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Effect of food on the antiviral activity of didanosine enteric‐coated capsules: a pilot comparative study *
Author(s) -
HernándezNovoa B,
Antela A,
Gutiérrez C,
PérezMolina JA,
PérezElías MJ,
Dronda F,
Moreno A,
Casado JL,
Page C,
Pumares M,
Galán JC,
Moreno S
Publication year - 2008
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2008.00543.x
Subject(s) - didanosine , medicine , confidence interval , gastroenterology , human immunodeficiency virus (hiv) , viral load , antiretroviral therapy , immunology
Objectives To determine the effect of food on the antiviral activity of enteric‐coated (EC) capsules of didanosine (ddI). Methods We conducted a pilot, randomized, open‐label study of 28‐day ddI‐EC capsules monotherapy‐administered in a fasted state (group 1, n =11) or with food (group 2, n =10) to treatment‐naïve chronically HIV‐1‐infected individuals. To assess the antiviral efficacy, HIV‐1 RNA was determined at baseline, day 3, day 7 and weekly thereafter. The area under the HIV‐1 RNA curve minus baseline weighted by time (AUCMB/day) was calculated. Results Mean baseline HIV‐1 RNA was 4.2 log 10 copies/mL in group 1 and 3.8 log 10 copies/mL in group 2. After 28 days, the mean HIV‐1 RNA reduction was 0.99 log 10 copies/mL [95% confidence interval (CI) 0.45–1.53] for group 1 and 0.89 log 10 copies/mL (95% CI 0.38–1.40) for group 2. AUCMB/day values were 0.775 log 10 copies/mL (95% CI 0.33–1.22) and 0.774 log 10 copies/mL (95% CI 0.48–1.07), respectively, showing no difference in the rate of decrease of HIV‐1 RNA ( P =0.995). Mean ddI plasma levels at day 28 were 0.0234 mg/L for group 1 and 0.0227 mg/L for group 2 ( P =0.96). Conclusions In this pilot study, the administration of food did not have any significant effect on the antiviral activity of ddI‐EC capsules.