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Volumn 16, Issue 8, 2015, Pages 477-484

Safety, tolerability and pharmacokinetics of rilpivirine following administration of a long-acting formulation in healthy volunteers

Author keywords

HIV; Long acting formulation; Nonnucleoside reverse transcriptase inhibitor; Pharmacokinetics; Rilpivirine

Indexed keywords

RILPIVIRINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; DELAYED RELEASE FORMULATION; RNA DIRECTED DNA POLYMERASE INHIBITOR;

EID: 84938742453     PISSN: 14642662     EISSN: 14681293     Source Type: Journal    
DOI: 10.1111/hiv.12247     Document Type: Article
Times cited : (45)

References (29)
  • 1
    • 84855823732 scopus 로고    scopus 로고
    • Edurant(rilpivirine) tablets, US prescribing information
    • Janssen-Cilag, Revised May 2014. Available at(accessed 30 September 2014).
    • Edurant(rilpivirine) tablets, US prescribing information. Janssen-Cilag, 2011; Revised May 2014. Available at http://www.edurant.com/sites/www.edurant-info.com.hcp/files/EDURANT-PI.pdf (accessed 30 September 2014).
    • (2011)
  • 2
    • 84938764398 scopus 로고    scopus 로고
    • Edurant(rilpivirine) tablets
    • Janssen-Cilag, Revised March 2014. Available at(accessed 30 September 2014).
    • Edurant(rilpivirine) tablets, EU summary of product characteristics. Janssen-Cilag, 2011; Revised March 2014. Available at http://www.medicines.org.uk/EMC/medicine/25490/SPC/Edurant+25+mg+tablets/#DOC (accessed 30 September 2014).
    • (2011) EU summary of product characteristics
  • 3
    • 84938764399 scopus 로고    scopus 로고
    • COMPLERA™ (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets, full prescribing information
    • Revised September 2014. Available at(accessed 30 September 2014).
    • COMPLERA™ (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets, full prescribing information. Gilead Sciences 2011. Revised September 2014. Available at http://www.gilead.com/pdf/complera_pi.pdf (accessed 30 September 2014).
    • (2011) Gilead Sciences
  • 4
    • 84938764400 scopus 로고    scopus 로고
    • EVIPLERA 200mg/25mg/245mg film-coated tablets, summary of product characteristics
    • Revised September 2014. Available at(accessed 30 September 2014).
    • EVIPLERA 200mg/25mg/245mg film-coated tablets, summary of product characteristics. Gilead Sciences 2011. Revised September 2014. Available at http://www.medicines.org.uk/emc/medicine/25518/SPC/ (accessed 30 September 2014).
    • (2011) Gilead Sciences
  • 5
    • 79960358849 scopus 로고    scopus 로고
    • Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naïve adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial
    • Cohen CJ, Andrade-Villanueva J, Clotet B etal. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naïve adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet 2011; 378: 229-237.
    • (2011) Lancet , vol.378 , pp. 229-237
    • Cohen, C.J.1    Andrade-Villanueva, J.2    Clotet, B.3
  • 6
    • 79960381844 scopus 로고    scopus 로고
    • Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naïve adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial
    • Molina JM, Cahn P, Grinsztejn B etal. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naïve adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet 2011; 378: 238-246.
    • (2011) Lancet , vol.378 , pp. 238-246
    • Molina, J.M.1    Cahn, P.2    Grinsztejn, B.3
  • 7
    • 84862777419 scopus 로고    scopus 로고
    • Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naïve, HIV-1-infected patients: pooled results from the phase 3 double-blind, randomized ECHO and THRIVE trials
    • Cohen C, Molina JM, Cahn P etal. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naïve, HIV-1-infected patients: pooled results from the phase 3 double-blind, randomized ECHO and THRIVE trials. J Acquir Immune Defic Syndr 2012; 60: 33-42.
    • (2012) J Acquir Immune Defic Syndr , vol.60 , pp. 33-42
    • Cohen, C.1    Molina, J.M.2    Cahn, P.3
  • 8
    • 84876406278 scopus 로고    scopus 로고
    • Week 96 efficacy and safety of rilpivirine in treatment-naïve, HIV-1 patients in two phase III randomized trials
    • Cohen C, Molina JM, Cassetti I etal. Week 96 efficacy and safety of rilpivirine in treatment-naïve, HIV-1 patients in two phase III randomized trials. AIDS 2013; 27: 939-950.
    • (2013) AIDS , vol.27 , pp. 939-950
    • Cohen, C.1    Molina, J.M.2    Cassetti, I.3
  • 9
  • 10
    • 83755175865 scopus 로고    scopus 로고
    • EACS guidelines: EACS European Guidelines for treatment of HIV infected adults in Europe
    • Version 7.02, June . Available at(accessed 30 September 2014).
    • EACS guidelines: EACS European Guidelines for treatment of HIV infected adults in Europe. Version 7.02, June 2014. Available at http://www.eacsociety.org/Portals/0/140601_EACS%20EN7.02.pdf (accessed 30 September 2014).
    • (2014)
  • 11
    • 84860382378 scopus 로고    scopus 로고
    • HIV drug resistance early warning indicators in cohorts of individuals starting antiretroviral therapy between 2004 and 2009: World Health Organization global report from 50 countries
    • Bennett DE, Jordan MR, Bertagnolio S etal. HIV drug resistance early warning indicators in cohorts of individuals starting antiretroviral therapy between 2004 and 2009: World Health Organization global report from 50 countries. Clin Infect Dis 2012; 54 (Suppl 4): S280-S289.
    • (2012) Clin Infect Dis , vol.54 , pp. S280-S289
    • Bennett, D.E.1    Jordan, M.R.2    Bertagnolio, S.3
  • 12
    • 33750142477 scopus 로고    scopus 로고
    • Depot medroxyprogesterone versus norethisterone oenanthate for long acting progestogenic contraception
    • Draper BH, Morrioni C, Hoffman M etal. Depot medroxyprogesterone versus norethisterone oenanthate for long acting progestogenic contraception. Cochrane Database Syst Rev 2006; (3)CD005214.
    • (2006) Cochrane Database Syst Rev , Issue.3
    • Draper, B.H.1    Morrioni, C.2    Hoffman, M.3
  • 13
    • 84924360291 scopus 로고    scopus 로고
    • The pharmacokinetics of long-acting antipsychotic medications
    • Spanarello S, La Ferla T. The pharmacokinetics of long-acting antipsychotic medications. Curr Clin Pharmacol 2014; 9: 310-317.
    • (2014) Curr Clin Pharmacol , vol.9 , pp. 310-317
    • Spanarello, S.1    La Ferla, T.2
  • 14
    • 84938764402 scopus 로고    scopus 로고
    • TMC278 long acting - a parenteral nanosuspension formulation that provides sustained clinically relevant plasma concentrations in HIV-negative volunteers
    • 17th International AIDS Conference. Mexico City, Mexico, July
    • Verloes R, van't Klooster G, Baert L etal. TMC278 long acting - a parenteral nanosuspension formulation that provides sustained clinically relevant plasma concentrations in HIV-negative volunteers. 17th International AIDS Conference. Mexico City, Mexico, July, 2008 [Abstract TUPE0042].
    • (2008)
    • Verloes, R.1    van't Klooster, G.2    Baert, L.3
  • 15
    • 84886089649 scopus 로고    scopus 로고
    • Long-acting injectable antivirals for HIV treatment and prevention
    • Spreen W, Margolis DA, Pottage JC. Long-acting injectable antivirals for HIV treatment and prevention. Curr Opin HIV AIDS 2013; 8: 565-571.
    • (2013) Curr Opin HIV AIDS , vol.8 , pp. 565-571
    • Spreen, W.1    Margolis, D.A.2    Pottage, J.C.3
  • 16
    • 84871923055 scopus 로고    scopus 로고
    • The promise of pre-exposure prophylaxis with antiretroviral drugs to prevent HIV transmission: a review
    • Hankins CA, Dybul MR. The promise of pre-exposure prophylaxis with antiretroviral drugs to prevent HIV transmission: a review. Curr Opin HIV AIDS 2013; 8: 50-58.
    • (2013) Curr Opin HIV AIDS , vol.8 , pp. 50-58
    • Hankins, C.A.1    Dybul, M.R.2
  • 18
    • 84866486028 scopus 로고    scopus 로고
    • Mononuclear phagocyte intercellular crosstalk facilitates transmission of cell-targeted nanoformulated antiretroviral drugs to human brain endothelial cells
    • Kanmogne GD, Singh S, Roy U etal. Mononuclear phagocyte intercellular crosstalk facilitates transmission of cell-targeted nanoformulated antiretroviral drugs to human brain endothelial cells. Int J Nanomedicine 2012; 7: 2373-2388.
    • (2012) Int J Nanomedicine , vol.7 , pp. 2373-2388
    • Kanmogne, G.D.1    Singh, S.2    Roy, U.3
  • 19
    • 84895467665 scopus 로고    scopus 로고
    • Antiretroviral solid drug nanoparticles with enhanced oral bioavailability: production, characterization, and in vitro-in vivo correlation
    • McDonald TO, Giardiello M, Martin P etal. Antiretroviral solid drug nanoparticles with enhanced oral bioavailability: production, characterization, and in vitro-in vivo correlation. Adv Healthc Mater 2014; 3: 400-411.
    • (2014) Adv Healthc Mater , vol.3 , pp. 400-411
    • McDonald, T.O.1    Giardiello, M.2    Martin, P.3
  • 20
    • 67449119172 scopus 로고    scopus 로고
    • Development of a long-acting injectable formulation with nanoparticles of rilpivirine (TMC278) for HIV treatment
    • Baert L, van't Klooster G, Dries W etal. Development of a long-acting injectable formulation with nanoparticles of rilpivirine (TMC278) for HIV treatment. Eur J Pharm Biopharm 2009; 72: 502-508.
    • (2009) Eur J Pharm Biopharm , vol.72 , pp. 502-508
    • Baert, L.1    van't Klooster, G.2    Dries, W.3
  • 21
    • 77951210910 scopus 로고    scopus 로고
    • Pharmacokinetics and disposition of rilpivirine (TMC278) nanosuspension as a long-acting injectable antiretroviral formulation
    • van't Klooster G, Hoeben E, Borghys H etal. Pharmacokinetics and disposition of rilpivirine (TMC278) nanosuspension as a long-acting injectable antiretroviral formulation. Antimicrob Agents Chemother 2010; 54: 2042-2050.
    • (2010) Antimicrob Agents Chemother , vol.54 , pp. 2042-2050
    • van't Klooster, G.1    Hoeben, E.2    Borghys, H.3
  • 22
    • 84938764403 scopus 로고    scopus 로고
    • Long-acting TMC278, a parenteral depot formulation delivering therapeutic NNRTI concentrations in preclinical and clinical settings
    • 15th Conference on Retroviruses and Opportunistic Infections. Boston, MA, USA, February
    • van't Klooster G, Verloes R, Baert L etal. Long-acting TMC278, a parenteral depot formulation delivering therapeutic NNRTI concentrations in preclinical and clinical settings. 15th Conference on Retroviruses and Opportunistic Infections. Boston, MA, USA, February, 2008 [Abstract 134].
    • (2008)
    • van't Klooster, G.1    Verloes, R.2    Baert, L.3
  • 24
    • 84938764404 scopus 로고    scopus 로고
    • Effect of intrinsic and extrinsic factors on the pharmacokinetics of TMC278 in antiretroviral-naïve, HIV-1-infected patients in ECHO and THRIVE
    • 10th International Congress on Drug Therapy in HIV Infection. Glasgow, UK, November
    • Crauwels HM, von Schaick E, van Heeswijk RPG, Vanveggel S, Boven K, Vis P. Effect of intrinsic and extrinsic factors on the pharmacokinetics of TMC278 in antiretroviral-naïve, HIV-1-infected patients in ECHO and THRIVE. 10th International Congress on Drug Therapy in HIV Infection. Glasgow, UK, November, 2010 [Abstract P186].
    • (2010)
    • Crauwels, H.M.1    von Schaick, E.2    van Heeswijk, R.P.G.3    Vanveggel, S.4    Boven, K.5    Vis, P.6
  • 25
    • 84907878697 scopus 로고    scopus 로고
    • A compartmental pharmacokinetic evaluation of long-acting rilpivirine in HIV-negative volunteers for pre-exposure prophylaxis
    • Jackson AG, Else LJ, Mesquita PM etal. A compartmental pharmacokinetic evaluation of long-acting rilpivirine in HIV-negative volunteers for pre-exposure prophylaxis. Clin Pharmacol Ther 2014; 96: 314-323.
    • (2014) Clin Pharmacol Ther , vol.96 , pp. 314-323
    • Jackson, A.G.1    Else, L.J.2    Mesquita, P.M.3
  • 26
    • 84887248504 scopus 로고    scopus 로고
    • Long-acting parenteral nanoformulated antiretroviral therapy: interest and attitudes of HIV-infected patients
    • Williams J, Sayles HR, Meza JL etal. Long-acting parenteral nanoformulated antiretroviral therapy: interest and attitudes of HIV-infected patients. Nanomedicine (Lond) 2013; 8: 1807-1813.
    • (2013) Nanomedicine (Lond) , vol.8 , pp. 1807-1813
    • Williams, J.1    Sayles, H.R.2    Meza, J.L.3
  • 27
    • 84885934539 scopus 로고    scopus 로고
    • Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744
    • Ford SL, Gould E, Chen S etal. Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744. Antimicrob Agents Chemother 2013; 57: 5472-5477.
    • (2013) Antimicrob Agents Chemother , vol.57 , pp. 5472-5477
    • Ford, S.L.1    Gould, E.2    Chen, S.3
  • 28
    • 84912536514 scopus 로고    scopus 로고
    • First study of repeat dose co-administration of GSK1265744 and TMC278 long-acting parenteral nanosuspensions: pharmacokinetics, safety, and tolerability in healthy adults
    • 7th Annual IAS Conference. Kuala Lumpur, Malaysia, June
    • Spreen W, Williams P, Margolis D etal. First study of repeat dose co-administration of GSK1265744 and TMC278 long-acting parenteral nanosuspensions: pharmacokinetics, safety, and tolerability in healthy adults. 7th Annual IAS Conference. Kuala Lumpur, Malaysia, June, 2013 [Abstract WEAB0103].
    • (2013)
    • Spreen, W.1    Williams, P.2    Margolis, D.3
  • 29
    • 84938764405 scopus 로고    scopus 로고
    • 744 and rilpivirine as two-drug oral maintenance therapy: LAI116482 (LATTE) week 48 results
    • 21st Conference on Retroviruses and Opportunistic Infections. Boston, MA, USA, March
    • Margolis D, Brinson C, Eron J etal. 744 and rilpivirine as two-drug oral maintenance therapy: LAI116482 (LATTE) week 48 results. 21st Conference on Retroviruses and Opportunistic Infections. Boston, MA, USA, March, 2014 [Abstract 91LB].
    • (2014)
    • Margolis, D.1    Brinson, C.2    Eron, J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.