메뉴 건너뛰기




Volumn 27, Issue 6, 2013, Pages 889-897

Rilpivirine vs. Efavirenz in HIV-1 patients with baseline viral load 100 000 copies/ml or less: Week 48 phase III analysis

Author keywords

Baseline viral load; Efavirenz; Nonnucleoside reverse transcriptase inhibitor; Rilpivirine; TMC278; Treatment naive

Indexed keywords

ALANINE AMINOTRANSFERASE; ALPHA AMYLASE PANCREAS ISOENZYME; ASPARTATE AMINOTRANSFERASE; CREATININE; EFAVIRENZ; ETRAVIRINE; LOW DENSITY LIPOPROTEIN CHOLESTEROL; NEVIRAPINE; RILPIVIRINE; TRIACYLGLYCEROL;

EID: 84876418846     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0b013e32835e1554     Document Type: Article
Times cited : (27)

References (27)
  • 1
    • 84876409392 scopus 로고    scopus 로고
    • Janssen-Cilag; December, http://www.accessdata.fda. gov/drugsatfda-docs/ label/2011/202022s000lbl.pdf. [Accessed 8 January 2013]
    • Prescribing information for EDURANT (rilpivirine) tablets. Janssen-Cilag; December 2012. http://www.edurant-info.com/sites/default/files/EDURANT-PI.pdf http://www.accessdata.fda. gov/drugsatfda-docs/label/2011/202022s000lbl.pdf. [Accessed 8 January 2013].
    • (2012) Prescribing Information for EDURANT (Rilpivirine) Tablets
  • 2
    • 85083121662 scopus 로고    scopus 로고
    • Summary of product characteristics. Janssen-Cilag; December, [Accessed 8 January 2013]
    • EDURANT (rilpivirine) tablets. Summary of product characteristics. Janssen-Cilag; December 2012. http://www.medicines.org.uk/EMC/medicine/25490/ SPC/Edurant25mg/[Accessed 8 January 2013].
    • (2012) EDURANT (Rilpivirine) Tablets
  • 4
    • 85083144021 scopus 로고    scopus 로고
    • Summary of product characteristics. Gilead Sciences; October, Accessed 8 January 2013
    • EVIPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets. Summary of product characteristics. Gilead Sciences; October 2012. http://www.medicines.org.uk/EMC/medicine/25518/SPC/ Eviplera+200+mg+25+mg+245+mg+film+coated+tablets/[Accessed 8 January 2013].
    • (2012) EVIPLERA (Emtricitabine/rilpivirine/tenofovir Disoproxil Fumarate) Tablets
  • 5
    • 79960381844 scopus 로고    scopus 로고
    • Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): A phase 3 randomised double-blind active-controlled trial
    • Molina J-M, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive 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    Lazzarin, A.4    Mills, A.5    Saag, M.6
  • 6
    • 79960358849 scopus 로고    scopus 로고
    • Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): A phase 3, randomised, noninferiority trial
    • Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): A phase 3, randomised, noninferiority trial. Lancet 2011; 378:229-237.
    • (2011) Lancet , vol.378 , pp. 229-237
    • Cohen, C.J.1    Andrade-Villanueva, J.2    Clotet, B.3    Fourie, J.4    Johnson, M.A.5    Ruxrungtham, K.6
  • 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, Clotet B, Fourie J, Grinsztejn B, et al. 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    Clotet, B.4    Fourie, J.5    Grinsztejn, B.6
  • 8
    • 84862876886 scopus 로고    scopus 로고
    • Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: A randomised, double-blind, phase 3 trial, analysis of results after 48 weeks
    • Sax PE, DeJesus E, Mills A, Zolopa A, Cohen C, Wohl D, et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: A randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet 2012; 379:2439-2448.
    • (2012) Lancet , vol.379 , pp. 2439-2448
    • Sax, P.E.1    Dejesus, E.2    Mills, A.3    Zolopa, A.4    Cohen, C.5    Wohl, D.6
  • 9
    • 85083144701 scopus 로고    scopus 로고
    • Dolutegravir (DTG; S/GSK1349572) + abacavir/lamivudine once daily statistically superior to tenofovir/emtricitabine/efavirenz: 48-week results - SINGLE (ING114467). San Francisco, CA; 9-12 September, Abstract H-556b
    • Walmsley S, Antela A, Clumeck N, et al. Dolutegravir (DTG; S/GSK1349572) + abacavir/lamivudine once daily statistically superior to tenofovir/ emtricitabine/efavirenz: 48-week results - SINGLE (ING114467). 52nd Interscience Conference on Antimicrobials and Chemotherapy; San Francisco, CA; 9-12 September 2012. Abstract H-556b.
    • (2012) 52nd Interscience Conference on Antimicrobials and Chemotherapy
    • Walmsley, S.1    Antela, A.2    Clumeck, N.3
  • 10
    • 77649201378 scopus 로고    scopus 로고
    • Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naïve HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study
    • Molina J-M, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, Neal D, et al. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naïve HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr 2010; 53:323-332.
    • (2010) J Acquir Immune Defic Syndr , vol.53 , pp. 323-332
    • Molina, J.-M.1    Andrade-Villanueva, J.2    Echevarria, J.3    Chetchotisakd, P.4    Corral, J.5    Neal, D.6
  • 11
    • 49649092719 scopus 로고    scopus 로고
    • Efficacy and safety of once-daily darunavir/ritonavir vs lopinavir/ritonavir in treatment naïve HIV-1-infected patients at week 48
    • Ortiz R, Dejesus E, Khanlou H, Voronin E, van Lunzen J, Andrade-Villanueva J, et al. Efficacy and safety of once-daily darunavir/ritonavir vs lopinavir/ritonavir in treatment naïve HIV-1-infected patients at week 48. AIDS 2008; 22:1389- 1397.
    • (2008) AIDS , vol.22 , pp. 1389-1397
    • Ortiz, R.1    Dejesus, E.2    Khanlou, H.3    Voronin, E.4    Van, L.J.5    Andrade-Villanueva, J.6
  • 12
    • 69449101785 scopus 로고    scopus 로고
    • Safety and efficacy of raltegravir-based vs efavirenz-based combination therapy in treatment naïve patients with HIV-1 infection: A multicentre, double-blind randomised controlled trial
    • Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, et al. Safety and efficacy of raltegravir-based vs efavirenz-based combination therapy in treatment naïve patients with HIV-1 infection: A multicentre, double-blind randomised controlled trial. Lancet 2009; 374:796-806.
    • (2009) Lancet , vol.374 , pp. 796-806
    • Lennox, J.L.1    Dejesus, E.2    Lazzarin, A.3    Pollard, R.B.4    Madruga, J.V.5    Berger, D.S.6
  • 13
    • 46349091980 scopus 로고    scopus 로고
    • Increased resilience to the development of drug resistance with modern boosted protease inhibitor-based highly active antiretroviral therapy
    • Lima VD, Gill VS, Yip B, Hogg RS, Montaner JS, Harrigan PR. Increased resilience to the development of drug resistance with modern boosted protease inhibitor-based highly active antiretroviral therapy. J Infect Dis 2008; 198:51-58
    • (2008) J Infect Dis , vol.198 , pp. 51-58
    • Lima, V.D.1    Gill, V.S.2    Yip, B.3    Hogg, R.S.4    Montaner, J.S.5    Harrigan, P.R.6
  • 14
    • 70449368908 scopus 로고    scopus 로고
    • Efficacy and safety of etravirine in treatment experienced, HIV-1 patients: Pooled 48 week analysis of two randomized, controlled trials
    • Katlama C, Haubrich R, Lalezari J, Lazzarin A, Madruga JV, Molina JM, et al. Efficacy and safety of etravirine in treatment experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS 2009; 23:2289-2300.
    • (2009) AIDS , vol.23 , pp. 2289-2300
    • Katlama, C.1    Haubrich, R.2    Lalezari, J.3    Lazzarin, A.4    Madruga, J.V.5    Molina, J.M.6
  • 15
    • 80055028058 scopus 로고    scopus 로고
    • Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1- infected patients (ACTG A5262)
    • Taiwo B, Zheng L, Gallien S, Matining RM, Kuritzkes DR, Wilson CC, et al. Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1- infected patients (ACTG A5262). AIDS 2011; 25:2113-2122.
    • (2011) AIDS , vol.25 , pp. 2113-2122
    • Taiwo, B.1    Zheng, L.2    Gallien, S.3    Matining, R.M.4    Kuritzkes, D.R.5    Wilson, C.C.6
  • 16
    • 81855166275 scopus 로고    scopus 로고
    • Raltegravir once daily or twice daily in previously untreated patients with HIV-1: A randomised, active-controlled, phase 3 noninferiority trial
    • Eron JJ Jr, Rockstroh JK, Reynes J, Andrade-Villanueva J, Ramalho-Madruga JV, Bekker LG, et al. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: A randomised, active-controlled, phase 3 noninferiority trial. Lancet Infect Dis 2011; 11:907-915.
    • (2011) Lancet Infect Dis , vol.11 , pp. 907-915
    • Eron Jr., J.J.1    Rockstroh, J.K.2    Reynes, J.3    Andrade-Villanueva, J.4    Ramalho-Madruga, J.V.5    Bekker, L.G.6
  • 17
    • 83655195258 scopus 로고    scopus 로고
    • Screening and baseline mutations in the TMC278 phase III trials ECHO and THRIVE: Prevalence and impact on virological response (abstract 41)
    • Vingerhoets J, Rimsky L, Van Eygen V, Nijs S, Vanveggel S, Boven K, et al. Screening and baseline mutations in the TMC278 phase III trials ECHO and THRIVE: prevalence and impact on virological response (abstract 41). Antivir Ther 2011; 16 (Suppl 1):A51.
    • (2011) Antivir Ther , vol.16 , Issue.SUPPL. 1
    • Vingerhoets, J.1    Rimsky, L.2    Van Eygen, V.3    Nijs, S.4    Vanveggel, S.5    Boven, K.6
  • 18
    • 0042454476 scopus 로고    scopus 로고
    • prepared by the Division of Antiviral Drug Products - Office of Drug Evaluation IV in the Centre for Drug Evaluation and Research (CDER), Appendix B; October, [Accessed 8 January 2013]
    • FDA Guidance for Industry. Antiretroviral drugs using plasma HIV RNA measurements: clinical considerations for accelerated and traditional approval, prepared by the Division of Antiviral Drug Products - Office of Drug Evaluation IV in the Centre for Drug Evaluation and Research (CDER), Appendix B; October 2002. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070968.pdf. [Accessed 8 January 2013].
    • (2002) Antiretroviral Drugs Using Plasma HIV RNA Measurements: Clinical Considerations for Accelerated and Traditional Approval
  • 20
    • 83655163698 scopus 로고    scopus 로고
    • Genotypic and phenotypic characterization of HIV-1 isolates obtained from patients on rilpivirine therapy experiencing virologic failure in the phase 3 ECHO and THRIVE studies: 48-week analysis
    • Rimsky L, Vingerhoets J, Van Eygen V, Eron J, Clotet B, Hoogstoel A, et al. Genotypic and phenotypic characterization of HIV-1 isolates obtained from patients on rilpivirine therapy experiencing virologic failure in the phase 3 ECHO and THRIVE studies: 48-week analysis. J Acquir Immune Defic Syndr 2012; 59:39-46.
    • (2012) J Acquir Immune Defic Syndr , vol.59 , pp. 39-46
    • Rimsky, L.1    Vingerhoets, J.2    Van, E.V.3    Eron, J.4    Clotet, B.5    Hoogstoel, A.6
  • 22
    • 73649148381 scopus 로고    scopus 로고
    • Efficacy and safety of TMC278 in antiretroviral- naive HIV-1 patients: Week 96 results of a phase IIb randomized trial
    • Pozniak AL, Morales-Ramirez J, Katabira E, Steyn D, Lupo SH, Santoscoy M, et al. Efficacy and safety of TMC278 in antiretroviral- naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS 2010; 24:55-65.
    • (2010) AIDS , vol.24 , pp. 55-65
    • Pozniak, A.L.1    Morales-Ramirez, J.2    Katabira, E.3    Steyn, D.4    Lupo, S.H.5    Santoscoy, M.6
  • 23
    • 83655201316 scopus 로고    scopus 로고
    • The HIV-1 reverse transcriptase M184I mutation enhances the E138K-associated resistance to rilpivirine and decreases viral fitness
    • Kulkarni R, Babaoglu K, Lansdon EB, Rimsky L, Van Eygen V, Picchio G, et al. The HIV-1 reverse transcriptase M184I mutation enhances the E138K-associated resistance to rilpivirine and decreases viral fitness. J Acquir Immune Defic Syndr 2012; 59:47-55.
    • (2012) J Acquir Immune Defic Syndr , vol.59 , pp. 47-55
    • Kulkarni, R.1    Babaoglu, K.2    Lansdon, E.B.3    Rimsky, L.4    Van Eygen, V.5    Picchio, G.6
  • 24
    • 80055119045 scopus 로고    scopus 로고
    • Compensation by the E138K mutation in HIV-1 reverse transcriptase for deficits in viral replication capacity and enzyme processivity associated with the M184I/V mutations
    • Xu HT, Asahchop EL, Oliveira M, Quashie PK, Quan Y, Brenner BG, Wainberg MA. Compensation by the E138K mutation in HIV-1 reverse transcriptase for deficits in viral replication capacity and enzyme processivity associated with the M184I/V mutations. J Virol 2011; 85:11300-11308.
    • (2011) J Virol , vol.85 , pp. 11300-11308
    • Xu, H.T.1    Asahchop, E.L.2    Oliveira, M.3    Quashie, P.K.4    Quan, Y.5    Brenner, B.G.6    Wainberg, M.A.7
  • 25
    • 80055103177 scopus 로고    scopus 로고
    • Interaction of reverse transcriptase (RT) mutations conferring resistance to lamivudine and etravirine: Effects on fitness and RT activity of human immunodeficiency virus type 1
    • Hu Z, Kuritzkes DR. Interaction of reverse transcriptase (RT) mutations conferring resistance to lamivudine and etravirine: effects on fitness and RT activity of human immunodeficiency virus type 1. J Virol 2011; 85:11309-11314.
    • (2011) J Virol , vol.85 , pp. 11309-11314
    • Hu, Z.1    Kuritzkes, D.R.2
  • 26
    • 82455163713 scopus 로고    scopus 로고
    • Short communication: Prevalence of susceptibility to etravirine by genotype and phenotype in samples received for routine HIV type 1 resistance testing in the United States
    • Picchio G, Vingerhoets J, Tambuyzer L, Coakley E, Haddad M, Witek J. Short communication: prevalence of susceptibility to etravirine by genotype and phenotype in samples received for routine HIV type 1 resistance testing in the United States. AIDS Res Hum Retroviruses 2011; 27:1271-1275.
    • (2011) AIDS Res Hum Retroviruses , vol.27 , pp. 1271-1275
    • Picchio, G.1    Vingerhoets, J.2    Tambuyzer, L.3    Coakley, E.4    Haddad, M.5    Witek, J.6
  • 27
    • 80055110312 scopus 로고    scopus 로고
    • Effect of mutations at position E138 in HIV-1 reverse transcriptase on phenotypic susceptibility and virologic response to etravirine
    • Tambuyzer L, Nijs S, Daems B, Picchio G, Vingerhoets J. Effect of mutations at position E138 in HIV-1 reverse transcriptase on phenotypic susceptibility and virologic response to etravirine. J Acquir Immune Defic Syndr 2011; 58:18-22.
    • (2011) J Acquir Immune Defic Syndr , vol.58 , pp. 18-22
    • Tambuyzer, L.1    Nijs, S.2    Daems, B.3    Picchio, G.4    Vingerhoets, J.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.