Pharmacokinetic interaction between nevirapine and darunavir with low-dose ritonavir in HIV-1-infected patients.
OBJECTIVE
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 > or =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.
Sekar
Vanitha
V
Tibotec Inc., 1020 Stony Hill Road, Yardley, PA 19067, USA. vsekar@tibus.jnj.com
Lefebvre
Eric
E
Mariën
Kris
K
De Pauw
Martine
M
Vangeneugden
Tony
T
Pozniak
Anton
A
Hoetelmans
Richard M W
RM
D000328:Adult; D018592:Cross-Over Studies; D000069454:Darunavir; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000493:pharmacokinetics; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000008:administration & dosage* / Q000493:pharmacokinetics; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000493:pharmacokinetics; D019438:Ritonavir / Q000008:administration & dosage* / Q000493:pharmacokinetics; D013449:Sulfonamides / Q000008:administration & dosage* / Q000493:pharmacokinetics; D016896:Treatment Outcome
D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D013449:Sulfonamides; D019829:Nevirapine; D019438:Ritonavir; D000069454:Darunavir