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  Bristol-Myers Squibb has started enrolling patients in an early access program to provide the experimental protease inhibitor, atazanavir, to eligible patients infected with HIV who are in need of an investigational antiretroviral agent.
An early access program (EAP) provides medicines to patients in need prior to the medicine's approval. Atazanavir is in the late stage of clinical development as a product to treat HIV infection in combination with other antiretroviral agents.
The initial phase of this program, which begins May 15, will provide atazanavir to patients worldwide who need atazanavir and meet specified entry criteria. As Bristol-Myers Squibb compiles safety data from its ongoing phase III clinical trials, the EAP and data on interactions between atazanavir and other drugs, the Company expects to modify some of the protocol restrictions which currently apply. This could allow a greater number of patients to access atazanavir.
The initial stage of the EAP will provide atazanavir to patients who are failing their current antiretroviral therapy (defined as an HIV RNA level > 5000 copies/ml and an absolute CD4 cell count of < 300 cells/mm3) and who are in need of atazanavir in order to construct a viable alternative treatment regimen. This stage of the program will also provide atazanavir to patients who have severe HAART-associated hyperlipidemia despite lipid lowering therapy, defined as a triglyceride level > 750 mg/dL or a cholesterol level meeting NCEP guidelines for use of a lipid lowering agent. The aforementioned viral load and CD4 cell count restrictions do not apply to this latter group of patients. Entry criteria are based on the experience Bristol-Myers Squibb has to date with atazanavir and are designed to ensure an appropriate benefit/risk ratio.
Some restrictions will apply during the initial phase of the EAP, regarding combined use of atazanavir with some of the other medications available for the treatment of HIV, until more is known about drug interactions between these agents and atazanavir.
Phase II data support the potency, safety, tolerability and sustained antiviral activity of atazanavir in previously treatment-na´ve and treatment-experienced HIV-infected patients. These data also suggest that atazanavir could be the first once-daily protease inhibitor. In addition, results from these studies have shown that, unlike currently marketed protease inhibitors, atazanavir does not appear to produce elevations in lipids and triglycerides.
To find out more about the atazanavir EAP, please call 1-877-7BMSEAP (1-877-726-7327).
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