHO, the BR was fixed to the specific nucleos(t)ide reverse transcriptase inhibitors (N(t)RTIs), tenofovir disoproxil fumarate plus emtricitabine.
  • In THRIVE, the BR consisted of two investigator-selected N(t)RTIs, tenofovir disoproxil fumarate plus emtricitabine or zidovudine plus lamivudine or abacavir plus lamivudine.

In the pooled analysis, demographics and baseline characteristics were balanced between both arms and randomization was stratified by screening viral load in both trials, and by nucleos(t)ide backbone in THRIVE.

Important Safety Information

Contraindications

  • Coadministration of EDURANT® with the following drugs is contraindicated because significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance and cross-resistance: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, proton pump inhibitors such as esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole, systemic dexamethasone (more than single dose), and products containing St. John's wort (Hypericum perforatum)

Warnings and Precautions

  • Depressive Disorders: Severe depressive disorders, defined as depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation, have been reported with EDURANT®. Immediate medical evaluation is recommended for severe depressive symptoms
  • Hepatotoxicity: Hepatic adverse events were reported. Patients with underlying hepatic disease, including hepatitis B or C, or marked elevations in transaminases before treatment may be at increased risk for worsening or development of transaminase elevations. Monitor liver function tests (LFTs) before and during treatment. A few hepatotoxicity cases occurred in patients with no pre-existing hepatic disease or other identifiable risk factors, therefore, monitoring of LFTs should be considered in all patients
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
  • Immune Reconstitution Syndrome has been reported in patients treated with combination ARV therapy, including EDURANT®. Autoimmune disorders (such as Graves disease, polymyositis, and Guillain-Barre syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment

Drug Interactions

  • EDURANT® should be used with caution when coadministered with drugs that may reduce the exposure of rilpivirine, such as antacids and H2-receptor antagonists
  • EDURANT® should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes
  • EDURANT® should not be used in combination with NNRTIs

This is not a complete list of potential drug interactions.

Please see full Prescribing Information for more details.

Use in Specific Populations

  • Hepatic Impairment: EDURANT® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT® have not been evaluated in these patients
  • Pregnancy Category B: EDURANT® should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women

Adverse Reactions

  • The most common adverse drug reactions reported (incidence >2%) of at least moderate intensity (greater than or equal to Grade 2) in patients taking EDURANT® through 96 weeks were: depressive disorders (5%), insomnia (3%), headache (3%), and rash (3%)

Please see full Prescribing Information for more details.

About Janssen Therapeutics
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in HIV and other infectious diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Headquartered in Titusville, New Jersey, Janssen Therapeutics, Division of Janssen Products, LP, is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Visit www.JanssenTherapeutics.com for more information and follow us on Twitter at @JanssenUS.

Media Contacts:
Tricia Geoghegan
Phone: (609) 730-3746
Email: [email protected]

Pam Van Houten
Phone: (609) 730-7902
Email: [email protected]

Investor Contacts:
Louise Mehrotra
Phone: (732) 524-6491

Stan Panasewicz
Phone: (732) 524-2524

SOURCE Janssen Therapeutics

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
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at Internet of @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, will discuss how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.

SUNNYVALE, Calif., Oct. 20, 2014 /PRNewswire/ -- Spansion Inc. (NYSE: CODE), a global leader in embedded systems, today added 96 new products to the Spansion® FM4 Family of flexible microcontrollers (MCUs). Based on the ARM® Cortex®-M4F core, the new MCUs boast a 200 MHz operating frequency and support a diverse set of on-chip peripherals for enhanced human machine interfaces (HMIs) and machine-to-machine (M2M) communications. The rich set of periphera...

SYS-CON Events announced today that Aria Systems, the recurring revenue expert, has been named "Bronze Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Aria Systems helps leading businesses connect their customers with the products and services they love. Industry leaders like Pitney Bowes, Experian, AAA NCNU, VMware, HootSuite and many others choose Aria to power their recurring revenue business and deliver exceptional experiences to their customers.
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce the value of the network in helping organizations to maximize their company’s cloud experience.
The Internet of Things (IoT) is making everything it touches smarter – smart devices, smart cars and smart cities. And lucky us, we’re just beginning to reap the benefits as we work toward a networked society. However, this technology-driven innovation is impacting more than just individuals. The IoT has an environmental impact as well, which brings us to the theme of this month’s #IoTuesday Twitter chat. The ability to remove inefficiencies through connected objects is driving change throughout every sector, including waste management. BigBelly Solar, located just outside of Boston, is trans...
SYS-CON Events announced today that Matrix.org has been named “Silver Sponsor” of Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Matrix is an ambitious new open standard for open, distributed, real-time communication over IP. It defines a new approach for interoperable Instant Messaging and VoIP based on pragmatic HTTP APIs and WebRTC, and provides open source reference implementations to showcase and bootstrap the new standard. Our focus is on simplicity, security, and supporting the fullest feature set.
Predicted by Gartner to add $1.9 trillion to the global economy by 2020, the Internet of Everything (IoE) is based on the idea that devices, systems and services will connect in simple, transparent ways, enabling seamless interactions among devices across brands and sectors. As this vision unfolds, it is clear that no single company can accomplish the level of interoperability required to support the horizontal aspects of the IoE. The AllSeen Alliance, announced in December 2013, was formed with the goal to advance IoE adoption and innovation in the connected home, healthcare, education, aut...
SYS-CON Events announced today that Red Hat, the world's leading provider of open source solutions, will exhibit at Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Red Hat is the world's leading provider of open source software solutions, using a community-powered approach to reliable and high-performing cloud, Linux, middleware, storage and virtualization technologies. Red Hat also offers award-winning support, training, and consulting services. As the connective hub in a global network of enterprises, partners, a...
The only place to be June 9-11 is Cloud Expo & @ThingsExpo 2015 East at the Javits Center in New York City. Join us there as delegates from all over the world come to listen to and engage with speakers & sponsors from the leading Cloud Computing, IoT & Big Data companies. Cloud Expo & @ThingsExpo are the leading events covering the booming market of Cloud Computing, IoT & Big Data for the enterprise. Speakers from all over the world will be hand-picked for their ability to explore the economic strategies that utility/cloud computing provides. Whether public, private, or in a hybrid form, clo...
Software AG helps organizations transform into Digital Enterprises, so they can differentiate from competitors and better engage customers, partners and employees. Using the Software AG Suite, companies can close the gap between business and IT to create digital systems of differentiation that drive front-line agility. We offer four on-ramps to the Digital Enterprise: alignment through collaborative process analysis; transformation through portfolio management; agility through process automation and integration; and visibility through intelligent business operations and big data.
Be Among the First 100 to Attend & Receive a Smart Beacon. The Physical Web is an open web project within the Chrome team at Google. Scott Jenson leads a team that is working to leverage the scalability and openness of the web to talk to smart devices. The Physical Web uses bluetooth low energy beacons to broadcast an URL wirelessly using an open protocol. Nearby devices can find all URLs in the room, rank them and let the user pick one from a list. Each device is, in effect, a gateway to a web page. This unlocks entirely new use cases so devices can offer tiny bits of information or simple i...
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.
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce the value of the network in helping organizations to maximize their company’s cloud experience.
Things are being built upon cloud foundations to transform organizations. This CEO Power Panel at 15th Cloud Expo, moderated by Roger Strukhoff, Cloud Expo and @ThingsExpo conference chair, will address the big issues involving these technologies and, more important, the results they will achieve. How important are public, private, and hybrid cloud to the enterprise? How does one define Big Data? And how is the IoT tying all this together?
TechCrunch reported that "Berlin-based relayr, maker of the WunderBar, an Internet of Things (IoT) hardware dev kit which resembles a chunky chocolate bar, has closed a $2.3 million seed round, from unnamed U.S. and Switzerland-based investors. The startup had previously raised a €250,000 friend and family round, and had been on track to close a €500,000 seed earlier this year — but received a higher funding offer from a different set of investors, which is the $2.3M round it’s reporting."
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, data security and privacy.
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. Over the summer Gartner released its much anticipated annual Hype Cycle report and the big news is that Internet of Things has now replaced Big Data as the most hyped technology. Indeed, we're hearing more and more about this fascinating new technological paradigm. Every other IT news item seems to be about IoT and its implications on the future of digital busines...
Cultural, regulatory, environmental, political and economic (CREPE) conditions over the past decade are creating cross-industry solution spaces that require processes and technologies from both the Internet of Things (IoT), and Data Management and Analytics (DMA). These solution spaces are evolving into Sensor Analytics Ecosystems (SAE) that represent significant new opportunities for organizations of all types. Public Utilities throughout the world, providing electricity, natural gas and water, are pursuing SmartGrid initiatives that represent one of the more mature examples of SAE. We have s...
IoT is still a vague buzzword for many people. In his session at Internet of @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, will discuss the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. The presentation will also discuss how IoT is perceived by investors and how venture capitalist access this space. Other topics to discuss are barriers to success, what is new, what is old, and what the future may hold.
The Internet of Things needs an entirely new security model, or does it? Can we save some old and tested controls for the latest emerging and different technology environments? In his session at Internet of @ThingsExpo, Davi Ottenheimer, EMC Senior Director of Trust, will review hands-on lessons with IoT devices and reveal privacy options and a new risk balance you might not expect.