Press room ... 2000 archive

New ddI Formulation Expanded Access Program

October 19, 2000

San Francisco, CA—Bristol-Myers Squibb is starting an expanded access program for their new enteric-coated formulation of ddI (Videx) for people who cannot tolerate the existing tablet or liquid formulations. There are a few advantages to the new formulation: it is taken once a day; it does not have the buffer now found in the tablets and as a result should result in fewer gastrointestinal side effects; and it does not have to be taken an hour before or after other drugs such as indinavir (Crixivan). However, enteric-coated ddI still needs to be taken on an empty stomach (30 minutes before or two hours after eating).

To qualify for the program, you must:

• Have a CD4+ cell count below 200 within the past 12 weeks
• Be intolerant to the currently available formulation of ddI as confirmed by your physician
• Be failing or failed (rebound in viral load) on one or more potent anti-HIV regimen
• Have no history of acute or chronic pancreatitis (inflammation of the pancreas), a side effect associated with ddI
• Have no liver function test abnormalities (less than four times the upper limits of normal)
• Have no ongoing moderate-to-severe peripheral neuropathy (a tingling sensation or pain usually in the hands, legs, or feet), another side effect associated with ddI
• Not have diarrhea (more than six loose stools per day for seven days or more) Not be on other drugs which can cause similar side effects to ddI, such as intravenous pentamidine, systemic chemotherapy, allopurinol or hydroxyurea

In order to participate in this expanded access program, your physician must call 1-877-418-3889 to register for the program.