New data support B/FTC/TAF use in HIV+ children

Data from a French study presented at CROI 2023 support the use of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (B/FTC/TAF) in the management of paediatric patients with HIV.

“B/FTC/TAF is now approved for use in HIV-positive children weighing ≥25 kg. However, published data about its efficacy in the paediatric population are limited to only one trial that includes subjects with suppressed viremia at baseline, good adherence to treatment, and short-term follow-up,” noted the team of researchers led by Dr Pierre Frange from the Necker-Enfants Malades Hospital, Paris, France.

Frange and colleagues thus conducted a ‘real-life’ study to provide long-term data on the risk of viral failure and acquired genotypic resistance in children and adolescents receiving B/FTC/TAF and followed at their facility.

They retrospectively analysed 60 consecutive paediatric patients (median age 11.1 years) who received B/FTC/TAF between 2019 and 2022. In this study, viral failure was defined as not achieving an undetectable plasma viral load (<50 copies/mL) within 3 months of initiating B/FTC/TAF treatment, or as experiencing a viral rebound (plasma viral load ≥50 copies/mL). [CROI 2023, abstract 830]

At baseline, more than 90 percent of participants had a previous exposure to antiretroviral therapy. Eighty-five percent had a prior exposure to dolutegravir and elvitegravir, both integrase strand transfer inhibitors. About two-thirds were virologically suppressed.

After a median follow-up of 27 months, 37 participants had sustained viral suppression. All had undetectable plasma viral load at the time of the last visit, without having to change their antiretroviral regimen.

The other 23 participants (38.3 percent) had viral failure after a median follow-up of 33 months, 12 of whom experiencing a viral rebound. Despite this high incidence of viral failure, 12 of these patients were able to achieve an undetectable plasma viral load at the last visit, the researchers noted.

Overall, with reinforced measures to improve adherence, 49 out of the 60 participants (81.7 percent) had undetectable plasma viral load at the last visit, underscored Frange.

Furthermore, despite a long duration of viraemia while on treatment (median 7.5 months), there was no emergence of resistance-associated mutations among the participants who had viral failure.

Taken together, these findings suggest that while viral failure was frequent, acquired resistance was rare, explained Frange and colleagues.

In most of the participants who had antiretroviral therapy exposure, the introduction of B/FTC/TAF reduced the treatment burden that their previous regimen entailed, which involved numerous pills (61 percent) or syrups (30 percent), twice-daily dosing (43 percent) and/or larger-sized pills (4 percent).

No participant ceased using B/FTC/TAF owing to drug-related side effects.

“Because of its good tolerance, high genetic barrier to resistance, and small pill burden, B/FTC/TAF could be especially useful in the paediatric population, wherein the risk of poor treatment adherence is high,” the researchers concluded.