On
October 4, 2001, Health Canada approved a new capsule formulation of the
anti-HIV drug ddI (didanosine, Videx). The new formulation is called
Videx EC and consists of a capsule filled with tiny beads of ddI. These
beads are covered with a coating designed to protect them from the
damaging effects of stomach acid. Videx EC is available in white
capsules containing the following doses of ddI:
- 400 mg
- 250 mg
- 200 mg
- 125 mg
This nucleoside analogue is approved
for use by HIV positive adults in combination with other anti-HIV drugs.
The recommended dose of Videx EC is 400 mg once daily for people who
weigh more than 60 kg (roughly 132 pounds), and 250 mg for those who
weigh less than 60 kg. The drug should be taken on an empty stomach, 30
minutes before a meal or two hours after a meal.
Previous formulations of ddI were taken together with an antacid
(buffer) to protect the drug from stomach acid. Indeed, 95% of a ddI
tablet consists of buffer. Because of the large amount of buffer, users
of ddI tablets often experienced symptoms such as nausea, bloating,
diarrhea and gas when they took the tablets. In a recent study comparing
ddI tablets to Videx EC, subjects who switched to the capsules had
significantly fewer of these side effects.
Another advantage to Videx EC is that, because it has no buffer, it does
not interact with drugs such as indinavir (Crixivan), Cipro and with the
"azole" group of antifungal drugs — fluconazole (Diflucan,
Triflucan), ketoconazole (Nizoral) or itraconazole (Sporanox).
Earlier concerns that Videx EC may not be as effective as the tablet
formulation have proven unfounded and regulatory authorities in the
European Union and the United States have also approved Videx EC for
once-daily use.
Videx EC should be available for sale in Canada by mid-January 2002. In
the meantime, there will be no expanded access to this drug.
This information was
provided by the Community AIDS Treatment Information Exchange (CATIE).
For more information, contact CATIE at 1-800-263-1638. |
