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Effect of Food on High‐Dose Oral Ganciclovir Disposition in HIV‐Positive Subjects
Author(s) -
Jung Donald,
Griffy Kay,
Dorr Albert
Publication year - 1999
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912709922007714
Subject(s) - dosing , medicine , ganciclovir , crossover study , pharmacokinetics , meal , regimen , oral administration , stomach , placebo , virus , human cytomegalovirus , alternative medicine , pathology , virology
The effect of food on the steady‐state pharmacokinetics of ganciclovir following high‐dose oral ganciclovir in HIV‐ and CMV‐seropositive subjects was investigated in an open‐label, randomized, two‐treatment crossover study. Over 2 consecutive weeks, subjects received in random order multiple oral doses of ganciclovir 2000 mg tid for 3 consecutive days either on an “empty stomach” (i.e., at least 1 hour before or 2 hours after a meal or snack) or within 30 minutes of finishing a meal. For the 3 days of dosing each week, the breakfast consisted of a standardized 602 calorie, high‐fat (46.5%) meal, while the contents of lunch, dinner, and snacks met American Dietetic Association recommendations (25%–35% fat). Serial blood samples over 24 hours were obtained on day 3 of each regimen over the first dosing interval. When ganciclovir was administered within 30 minutes following the breakfast, there was a mean increase of 110.6% ± 79.0% and 114.1% ± 81.7% in C max0‐5 and AUC 0–5 , respectively, with a prolongation of mean T max from 1.8 to 2.7 hours. Over the total day of dosing, there was a mean increase of 47.6% ± 12.3% and 97.2% ± 30.9% in C max0‐24 and AUC 0–24 , respectively, and a 36.0% ± 18.0% decrease in half‐life when doses were taken following a meal as compared to when taken on an empty stomach. Since food increases the systemic availability of ganciclovir, it is recommended that patients be instructed to take each dose of ganciclovir with food.