Population pharmacokinetics and pharmacogenetics of ritonavir-boosted darunavir in the presence of raltegravir or tenofovir disoproxil fumarate/emtricitabine in HIV-infected adults and the relationship with virological response:a sub-study of the NEAT001/ANRS143 randomized trial
| العنوان: | Population pharmacokinetics and pharmacogenetics of ritonavir-boosted darunavir in the presence of raltegravir or tenofovir disoproxil fumarate/emtricitabine in HIV-infected adults and the relationship with virological response:a sub-study of the NEAT001/ANRS143 randomized trial |
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| المؤلفون: | Dickinson L., Gurjar R., Stohr W., Bonora S., Owen A., D'Avolio A., Cursley A., Molina J. -M., Faetkenheuer G., Vandekerckhove L., Di Perri G., Pozniak A., Richert L., Raffi F., Boffito M., Dedes N., Chene G., Allavena C., Autran B., Antinori A., Bucciardini R., Vella S., Horban A., Arribas J., Babiker A. G., Pillay D., Franquet X., Schwarze S., Grarup J., Fischer A., Wallet C., Diallo A., Saillard J., Moecklinghoff C., Stellbrink H. -J., Vanleeuwen R., Gatell J., Sandstrom E., Flepp M., Ewings F., George E. C., Hudson F., Pearce G., Quercia R., Rogatto F., Leavitt R., Nguyen B. -Y., Peto T., Goebel F., Marcotullio S., Miller V., Sasieni P., Arnault F., Boucherie C., Jean D., Paniego V., Paraina F., Rouch E., Schwimmer C., Soussi M., Taieb A., Termote M., Touzeau G., Babiker A., Dodds W., Hoppe A., Kummeling I., Pacciarini F., Paton N., Russell C., Taylor K., Ward D., Aagaard B., Eid M., Gey D., Gramjensen B., Jakobsen M. -L., Jansson P. O., Jensen K., Mariajoensen Z., Moseholmlarsen E., Pahl C., Pearson M., Nielsen B. R., Reilev So. S., Christ I., Lathouwers D., Manting C., Van Leeuwen R., Mendy B., Metro A., Couffin-Cadiergues S., Knellwolf A. -L., Palmisiano L., Aznar E., Barea C., Cotarelo M., Esteban H., Girbau I., Moyano B., Ramirez M., Saiz C., Sanchez I., Yllescas M., Binelli A., Colasanti V., Massella M., Anagnostou O., Gioukari V., Touloumi G., Schmied B., Rieger A., Vetter N., Dewit S., Florence E., Gerstoft J., Mathiesen L., Katlama C., Cabie A., Cheret A., Dupon M., Ghosn J., Girard P. -M., Goujard C., Levy Y., Morlat P., Neau D., Obadia M., Perre P., Piroth L., Reynes J., Tattevin P., Ragnaud J. M., Weiss L., Yazdan Y., Yeni P., Zucman D., Esser S., Fatkenheuer G., Hoffmann C., Jessen H., Rockstroh J., Schmidt R., Stephan C., Unger S., Hatzakis A., Daikos G. L., Papadopoulos A., Skoutelis A., Banhegyi D., Mallon P., Mulcahy F., Andreoni M., Castelli F., D'Arminiomonforte A., Diperri G., Galli M., Lazzarin A., Mazzotta F., Torti C., Vullo V., Prins J., Richter C., Verhagen D., Vaneeden A., Doroana M., Antunes F., Maltez F., Sarmento-Castro R., Gonzalez Garcia J., Aldeguer J. L., Clotet B., Domingo P., Gatell J. M., Knobel H., Marquez M., Pilarmiralles M., Portilla J., Soriano V., Tellez M., Thalme A., Blaxhult A., Gisslen M., Winston A., Fox J., Gompels M., Herieka E., Johnson M., Leen C., Teague A., Williams I., Boyd M., Moller N. F., Moseholmlarsen E. F., Lemoing V., Wit F. W. N. M., Kowalska J., Berenguer J., Moreno S., Muller N. J., Torok E., Post F., Angus B., Calvez V., Boucher C., Collins S., Dunn D., Lambert S., Marcelin A. -G., Perno C. F., White E., Ammassari A., Schmidt R. E., Odermarsky M., Smith C., Thiebaut R., Delaserna J. I. B., Castagna A., De Wit S., Furrer H. -J., Mocroft A., Reiss P., Fragola V., Lauriola M., Murri R., Nieuwkerk P., Spire B., Volny-Anne A., West B., Amieva H., Llibre Codina J., Braggion M., Foca E. |
| المساهمون: | Dickinson, L., Gurjar, R., Stohr, W., Bonora, S., Owen, A., D'Avolio, A., Cursley, A., Molina, J. -M., Faetkenheuer, G., Vandekerckhove, L., Di Perri, G., Pozniak, A., Richert, L., Raffi, F., Boffito, M., Dedes, N., Chene, G., Allavena, C., Autran, B., Antinori, A., Bucciardini, R., Vella, S., Horban, A., Arribas, J., Babiker, A. G., Pillay, D., Franquet, X., Schwarze, S., Grarup, J., Fischer, A., Wallet, C., Diallo, A., Saillard, J., Moecklinghoff, C., Stellbrink, H. -J., Vanleeuwen, R., Gatell, J., Sandstrom, E., Flepp, M., Ewings, F., George, E. C., Hudson, F., Pearce, G., Quercia, R., Rogatto, F., Leavitt, R., Nguyen, B. -Y., Peto, T., Goebel, F., Marcotullio, S., Miller, V., Sasieni, P., Arnault, F., Boucherie, C., Jean, D., Paniego, V., Paraina, F., Rouch, E., Schwimmer, C., Soussi, M., Taieb, A., Termote, M., Touzeau, G., Babiker, A., Dodds, W., Hoppe, A., Kummeling, I., Pacciarini, F., Paton, N., Russell, C., Taylor, K., Ward, D., Aagaard, B., Eid, M., Gey, D., Gramjensen, B., Jakobsen, M. -L., Jansson, P. O., Jensen, K., Mariajoensen, Z., Moseholmlarsen, E., Pahl, C., Pearson, M., Nielsen, B. R., Reilev, So. S., Christ, I., Lathouwers, D., Manting, C., Van Leeuwen, R., Mendy, B., Metro, A., Couffin-Cadiergues, S., Knellwolf, A. -L., Palmisiano, L., Aznar, E., Barea, C., Cotarelo, M., Esteban, H., Girbau, I., Moyano, B., Ramirez, M., Saiz, C., Sanchez, I., Yllescas, M., Binelli, A., Colasanti, V., Massella, M., Anagnostou, O., Gioukari, V., Touloumi, G., Schmied, B., Rieger, A., Vetter, N., Dewit, S., Florence, E., Gerstoft, J., Mathiesen, L., Katlama, C., Cabie, A., Cheret, A., Dupon, M., Ghosn, J., Girard, P. -M., Goujard, C., Levy, Y., Morlat, P., Neau, D., Obadia, M., Perre, P., Piroth, L., Reynes, J., Tattevin, P., Ragnaud, J. M., Weiss, L., Yazdan, Y., Yeni, P., Zucman, D., Esser, S., Fatkenheuer, G., Hoffmann, C., Jessen, H., Rockstroh, J., Schmidt, R., Stephan, C., Unger, S., Hatzakis, A., Daikos, G. L., Papadopoulos, A., Skoutelis, A., Banhegyi, D., Mallon, P., Mulcahy, F., Andreoni, M., Castelli, F., D'Arminiomonforte, A., Diperri, G., Galli, M., Lazzarin, A., Mazzotta, F., Torti, C., Vullo, V., Prins, J., Richter, C., Verhagen, D., Vaneeden, A., Doroana, M., Antunes, F., Maltez, F., Sarmento-Castro, R., Gonzalez Garcia, J., Aldeguer, J. L., Clotet, B., Domingo, P., Gatell, J. M., Knobel, H., Marquez, M., Pilarmiralles, M., Portilla, J., Soriano, V., Tellez, M., Thalme, A., Blaxhult, A., Gisslen, M., Winston, A., Fox, J., Gompels, M., Herieka, E., Johnson, M., Leen, C., Teague, A., Williams, I., Boyd, M., Moller, N. F., Moseholmlarsen, E. F., Lemoing, V., Wit, F. W. N. M., Kowalska, J., Berenguer, J., Moreno, S., Muller, N. J., Torok, E., Post, F., Angus, B., Calvez, V., Boucher, C., Collins, S., Dunn, D., Lambert, S., Marcelin, A. -G., Perno, C. F., White, E., Ammassari, A., Schmidt, R. E., Odermarsky, M., Smith, C., Thiebaut, R., Delaserna, J. I. B., Castagna, A., De Wit, S., Furrer, H. -J., Mocroft, A., Reiss, P., Fragola, V., Lauriola, M., Murri, R., Nieuwkerk, P., Spire, B., Volny-Anne, A., West, B., Amieva, H., Llibre Codina, J., Braggion, M., Foca, E., Infectious diseases, AII - Infectious diseases, APH - Aging & Later Life, Global Health, APH - Personalized Medicine, APH - Mental Health, Medical Psychology |
| المصدر: | Dickinson, L, Gurjar, R, Stöhr, W, Bonora, S, Owen, A, D'Avolio, A, Cursley, A, Molina, J-M, Fäetkenheuer, G, Vandekerckhove, L, Di Perri, G, Pozniak, A, Richert, L, Raffi, F, Boffito, M, NEAT001/ANRS143 Study Group, Dedes, N, Chene, G, Richert, L, Grarup, J, Aagaard, B, Eid, M, Gey, D, Jensen, B G, Grarup, J, Jakobsen, M L, Jansson, P O, Jensen, K, Joensen, Z M, Larsen, E M, Pahl, C, Pearson, M, Nielsen, B R, Reilev, S S, Gerstoft, J, Mathiesen, L, Friis-Møller, N & Larsen, E F M 2020, ' Population pharmacokinetics and pharmacogenetics of ritonavir-boosted darunavir in the presence of raltegravir or tenofovir disoproxil fumarate/emtricitabine in HIV-infected adults and the relationship with virological response : a sub-study of the NEAT001/ANRS143 randomized trial ', Journal of Antimicrobial Chemotherapy, vol. 75, pp. 628-639 . https://doi.org/10.1093/jac/dkz479Test JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY Journal of antimicrobial chemotherapy, 75(3), 628-639. Oxford University Press |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | 0301 basic medicine, Microbiology (medical), Adult, Male, medicine.medical_specialty, Anti-HIV Agents, 030106 microbiology, HIV Infections, Emtricitabine, 030226 pharmacology & pharmacy, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, immune system diseases, Internal medicine, Raltegravir Potassium, medicine, Humans, Pharmacology (medical), Tenofovir, Darunavir, Constitutive Androstane Receptor, Pharmacology, Ritonavir, biology, business.industry, Liver-Specific Organic Anion Transporter 1, virus diseases, Lopinavir, Viral Load, Raltegravir, Multidrug Resistance-Associated Protein 2, 3. Good health, NONMEM, SISTM, Infectious Diseases, Pharmacogenetics, biology.protein, Female, SLCO1B1, business, medicine.drug |
| الوصف: | Objectives NEAT001/ANRS143 demonstrated non-inferiority of once-daily darunavir/ritonavir (800/100 mg) + twice-daily raltegravir (400 mg) versus darunavir/ritonavir + tenofovir disoproxil fumarate/emtricitabine (245/200 mg once daily) in treatment-naive patients. We investigated the population pharmacokinetics of darunavir, ritonavir, tenofovir and emtricitabine and relationships with demographics, genetic polymorphisms and virological failure. Methods Non-linear mixed-effects models (NONMEM v. 7.3) were applied to determine pharmacokinetic parameters and assess demographic covariates and relationships with SNPs (SLCO3A1, SLCO1B1, NR1I2, NR1I3, CYP3A5*3, CYP3A4*22, ABCC2, ABCC10, ABCG2 and SCL47A1). The relationship between model-predicted darunavir AUC0–24 and C24 with time to virological failure was evaluated by Cox regression. Results Of 805 enrolled, 716, 720, 347 and 361 were included in the darunavir, ritonavir, tenofovir and emtricitabine models, respectively (11% female, 83% Caucasian). No significant effect of patient demographics or SNPs was observed for darunavir or tenofovir apparent oral clearance (CL/F); coadministration of raltegravir did not influence darunavir or ritonavir CL/F. Ritonavir CL/F decreased by 23% in NR1I2 63396C>T carriers and emtricitabine CL/F was linearly associated with creatinine clearance (P Conclusions Darunavir concentrations were unaltered in the presence of raltegravir and not associated with virological failure. Polymorphisms investigated had little impact on study-drug pharmacokinetics. Darunavir/ritonavir + raltegravir may be an appropriate option for patients experiencing NRTI-associated toxicity. |
| وصف الملف: | application/pdf; application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| اللغة: | English |
| تدمد: | 0305-7453 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3dbe53a0b53bf6926498ee438b2c6427Test https://curis.ku.dk/ws/files/290397175/Stohr_Population_pharmacokinetics_and_pharmacogenetics_of_ritonavir_boosted_darunavir_accepted_version_.pdfTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....3dbe53a0b53bf6926498ee438b2c6427 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 03057453 |
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