|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.