Acceptability of a Dolutegravir Oral Dispersible Film in Term Neonates Born to Mothers Living With HIV
Lario Viljoen, Charlene Purdy, Verah Luke, Samantha du Toit, Marisa Groenewald, Lindee Ganger, Anneke C. Hesseling, Anthony J. Garcia‐Prats, Tim R. Cressey, Adrie BekkerABSTRACT
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.