|By PR Newswire||
|February 3, 2014 07:00 AM EST||
LONDON, February 3, 2014 /PRNewswire/ --
ViiV Healthcare today launches its first new treatment, the integrase inhibitor, dolutegravir (TIVICAY®) a treatment for human immunodeficiency virus (HIV). It represents a new option for a wide range of people living with HIV, with proven efficacy in people starting treatment and in those who have developed resistance to multiple HIV drugs. Dolutegravir is indicated for use in combination with other antiretroviral agents for the treatment of adults and adolescents over 12 years of age infected with HIV. Most patients prescribed dolutegravir can take it as a convenient once-daily dose; it can be taken with or without food.
Dr Anton Pozniak, HIV Service Director at Chelsea and Westminster Hospital commented, "Every day we face treatment choices in the management of HIV to balance efficacy with tolerability and convenience. As a new treatment alternative, dolutegravir provides us with an option that seems to address these issues and offers a positive treatment choice for both patients and physicians."
The dolutegravir clinical development programme involved more than 2,500 people living with HIV. The trials demonstrated the efficacy of dolutegravir in people at different stages of treatment, including those starting for the first time,,as well as people who had started treatment and had developed resistance to other HIV medicines.,
In people living with HIV and taking treatment for the first time, dolutegravir was shown to be:
- comparable to another integrase inhibitor, raltegravir.
- superior to two other commonly prescribed HIV medicines: boosted darunavir and Atripla®.,
In people who had been treated with other HIV medicines (not including integrase inhibitors) and had developed resistance, dolutegravir was found to be superior to raltegravir.
For those who had developed resistance to other integrase inhibitors, dolutegravir was highly effective and reduced the amount of virus circulating in the blood to undetectable levels in more than half of people.
Dolutegravir is generally well tolerated; in the clinical trials, fewer people stopped taking dolutegravir because of adverse reactions than those taking the comparator drugs. The most commonly seen side effects were nausea (seen in 15% of people taking dolutegravir), diarrhoea (16%) and headaches (14%).
Dr Andrew Benzie, ViiV Healthcare UK Medical Director, commented, "The launch of dolutegravir is an important step forward in the treatment of people living with HIV in the UK. At ViiV Healthcare, our focus is on delivering advances in treatment and care for people living with HIV and dolutegravir is the first from our pipeline to be approved. We are working with the NHS to ensure that appropriate patients are able to access this treatment as soon as possible."
A recent UK survey conducted by IPSOS Mori* asking people living with HIV and clinicians about their feelings towards treatment showed that treatment effectiveness is the most important attribute for both groups, followed by side effects and then how easy the treatment is to take.
- Tivicay (dolutegravir) Summary of Product Characteristics (SmPC). Available at http://www.viivhealthcare.com/our-medicines.aspx.
- Walmsley S, Antela A, Clumeck N et al. N Engl J Med 2013;369:1807-18.
- Clotet B et al. European AIDS Clinical Society (EACS), Brussels, 17 October 2013.
- Raffi F, Rachlis A, Stellbrink H-J et al. Lancet 2013;381(9868):735-743.
- Cahn P, Pozniak AL, Mingrone H et al Lancet 2013;382(9893):700-708.
- Nichols G, Lazzarin A, Maggiolo F, et al, on behalf of the VIKING-3 investigators. Poster presented at: 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention; June 30-July 3, 2013. Kuala Lumpur, Malaysia. Poster TULBPE19
Notes to editors:
Tivicay® is the first new treatment delivered by ViiV Healthcare. It was approved by the U.S. FDA in August 2013 and by Health Canada in October 2013. It is a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle. Please refer to the full Summary of Product Characteristics for full prescribing information, including contraindications, special warnings and precautions for use.
Regulatory applications are being evaluated in other countries worldwide. Regulatory applications for ViiV Healthcare's developmental single-tablet regimen (STR) combining Tivicay with Kivexa®/Epzicom® (abacavir/lamivudine) were submitted to regulatory authorities in Europe, Canada and the U.S. in October 2013.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com.
* About the UK survey
Ipsos MORI interviewed a self-selected sample of 50 physicians and 50 nurses who treat patients with HIV and 50 adults aged 18 years and above diagnosed with HIV across Great Britain. Interviews were conducted online between 4th November and 18th December 2013. Respondents were drawn from healthcare specific market research panels. Data are unweighted and due to the small sample sizes, can only be considered as indicative rather than representative of the population.
With so much going on in this space you could be forgiven for thinking you were always working with yesterday’s technologies. So much change, so quickly. What do you do if you have to build a solution from the ground up that is expected to live in the field for at least 5-10 years? This is the challenge we faced when we looked to refresh our existing 10-year-old custom hardware stack to measure the fullness of trash cans and compactors.
Aug. 24, 2016 01:00 AM EDT Reads: 1,567
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Aug. 24, 2016 12:45 AM EDT Reads: 2,014
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions wi...
Aug. 24, 2016 12:30 AM EDT Reads: 1,815
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....
Aug. 24, 2016 12:00 AM EDT Reads: 2,769
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Aug. 23, 2016 11:30 PM EDT Reads: 2,203
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 23, 2016 11:00 PM EDT Reads: 3,477
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Aug. 23, 2016 09:15 PM EDT Reads: 1,637
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Aug. 23, 2016 09:00 PM EDT Reads: 2,960
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Aug. 23, 2016 08:45 PM EDT Reads: 3,735
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 23, 2016 08:15 PM EDT Reads: 1,622
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Aug. 23, 2016 08:15 PM EDT Reads: 1,384
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
Aug. 23, 2016 07:45 PM EDT Reads: 1,224
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 23, 2016 07:00 PM EDT Reads: 3,787
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. ...
Aug. 23, 2016 06:30 PM EDT Reads: 281
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 23, 2016 05:00 PM EDT Reads: 2,882