PrEP initiation, persistence, and adherence during pregnancy through the postpartum period: a prospective analysis in Kenya

Abstract

Objective: We evaluated pre-exposure prophylaxis (PrEP) initiation, persistence, and adherence measured via tenofovir-diphosphate (TFV-DP) concentrations in dried blood spots (DBS) among women offered PrEP during pregnancy. Methods:We prospectively analyzed data from participants in the PrIMA Study (NCT03070600) who were offered PrEP during the second trimester and followed through 9 months postpartum. At follow-up visits (monthly in pregnancy; 6 weeks, 6 months, 9 months postpartum), self-reported PrEP use was assessed, and DBS were collected for quantifying TFV-DP concentrations.Results: In total, 2949 participants were included in the analysis. At enrollment, median age was 24 years [interquartile range IQR) 21-29], gestational age 24 weeks (IQR 20-28), and 4% had a known partner living with HIV. Overall, 405 (14%) participants initiated PrEP in pregnancy with higher frequency among those with risk factors for HIV acquisition, including >2 lifetime sexual partners, syphilis during pregnancy, forced sex, and intimate partner violence (P < 0.05). At 9 months postpartum, 58% of PrEP initiators persisted with PrEP use, of which 54% self-reported not missing any PrEP pills in the last 30 days. Among DBS randomly selected from visits where participants persisted with PrEP (n ¼ 427), 50% had quantifiable TFV-DP. Quantifiable TFV-DP was twice as likely in pregnancy than postpartum [adjusted risk ratio (aRR) ¼ 1.90, 95% confidence interval (CI) 1.40-2.57, P < 0.001]. Having a partner known to be living with HIV was the strongest predictor of PrEP initiation, persistence, and quantifiable TFV-DP (P < 0.001).Conclusions: PrEP persistence and adherence waned postpartum, though over half of PrEP initiators persisted through 9-months postpartum. Interventions should prioritize increasing knowledge of partner HIV status and sustaining adherence in the postpartum period.

Safety surveillance for PrEP in pregnant and breastfeeding women

“…Adherence was higher in pregnancy compared to postpartum and having a partner with a known HIV infection was the most significant predictor of initiation, adherence, and continued use. Interestingly tolerance to ARVs side effects was not an important predictor of adherence ( 9 ). The PrIYA program in Kenya evaluated pregnancy outcomes in 1530 mother-child pairs in Kenya, including 206 women who initiated TDF/FTC pre-conception compared to 1,324 with no TDF/FTC exposure ( 29 ).…”

“…The incidence of new HIV infections in pregnant and breastfeeding women, as well as adolescent girls and young women (15-24 years), has declined (although at a slower rate compared to adolescent male counterparts) with Graybill et al, reporting HIV incidence of 4.1 per 100 person years (95% PI: 1.1, 12.2) pre-2010, compared to 2.1/100 person years (95% PI: 0.7, 6.5) post-2014 (4,6,7). Several studies have clearly demonstrated the efficacy and acceptability of pre-exposure prophylaxis for HIV (PrEP) in pregnant as well as non-pregnant and breastfeeding women (8)(9)(10)(11)(12)(13)(14)(15). National HIV programmes globally are implementing policies that include the rollout of products for the prevention of HIV in all populations considered to be at risk, including WOCP, pregnant and breastfeeding women (16-18).…”