by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer

October 24, 2023

Featured Literature:

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.

Author’s Commentary:

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.     

View archived Clinical Research Update entries here.