NEW YORK -- December 8, 2008 -- The Scottish Medicines Consortium (SMC) has approved atazanavir sulphate (Reyataz) once-daily, as part of combination therapy in treatment-naïve HIV-1 infected patients.
"The SMC's decision to extend the use of atazanavir, in combination with other antiretrovirals, to treatment-naïve HIV-1 adults is positive news, especially for those newly diagnosed with HIV," said Clifford Leen, MD, Western General Hospital, Edinburgh, Scotland.
Doctors in Scotland commented that they now have another effective tool for early treatment of HIV. Patients will have the added benefits of receiving a treatment with a lower incidence of nausea and diarrhoea and a lower rise in lipids compared with 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 approval is based on 48-week results from the CASTLE study, which demonstrated similar antiviral efficacy of atazanavir/ritonavir (atazanavir/r) to twice-daily lopinavir/ritonavir (lopinavir/r), each as part of HIV combination therapy in treatment-naïve HIV-1 infected adult patients.
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.
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) and the Infectious Diseases Society of America (IDSA) 46th Annual Conference in Washington, DC, and the results 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 with lopinavir.
SOURCE: Bristol-Myers Squibb
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