icon star paper   Articles  
Back grey_arrow_rt.gif
Atazanavir Early Access Program
reported by Jules Levin
  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.
  icon paper stack View Older Articles   Back to Top   www.natap.org