Background
Oral liquids and syrup formulations of zidovudine (ZDV) and nevirapine (NVP) are the cornerstone of antiretrovirals (ARVs) for neonates born to mothers with HIV for prevention and treatment. These formulations have a short shelf-life, poor palatability, require frequent dosing, and are associated with stock-outs. The World Health Organization recommends switching to solid oral dosage forms soonest, with ARV dispersible tablets preferred over syrups for children. We assessed preferences for ARV formulations among mothers with neonates enrolled in the PETITE-DTG study.
Methods
PETITE-DTG is an ongoing phase I/II, open-label, two-stage study conducted in South Africa (NCT05590325) evaluating the pharmacokinetics, safety and acceptability of 2 solid pediatric dolutegravir (DTG) formulations in neonates. Neonates were randomized to receive either a 5mg DTG dispersible tablet (DTG-DT) or a 5mg novel DTG oral dispersible film (DTG-OF), with ZDV prophylaxis. Interviews were conducted in a sub-set of mothers (n=26) to determine infant ARV formulation preferences. Assessments included relative ranking of formulation preferences of 3 existing (DTG-DT, ZDV, NVP), 1 novel (DTG-OF), and 2 formulations in development (long-acting injectable, transdermal patch). We characterized and compared preferences using rank summaries (1 = most preferred; 6 = least preferred).
Results
Mothers had a strong preference for DTG-OF (score 56), independent of the DTG formulation their infants received (Table 1). Reported advantages included ease of administration, confidence in full dose administration, and perceived discreetness. Next was the long-acting injectable (score 66), reported as familiar, positively compared to routine vaccines, and, despite feared discomfort for babies, described as convenient (monthly vs daily). DTG-DT (score 96) was described as palatable for babies but caregivers were worried about preparation and dosing volume. For existing syrups (ZDV, NVP; score 99, 104) mothers cited concerns with administration frequency and underdosing (spillage, spitting). The transdermal patches ranked the lowest (score 125) with mothers fearing interaction with water, discomfort for infants, and uncertainties regarding effectiveness.
Conclusions
Mothers preferred the use of solid oral ARVs above syrups, with a strong preference for the DTG-OF even if their babies were receiving DTG-DT. Monthly injectables were also preferred, highlighting the importance of usability, ease of administration, and dosing frequency.
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