Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial

Perinatal outcomes associated with pre-exposure prophylaxis for HIV prevention during pregnancy: a systematic review and meta-analysis

“… 23 , 24 , 25 , 26 , 27 Thirteen studies met the meta-analysis eligibility criteria. 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 Thirty-five potentially relevant studies were excluded because they are ongoing and did not have any data available at present.

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“…Recruitment in six studies exclusively targeted pregnant women or women trying to conceive. 24 , 27 , 30 , 32 , 33 , 35 Women in the remaining seven studies fell pregnant while participating in other PrEP studies. 23 , 25 , 26 , 27 , 29 , 31 , 34 All RCTs had a high risk of bias, mainly due to a risk of outcome measurement bias (suboptimal method to assess gestational age, which increases the risk of misclassification bias), while three cohort studies were average quality and two were poor quality ( Table 1 , Appendix 3 and 4 ).…”

“…Twins included. High risk of bias Moodley 2023 30 , 36 CAP016 South Africa 2-arm 540 9/2017–12/2019 d Pregnant women (all black South African) were recruited at one site. Women had a median age of 23 years (IQR 20–26), BMI at enrolment of 27.9 (IQR 24.3–31.9) in the intervention group versus 26.6 (23.2–31.3) in the comparator group.…”

Pregnancy outcomes following self-reported and objective-measured exposure to oral preexposure prophylaxis in South Africa

“…Prior studies have evaluated PrEP for safety among PLP without HIVas well as antiretroviral therapy in women living with HIV [12][13][14][15][16]. A recent randomized control trial of n ¼ 540 pregnant women comparing immediate to delayed PrEP use in pregnant women found that PrEP was not associated with preterm birth nor small for gestational age (SGA) [17]. The risk difference for preterm birth was -4.7% (90% CI ¼ -10.7, 1.2), 2.5% for low birthweight, and 0.9% for SGA; all limits exceeded the noninferiority margin [17].…”

“…Existing insights into the possible effect of PrEP use on pregnancy outcomes face significant limitations in their reliance on self-reported use. To date, exposure has been measured using self-reported recent adherence or pill counts [17][18][19], which may result in an over or underreporting of actual use and drug exposure. Potential nondifferential misclassification of exposure can lead to underestimation of the true measure of effect [20].…”