Maternal and health worker preferences for paediatric antiretroviral formulations in neonates exposed to HIV.

Oral liquid formulations of zidovudine (ZDV) and nevirapine (NVP) are the main antiretrovirals (ARVs) for neonates born to mothers living with HIV, but they have limitations including poor palatability, short shelf-life, frequent dosing and supply challenges. Understanding caregiver and provider preferences for infant ARV formulations is essential to guide the development of acceptable alternatives. Within the PETITE-DTG trial in South Africa (NCT05590325), evaluating the pharmacokinetics, safety and acceptability of novel dolutegravir (DTG) formulations in neonates, we explored ARV preferences among mothers (n = 28) and health workers (n = 6). Participants completed interviews ranking six formulations: existing ZDV and NVP syrups, a DTG dispersible tablet (DTG-DT), a novel DTG oral dispersible film (DTG-film) and two pipeline options (long-acting injectable; transdermal patch). Both groups strongly favoured DTG-film, highlighting ease of administration, confidence in accurate dosing and discreetness. Long-acting injectables were next preferred, viewed as convenient despite concerns about discomfort. DTG-DT, ZDV and NVP ranked lower due to preparation challenges and risk of spillage. Transdermal patches were least favoured, with concerns regarding the comfort of neonates, impact of water exposure and effectiveness. These findings underscore strong support for innovative ARV options, emphasizing usability, ease of administration and reduced dosing frequency for the treatment of neonates.