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 population, 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 multiple databases 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.

Scaling-up PrEP Delivery in Sub-Saharan Africa: What Can We Learn from the Scale-up of ART?

“…Unnecessary restriction of PrEP prescription and refill authority will significantly constrain the reach of PrEP delivery and risk further over taxing ART service providers. Since PrEP is generally very well-tolerated and the risk of severe adverse events including kidney impairment are very rare [43,52], moving quickly to PrEP provision by non-NIMART-trained nurses and other healthcare cadres should be strongly encouraged. Nurses working in family planning, maternal child health, anti-natal, STI, and other clinics where there is routine HIV testing would be very well-placed to implement rapid screening for and initiation and follow-up of PrEP clients [53].…”

“…However, the majority of persons for whom PrEP is most useful are likely to find it challenging to obtain these laboratory tests this frequently in public health facilities and health providers will be less likely to embrace PrEP as a feasible HIV prevention intervention if they fear its safe implementation requires frequent laboratory monitoring. TDF-based PrEP is demonstrably very safe, with the most frequently reported side effect being gastro-intestinal symptoms which are normally self-limiting within 1–2 weeks of PrEP initiation [16, 43]. The risk of severe toxicities, including kidney injury and decrease in bone mineral density which were the initial main concern for PrEP, have been shown to be rare and limited both in frequency (< 2%) and magnitude [44–46].…”

Southern African guidelines on the safe, easy and effective use of pre-exposure prophylaxis: 2020

“… 2 , 3 , 4 , 5 Since then a further seven randomised controlled trials (RCTs) and numerous open label demonstration studies have led to the registration of combination therapy, with tenofovir and emtricitabine or related variations thereof as effective tools in the prevention of human immunodeficiency virus (HIV) transmission to uninfected persons. 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 The World Health Organization (WHO) set a target of 3 million PrEP users worldwide by 2020. With 240 000 incident HIV infections per year in South Africa, which is equivalent to almost 15% of all new infections globally, 20 a significant portion of those effective PrEP users should be in this country.…”

Evaluating the vertical HIV transmission risks among South African female sex workers; have we forgotten PMTCT in their HIV programming?

“…Given the frequent postnatal HIV seroconversions among FSW, the elevated MTCT risks associated with seroconversion during pregnancy [20], promoting repeat testing among pregnant and breastfeeding FSW may be particularly important to allow for early detection of new HIV infections and early initiation of treatment [21]. PrEP use for pregnant and breastfeeding FSW could also be encouraged, given favorable safety findings to date and that is a current WHO recommendation [22–24].…”