A review of pharmacokinetic data describing long-acting injectable cabotegravir during pregnancy.

INTRODUCTION

Eliminating vertical human immunodeficiency virus (HIV) transmission is a global health objective. Significant progress has been accomplished through advancements in antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP). Long-acting cabotegravir (CAB-LA) is a novel strategy addressing daily oral adherence challenges for both treatment and prevention of HIV. For treatment, CAB-LA is currently approved in combination with long-acting rilpivirine (RPV-LA). Despite its promise, there are limited data surrounding the utilization of CAB-LA in pregnancy. Understanding potential CAB-LA pharmacokinetic (PK) changes during pregnancy is necessary to ensure effectiveness and safety.

AREAS COVERED: Current PK data for CAB-LA in pregnant individuals, including physiological changes affecting PK, physiologically based PK modeling, and clinical PK data.

EXPERT OPINION: Long-acting therapies represent the future of HIV treatment and prevention. Available data demonstrate no clinically significant change in CAB PK, supporting CAB-LA for PrEP in pregnant individuals. However, available data for oral RPV and RPV-LA during pregnancy demonstrate lower drug concentrations, which limit CAB-LA utilization for HIV treatment until alternative partner drugs are available. Other long-acting prevention and treatment strategies are in development. Future studies assessing long-acting strategies are necessary during drug development to ensure equitable and timely access to novel therapies for all individuals.