<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">vedomostiregmed</journal-id><journal-title-group><journal-title xml:lang="ru">Регуляторные исследования и экспертиза лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Regulatory Research and Medicine Evaluation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-3062</issn><issn pub-type="epub">3034-3453</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-134</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group></article-categories><title-group><article-title>Особенности клинической фармакологии лекарственных средств, применяемых для фармакотерапии ВИЧ-инфекции во время беременности</article-title><trans-title-group xml:lang="en"><trans-title>Clinical pharmacology aspects of drugs for hiv-infected pregnant women</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сокова</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Sokova</surname><given-names>E. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мазеркина</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Mazerkina</surname><given-names>I. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Демидова</surname><given-names>О. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Demidova</surname><given-names>O. A.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Александрова</surname><given-names>Т. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Aleksandrova</surname><given-names>T. V.</given-names></name></name-alternatives><email xlink:type="simple">noemail@neicon.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>НЦ экспертизы средств медицинского применения</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2017</year></pub-date><pub-date pub-type="epub"><day>13</day><month>02</month><year>2018</year></pub-date><volume>7</volume><issue>3</issue><fpage>150</fpage><lpage>154</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Сокова Е.А., Мазеркина И.А., Демидова О.А., Александрова Т.В., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Сокова Е.А., Мазеркина И.А., Демидова О.А., Александрова Т.В.</copyright-holder><copyright-holder xml:lang="en">Sokova E.A., Mazerkina I.A., Demidova O.A., Aleksandrova T.V.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.vedomostincesmp.ru/jour/article/view/134">https://www.vedomostincesmp.ru/jour/article/view/134</self-uri><abstract><p>Проведен обзор данных литературы по проблеме фармакотерапии ВИЧ-инфекции у беременных с позиции клинической фармакологии. Рассмотрены общие принципы проведения антиретровирусной терапии у ВИЧ-инфицированных беременных женщин и профилактики передачи ВИЧ-инфекции от матери к ребенку. Приведены особенности фармакокинетики антиретровирусных препаратов у беременных. Представлена информация по особенностям влияния беременности на метаболизм антиретровирусных препаратов, характеру их взаимодействия с ABC- и SCL-транспортерами лекарственных средств, рассмотрены аспекты клинического значения этих изменений. Обоснована необходимость проведения терапевтического лекарственного мониторинга ингибиторов протеаз у ВИЧ-инфицированных беременных женщин.</p></abstract><trans-abstract xml:lang="en"><p>The article summarises literature data on clinical management of HIV infection in pregnant women. It discusses the general principles of antiretroviral therapy for HIV-infected pregnant women and prevention of mother-to-child transmission of HIV infection. It also describes pharmacokinetic properties of antiretroviral drugs for pregnant women. The article highlights issues concerning the effects of pregnancy on drug metabolism, patterns of drug interaction with both ABC and SCL drug transporters and associated clinical implications for antiretroviral therapy. The authors demonstrate the need for therapeutic drug monitoring of protease inhibitors in HIV-infected pregnant women.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>беременность</kwd><kwd>ВИЧ-инфекция</kwd><kwd>антиретровирусный препарат</kwd><kwd>фармакокинетика</kwd><kwd>безопасность</kwd><kwd>эффективность</kwd><kwd>транспортеры лекарственных средств</kwd><kwd>межлекарственное взаимодействие</kwd><kwd>pregnancy</kwd><kwd>HIV infection</kwd><kwd>antiretroviral drugs</kwd><kwd>pharmacokinetics</kwd><kwd>safety</kwd><kwd>efficacy</kwd><kwd>drug transporters</kwd><kwd>therapeutic drug monitoring</kwd><kwd>drug-drug interactions</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Darak S, Parchure R, Darak T, Talavlikar R, Kulkarni S, Kulkarni V. Advances in the prevention of mother-to-child transmission of HIV and resulting clinical and programmatic implications. Research and Reports in Neonatology 2014; 4: 111-23.</mixed-citation><mixed-citation xml:lang="en">Darak S, Parchure R, Darak T, Talavlikar R, Kulkarni S, Kulkarni V. Advances in  the prevention of mother-to-child transmission of HIV and resulting clinical and  programmatic implications. Research and Reports in Neonatology 2014; 4: 111–23.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Roustit M, Jlaiel M, Leclercq P, Stanke-Labesque F. Pharmacokinetics and therapeutic drug monitoring of antiretrovirals in pregnant women. Br J Clin Pharmacol. 2008; 66(2): 179-95.</mixed-citation><mixed-citation xml:lang="en">Roustit M, Jlaiel M, Leclercq P, Stanke-Labesque F. Pharmacokinetics and  therapeutic drug monitoring of antiretrovirals in pregnant women. Br J Clin  Pharmacol. 2008; 66(2): 179–95.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Сокова ЕА, Чилова РА, Проклова ГФ, Мекша ЮВ, Демидова ОА. Особенности метаболизма лекарственных средств во время беременности. Вестник современной клинической медицины 2016; 9(5): 70-5.</mixed-citation><mixed-citation xml:lang="en">Sokova EA, Chilova RA, Proklova GF, Meksha YuV, Demidova OA. The characteristics  of drug metabolism during pregnancy. The Bulletin of Contemporary Clinical Medicine 2016; 9(5): 70–5 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Mattison DR. Clinical pharmacology during pregnancy. Amsterdam: Elsevier; 2013.</mixed-citation><mixed-citation xml:lang="en">Mattison DR. Clinical pharmacology during pregnancy. Amsterdam: Elsevier; 2013.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services [Internet]. 2016 [cited 2017 Jul 10]. Available from: https://goo.gl/ RpJPfc.</mixed-citation><mixed-citation xml:lang="en">Guidelines for the use of antiretroviral agents in HIV-1-infected adults and  adolescents. Department of Health and Human Services [Internet]. 2016 [cited 2017  Jul 10]. Available from: https://goo.gl/RpJPfc.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, et al. Initiation of antiretroviral therapy in early asymptomatic HIV Infection. № Engl J Med. 2015; 373(9): 795-807.</mixed-citation><mixed-citation xml:lang="en">Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, et al. Initiation  of antiretroviral therapy in early asymptomatic HIV Infection.¹ Engl J Med. 2015; 373(9): 795–807.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States [Internet]. 2016 [cited 2017 Jul 10]. Available from: https://goo.gl/5VKzKy.</mixed-citation><mixed-citation xml:lang="en">Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women  for maternal health and interventions to reduce perinatal HIV transmission in the  United States [Internet]. 2016 [cited 2017 Jul 10]. Available from: https://goo.gl/5VKzKy.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Журавлева ЕО, Вельц НЮ, Затолочина КЭ, Глаголев СВ, Поливанов ВА, Дармостукова МА. и др. Анализ спонтанных сообщений о нежелательных реакциях, развившихся при применении лекарственных средств во время беременности. Безопасность и риск фармакотерапии 2017; 5(2): 61-69.</mixed-citation><mixed-citation xml:lang="en">Zhuravleva EO, Velts NYu, Zatolochina KE, Glagolev SV, Polivanov VA, Darmostukova  MA, et al. Analysis of spontaneous reports of adverse reactions, developed in the  use of drugs during pregnancy. Safety and Risk of Pharmacotherapy 2017; 5(2): 61–69  (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Применение антиретровирусных препаратов в комплексе мер, направленных на профилактику передачи ВИЧ от матери ребенку. Клинические рекомендации (протокол лечения) Министерства здравоохранения Российской Федерации. Available from: http://minzdrav.midural.ru/uploads/1120%D0%B0.pdf.</mixed-citation><mixed-citation xml:lang="en">The use of antiretroviral drugs as part of a set of measures aimed at preventing  the transmission of HIV from mother to child. Clinical recommendations (protocol of  treatment) of the Ministry of Health of the Russian Federation. Available from:  http://minzdrav.midural.ru/uploads/1120%D0%B0.pdf (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Шефер К, Шпильманн Х, Феттер К. Лекарственная терапия в период беременности и лактации. М.: Логосфера; 2010.</mixed-citation><mixed-citation xml:lang="en">Schaefer C, Spielmann H, Vetter K. Drug therapy during pregnancy and lactation. Moscow: Logosfera; 2010 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Best B, Stek A, Hu C, Burchett SK, Rossi SS, Smith E, et al. High-dose Lopinavir and standard dose emtricitabine pharmacokinetics during pregnancy and postpartum. 15th Conference on Retroviruses and Opportunistic Infections, February 3-6, 2008, Boston, MA, USA.</mixed-citation><mixed-citation xml:lang="en">Best B, Stek A, Hu C, Burchett SK, Rossi SS, Smith E, et al. High-dose Lopinavir  and standard dose emtricitabine pharmacokinetics during pregnancy and postpartum.  15th Conference on Retroviruses and Opportunistic Infections, February 3–6, 2008,  Boston, MA, USA.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Capparelli EV, Aweeka F, Hitti J, Stek A, Hu C, Burchett SK, et al. Chronic administration of Nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. HIV Med. 2008; 9(4): 214-20.</mixed-citation><mixed-citation xml:lang="en">Capparelli EV, Aweeka F, Hitti J, Stek A, Hu C, Burchett SK, et al. Chronic  administration of Nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. HIV Med. 2008; 9(4): 214–20.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Van der Lugt J, Colbers A, Molto J, Hawkins D, van der Ende M, Vogel M, et al. The pharmacokinetics, safety and efficacy of boosted Saquinavir tablets in HIV type-1-infected pregnant women. Antivir Ther. 2009; 14(3): 443-50.</mixed-citation><mixed-citation xml:lang="en">Van der Lugt J, Colbers A, Molto J, Hawkins D, van der Ende M, Vogel M, et al.  The pharmacokinetics, safety and efficacy of boosted Saquinavir tablets in HIV type- 1-infected pregnant women. Antivir Ther. 2009; 14(3): 443–50.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">De Cock KM, Fowler MG, Mercier E, de Vincenzi I, Saba J, Hoff E, et al. Prevention of mother-to-child HIV transmission in resource-poor countries: translating research into policy and practice. JAMA 2000; 283(9): 1175-82.</mixed-citation><mixed-citation xml:lang="en">De Cock KM, Fowler MG, Mercier E, de Vincenzi I, Saba J, Hoff E, et al. Prevention of mother-to-child HIV transmission in resource-poor  countries:  translating research into policy and practice. JAMA 2000; 283(9): 1175–82.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Flynn PM, Mirochnick M, Shapiro DE, Bardeguez A, Rodman J, Robbins B, et al. Pharmacokinetics and safety of single-dose Tenofovir disoproxil fumarate and Emtricitabine in HIV-1-infected pregnant women and their infants. Antimicrob Agents Chemother. 2011; 55(12): 5914-22.</mixed-citation><mixed-citation xml:lang="en">Flynn PM, Mirochnick M, Shapiro DE, Bardeguez A, Rodman J, Robbins B, et al.  Pharmacokinetics and safety of single-dose Tenofovir disoproxil fumarate and  Emtricitabine in HIV-1-infected pregnant women and their infants. Antimicrob Agents  Chemother. 2011; 55(12): 5914–22.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Сокова ЕА. Мониторинг безопасности зарегистрированных лекарственных средств у беременных: фармакогенетические аспекты. Безопасность и риск фармакотерапии 2015; (3): 30-35.</mixed-citation><mixed-citation xml:lang="en">Sokova EA. Monitoring post-approval drug safety in pregnancy: pharmacogenetic  aspects. Safety and Risk of Pharmacotherapy 2015; (3): 30–35 (in Russian).</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Gedeon C, Koren G. Designing pregnancy centered medications: drugs which do not cross the human placenta. Placenta 2006; 27(8): 861-8.</mixed-citation><mixed-citation xml:lang="en">Gedeon C, Koren G. Designing pregnancy centered medications: drugs which do not  cross the human placenta. Placenta 2006; 27(8): 861–8.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Sudhakaran S, Rayner CR, Li J, Kong DC, Gude NM, Nation RL. Inhibition of placental P-glycoprotein: impact on indinavir transfer to the foetus. Br J Clin Pharmacol. 2008; 65(5): 667-73.</mixed-citation><mixed-citation xml:lang="en">Sudhakaran S, Rayner CR, Li J, Kong DC, Gude NM, Nation RL. Inhibition of  placental P-glycoprotein: impact on indinavir transfer to the foetus. Br J Clin Pharmacol. 2008; 65(5): 667–73.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Storch CH, Theile D, Lindenmaier H, Haefeli WE, Weiss J. Comparison of the inhibitory activity of anti-HIV drugs on P-glycoprotein. Biochem Pharmacol. 2007; 73(10): 1573-81.</mixed-citation><mixed-citation xml:lang="en">Storch CH, Theile D, Lindenmaier H, Haefeli WE, Weiss J. Comparison of the  inhibitory activity of anti-HIV drugs on P-glycoprotein. Biochem Pharmacol. 2007; 73(10): 1573–81.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Minuesa G, Volk C, Molina-Arcas M, Gorboulev V, Erkizia I, Arndt P, et al. Transport of Lamivudine [(-)-beta-L-2’, 3’-dideoxy-3’-thiacytidine] and high-affinity interaction of nucleoside reverse transcriptase inhibitors with human organic cation transporters 1, 2, and 3. J Pharmacol Exp Ther. 2009; 329(1): 252-61.</mixed-citation><mixed-citation xml:lang="en">Minuesa G, Volk C, Molina-Arcas M, Gorboulev V, Erkizia I, Arndt P, et al.  Transport of lamivudine [(-)-beta-L-2, 3-dideoxy-3-thiacytidine] and high-affinity  interaction of nucleoside reverse transcriptase inhibitors with human organic cation  transporters 1, 2, and 3. J Pharmacol Exp Ther. 2009; 329(1): 252–61.</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Weiss J, Rose J, Storch CH, Ketabi-Kiyanvash N, Sauer A, Haefeli WE, Efferth T. Modulation of human BCRP (ABCG2) activity by anti-HIV drugs. J Antimicrob Chemother. 2007; 59(2): 238-45.</mixed-citation><mixed-citation xml:lang="en">Weiss J, Rose J, Storch CH, Ketabi-Kiyanvash N, Sauer A, Haefeli WE, Efferth T.  Modulation of human BCRP (ABCG2) activity by anti-HIV drugs. J Antimicrob Chemother. 2007; 59(2): 238–45.</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">Gulati A, Gerk PM. Role of placental ATP-binding cassette (ABC) trasporters in antiretroviral therapy during pregnanacy. J Pharm Sci. 2009; 98(7): 2317-35.</mixed-citation><mixed-citation xml:lang="en">Gulati A, Gerk PM. Role of placental ATP-binding cassette (ABC) trasporters in  antiretroviral therapy during pregnanacy. J Pharm Sci. 2009; 98(7): 2317–35.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
