Pre‐exposure prophylaxis for HIV prevention during pregnancy and lactation: forget not the women and children

Lisa Horgan, Christopher C Blyth, Asha C Bowen, David A Nolan and Andrew P McLean‐Tooke
Med J Aust 2019; 210 (6): . || doi: 10.5694/mja2.50052
Published online: 1 April 2019



  • Pregnancy is known to be a time of increased susceptibility to acquiring to human immunodeficiency virus (HIV) infection and this increased maternal risk places the unborn child at risk of vertical transmission.
  • Pre‐exposure prophylaxis (PrEP) involves the provision of antiretroviral therapy to an HIV‐negative individual with ongoing risk of HIV exposure to limit the likelihood of HIV transmission.
  • The inclusion of PrEP as part of a comprehensive strategy is recognised as an effective and safe means of reducing HIV infection in serodiscordant couples, thereby reducing the risk of vertical transmission of HIV.
  • Current data suggest that PrEP is safe to continue during pregnancy and breastfeeding in HIV‐negative women who remain vulnerable to acquiring HIV.
  • The recent Pharmaceutical Benefits Scheme subsidisation of PrEP has reduced the financial and practical obstacles of PrEP provision, and a subsequent increase in patient awareness and acceptance of PrEP is expected.
  • The framework for appropriately identifying and managing at‐risk pregnant and lactating women requiring PrEP is poorly defined and warrants further clarification to better support clinicians and this patient group.
  • This review discusses the current recommendations highlighting the gaps in the guidelines and makes some recommendations for future guideline development.


  • 1 Perth Children's Hospital, Perth, WA
  • 2 University of Western Australia, Perth, WA
  • 3 Princess Margaret Hospital for Children, Perth, WA
  • 4 Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, WA
  • 5 Royal Perth Hospital, Perth, WA
  • 6 PathWest Laboratory Medicine WA, Perth, WA

Competing interests:

No relevant disclosures.

  • 1. Mugo NR, Heffron R, Donnell D, et al. Increased risk of HIV‐1 transmission in pregnancy: a prospective study among African HIV‐1 serodiscordant couples. AIDS 2011; 25: 1887–1895.
  • 2. Thomson K. Increased risk of female HIV‐1 acquisition throughout pregnancy and postpartum: a prospective per‐coital act analysis among women with HIV‐1 infected partners. J Infect Dis 2018; 18: 16–25.
  • 3. Drake Al, Wagner A, Richardson B. Incident HIV during pregnancy and postpartum and risk of mother‐to‐child transmission: a systematic review and meta‐analysis. PLoS Med 2014; 11: e1001608.
  • 4. Wira CR, Fahey JV, Rodriguez‐Garcia M, Shen Z, Patel MV. Regulation of mucosal immunity in the female reproductive tract: the role of sex hormones in immune protection against sexually transmitted pathogens. Am J Reprod Immunol 2014; 72: 236–238.
  • 5. Sheffield JS, Wendel GD Jr, McIntire DD, Norgard MV. The effect of progesterone levels and pregnancy on HIV‐1 coreceptor expression. Reprod Sci 2009; 16: 20–31.
  • 6. Morrison C, Fichorova RN, Mauck C, et al. Cervical inflammation and immunity associated with hormonal contraception, pregnancy, and HIV‐1 seroconversion. J Acquir Immune Defic Syndr 2014; 66: 109–117.
  • 7. World Health Organization. Global and regional estimates of violence against women: prevalence and health effects of intimate partner violence and non‐partner sexual violence. Geneva: WHO, 2013. (viewed Jan 2018).
  • 8. The Kirby Institute. HIV, viral hepatitis and sexually transmissible infections in Australia: annual surveillance report 2017. Sydney: Kirby Institute, UNSW, 2017. (viewed Feb 2018).
  • 9. Birkhead GS, Pulver WP, Warren BL, et al. Acquiring human immunodeficiency virus during pregnancy and mother‐to‐child transmission in New York: 2002‐2006. Obstet Gynecol 2010; 115: 1247–1255.
  • 10. Nesheim S, Harris LF, Lampe M. Elimination of perinatal HIV infection in the USA and other high‐income countries: achievements and challenges. Curr Opin HIV AIDS 2013; 8: 447–456.
  • 11. Nduati R, John G, Mbori‐Ngacha D, et al. Effect of breastfeeding and formula feeding on transmission of HIV‐1: a randomised clinical trial. JAMA 2000; 283: 1167–1174.
  • 12. Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine. Women and HIV. Anteretroviral guidelines: US DHHS guidelines with Australian commentary. Sydney: ASHM, 2016. (viewed Feb 2019).
  • 13. Donnell D, Baeten JM, Kiarie J, et al. Heterosexual HIV‐1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet 2010; 375: 2092–2098.
  • 14. McDonald AM, Zurynski YA, Wand HC, et al. Perinatal exposure to HIV among children born in Australia, 1982‐2006. Med J Aust 2009; 190: 416–420.
  • 15. Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Routine antenatal assessment in the absence of pregnancy complications. Melbourne: RANZCOG, 2016. (viewed June 2018).
  • 16. Sedgh G, Singh S, Hussain R. Intended and unintended pregnancies worldwide in 2012 and recent trends. Stud Fam Plann 2014; 45: 301–314.
  • 17. Baeten JM, Donnell D, Ndase P. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012; 367: 399–410.
  • 18. Donnell D, Baeten JM, Bumpus NN, et al. HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention. J Acquir Immune Defic Syndr 2014; 66: 340–348.
  • 19. Callahan R, Nanda K, Kapiga S, et al; FEM‐PrEP Study Group. Pregnancy and contraceptive use among women participating in the FEM‐PrEP trial. J Acquir Immune Defic Syndr 2015; 68: 196–203.
  • 20. Marrazzo J, Ramjee G, Richardson B. Tenofovir‐based preexposure prophylaxis for HIV infection among African women. N Engl J Med 2015; 372: 509–518.
  • 21. World Health Organization. WHO technical brief: preventing HIV during pregnancy and breastfeeding in the context of PrEP. Geneva: WHO, 2017. (viewed Jan 2018).
  • 22. Mugo NR, Hong T, Celum C, et al. Pregnancy incidence and outcomes among women receiving pre‐exposure prophylaxis for HIV prevention: a randomised clinical trial. JAMA 2014; 312: 362–371.
  • 23. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2nd ed. Geneva: WHO, 2016. (viewed Jan 2018).
  • 24. Mofenson LM, Baggaley RC, Mameletzis I. Tenofovir disoproxil fumarate safety for women and their infants during pregnancy and breastfeeding: systematic review. AIDS 2017; 31: 213–232.
  • 25. Benaboud S, Pruvost A, Coffie PA, et al. Concentrations of tenofovir and emtricitabine in breast milk of HIV‐1‐infected women in Abidjan, Cote d'Ivoire, in the ANRS 12109 TEmAA study, step 2. Antimicrob Agents Chemother 2011; 55: 1315–1317.
  • 26. Ehrhardt S, Xie C, Guo N, et al. Breastfeeding while taking lamivudine or tenofovir disoproxil fumarate: a review of the evidence. Clin Infect Dis 2015; 60: 275–278.
  • 27. Siberry GK, Jacobson DL, Kalkwarf HJ, et al. Lower newborn bone mineral content associated with maternal use of tenofovir disoproxil fumarate during pregnancy. Clin Infect Dis 2015; 61: 996–1003.
  • 28. Siberry GK, Tierney C, Stranix‐Chibanda L, et al. Impact of maternal tenofovir use on HIV‐exposed newborn bone mineral. Conference on Retroviruses and Opportunistic Infections; 2016 Feb 22‐25; Boston, MA. (viewed Jan 2018).
  • 29. Centers for Disease Control and Prevention. Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. MMWR Morb Mortal Wkly Rep 2012; 61: 586–589.
  • 30. World Health Organization. Guideline on when to start antiretroviral therapy and on pre‐exposure prophylaxis for HIV. Geneva: WHO, 2015. (viewed Jan 2018).
  • 31. Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States – 2017 update: a clinical practice guideline. Atlanta, GA: CDC, 2018. (viewed May 2018).
  • 32. Wright E, Grulich A, Roy K, et al. Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine HIV pre‐exposure prophylaxis: clinical guidelines. J Virus Eradication 2017; 3: 168–184.
  • 33. Smith DK, Pals SL, Herbst JH, et al. Development of a clinical screening index predictive of incident HIV infection among men who have sex with men in the United States. J Acquir Immune Defic Syndr 2012; 60: 421–427.
  • 34. Balkus J, Brown E, Palanee T. An empiric HIV risk scoring tool to predict HIV‐1 acquisition in African women. J Acquir Immune Defic Syndr 2016; 72: 333–343.


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