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DDI EC and Food and Timing of Dosing
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Researchers from Bristol-Myers Squibb & now Dupont reported at ICAAC on a study (abstract A-499) looking at the effect of food and the timing of a meal on the oral bioavailability of DDI EC in healthy volunteers (encapsulated enteric coated beads). There has been some controversy about the effect of food and timing of taking meds with ddI EC.
Four studies were conducted in 334 healthy volunteers and each study was an open-label, single-dose, randomized, crossover study (patients were crossed over from one arm to the other). 400 mg of Videx (ddI) EC was given under fasting conditions, with a hi-fat meal (757 calories), with a light meal (373 calories), with the beads sprinkled on yogurt (69 calories), and with the beads sprinkled on applesauce (25 calories). DDI was given under fasting or with a light meal at various dosing intervals before and after a light meal.
RESULTS
The AUC (total amount of ddI the person would be exposed to) decreased relative to being taken under fasting conditions by 19% with a hi-fat meal, by 27% with a light meal, by 20% with yogurt, and by 18% with applesauce. The Cmax (highest peak level of drug in blood) was decreased by 46%, 22%, 30%, and 24%, respectively.
When ddI EC was taken 1 hour before a light meal Cmax decreased by 15% and AUC by 24%. When ddI EC was taken 1.5, 2, or 3 hours before a light meal, there was no change in the Cmax or AUC. When ddI EC was taken 2 hours after a light meal AUC was decreased by 10% and Cmax by 15%.
This study was not conducted in HIV-infected patients but shows a food effect. The effect may be considered modest and we donšt know if the reductions in AUC or Cmax are clinically significant. In other words, would these reductions in blood levels affect the antiviral effectiveness of ddI EC, particularly when HAART is used. We donšt have a clear answer to that.
BMS concluded: ddI EC should be administered on an empty stomach. Taking DDI EC 1.5 to 2 hours after meals resulted in the same systemic exposures as taking it on an empty stomach.
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