AEGiS-ATDN: New Zrivada Program

Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

New Zrivada Program

Information Bulletin #15 - May 2002

Zrivada (atazanavir) Early Access Program - A new Protease Inhibitor not yet approved by the FDA is going to become available free to patients in an Early Access Program, sponsored by the maker, Bristol Myers Squibb. On-going clinical trials have shown Zrivada to be effective in people who have protease inhibitor resistant viruses. This program will provide access to this experimental drug to people whose current treatment regimen is not working. Even though the program has not yet opened, people who are interested should ask their doctor to call the number and be put on a waiting list.

Eligibility criteria to enroll into the program are still being formed; the following is an on going guide, which will be finalized in May 2002. At this point, you must have less than 300 CD4 cells, and an HIV viral load over 5,000. You must be unable to construct an alternate regimen due to virologic failure or intolerance. The other criteria that may make you eligible for the program is to have HIV-treatment related hyperlipidemia (triglyceride levels of 750 or higher) that is unresponsive to lipid-lowering treatment, regardless of your viral load viral load or CD4 count. In both cases, being part of the Expanded Access Program will require infrequent study visits, a 2 month drug supply, and limited mandatory testing for ALT and bilirubin. You will also need to have an echocardiogram done.

You are not eligible for the program if you already have heart problems, including heart block. Liver enzymes cannot be higher than 5 times the upper limit of normal. You cannot be taking Norvir, Kaletra, Crixivan, or Sustiva, due their drug-drug interactions with Atazanavir. The phone number to call is 1 (877) - 726 - 7327.

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