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:
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.
REFERENCE
Kunches LM, Reinhalter NE, Marquis A, et al. Tolerablility of enteric_coated didanosine capsules compared with didanosine tablets in adults with HIV infection. Journal of Acquired Immune Deficiency Syndromes 2001;28(2):150_153.
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