Press Release

December 8th, 2008, Uxbridge, UK – Guidance published today by the Scottish Medicines Consortium (SMC) approves Bristol-Myers Squibb’s once-daily protease inhibitor REYATAZ® (atazanavir), for use within NHS Scotland in antiretroviral treatment-naïve HIV-1 infected adults, in combination with other antiretroviral medicinal products. This latest recommendation is an extension of previous guidance issued in September 2004 approving atazanavir for use in HIV-1 infected, antiretroviral treatment-experienced adults, in combination with other antiretroviral medicinal products in those patients who do not require concomitant statin use.1

"The SMC's decision to extend the use of atazanavir, in combination with other antiretrovirals, to treatment-naive HIV-1 adults is positive news, especially for those newly diagnosed with HIV," commented Dr Clifford Leen, Consultant, Infectious Diseases, Western General Hospital, Edinburgh. "Doctors in Scotland now have another effective tool for early treatment of HIV. Patients will have the added benefits of receiving a treatment where there is a lower incidence of nausea and diarrhoea, and less of a lipid rise, compared to those on lopinavir. Additionally, as atazanavir is a once-daily pill, it will be more convenient, particularly as many patients are on other medications."
The SMC guidance is supported by 48-week data from the CASTLE study which showed atazanavir/ritonavir had similar efficacy compared to lopinavir/ritonavir in antiretroviral-naïve HIV-1 patients, with 78 percent and 76 percent of patients respectively, achieving and maintaining an undetectable viral load (defined as HIV-1 RNA less than 50 copies/mL). The CASTLE results also demonstrated that atazanavir/r was associated with lower incidences of diarrhoea and lipid adverse-effects and a higher incidence of hyperbilirubinaemia in this patient population, information which is reflected in the SMC guidance.2

Since the SMC submission, the 96-week results from the CASTLE study were presented at the joint 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/ Infectious Diseases Society of America (IDSA) 46th annual conference in Washington, D.C. and continued to show similar efficacy between atazanavir/r and lopinavir/r. These data also showed differences at 96-weeks in gastrointestinal and lipid effects for atazanavir compared to lopinavir.3

In reaction to the SMC guidance, Richard Marsh, Director of External Affairs and Market Access at Bristol-Myers Squibb said, “Bristol-Myers Squibb is committed to extending and enhancing the lives of those affected by HIV through effective and appropriate treatment. We are pleased that the SMC’s decision on the cost and clinical effectiveness of Reyataz for treatment-naive patients, will mean that HIV patients in Scotland will have access to another valuable treatment option.”

By June 2008, there were 5,525 diagnosed cases of HIV identified in Scotland, which is equivalent to 6% of all people diagnosed with HIV in the UK.4 The number of people diagnosed with HIV is rising each year due to increased testing and an increase in previously infected individuals immigrating to Scotland from high prevalence areas such as sub-Saharan Africa.5 While there is no cure for HIV/AIDS, early intervention with antiretroviral therapies such as atazanavir can lead to reduced viral load and improved immunological response.

Bristol-Myers Squibb is a global biopharmaceutical and related health care products company whose mission is to extend and enhance human life.

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REYATAZ® (atazanavir sulfate) is a registered trademark of Bristol-Myers Squibb Company.

Further details of the SMC recommendation can be found on the SMC website: www.scottishmedicines.org.uk

About REYATAZ? (atazanavir sulfate)
Atazanavir is a protease inhibitor that has been studied extensively in both treatment-naive and treatment-experienced HIV-infected patients and is administered once-daily in all patient populations. Atazanavir is indicated in Scotland for the treatment of antiretroviral treatment-experienced and antiretroviral treatment-naive HIV-1 infected adults, in combination with other antiretroviral medicinal products.1

For further information, or a copy of the summary of product characteristics (SmPC) please contact:

1. Scottish Medicines Consortium, Reyataz Guidance Document, December 2008 www.scottishmedicines.org.uk
2. Molina, JM et al. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naïve HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. The Lancet, 23 August 2008, Vol 372.
3. Molina, J-M et al. CASTLE: Atazanavir-ritonavir vs Lopinavir-ritonavir in Antiretroviral-naïve HIV-1 infected Patients: 96 Week Efficacy & Safety. The joint 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/ Infectious Diseases Society of America (IDSA) 46th annual conference, Washington, D.C. Oral presentation.
4. Avert Website. United Kingdom Statistics by Exposure Category. http://www.avert.org/stats.htm accessed November 2008
5. Health Protection Scotland. HIV and AIDS. http://www.hps.scot.nhs.uk/bbvsti/hivandaids.aspx accessed November 2008
 

For more information:
http://www.scottishmedicines.org.uk