Safety of oral tenofovir disoproxil fumarate-based HIV pre-exposure prophylaxis use in lactating HIV-uninfected women

ABSTRACT

Introduction: In settings where HIV is prevalent in heterosexual populations, pregnancy and postpartum breastfeeding periods can be associated with substantial HIV acquisition risk. Pre-exposure prophylaxis (PrEP) with daily oral tenofovir disoproxil fumarate (TDF)/emtricitabine is an attractive HIV prevention option for women who are lactating but data are limited on its safety during the lactation period.

Areas covered: We provide a concise synthesis and summary of current evidence on the safety of TDF-based PrEP during breastfeeding. We conducted a review, searching Pubmed database and major PrEP conferences for primary studies with TDF-based PrEP exposure during postpartum breastfeeding.

Expert opinion: TDF-based oral PrEP is an effective female-controlled HIV prevention option. There is evidence supporting the safety of TDF use for infant outcomes during breastfeeding in antiretroviral treatment regimens for HIV and hepatitis B virus, and more limited, but consistently safe, data from use of TDF as PrEP. The potential for risk is arguably outweighed for at-risk individuals by HIV prevention benefits, including indirect protection to the infant as a result of preventing HIV in the breastfeeding mother. As PrEP delivery is scaled up in heterosexual populations in high HIV prevalence settings and for at-risk persons in other settings, implementation science studies can provide a framework to increase the accrual of safety, acceptability, and use data related to PrEP during lactation.

KEYWORDS:

• Breastfeeding
• pre-exposure prophylaxis
• tenofovir disoproxil fumarate
• HIV prevention
• HIV uninfected women

Declaration of interest

J Baeten received research grants related to tenofovir disoproxil fumarate pre-exposure prophylaxis from US Government agencies and the Bill and Melinda Gates foundation. GJ Stewart received research grants related to tenofovir disoproxil fumarate pre-exposure prophylaxis funding from US Government agencies. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed

Additional information

Funding

This work was supported by the National Institute of Mental Health [R01MH095507], the Bill and Melinda Gates Foundation [OPP1056051], and the University of Washington/ Fred Hutch Center for AIDS Research [P30 AI027757].