As optimized antiretroviral therapy (ART) regimens are prepared for introduction in low-income and middle-income countries (LMIC), we consider the current evidence related to dosing, efficacy and safety during pregnancy and breastfeeding of next-generation first-line and second-line ART regimens proposed for imminent introduction in the global marketplace.
Pregnancy pharmacokinetic considerations include potentially insufficient efavirenz exposure if dosed at 400 mg/day, the need for twice daily darunavir dosing and the paucity of data related to tenofovir alafenamide and dolutegravir dosing, safety and efficacy. Increasingly evidence suggests an association with adverse birth outcomes, particularly in women conceiving on ART, and with varying risk by drug and drug combination. Clinical trials and studies are in progress or planned that aim to determine dosing, safety and efficacy of several new antiretrovirals (ARVs).
Having a universal, highly potent and safe ART regimen for all individuals living with HIV in LMIC including pregnant women is clearly the most beneficial strategy to keep mothers alive and healthy and to prevent transmission of HIV to their children. It will have to be determined whether the use of this next generation of optimized ARVs will also optimize health outcomes of pregnant women and their children.
aCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town
bDepartment of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
cHIV i-Base, London, UK
dICAP at Columbia University, Mailman School of Public Health
eCollege of Physicians and Surgeons, Columbia University, New York, New York, USA
Correspondence to Elaine J. Abrams, ICAP at Columbia University, Mailman School of Public Health, 722 W 168th Street, New York, NY 10032, USA. Tel: +1 212 342-0543; e-mail: firstname.lastname@example.org