3848Pregnancy and neonatal outcomes following prenatal exposure to cabotegravir (CAB): data from The Antiretroviral Pregnancy Registry (APR)

V. Vannappagari¹, J. Albano², L. Ragone¹, A. Scheuerle³, L. Mofenson⁴, W. Short⁵, C. Thorne⁶, N. Carneal-Frazer², T. Cook², C. Zhang², K. Brown¹, A. de Ruiter^{7 1}ViiV Healthcare, Durham, United States, ²Syneos Health, Morrisville, United States, ³University of Texas Southwestern Medical Center, Dallas, United States, ⁴Elizabeth Glaser Pediatric AIDS Foundation, Silver Spring, United States, ⁵The Perelman School of Medicine, University of Pennsylvania, Philadelphia, United States, ⁶University College London Great Ormond Street Institute of Child Health, London, United Kingdom, ⁷ViiV Healthcare, London, United Kingdom

BACKGROUND: Cabotegravir (CAB) is indicated for the treatment of HIV-1 infection in combination with rilpivirine and as a single agent for prevention of HIV. There are limited human data on the use of CAB during pregnancy to adequately assess effect on pregnancy outcomes.
METHODS: The APR is a prospective, international exposure-registration cohort study, monitoring for early warning signals of major teratogenic effects of antiretrovirals (ARVs) used during pregnancy. This descriptive analysis assesses pregnancy and neonatal outcomes including birth defects among infants with prenatal exposure to CAB using APR data through 31 July 2024.
RESULTS: Forty-two reported pregnancies with exposure to CAB (28 (66.7%) as CAB for treatment and 14 (33.3%) as CAB for pre-exposure prophylaxis (PrEP)) resulted in 43 outcomes including 35 (81.4%) live births, 1 (2.3%) stillbirth, 3 (7.0%) spontaneous abortions, and 4 (9.3%) induced abortions (Table 1). Among live births, 1 (2.9%) reported a birth defect (congenital ptosis). Among 33 singleton, live births without defects, 5 (15.2%) were preterm and 6 (18.2%) had low birth weight (LBW) including 3 (9.1%) very LBW. Of the 42 CAB-exposed pregnancies, 39 had CAB pre-conception exposure (27 with earliest exposure 0-6 months prior to pregnancy and 12 with earliest exposure 6-12 months prior to pregnancy) and 3 had earliest exposure during pregnancy (1 each in the 1^st, 2^nd and 3^rd trimester). For the 41 pregnancies where route of administration was known, 38 (92.7%) were exposed to injectable CAB while 3 (7.3%) were exposed to oral CAB.
CONCLUSIONS: While no significant safety concerns were seen, definitive conclusions on the safety of CAB use in pregnancy cannot be drawn due to a limited number of pregnancies reported and the data should be interpreted with caution. Providers are encouraged to register ARV exposed pregnancies, especially those exposed to newer ARVs such as CAB, at APR (apregistry.com). ?