Brief Report: Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Females Living With HIV: An Integrated Analysis of 5 Trials.
Adenine
/ therapeutic use
Adolescent
Adult
Aged
Alanine
/ therapeutic use
Amides
/ therapeutic use
Anti-HIV Agents
/ adverse effects
Child
Drug Combinations
Emtricitabine
/ therapeutic use
Female
HIV Infections
/ drug therapy
HIV-1
/ drug effects
Heterocyclic Compounds, 3-Ring
/ therapeutic use
Heterocyclic Compounds, 4 or More Rings
/ therapeutic use
Humans
Middle Aged
Piperazines
/ therapeutic use
Pyridones
/ therapeutic use
Tenofovir
/ analogs & derivatives
Treatment Outcome
Young Adult
Journal
Journal of acquired immune deficiency syndromes (1999)
ISSN: 1944-7884
Titre abrégé: J Acquir Immune Defic Syndr
Pays: United States
ID NLM: 100892005
Informations de publication
Date de publication:
01 12 2021
01 12 2021
Historique:
received:
18
03
2021
accepted:
16
08
2021
pubmed:
11
9
2021
medline:
18
1
2022
entrez:
10
9
2021
Statut:
ppublish
Résumé
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). Integrated analysis. 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. 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. 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.
Sections du résumé
BACKGROUND
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.
Identifiants
pubmed: 34506342
doi: 10.1097/QAI.0000000000002789
pii: 00126334-202112010-00011
pmc: PMC8547745
doi:
Substances chimiques
Amides
0
Anti-HIV Agents
0
Drug Combinations
0
Heterocyclic Compounds, 3-Ring
0
Heterocyclic Compounds, 4 or More Rings
0
Piperazines
0
Pyridones
0
bictegravir
8GB79LOJ07
Tenofovir
99YXE507IL
tenofovir alafenamide
EL9943AG5J
Emtricitabine
G70B4ETF4S
Adenine
JAC85A2161
Alanine
OF5P57N2ZX
Types de publication
Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
393-398Informations de copyright
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
C.O. reports grants and personal fees from Gilead during the conduct of the included study; grants, personal fees, speaker bureau fees, and travel expenses from Gilead, and speaker bureau fees from GlaxoSmithKline, Janssen, MSD, and VIIV, outside the submitted work. C.K. reports grants to her institution from Gilead during the conduct of the included study. B.G.-P., H.W., Y.L., X.W., K.W., T.M., C.P., I.M., S.E.C., D.B., and S.K.C. are employees of and hold stocks in Gilead Sciences. The remaining authors have no conflicts of interest to disclose. Data Sharing: Gilead Sciences shares anonymized individual patient data on request or as required by law or regulation with qualified external researchers based on submitted curriculum vitae and reflecting nonconflict of interest. The request proposal must also include a statistician. Approval of such requests is at Gilead Science's discretion and is dependent on the nature of the request, the merit of the research proposed, the availability of the data, and the intended use of the data. Data requests should be sent to datarequest@gilead.com.
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