Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials
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Date
1999
Journal Title
Journal ISSN
Volume Title
Publisher
Journal of Acquired Immune Deficiency Syndromes
Abstract
We characterized the efficacy and safety of
bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in a
broad population of pediatric/adolescent/adult/elderly females living
with HIV (FWH).
Setting: Integrated analysis.
Methods: Available data from 5 trials were integrated. Week 48
virologic suppression (HIV-1 RNA ,50 copies/mL), resistance,
adverse events (AEs), and laboratory parameters were assessed.
Results: Three hundred and seventy-three FWH [304 virologically
suppressed; 69 antiretroviral therapy (ART)-naive] received B/F/TAF
[data from comparator regimens available for 306 individuals (236
virologically suppressed and 70 ART-naive participants)]. Virologic
suppression rates with B/F/TAF at week 48 were high regardless of
age in participants virologically suppressed at baseline ($95%) and in
ART-naive participants ($87%). Virologic suppression rates were
similar in B/F/TAF and comparator regimens (both virologically
suppressed and ART-naive groups). Treatment-emergent resistance
was not detected in the B/F/TAF group. AEs considered related to
study drugs were experienced by 9.2% (B/F/TAF) and 5.5%
(comparator regimen) of virologically suppressed participants and
15.9% (B/F/TAF) and 31.4% (comparator regimen) of ART-naive
participants. For virologically suppressed and ART-naive FWH
combined, only 1 of the 373 B/F/TAF–treated and 2 of the 306
comparator-regimen participants discontinued because of AEs (none
were bone/renal/hepatic AEs); grade 3/4 AEs were experienced by
5.1% (B/F/TAF) and 7.8% (comparator regimen); and grade 3/4
elevation of low-density lipoprotein/total cholesterol occurred in 2.7%/
0.3% (B/F/TAF) and 5.9%/2.0% (comparator regimen). At week 48,
median changes from baseline estimated glomerular filtration rate in
adults were ,5 mL/min; results were similar in B/F/TAF and
comparator-regimen groups.
Conclusion: B/F/TAF treatment was effective and well tolerated
over 48 weeks, confirming B/F/TAF as an option for a broad
population of FWH.
Description
Keywords
Female, Bictegravir, Emtricitabine, Child, HIV, Adolescent
Citation
Orkin, C., Ajana, F., Kityo, C., Koenig, E., Natukunda, E., Gandhi-Patel, B., ... & Chuck, S. K. (2021). Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials. Journal of Acquired Immune Deficiency Syndromes (1999).