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PHARMACOKINETICS

The Effect of Different Meal Types on the Pharmacokinetics of Darunavir (TMC114)/Ritonavir in HIV-Negative Healthy Volunteers

Vanitha Sekar, PhD, Dries Kestens, MSc, Sabrina Spinosa-Guzman, MD, Martine De Pauw, PharmD, Els De Paepe, MSc, Tony Vangeneugden, MSc, Eric Lefebvre, MD and Richard M. W. Hoetelmans, PharmD, PhD

From Tibotec, Inc, Yardley, Pennsylvania (Dr Sekar, Dr Lefebvre), and Tibotec BVBA, Mechelen, Belgium (D. Kestens, Dr Spinosa-Guzman, Dr De Pauw, E. De Paepe, T. Vangeneugden, Dr Hoetelmans).

This open-label, randomized, crossover study investigated the bioavailability, short-term safety, and tolerability of darunavir (TMC114) coadministered with low-dose ritonavir under fasted conditions and after different meal types in HIV-negative healthy volunteers. All volunteers received ritonavir 100 mg twice daily on days 1 to 5, with a single darunavir 400-mg tablet given on day 3 (darunavir/rtv). Pharmacokinetic parameters for darunavir and ritonavir were determined under fasted conditions and following a standard breakfast, a high-fat breakfast, a nutritional protein-rich drink, or a croissant with coffee. Administration of darunavir/rtv in a fasting state resulted in a decrease in darunavir Cmax and AUClast of approximately 30% compared with administration after a standard meal. No significant differences in darunavir plasma concentrations were observed between different fed states. Darunavir/rtv should therefore be administered with food, but exposure to darunavir is not affected by the type of meal.

Key Words: HIV • protease inhibitors • pharmacokinetics • darunavir • Prezista • food

Address for reprints: Richard M. W. Hoetelmans, PharmD, PhD, Tibotec BVBA, Generaal De Wittelaan L11 B3, 2800 Mechelen, Belgium; e-mail: rhoetelm{at}tibbe.jnj.com.


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