Remarks

• This recommendation has been adapted and integrated from the WHO 2016 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach, second edition (42), where it was considered a strong recommendation based on high-certainty evidence.
• Pregnant and lactating women living in settings where HIV incidence is greater than 3 per 100 personyears, particularly in sub-Saharan Africa, often remain at substantial and increased risk of HIV acquisition during pregnancy and breastfeeding. Biological factors increase susceptibility, and social and behavioural factors may increase exposure to HIV infection.
• The source guideline states that there is no safety-related rationale for disallowing or discontinuing PrEP use during pregnancy and breastfeeding for HIV-negative women who are receiving PrEP and remain at risk of HIV acquisition. The Guideline Development Group responsible for the original recommendation concluded that in such situations the risk of HIV acquisition and accompanying increased risk of motherto-child HIV transmission outweigh any potential risks of PrEP, including any risks of fetal and infant exposure to TDF in PrEP regimens.
• As countries roll out PrEP to postpartum and/or lactating women, the source guideline notes the need for active surveillance of this population, including for adverse maternal and infant outcomes. a Substantial risk is provisionally defined as HIV incidence greater than 3 per 100 person-years in the absence of PrEP.