Use of darunavir in HIV-infected women during pregnancy


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Abstract

The use of antiretroviral drugs (ARVDs) in a mother and a child can reduce the risk of vertical transmission of human immunodeficiency virus (HIV) to less than 1%; therefore, highly active antiretroviral therapy is used in all pregnant women regardless of indications for HIV-infection treatment. The major requirements for choosing an ARVD to prevent mother-to-child HIV transmission are its high safety for a pregnant woman, a fetus, and a baby and its high therapeutic efficacy. Clinical trials of darunavir (DRV) in adults and children have shown a high virologic response, good tolerance, and safety. Trials and observations have demonstrated the high efficacy and safety of a DRV when used in pregnant women. Pharmacokinetic studies in pregnant women have indicated the effective and well-tolerated concentration of a DRV when it is co-administered with low-dose ritonavir, which permits the use of a DRV for both the prevention of mother-to-child HIV transmission and the treatment of pregnant women who require antiretroviral therapy. The Russian clinical protocol "Use of ARVDs in the package of measures for the prevention of mother-to-child HIV transmission" approved by the National Scientific Society of Infectiologists in 2013 recommends DRV as an alternative drug in antiretroviral therapy regimens for pregnant women to prevent mother-to-child HIV transmission and to treat maternal HIV infection.

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Применение дарунавира у ВИЧ-инфицированных женщин во время беременности. - Аннотация. Применение антиретровирусных препаратов (АРВП) у матери и ребенка позволяет снизить риск вертикальной передачи вируса иммунодефицита человека (ВИЧ) до менее 1%, поэтому независимо от наличия показаний к лечению ВИЧ-инфекции, высокоактивная антиретровирусная терапия назначается всем беременным. При выборе АРВП для профилактики передачи ВИЧ от матери ребенку основными требованиями являются безопасность для беременной, плода и ребенка и высокая терапевтическая эффективность. Клинические исследования дарунавира (DRV) у взрослых и детей показали высокий вирусологический ответ, хорошую переносимость и безопасность. В исследованиях и наблюдениях продемонстрированы высокая эффективность и безопасность DRV при его использовании у беременных. Фармакокинетические исследования у беременных показали эффективную и хорошо переносимую концентрацию DRV при одновременном приеме с низкими дозами ритонавира, что позволяет использовать DRV как для профилактики передачи ВИЧ от матери ребенку, так и для лечения беременных, нуждающихся в антиретровирусной терапии. Российским клиническим протоколом "Применение АРВП в комплексе мер, направленных на профилактику передачи ВИЧ от матери ребенку", утвержденным Национальным научным обществом инфекционистов в 2013 г., DRV рекомендован беременным в качестве альтернативного препарата в схемах антиретровирусной терапии для профилактики передачи ВИЧ от матери ребенку и лечения ВИЧ-инфекции у матери.
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