Use of darunavir in HIV-infected women during pregnancy

Full Text


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.

Full Text

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.


  1. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry International Interim Report for 1 January 1989 through 31 January 2013. Wilmington, NC: Registry Coordinating Center; 2013. Available from URL:
  2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at
  3. The European AIDS Clinical Society (EACS) Guidelines Version 6.1 - November 2012. Available from URL:
  4. Full Prescribing Information for PREZISTA. Revised:05/2013. Available from URL:,202895s004lbl.pdf.
  5. Phung B.C., Yeni P. Darunavir: an effective protease inhibitor for HIV-infected patients. Expert Rev Anti Infect Ther 2011; 9 (6): 631-643.
  6. Sekar V.J., Kestens D., Spinosa-Guzman S. et al. The effect of different meal types on the pharmacokinetics of darunavir (TMC114)/ritonavir in HIV negative volunteers. J Clin Pharmacol 2007? 47: 479-484.
  7. Yeni P., Roberts A., Van Baelen B., Lavreys L. Safety and tolerability of darunavir/ritonavir in treatment experienced HIV1infected patients at 96 weeks in the POWER 1, 2 and 3 trials. Poster (P7.2/04) presented at the 11th European AIDS Congress (EACS); 2007; October 2427: Madrid, Spain.
  8. Bánhegyi D., Katlama C., Da Cunha C. et al. Phase III TITAN week 96 final analysis: efficacy/safety of darunavir/r (DRV/r) vs. lopinavir/r (LPV/r) in LPV naïve, treatment experienced patients. J Intern AIDS Soc 2008; 11 (Suppl. 1): 22.
  9. Mills T. 48th ICAAC/46th IDSA 2008. Abstract H-1250 c.
  10. Orkin C., DeJesus E., Khanlou H. et al. ARTEMIS: Week 192 efficacy and safety of once daily darunavir/ritonavir versus lopinavir/ritonavir in treatment naive, HIV infected adults. The 10th International Conference on Drug Therapy in HIV Infection. Glasgow, UK. 2010. Poster presented.
  11. Sekar V., Abeele C.V., Van Baelen B. et al. Pharmacokinetic, pharmacodynamic analyses of once daily darunavir in the ARTEMIS study. The 15th Conference on Retroviruses and Opportunistic Infections. Boston, USA. 2008. Abstract presented 36.
  12. Orkin C., DeJesus E., Khanlou H. et al. ARTEMIS: 192-week efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naïve, HIV-1-infected adults HIV 10. Glasgow 2010. Poster P3.
  13. Ortiz R., Dejesus E., Khanlou H. et al. Efficacy and safety of once daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS 2008; 22 (12): 1389-1397.
  14. Bologna R., Rugina S., Cahn P. et al. DELPHI: Darunavir Evaluation in Pediatric HIV-1-Infected treatment-experienced patients (Safety and efficacy of darunavir co-administered with low-dose ritonavir in treatment-experienced children and adolescents at Week 24). 15th Conference on Retroviruses and Opportunistic Infections. Boston, MA, USA. 2008. Abstract 78LB.
  15. Patterson К., Rezk N., Jennings S. et al. Darunavir, Ritonavir, and Etravirine Steady-state Pharmacokinetics in the Cervicovaginal Fluid and Blood Plasma of HIV-infected Women Enrolled in the GRACE Study. Intern Med 2010; 153 (6): 349-357.
  16. Dumond J.B., Yeh R.F., Patterson K.B. et al. Antiretroviral drug exposure in the female genital tract: implications for oral pre- and post-exposure prophylaxis. AIDS 2007; 21: 1899-1907.
  17. Dumond J.B., Patterson K.B., Pecha A.L. et al. Maraviroc concentrates in the cervicovaginal fluid and vaginal tissue of HIV-negative women. J Acquir Immune Defic Syndr 2009; 51: 546-­553.
  18. Patterson K., Jennings S., Falcon R. et al. Darunavir, Ritonavir, and Etravirine Pharmacokinetics in the Cervicovaginal Fluid and Blood Plasma of HIV-Infected Women. Antimicrob Agents Chemother 2011; 55 (3): 1120-1122.
  19. Ripamonti D., Cattaneo D., Cortinovis M. et al. Transplacental passage of ritonavir-boosted darunavir in two pregnant women. Intern J STD & AIDS 2009; 20: 215-216.
  20. Furcoa A., Gosrania B., Nicholas S. Successful use of darunavir, etravirine, enfuvirtide and tenofovir/emtricitabine in pregnant woman with multiclass HIV resistance. AIDS 2009; 23 (3): 434-435.
  21. Jaworsky D., Thompson C., Yudin M.H. et al. Use of newer antiretroviral agents, darunavir and eravirine with raltegravir in pregnancy: a report of two cases. Antiviral Ther 2010; 15: 677-680.
  22. Ivanovic J., Bellagamba R., Nicastri E. et al. Use of darunavir/ritonavir once daily in treatment-naive pregnant woman: pharmacokinetics, compartmental exposure, efficacy and safety. AIDS 2010; 24 (7): 1083-1084.
  23. Courbon E., Matheron S., Mandelbrot L. Safety, Efficacy and Pharmacokinetic of Darunavir/ritonavir-containing Regimen in Pregnant HIV+ Women. 19 Conference on Retroviruses and Opportunistic Infections. Washington. 2012. 177 Poster Abstracts 1011.
  24. Zorrilla C., Wright R., Olayemi O. Osiyemi. Total and Unbound Darunavir (DRV) Pharmacokinetics (PK) in HIV-1-Infected Pregnant Women. 19 Conference on Retroviruses and Opportunistic Infections. Washington. 2012. 177 Poster Abstracts 1012.
  25. Бабанов С.А., Агаркова И.А. Фармакотерапия во время беременности. Гинекология 2010; 2: 7-12.
  26. Brucker M.C. Top ten pharmacologic considerations in pregnancy. The 5th Annual Conference of the National Association of Nurse Practitioners in Women's Health. Scottsdale, Arizona. 2002. Program and abstracts.
  27. Weiss S.R. Prescription Medication Use in Pregnancy. Medscape Pharmacother 2000; 2: 2.
  28. Pinnetti C., Tamburrini Е., Ragazzoni Е. еt al. Decreased plasma levels of darunavir/ritonavir in a vertically infected pregnant woman carrying multiclass-resistant HIV type-1 Antivir Ther 2010; 15 (1): 127-129.
  29. Else L.J., Douglas M., Dickinson L. еt al. Improved oral bio­availability of lopinavir in melt-extruded tablet formulation reduces impact of third trimester on lopinavir plasma concentrations. Antimicrob Agents Chemother 2012; 56 (2): 816-824.
  30. Conradie F., Zorrilla C., Josipovic D. et al. Safety and exposure of once-daily ritonavir-boosted atazanavir in HIVinfected pregnant women. HIV Med 2011;12 (9): 570-579. Available at:
  31. Mirochnick M., Best B.M., Stek A.M. et al. Atazanavir pharmacokinetics with and without tenofovir during pregnancy. J Acquir Immune Defic Syndr. 2011; 56 (5): 412-419. Available at:
  32. Pacanowski J., Bollens D., Poirier J.-M. et al. Efficacy of darunavir despite low plasma trough levels during late pregnancy in an HIV-hepatitis C virus-infected patient. AIDS 2009; 23 (14): 1923-1924.
  33. Stek A.M., Mirochnick M., Capparelli E. et al. for the PACTG 1026s study team. Reduced lopinavir exposure during pregnancy. AIDS 2006; 20 (15): 1931-1939.
  34. Colbers А., Molto J., Ivanovic J. et al. A Comparison of the Pharmacokinetics of Darunavir, Atazanavir, and Ritonavir during Pregnancy and Post-partum. 19 Conference on Retroviruses and Opportunistic Infections. Washington. 2012. Session 177. Poster Abstracts 1013.
  35. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. 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. Available at
  36. Афонина Л.Ю., Воронин Е.Е., Фомин Ю.А. и др. Применение антиретровирусных препаратов в комплексе мер, направленных на профилактику передачи ВИЧ от матери ребенку. Клинический протокол, версия май, 2013. М 2013; 45.



Abstract: 212

Article Metrics

Metrics Loading ...


  • There are currently no refbacks.

Copyright (c) 2013 Afonina L.I., Voronin E.E.

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Address of the Editorial Office:

  • Novij Zykovskij proezd, 3, 40, Moscow, 125167

Correspondence address:

  • Novoslobodskaya str 31c4., Moscow, 127005, Russian Federation

Managing Editor:


© 2018-2021 "Consilium Medicum" Publishing house

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies