Pharmacokinetics and pharmacodynamics of darunavir and etravirine in HIV-1-infected, treatment-experienced patients in the gender, race, and clinical experience (GRACE) trial

AIDS Research and Treatment

Volumn 2012, Issue , 2012, Pages

  Kakuda, Thomas ^a   Sekar, Vanitha ^a   Vis, Peter ^b   Coate, Bruce ^a   Ryan, Robert ^a   Anderson, David ^a   De La Rosa, Guy ^a   Mrus, Joseph ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b JANSSEN RESEARCH FOUNDATION   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84873847180     PISSN: 20901240     EISSN: 20901259     Source Type: Journal    
DOI: 10.1155/2012/186987     Document Type: Article

References (25)

1. Gandhi M., Aweeka F., Greenblatt R. M., Blaschke T. F., Sex Differences in Pharmacokinetics and Pharmacodynamics. Annual Review of Pharmacology and Toxicology 2004 44 499 523 2-s2.0-1342302371 10.1146/annurev.pharmtox.44.101802. 121453 (Pubitemid 38263851)
2. Umeh O. C., Currier J. S., Sex differences in pharmacokinetics and toxicity of antiretroviral therapy. Expert Opinion on Drug Metabolism and Toxicology 2006 2 2 273 283 2-s2.0-33847761503 10.1517/17425255.2.2.273 (Pubitemid 46372369)
3. Ofotokun I., Chuck S. K., Hitti J. E., Antiretroviral pharmacokinetic profile: a review of sex differences. Gender Medicine 2007 4 2 106 119 2-s2.0-34547879291 10.1016/S1550-8579(07)80025-8 (Pubitemid 47248489)
4. Sekar V., De Paepe E., Van Baelen B., Effect of extrinsic and intrinsic factors on the pharmacokinetics of darunavir/ritonavir (DRV/r) in HIV-1 patients: results of a randomized, controlled, phase III study (TITAN). Proceedings of the 11th European AIDS Conference October 2007 Madrid, Spain. Abstract no. PS4/5
5. Sekar V., Vanden Abeele C., Van Baelen B., Effect of extrinsic and intrinsic factors on the pharmacokinetics of darunavir/ritonavir in HIV-1-infected patients: results of a randomized, controlled, Phase III study (ARTEMIS). Proceedings of the 9th International Workshop on Clinical Pharmacology of HIV Therapy April 2008 New Orleans, La, USA. Poster no. P41
6. Sekar V., De La Rosa G., Van de Casteele T., Spinosa-Guzman S., Vis P., Hoetelmans R., Pharmacokinetic and pharmacodynamic analyses of once- and twice-daily darunavir/ritonavir in the ODIN trial. Proceedings of the 10th International Conference on Drug Therapy in HIV Infection November 2010 Glasgow, UK. Poster P185
7. Kakuda T. N., Wade J. R., Snoeck E., Vis P., Schöller-Gyüre M., Peeters M. P., Corbett C., Nijs S., Vingerhoets J., Leopold L., De Smedt G., Woodfall B. J., Hoetelmans R. M. W., Pharmacokinetics and pharmacodynamics of the non-nucleoside reverse-transcriptase inhibitor etravirine in treatment-experienced HIV-1-infected patients. Clinical Pharmacology and Therapeutics 2010 88 5 695 703 2-s2.0-77958509123 10.1038/clpt.2010.181
8. Currier J., Bridge D. A., Hagins D., Zorrilla C. D., Feinberg J., Ryan R., Falcon R., Tennenberg A., Mrus J., Squires K., Sex-based outcomes of darunavir-ritonavir therapy: a single-group trial. Annals of Internal Medicine 2010 153 6 349 357 2-s2.0-77957354649
9. Vis P., Sekar V., van Schaick E., Hoetelmans R., Development and application of a population pharmacokinetic model of TMC114 in healthy volunteers and HIV-1 infected subjects after administration of TMC114 in combination with low dose ritonavir. Proceedings of the 15th meeting of the Population Approach Group in Europe June 2006 Bruges, Belgium. Poster 964
10. Schöller-Gyüre M., Kakuda T. N., Sekar V., Woodfall B., De Smedt G., Lefebvre E., Peeters M., Hoetelmans R. M., Pharmacokinetics of darunavir/ritonavir and TMC125 alone and coadministered in HIV-negative volunteers. Antiviral Therapy 2007 12 5 789 796 2-s2.0-34547780413 (Pubitemid 47235493)
11. Kakuda T. N., Schöller-Gyüre M., De Smedt G., Beets G., Aharchi F., Peeters M. P., Vandermeulen K., Woodfall B. J., Hoetelmans R. M. W., Assessment of the steady-state pharmacokinetic interaction between etravirine administered as two different formulations and tenofovir disoproxil fumarate in healthy volunteers. HIV Medicine 2009 10 3 173 181 2-s2.0-61349103126 10.1111/j.1468-1293.2008.00668.x
12. Smith K. Y., Garcia F., Kumar P., Assessing darunavir/ritonavir-based therapy in a racially diverse population: 48-week outcomes from GRACE. Journal of the National Medical Association. In press
13. Hodder S., Jayaweera D., Mrus J., Ryan R., Witek J., GRACE (Gender, Race And Clinical Experience): etravirine (ETR) subgroup analysis at week 48. Proceedings of the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy September 2009 San Francisco, Calif, USA. Poster H-919
14. Sekar V., De Meyer S., Vangeneugden T., Absence of TMC114 exposure-efficacy and exposure-safety relationships in POWER 3. Proceedings of the 16th International AIDS Conference August 2006 Toronto, Canada. Poster TUPE0078
15. Boffito M., Winston A., Jackson A., Fletcher C., Pozniak A., Nelson M., Moyle G., Tolowinska I., Hoetelmans R., Miralles D., Gazzard B., Pharmacokinetics and antiretroviral response to darunavir/ritonavir and etravirine combination in patients with high-level viral resistance. AIDS 2007 21 11 1449 1455 2-s2.0-34250854707 10.1097/QAD.0b013e3282170ab1 (Pubitemid 46988005)
16. Csajka C., Marzolini C., Fattinger K., Décosterd L. A., Telenti A., Biollaz J., Buclin T., Population pharmacokinetics of indinavir in patients infected with human immunodeficiency virus. Antimicrobial Agents and Chemotherapy 2004 48 9 3226 3232 2-s2.0-4344588324 10.1128/AAC.48.9.3226-3232. 2004 (Pubitemid 39129311)
17. Fletcher C. V., Jiang H., Brundage R. C., Acosta E. P., Haubrich R., Katzenstein D., Gulick R. M., Sex-based differences in saquinavir pharmacology and virologic response in AIDS Clinical Trials Group Study 359. Journal of Infectious Diseases 2004 189 7 1176 1184 2-s2.0-1842450852 10.1086/382754 (Pubitemid 38457241)
18. Ofotokun I., Chuck S. K., Binongo J. N., Palau M., Lennox J. L., Acosta E. P., Lopinavir/ritonavir pharmacokinetic profile: impact of sex and other covariates following a change from twice-daily to once-daily therapy. Journal of Clinical Pharmacology 2007 47 8 970 977 2-s2.0-34447619487 10.1177/ 0091270007302564 (Pubitemid 47094097)
19. Barrail-Tran A., Mentre F., Cosson C., Influence of alpha-1 glycoprotein acid concentrations and variants on atazanavir pharmacokinetics in HIV-infected patients included in the ANRS 107 trial. Antimicrobiology Agents Chemotherapy 2010 54 614 619
20. Holladay J. W., Dewey M. J., Michniak B. B., Wiltshire H., Halberg D. L., Weigl P., Liang Z., Halifax K., Lindup W. E., Back D. J., Elevated alpha-1-acid glycoprotein reduces the volume of distribution and systemic clearance of saquinavir. Drug Metabolism and Disposition 2001 29 3 299 303 2-s2.0-0035111994 (Pubitemid 32179531)
21. Sekar V., Ryan R., Schaible D., Mazikewich A., Mrus J., Pharmacokinetic profile of darunavir (DRV) co-administered with low-dose ritonavir (DRV/r) in treatment-experienced women and men with HIV infection: 4-Week analysis in a substudy of the GRACE (Gender, Race, And Clinical Experience) study. Proceedings of the 9th International Workshop on Clinical Pharmacology of HIV Therapy April 2008 New Orleans, La, USA. Abstract no. O16
22. Else L., Liptrott N., Moss D., Evaluating the affect of gender on darunavir and ritonavir (DRV/r) exposure in HIV infected subjects (a post-hoc analysis of the GRACE PK sub-study). Proceedings of the 11th International Workshop on Clinical Pharmacology of HIV Therapy April 2010 Sorrento, Italy. Poster 11
23. Sekar V., Vanden Abeele C., Van Baelen B., Pharmacokinetic- pharmacodynamic analyses of once-daily darunavir in the ARTEMIS study. Proceedings of the 15th Conference on Retroviruses and Opportunistic Infections February 2008 Boston, Mass, USA. Poster 769
24. Katlama C., Haubrich R., Lalezari J., Lazzarin A., Madruga J. V., Molina J. M., Schechter M., Peeters M., Picchio G., Vingerhoets J., Woodfall B., De Smedt G., Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS 2009 23 17 2289 2300 2-s2.0-70449368908 10.1097/QAD.0b013e3283316a5e
25. PREZISTA (darunavir) Tablets, Full prescribing information. http://prezista.com/sites/default/files/pdf/us-package-insert.pdf, 2011