Effect of food on the antiviral activity of didanosine enteric-coated capsules: a pilot comparative study

Authors


  • *Presented in part at IX Congreso Nacional sobre el Sida, 29–31 March 2006, Barcelona, Spain (Abstract CO2,4) and the Eighth International Congress on Drug Therapy in HIV Infection, 12–16 November 2006, Glasgow, UK (Abstract P301).

Dr Beatriz Hernández-Novoa, Servicio de Enfermedades Infecciosas, Hospital Ramón y Cajal, Ctra Colmenar, Km 9100, 28034 Madrid, Spain. Tel: +34 91 336 8711; fax: +34 91 336 8792; e-mail: bhernandez.hrc@salud.madrid.org

Abstract

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 log10 copies/mL in group 1 and 3.8 log10 copies/mL in group 2. After 28 days, the mean HIV-1 RNA reduction was 0.99 log10 copies/mL [95% confidence interval (CI) 0.45–1.53] for group 1 and 0.89 log10 copies/mL (95% CI 0.38–1.40) for group 2. AUCMB/day values were 0.775 log10 copies/mL (95% CI 0.33–1.22) and 0.774 log10 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.

Ancillary