by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer
October 24, 2023
Frange P, Veber F, Burgard M, Blanche S, Avettand-Fenoel V. Bictegravir/emtricitabine/tenofovir alafenamide in pediatrics: real-life experience from a French cohort (2018-2023). HIV Med. 2023 Oct 8. doi: 10.1111/hiv.13562. PMID: 37807595
This retrospective study of the French Necker cohort evaluated safety and efficacy of co-formulated bictegravir/emtricibine/tenofovir alafenamide (BIC/F/T) among 74 children and adolescents weighing ≥25kg between January 2019 and July 2023. 93.2% were ART experienced and median duration of prior ART use was 7.2 years. 85.1% had previous INSTI exposure (mostly dolutegravir). Prior to BIC/F/T initiation, 67.6% were suppressed, 25.7% had VL ≥ 50 on baseline ART, and 6.8% were ART-naïve. Among individuals with baseline/historical genotype information, 0/59 (0%) had mutations associated with BIC resistance, 15/69 (21.7%) had FTC-associated mutations, and 3/69 (4.3%) had TAF-associated mutations. Overall, one patient discontinued BIC/F/T due to adverse event (suspected gastrointestinal and psychiatric toxicity) and one changed to a two-drug regimen. Over a median follow-up of 40 months, 97.3% remained on BIC/F/T and virologic failure occurred in 28/74 (37.8%). With reinforced adherence support and no change in ART, 16/28 (57.1%) patients with virologic failure re-suppressed by the last visit. Emergent T69D/N was identified in one patient and no emergent INSTI mutations were identified.
Overall, higher rates of virologic failure were observed in this retrospective pediatric cohort study compared to clinical trials and real-world studies involving adults on BIC/F/TAF. Nevertheless, over half who experienced failure were able to re-suppress with tailored adherence interventions. Perhaps unsurprisingly, BIC/F/T initiation resulted in high rates of virologic suppression among patients who were already suppressed or ART-naïve at baseline. Virologic failure was significantly more common in patients who were viremic prior to BIC/F/TAF. Additionally, given pre-treatment genotypic susceptibility scores in this population, findings of this study may not be generalizable to heavily treatment experienced children/youth with extensive HIV drug resistance. Additionally, the observed association between presence of archived M184V/I and virologic failure bears further investigation.
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