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Pharmacokinetic interaction between nevirapine and darunavir with low‐dose ritonavir in HIV‐1‐infected patients
Author(s) -
Sekar Vanitha,
Lefebvre Eric,
Mariën Kris,
De Pauw Martine,
Vangeneugden Tony,
Pozniak Anton,
Hoetelmans Richard M. W.
Publication year - 2009
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2009.03430.x
Subject(s) - darunavir , nevirapine , ritonavir , pharmacokinetics , reverse transcriptase inhibitor , pharmacology , medicine , protease inhibitor (pharmacology) , population , drug interaction , crossover study , didanosine , virology , human immunodeficiency virus (hiv) , viral load , antiretroviral therapy , alternative medicine , environmental health , pathology , placebo
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • The protease inhibitor (PI) darunavir with low‐dose ritonavir (DRV/r) and the non‐nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine (NVP) are used in combination with other antiretroviral agents and they may be co‐administered for the treatment of HIV‐1 infection. • There is the potential for a pharmacokinetic interaction between NVP and DRV/r, since these drugs use similar metabolic pathways. WHAT THIS STUDY ADDS • This study assesses for the first time the extent of the drug–drug interaction between NVP and DRV/r in the relevant population of HIV‐1‐infected patients. AIM To investigate the pharmacokinetic interaction between darunavir/ritonavir (DRV/r) and nevirapine (NVP) in 19 HIV‐infected patients. METHODS An open‐label, randomized, crossover study. Patients received Treatment A [NVP 200 mg b.i.d. plus ≥2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] and Treatment B [A plus DRV/r 300/100 mg b.i.d. (DRV oral solution)] or Treatment B2 [A plus DRV/r 400/100 mg b.i.d. (DRV tablet)] in two 14‐day sessions. RESULTS Mean NVP AUC 12h increased by 27% [least square means ratio 1.27 (95% confidence interval 1.02, 1.58)]. Mean DRV and ritonavir exposures were similar to historical data. Co‐administration was well tolerated. CONCLUSIONS DRV/r and NVP have no clinically relevant interaction. No dose adjustments are required.