|By PR Newswire||
|January 16, 2013 03:01 AM EST||
CORK, Ireland, January 16, 2013 /PRNewswire/ --
Janssen R&D Ireland announced today that the European Commission (EC) has approved a new PREZISTA® (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day. Darunavir is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced and treatment-naïve patients with no darunavir resistance-associated mutations[i]. Darunavir is always taken in combination with ritonavir and other HIV medicines together with food. This new tablet strength has been developed to allow patients taking darunavir once daily to reduce the number of darunavir tablets by half.
The approval is based on study C176 which evaluated the 400 mg tablet formulation versus the 800 mg formulation. One hundred and twenty eight healthy volunteers, were included in this study and received treatment under fasting (n=83) or under fed conditions (n=45). The results of this study show that the rate and extent of absorption were similar between intake of a single 800 mg dose of darunavir formulated as one 800 mg tablet or two 400 mg tablets.
"Strict adherence to treatment regimens is crucial to prevent virological failure and the development of drug resistance when treating HIV," said Brian Woodfall, Vice President, Medical Affairs, Janssen EMEA. "This single 800 mg tablet formulation is a direct reflection of the ongoing commitment of Janssen to further develop treatment options for people living with HIV. With this approval we are providing an alternative solution and a reduced pill burden which should make it easier for patients to manage their treatment on a day-by-day basis and keep their HIV at undetectable levels."
i. ART-experienced adults with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l.
It is estimated that currently there are 34.5 million people living with HIV globally, with 2.5 million people becoming newly infected each year.Thanks to significant advances in treatment for HIV over the past 30 years a diagnosis for these people is no longer a death sentence. Yet, data shows that after 8 months of treatment only 65% of patients will achieve 100% compliance. Missing doses can allow drug levels in the blood to fall which could allow viral replication to occur and greatly increase the risk of resistance emerging.
About PREZISTA® (darunavir)
Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients as well as antiretroviral therapy (ART) experienced paediatric patients from the age of 3 years and at least 15 kg body weight.
Since its initial approval in 2007, darunavir has also been indicated for use in HIV-1 infected treatment-naïve and treatment-experienced adult patients, including those who have been highly pre-treated, in combination with ritonavir and other ARTs. For treatment-experienced adult patients, the licensed dosing for darunavir (DVR) is 600 mg taken with 100 mg ritonavir twice daily with food or 800 mg taken with 100 mg ritonavir once daily with food for patients with no DRV Resistance Associated Mutations (RAMs)[ii] and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10/L. For treatment-naive adult patients, the licensed dosing for darunavir is 800 mg taken with 100 mg ritonavir once daily with food.
ii. V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V
Important Safety Information
In the registrational studies, darunavir was generally well tolerated. The majority of the adverse reactions reported in patients who initiated therapy with darunavir co-administered with 100 mg ritonavir were mild to moderate in severity. The most frequent adverse reactions reported in clinical trials and as spontaneous reports are diarrhoea, immune reconstitution syndrome, nausea, pyrexia and rash. The most frequent serious reactions are diarrhoea, hepatitis, immune reconstitution syndrome, pyrexia and rash. Please see the Summary of Product Characteristics for a complete list of all possible side effects.
Before taking darunavir, patients should tell their doctor if they have any medical conditions, including liver problems, including hepatitis B or C, diabetes, symptoms of infections, change in body fat, haemophilia, musculoskeletal problems, or allergy to sulfa medicines and should tell their doctor if they are pregnant or planning to become pregnant, or are nursing.
Darunavir should not be used in patients allergic (hypersensitive) to it or ritonavir or with severe liver problems.
Due to potential drug interactions, patients should talk to their healthcare provider about all the medicines they are taking or plan to take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Darunavir does not cure HIV infection or AIDS, and does not prevent passing HIV to others. Please see full Summary of Product Characteristics for more details.
About Janssen in HIV - Commitment to Innovative Research & Development
Over the last five years, Janssen has launched three therapies for people living with HIV. Janssen has a long heritage in HIV and is committed to innovation in HIV therapies. Janssen is constantly striving for improvements in efficacy, safety and dosing simplification and is committed to evaluating HIV treatments for a broad range of patients-from treatment-naïve to treatment-experienced-with the goal of helping all patients achieve an undetectable viral load and a better quality of life.
More information about Janssen can be found at http://www.janssen-emea.com
- PREZISTA 800 mg. Summary of Product Characteristics, 2012.
- Janssen data on file.
- World Health Organization. Global summary of the AIDS epidemic. Available at URL: http://www.who.int/hiv/data/2012_epi_core_en.png . Last accessed December 3, 2012.
- Mannheimer S, Friedland G, Matts J, et al. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials. Clinical Infectious Diseases. 2002; 34:1115-1121.
- Aids Map. Adherence. Available at URL: http://www.aidsmap.com/Adherence/page/1730785/. Last accessed December 3, 2012.
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
Sep. 28, 2016 06:30 PM EDT Reads: 3,057
One of biggest questions about Big Data is “How do we harness all that information for business use quickly and effectively?” Geographic Information Systems (GIS) or spatial technology is about more than making maps, but adding critical context and meaning to data of all types, coming from all different channels – even sensors. In his session at @ThingsExpo, William (Bill) Meehan, director of utility solutions for Esri, will take a closer look at the current state of spatial technology and ar...
Sep. 28, 2016 06:15 PM EDT Reads: 251
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
Sep. 28, 2016 06:00 PM EDT Reads: 1,763
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 ...
Sep. 28, 2016 05:15 PM EDT Reads: 220
Businesses are struggling to manage the information flow and interactions between all of these new devices and things jumping on their network, and the apps and IT systems they control. The data businesses gather is only helpful if they can do something with it. In his session at @ThingsExpo, Chris Witeck, Principal Technology Strategist at Citrix, will discuss how different the impact of IoT will be for large businesses, expanding how IoT will allow large organizations to make their legacy ap...
Sep. 28, 2016 05:15 PM EDT Reads: 220
The many IoT deployments around the world are busy integrating smart devices and sensors into their enterprise IT infrastructures. Yet all of this technology – and there are an amazing number of choices – is of no use without the software to gather, communicate, and analyze the new data flows. Without software, there is no IT. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will look at the protocols that communicate data and the emerging data analy...
Sep. 28, 2016 05:00 PM EDT Reads: 1,715
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the a...
Sep. 28, 2016 04:45 PM EDT Reads: 359
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...
Sep. 28, 2016 04:30 PM EDT Reads: 2,804
Creating replica copies to tolerate a certain number of failures is easy, but very expensive at cloud-scale. Conventional RAID has lower overhead, but it is limited in the number of failures it can tolerate. And the management is like herding cats (overseeing capacity, rebuilds, migrations, and degraded performance). Download Slide Deck: ▸ Here In his general session at 18th Cloud Expo, Scott Cleland, Senior Director of Product Marketing for the HGST Cloud Infrastructure Business Unit, discusse...
Sep. 28, 2016 04:15 PM EDT Reads: 2,428
Whether they’re located in a public, private, or hybrid cloud environment, cloud technologies are constantly evolving. While the innovation is exciting, the end mission of delivering business value and rapidly producing incremental product features is paramount. In his session at @DevOpsSummit at 19th Cloud Expo, Kiran Chitturi, CTO Architect at Sungard AS, will discuss DevOps culture, its evolution of frameworks and technologies, and how it is achieving maturity. He will also cover various st...
Sep. 28, 2016 04:15 PM EDT Reads: 1,863
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Sep. 28, 2016 04:15 PM EDT Reads: 1,485
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of So...
Sep. 28, 2016 04:00 PM EDT Reads: 1,481
What are the new priorities for the connected business? First: businesses need to think differently about the types of connections they will need to make – these span well beyond the traditional app to app into more modern forms of integration including SaaS integrations, mobile integrations, APIs, device integration and Big Data integration. It’s important these are unified together vs. doing them all piecemeal. Second, these types of connections need to be simple to design, adapt and configure...
Sep. 28, 2016 03:15 PM EDT Reads: 354
Digital innovation is the next big wave of business transformation based on digital technologies of which IoT and Big Data are key components, For example: Business boundary innovation is a challenge to excavate third-party business value using IoT and BigData, like Nest Business structure innovation may propose re-building business structure from scratch, as Uber does in the taxicab industry The social model innovation is also a big challenge to the new social architecture with the design fr...
Sep. 28, 2016 03:15 PM EDT Reads: 1,308
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Sep. 28, 2016 03:15 PM EDT Reads: 4,144