|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.
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 20th Cloud Expo, which will take place on June 6-8, 2017 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 add...
Mar. 27, 2017 08:30 AM EDT Reads: 1,192
Building custom add-ons does not need to be limited to the ideas you see on a marketplace. In his session at 20th Cloud Expo, Sukhbir Dhillon, CEO and founder of Addteq, will go over some adventures they faced in developing integrations using Atlassian SDK and other technologies/platforms and how it has enabled development teams to experiment with newer paradigms like Serverless and newer features of Atlassian SDKs. In this presentation, you will be taken on a journey of Add-On and Integration ...
Mar. 27, 2017 08:15 AM EDT Reads: 3,051
There are 66 million network cameras capturing terabytes of data. How did factories in Japan improve physical security at the facilities and improve employee productivity? Edge Computing reduces possible kilobytes of data collected per second to only a few kilobytes of data transmitted to the public cloud every day. Data is aggregated and analyzed close to sensors so only intelligent results need to be transmitted to the cloud. Non-essential data is recycled to optimize storage.
Mar. 27, 2017 08:15 AM EDT Reads: 3,020
"I think that everyone recognizes that for IoT to really realize its full potential and value that it is about creating ecosystems and marketplaces and that no single vendor is able to support what is required," explained Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Mar. 27, 2017 08:00 AM EDT Reads: 4,229
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
Mar. 27, 2017 07:45 AM EDT Reads: 1,034
The essence of cloud computing is that all consumable IT resources are delivered as services. In his session at 15th Cloud Expo, Yung Chou, Technology Evangelist at Microsoft, demonstrated the concepts and implementations of two important cloud computing deliveries: Infrastructure as a Service (IaaS) and Platform as a Service (PaaS). He discussed from business and technical viewpoints what exactly they are, why we care, how they are different and in what ways, and the strategies for IT to transi...
Mar. 27, 2017 05:00 AM EDT Reads: 6,165
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership abi...
Mar. 27, 2017 05:00 AM EDT Reads: 11,048
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service.
Mar. 27, 2017 03:45 AM EDT Reads: 2,973
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. 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.
Mar. 27, 2017 03:15 AM EDT Reads: 3,158
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Mar. 27, 2017 03:00 AM EDT Reads: 2,995
SYS-CON Events announced today that Outlyer, a monitoring service for DevOps and operations teams, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outlyer is a monitoring service for DevOps and Operations teams running Cloud, SaaS, Microservices and IoT deployments. Designed for today's dynamic environments that need beyond cloud-scale monitoring, we make monitoring effortless so you ...
Mar. 27, 2017 02:15 AM EDT Reads: 4,178
Virtualization over the past years has become a key strategy for IT to acquire multi-tenancy, increase utilization, develop elasticity and improve security. And virtual machines (VMs) are quickly becoming a main vehicle for developing and deploying applications. The introduction of containers seems to be bringing another and perhaps overlapped solution for achieving the same above-mentioned benefits. Are a container and a virtual machine fundamentally the same or different? And how? Is one techn...
Mar. 27, 2017 01:45 AM EDT Reads: 2,980
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
Mar. 27, 2017 01:45 AM EDT Reads: 2,914
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Mar. 27, 2017 01:15 AM EDT Reads: 1,867
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
Mar. 27, 2017 12:45 AM EDT Reads: 2,118