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Treatment Briefs: ddI: Once Daily & New Formulation

Treatment Issues: Newsletter of Experimental AIDS Therapies - Volume 13, Number 11/12, November/December 1999
Gil Shepard

Although ddI (didanosine, Videx) is a highly potent nucleoside analog, it is associated with occasionally severe toxicities (see above) and can be difficult to take. ddI was initially approved for twice-a-day dosing, which by itself is not too demanding. However, a buffering agent in ddI interferes with the absorption of other drugs, including indinavir (Crixivan), so the drugs have to be taken an hour apart. In addition, ddI should be taken on an empty stomach. As a result, ddI-containing regimens have been difficult to follow, leading to problems with adherence. Things have become easier since the FDA approved once-daily dosing (two 200 mg tablets) of ddI last year, a decision that was based on studies showing once and twice daily doses were equivalent at reducing viral load and raising CD4 counts (see Treatment Issues, July/August 1999).

And taking ddI might become even easier. In January Bristol-Myers Squibb, the manufacturer of ddI, announced that it had applied for a New Drug Application (NDA) for a new formulation of ddI. The new capsules have an enteric coating that makes the buffer in older formulations unnecessary. If the new formulation is FDA approved, patients may only be required to take one ddI pill per day.

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