Acceptability of a Dolutegravir Oral Dispersible Film in Term Neonates Born to Mothers Living With HIV

INTRODUCTION: Dolutegravir (DTG) is a key antiretroviral (ARV) drug for children living with HIV, but no specific formulation is available for neonates (<28 days old). One of the DTG formulations evaluated in the PETITE-DTG trial was a novel 5 mg oral DTG dispersible film (DTG-Film). Acceptability to end-users is essential when introducing new ARV drugs. We report on the experiences of mothers and health workers related to the DTG-Film. METHODS: PETITE-DTG was a phase I/II, open-label two-stage study evaluating the pharmacokinetics, safety and acceptability of two paediatric DTG formulations in term neonates in South Africa. In the multi-dose stage, 43 term neonates born to women with HIV were randomized to receive either the 5 mg DTG-Film or half of a 10 mg DTG dispersible tablet, in addition to zidovudine syrup prophylaxis, for 28 days. In-depth interviews were conducted in a sub-set of mothers whose neonates received DTG-Film (at three time points) and with health workers (at two time points). Thematic analysis was employed. RESULTS: Data were collected (September 2023-October 2024) from 16 virologically suppressed mothers (median age: 38 years) whose neonates received DTG-Film and six female health workers (median age: 47 years) involved in the study. Usability was described positively-with participants highlighting ease of administration, quick dissolution, accurate dosing with no spillage and convenient packaging. Some mothers were initially hesitant due to unfamiliarity with the film, but after 1-2 doses, most reported liking or preferring the DTG-Film above other known ARV formulations. The film integrated well into households, was supported by family members and was considered discreet, helping to avoid unintentional HIV-status disclosure. Previous experience with neonatal ARV drugs and trust in health workers supported acceptability. Health workers noted DTG-Film was potentially fit for use in public health settings, where other formulations require manipulation prior to administration. Health workers played a key role in reassuring mothers that the "paper" was indeed medicine. CONCLUSIONS: Mothers and health workers found the new DTG-Film acceptable for neonatal use. While initial hesitancy was noted, acceptability increased with use. Targeted peer support and engagement with mothers and health workers will be essential to familiarize end-users with the novel DTG-Film.