LONDON and CAMBRIDGE, England, December 20 /PRNewswire/ --
- ATRIPLA is a Landmark Achievement of Two Co-operating Companies
ATRIPLA (600 mg efavirenz / 200 mg emtricitabine / 245 mg tenofovir disoproxil as fumarate), launched today in the UK, is the first and only complete HIV treatment in one pill once-daily for virologically suppressed adults, and represents a new era in HIV therapy for these patients. (1,2) In a unique collaboration, two companies - Bristol-Myers Squibb and Gilead Sciences - have come together to develop a single treatment to improve the lives of people with HIV. ATRIPLA offers virologically suppressed adults effective and discreet HIV treatment in one pill, once daily.(2-5)
"The availability of an effective HIV treatment in a single pill requiring a once-daily dose is a welcome advance in the management of the condition," said Professor Brian Gazzard, Clinical Research Director, Chelsea and Westminster Hospital, London. "Not only does ATRIPLA offer the patient more convenience, it also helps adherence. This is important because inadequate adherence, often associated with a more complex pill burden, can lead to a patient developing resistance and needing to switch to a different treatment, in turn limiting future therapy options. ATRIPLA provides long-term efficacy, durability and tolerability plus the unparalleled convenience of a single pill, and will prove particularly important as patients stay on therapy longer."
ATRIPLA is a combination of the most widely prescribed highly active antiretroviral therapies (HAART) SUSTIVA (efavirenz) and TRUVADA (emtricitabine/tenofovir disoproxil as fumarate)(6), which are currently recommended as first-line therapy by the British HIV Association (BHIVA)(7). Studies have shown that patients can be switched from other regimens to ATRIPLA while maintaining viral suppression and prolonging efficacy(5).
"Treatments for HIV mean it's no longer a death sentence for most people in the UK, but they can sometimes be difficult to take. Most people have trouble with a week's worth of antibiotics - imagine taking them for life. So combining an already widely used combination of treatments into one pill, once a day will help many people with HIV maintain a normal life at work and home. It's important that people understand how far treatment for HIV has advanced in the UK, and how important it is that if they've been at risk, they get tested and treated in order to be able to carry on with their lives," said Lisa Power, Head of Policy, Terrence Higgins Trust.
"ATRIPLA means that for the first time ever effective and discreet HIV treatment is available in one pill, once-daily for virally suppressed adults. In recent years we have come a long way in terms of treatment advances; patients historically required up to 30 pills a day and now some need just one pill," said Frank Pasqualone, General Manager, Bristol-Myers Squibb UK.
This statement was supported by Andrew Whitaker, General Manager, Gilead Sciences UK, who stated "Patients have been asking for simpler treatments since the dawn of HIV therapy and this has been a key driver behind our two companies coming together".
HIV is the fastest growing serious health condition in the UK(8). Around 89,000 cases of HIV have been reported since the early 1980s(8), and there are currently estimated to be up to 73,000 people living with HIV(9), with one in three infections remaining undiagnosed(10). HIV remains a life- threatening condition. The introduction of drug therapies has improved the lives of many people with HIV, but there is still no cure(11).
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercialises innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
Notes to Editors
ATRIPLA is the first and only once-daily single tablet regimen approved for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of less than 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in ATRIPLA prior to initiation of their first antiretroviral treatment regimen.(1)
The MAA for ATRIPLA was granted in the EU by the European Commission in December 2007, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in October 2007.
ATRIPLA Efficacy and safety
In the EU, the ATRIPLA MAA decision was based on clinical data in virologically suppressed patients switching to ATRIPLA. These data were provided as part of the European review and form the basis for the ATRIPLA indication in the EU. The ATRIPLA indication in the EU is therefore a reflection of that patient population.
The clinical study is a 48-week ongoing open-label, randomised trial in HIV-infected patients who were virologically suppressed on a stable background regimen (SBR) of either two nucleoside reverse transcriptase inhibitors (NRTIs) with either a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI).(1) 203 HIV patients were randomised to switch to ATRIPLA and 97 continued their SBR. The 24-week results showed that high levels of virologic suppression were maintained in patients who were randomised to change to ATRIPLA, compared to the original treatment regimen - 99.5% and 99.5% of subjects had plasma HIV-1 RNA concentrations <200copies/mL and <50 copies/mL, respectively, compared with 95.7% and 98.9%, respectively, in the SBR group.
Refer to the ATRIPLA Summary of Product Characteristics for further information or contact Caroline Almeida, Tel: +44-1895-52-3519 for a copy.
1) ATRIPLA SmPC, December 2007.
2) Killingley B and Pozniak A. The first once-daily single-tablet regimen for the treatment of HIV-infected patients. Drugs of Today 2007; 43:427-442.
3) Gallant JE, deJesus E, Arribas JR et al. Tenofovir DF, emtricitabine and efavirenz vs. zidovudine, lamivudine and efavirenz for HIV. New England Journal of Medicine 2006; 354:251-260.
4) Arribas J, Pozniak A, Gallant J et al. Three-year safety and efficacy of emtricitabine (FTC)/tenofovir DF (TDF) and efavirenz (EFV) compared to fixed dose zidovudine/lamivudine (CBV) and EFV in antiretroviral treatment-naïve patients. 4th IAS Conference. July 22-25, 2007. Sydney, AU. Poster WePeBo29.
5) deJesus E, Young B, Fisher A et al. Virologic suppression is maintained after change to efavirenz/emtricitabine/tenofovir disoproxil fumarate single tablet regimen (EFV/FTC/TDF) vs. continuation of current antiretroviral therapy: study 073 - results of 24-week interim efficacy analyses. Presentation LBPS7/6 11th European AIDS Conference, Madrid, Spain, October 26, 2007
6) Synovate data 2007.
7) Gazzard B, Bernard AJ, Boffito M, Churchill D, Edwards S, Fisher N, Geretti AM, Johnson M, Leen C, Peters B, Pozniak A, Ross J, Walsh J, Wilkins E, Youle M; Writing Committee, British HIV Association. British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy (2006). HIV Med. 2006 Nov; 7(8):487-503.
8) http://www.tht.org.uk/informationresources/factsandstatistics/uk/ Accessed December 2007
9) http://www.hpa.org.uk/hpa/news/articles/press_releases/2007/071123_hiv_s... Accessed December 2007
10) http://www.nat.org.uk/Media-Centre/Statistics. Accessed December 2007
11) http://www.dh.gov.uk/en/Policyandguidance/Healthandsocialcaretopics/HIV/... Accessed December 2007
For further information, please contact: Caroline Almeida, Communications Manager, Bristol-Myers Squibb, +44-1895-523519; +44-7970-871722. Stephen Head, Senior MSL, Gilead Sciences, +44-7768-705945. Natalie Henson, Programme Director, Axon Communications, +44-7809-390667