Global and national guidance for the use of pre-exposure prophylaxis during peri-conception, pregnancy and breastfeeding

Abstract

Background. Pre-exposure prophylaxis (PrEP) is a well-established biomedical HIV prevention strategy and recommended as a safe strategy to reduce HIV risk during peri-conception, pregnancy and breastfeeding. Efforts are now needed to translate global recommendations into national guidelines and implementation strategies. This article presents the current status of policy guidance for the use of PrEP during periconception, pregnancy and breastfeeding, with a particular focus on high prevalence countries including those in sub-Saharan Africa. Methods. We reviewed and summarized PrEP clinical guidelines released by ministries of health or other national-level health bodies that have authored normative guidelines with a particular focus on recommendations for PrEP use during peri-conception, pregnancy, and/or breastfeeding. Results. Among countries with PrEP guidelines and/or policy, pregnancy is recognized as a period with increased HIV vulnerability and some specifically recommend PrEP use during pregnancy. Only one country specifically notes that PrEP is contraindicated during pregnancy recognizing a gap in complete safety data from women using PrEP throughout pregnancy. PrEP is not contraindicated as a peri-conception HIV prevention strategy in any country but only three countries have specific guidance for peri-conception HIV prevention. Multiple barriers to the implementation of PrEP during pregnancy and breastfeeding are discussed including barriers at the policy, health systems, social, and personal levels. Conclusion. Although pregnancy is a period of heightened risk and fertility rates are high in many settings with high HIV burden, few PrEP policies have included guidance for PrEP use specific to peri-conception, pregnancy and breastfeeding periods. This gap can be overcome by the development or adoption of national clinical guidelines and implementation strategies from exemplary countries.

Emerging evidence from a systematic review of safety of pre‐exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?

“…The World Health Organization (WHO) recommends offering tenofovir (TFV) disoproxil fumarate (TDF)‐based oral pre‐exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV acquisition . Although TDF is available as part of antiretroviral treatment (ART) regimens for pregnant women living with HIV, the availability of TDF‐based PrEP for HIV‐uninfected mothers remains limited in many of these settings .…”

“…Expanding delivery of PrEP to pregnant women at high risk of HIV is an important prevention strategy, yet national guidelines differ substantially in recommending PrEP use during pregnancy and lactation . Programmatic PrEP delivery to pregnant women is ongoing in Kenya .…”

“…Programmatic PrEP delivery to pregnant women is ongoing in Kenya . Guidelines in Zimbabwe , Swaziland, Australia, New Zealand, Canada and US are permissive of PrEP use during pregnancy . Uganda and Botswana have policies that recommend or allow PrEP for discordant couples trying to conceive .…”

“…Guidelines in Zimbabwe , Swaziland, Australia, New Zealand, Canada and US are permissive of PrEP use during pregnancy . Uganda and Botswana have policies that recommend or allow PrEP for discordant couples trying to conceive . In contrast, the desire for additional safety data on maternal PrEP use has hindered PrEP implementation among pregnant women in South Africa, Malawi, Zambia and other HIV high‐burden settings .…”

Response to “Being prepared to evaluate pregnancy PrEP”

“…We appreciate Dr. Slogrove's summary of the methodological limitations of programmatic data for assessing infant outcomes, and we concur with the need for a global consensus on acceptable strength of safety evidence for PrEP-exposed pregnancies, as the safety threshold for a preventive agent is necessarily high. Following approval of PrEP for HIV prevention, the World Health Organization and countries both in Sub-Saharan Africa and elsewhere developed guidelines that permit the use of PrEP in pregnancy by women at high risk for HIV acquisition [1][2][3][4][5][6]. Data to support that recommendation have come from the pivotal placebo-controlled trials of PrEP, demonstration studies and registry information, and use of PrEP medications as part of HIV or HBV treatment [7]; that body of evidence continues to increase, including with our PrIYA data [8].…”