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Pharmacokinetics of saquinavir hard gel/ritonavir (1000/100 mg twice daily) when administered with tenofovir diproxil fumarate in HIV‐1‐infected subjects
Author(s) -
Boffito Marta,
Back David,
StainsbyTron Meredith,
Hill Andrew,
Di Perri Giovanni,
Moyle Graeme,
Nelson Mark,
Tomkins Jaqui,
Gazzard Brian,
Pozniak Anton
Publication year - 2005
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.1365-2125.2004.02240.x
Subject(s) - saquinavir , ritonavir , pharmacokinetics , regimen , pharmacology , medicine , chemistry , human immunodeficiency virus (hiv) , virology , viral load , antiretroviral therapy
Aims To investigate whether the administration of tenofovir diproxil fumarate 300 mg once daily alters the plasma pharmacokinetics of the saquinavir hard gel/ritonavir combination in HIV‐1 infected individuals. Methods On day 1, 12 h pharmacokinetic profiles for saquinavir/ritonavir (1000/100 mg given twice daily) were obtained for 18 subjects. All subjects were receiving ongoing treatment with a saquinavir/ritonavir‐containing regimen. Tenofovir diproxil fumarate 300 mg given once daily was then added to the regimen and blood sampling was repeated at days 3 and 14. Saquinavir and ritonavir concentrations were measured by HPLC–MS/MS, and tenofovir concentrations by HPLC with UV detection. Results Following the addition of tenofovir diproxil fumarate to the regimen, saquinavir and ritonavir plasma concentrations were not significantly different compared with day 1. Thus the geometric mean ratios (95% confidence intervals) for the area under the concentration‐time curve were 1.16 (0.97, 1.59) and 0.99 (0.87, 1.30) for saquinavir and 1.05 (0.92, 1.28) and 1.08 (0.97, 1.30) for ritonavir, on days 3 and 14, respectively. Conclusions Tenofovir diproxil fumarate did not alter the pharmacokinetics of saquinavir hard gel/ritonavir.