IMPAACT 2009
IMPAACT 2009: Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Postpartum in Adolescents and Young Women and their Infants
Rationale
Feasibility, Acceptability and Safety of pre-exposure prophylaxis during Pregnancy and Breast Feeding to establish drug thresholds for optimal adherence when FTC/TDF is administered daily under direct observation during pregnancy and in the postpartum period.
Primary Objectives
- To characterize PrEP adherence among HIV-uninfected adolescent and young adult women (aged 16-24 years) who initiate once-daily emtricitabine-tenofovir disoproxil fumarate (FTC/TDF) in pregnancy and are followed through 6 months postpartum, when offered adherence support through mobile technology and drug level-directed counseling.
- To compare maternal and infant adverse events (including pregnancy outcomes) between women who initiate PrEP and women who decline PrEP over the observation period.
Investigators
- Dr Elizea Horne, Principal Investigator
- Dr Faeezah Patel, Sub-Investigator
- Dr Mrinmayee Dhar, Sub-Investigator
- Jeanne Coetzee, Sub-Investigator
- Tiffany Seef, Clinical Associate
Study Status
- Results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in March 2024
Chi BH, Kacanek D, Brown E, Amico KR, Huang S, Nematadzira T, Horne E, Nakabiito C, Mambiya SK, Korutaro V, Johnston B, Rooney JF, Spiegel H, Stranix-Chibanda L, CROI, Denver, Colorado, 2024. 03 – 06 March 2024.
Background: Pregnancy represents a period of high risk for HIV acquisition, especially in settings of high HIV prevalence. Use of daily oral pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate (FTC-TDF) can reduce horizontal HIV transmission and is recommended for pregnant and postpartum populations. To date, however, few studies have evaluated uptake, maternal safety, and pregnancy outcomes in the context of a clinical trial.
Results: From March to December 2022, 350 eligible participants were enrolled and included in the maternal safety analysis. Of those, 324 participants had complete delivery information recorded and were included in the pregnancy outcome analysis. Overall, 233 participants-initiated PrEP during pregnancy: 229 started at entry and four started later. Median duration of antenatal PrEP use was 11 weeks (IQR: 7.7-15). In contrast, 117 participants declined PrEP at entry and never initiated PrEP during pregnancy (Tables 1 and 2). A total of 31 (9%) participants experienced at least one grade >3 AE through delivery, with a greater proportion among PrEP initiators (11.2%; 95%CI: 7.4-15.9%) vs. decliners (4.3%, 95%CI: 1.4-9.7%; Table 3).
Conclusion: Daily oral FTC-TDF remains a safe and essential component of HIV prevention in pregnancy, even as the options for PrEP expand. A high occurrence of grade > 3 AEs was noted; however, none were thought to be related to PrEP use. Over 40% of those initiating PrEP stopped by the time they gave birth, reflecting the evolving needs for HIV prevention. Programs should prepare for and support such choices in clinical settings.
Latest Update:
June 2025
For more about IMPAACT 2009 please email EHorne@wrhi.ac.za
