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Title
High acceptability and preference for pediatric dolutegravir 10mg among children living with HIV in Nigeria at 1- and 6-month follow up, an observational study
Presenter
Oluwakemi Sowale
Authors
O. Sowale1, N. Otubu1, J. Campbell2, W. Eigege1, O. Abudiore1, B. Levy-Braide1, B. Jack1, A. Inyang1, D. Rathakrishnan3, I. Amamilo3, Z. Panos3, F. Lufadeju1, O. Wiwa1, C. Amole3, I. Lawal4, C. Adesigbin5, E. Etiobhio5, U. Atu5, P. Mohammed-Ibrahim5, A. Ikpeazu5, U. Elemuwa6, F. Jajere6, B. Fraden6, M. Adeyeye6, O. Agbaji7, S. Akanmu8, U. Lawal9, S. Ochigbo10
Institutions
1Clinton Health Access Initiative, HIV Access Program, Abuja, Nigeria, 2Clinton Health Access Initiative, Analytics and Implementation Research, Boston, United States, 3Clinton Health Access Initiative, HIV Access Program, Boston, United States, 4U.S. Department of Defence, Abuja, Nigeria, 5Federal Ministry of Health, National AIDS, Viral Hepatitis and STI Control Program, Abuja, Nigeria, 6Federal Ministry of Health, National Agency for Food and Drug Administration and Control, Abuja, Nigeria, 7Jos University Teaching Hospital, Jos, Nigeria, 8Lagos University Teaching Hospital, Lagos, Nigeria, 9Ahmadu Bello University Teaching Hospital, Zaria, Nigeria, 10University of Calabar Teaching Hospital, Calabar, Nigeria

BACKGROUND: Nigeria is an early adopter country of the generic formulation of pediatric dolutegravir 10mg (pDTG) that became accessible in December 2020. This study aims to assess the acceptability and preference of pDTG among children living with HIV newly initiated or transitioned to the drug. Findings from the study was used to guide national scale-up.
METHODS: Pediatric clients weighing >3kg and <20kg were enrolled between September and December 2021 in 7 sites across 7 state (Akwa-Ibom, Benue, Cross river, Lagos, Plateau, Rivers and Sokoto). Acceptability and experiences were assessed through surveys conducted with clients and their caregivers as respondents at 1 and 6 months following pDTG initiation using a structured questionnaire. Participants were asked about side effects, ease of administration, and regimen preferences. Data from 1- and 6-month follow-ups were analyzed for frequencies and trends.
RESULTS: The study enrolled 180 clients and the mean age was 4.7 years, with 98% being treatment experienced.
At month 1, 99% of the treatment experienced respondents prefer the pDTG-based regimen to their previous regimen, this increased to 100% at month 6. On ease of administration, at month 6, 99% and 100% of respondents respectively reported that pDTG tastes better and was easier to administer than previous regimen, compared to 99% and 96% respectively at month 1. 99% of respondents at both months 1 and 6 were satisfied or very satisfied with their pDTG regimen.
The most common side-effect reported at months 1 and 6 was increased appetite (25% and 43% respectively). 97% and 94% of respondents at months 1 and 6 respectively reported that the client either gained weight appropriately or had no change in weight. Hyperactivity was reported by 29% of participants at month 6.
CONCLUSIONS: There is a high acceptability and preference for pDTG compared to legacy regimens such as LPV/r, with improved taste and ease of administration. Increased appetite was the most common side-effect reported. With the favourable findings from the study to date, national HIV program has commenced scale-up of pDTG with emphasis on pharmacovigilance. Further follow-up at 12 months will provide more evidence of pDTG’s impact.

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