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Atazanavir Early Access Program
reported by Jules Levin
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The early access program for this drug includes patients with serious
cholesterol and triglycerides elevations. Speak to your doctor about this if
you feel you qualify, criteria is reported below. A 48 week study reported at
this ICAAC meeting show, as previous studies have shown, that cholesterol and
triglycerides can be reduced on atazanavir. As well, a study reported here
preliminary findings that patients on atazanavir did not experience glucose
elevations. These studies need longer follow-up.
Bristol-Myers Squibb Early Access Program Can Provide Investigational
Protease Inhibitor Atazanavir for Eligible Patients With HIV
Press Release
PRINCETON, N.J. -- Bristol-Myers Squibb Company has started enrolling
patients in an early access program to provide the investigational protease
inhibitor, atazanavir, to eligible
patients infected with HIV.
An early access program (EAP) provides medicines to eligible patients in need
of alternative therapy prior to the medicine's approval. Atazanavir,
currently in phase III clinical development
by Bristol-Myers Squibb, is an azapeptide belonging to the HIV-1 protease
inhibitor class.
This program will provide atazanavir to HIV-infected patients who meet
specified entry criteria. Atazanavir can be provided in the EAP to patients
who are failing their current antiretroviral
therapy (defined as an HIV RNA level > 5000 copies/ml and have had an
absolute CD4 count < 300 cells/mm3) and unable to construct an alternative
treatment regimen using other available
antiretroviral agents due to prior virologic failure and/or drug intolerance.
This 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 National Cholesterol Education Program guidelines
for use of a lipid lowering agent.
Eligible patients also include those who have a sufficient degree of
intolerance or adherence problems with current antiretroviral agents and
unable to construct an alternative treatment regimen without use of
atazanavir. The viral load and CD4 cell count restrictions do not apply to
these two groups of patients.
To date, more than 1,500 patients -- covering all stages of HIV infection --
have received atazanavir in clinical trials. Asymptomatic increases in
unconjugated bilirubin without evidence
of hepatotoxicity have occurred with atazanavir. Reversible jaundice or
yellowing of skin or eyes also occurred in some patients with elevated
bilirubin. Fewer than 1 percent of
individuals studied have discontinued atazanavir for elevated bilirubin or
jaundice. Patients may be enrolled in the EAP through physicians only.
Physicians may call 1-877-7BMSEAP
(1-877-726-7327) for more information about the program.
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