Perinatal outcomes following maternal pre‐exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya

Abstract

Introduction The World Health Organization, while recommending pre‐exposure prophylaxis (PrEP) for HIV‐negative pregnant and postpartum women in HIV high‐burden settings, advocates for continued safety evaluation of PrEP in this population. Methods The PrEP Implementation in Young Women and Adolescents (PrIYA) program delivered PrEP to pregnant and postpartum women integrated within routine maternal and child health clinics (MCH) at 16 sites in Western Kenya. PrEP exposure and perinatal outcome data were collected among women obtaining postnatal services during programme evaluation. PrEP use was self‐reported and confirmed with clinical records. Perinatal outcomes including gestational age at birth, birthweight, congenital malformations and infant growth outcomes were abstracted from clinical records for mother‐infant pairs attending the six week visit. Associations between infant outcomes and maternal prenatal PrEP use were assessed using univariate and multivariate logistic and linear regression. Results The PrIYA evaluation identified 1530 postpartum mother‐infant pairs with data on prenatal PrEP exposure: 206 with prenatal PrEP use, 1324 without. Median maternal age was 24 years in both groups. PrEP users (any reported PrEP use) were significantly more likely to report HIV risk factors such as: intimate partner violence, sexually transmitted infections and having a partner with positive or unknown HIV status. Most mothers initiated PrEP during the second trimester (n = 116, 57%) and used PrEP for more than one month (n = 110, 58%). The mean birthweight was 3.3 kg and gestational age at birth was 38.5 weeks in both groups. There were no major differences between PrEP exposed and unexposed infants in rates of preterm birth and low birthweight. There were no congenital malformations identified in the PrEP‐exposed group and five reported in the PrEP unexposed group. At six weeks postpartum, infants in both groups had similar growth. No differences in infant outcomes were found by duration PrEP exposure, trimester of PrEP initiation, a subset analysis of women 15 to 24 years old or in multivariate analyses. This analysis demonstrates that monitoring of infant outcomes is feasible within large‐scale programmatic implementation of PrEP among pregnant and postpartum populations. Conclusions Pregnancy outcomes and early infant growth did not differ by PrEP exposure.

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?

“…Maternal and/or infant exposure to TDF/FTC during pregnancy was not quantified using drug level testing in any PrEP in pregnancy safety study to date and TDF/FTC drug levels may vary by when PrEP use started in pregnancy, duration of PrEP use in pregnancy and breastfeeding and maternal adherence (Table ). A recently completed evaluation of programmatic PrEP delivery via routine ante‐/post‐natal clinics in Kenya (the PrEP Implementation for Young Women and Adolescents [PrIYA] Programme) found no association between PrEP use during pregnancy and early infant outcomes including gestational age at birth, birth length/weight and growth indicators at six weeks . Infants were evaluated at six weeks in n = 246 pregnant women.…”

Accelerating progress towards the elimination of mother‐to‐child transmission of HIV: a narrative review

“…When adherence is maintained, PrEP – formulated as once daily tenofovir disoproxil fumarate and emtricitabine (TDF‐FTC) – has been shown to be highly effective across numerous randomized trials in women [26]. TDF‐FTC has been shown to be safe in studies of HIV‐positive pregnant women receiving TDF‐based ART, hepatitis‐B mono‐infected pregnant women receiving TDF alone, and HIV‐negative women receiving PrEP at the time they became pregnant or while they were pregnant [27‐32]. Although the WHO supports its use during pregnancy and breastfeeding [33], many national programs have not adopted full‐scale implementation for pregnant and breastfeeding women [34].…”

Pregnant and breastfeeding women’s prospective acceptability of two biomedical HIV prevention approaches in Sub Saharan Africa: A multisite qualitative analysis using the Theoretical Framework of Acceptability

“…The Word Health Organisation recommends offering daily Truvada™ or emtricitabine(FTC) / tenofovir disoproxil fumarate (TDF) pills to women at considerable risk of HIV infection [ 5 ]. Oral PrEP is safe and effective in P/BF women [ 8 – 10 ]. However, access and availability of oral PrEP for uninfected mothers remains limited in many settings [ 11 , 12 ].…”