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- Protocol of a drug-drug interaction study between bictegravir/emtricitabine/tenofovir alafenamide and feminizing hormones in trans women living with HIV.
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
No description defined |
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Statements
Trans/transfeminine women are disproportionally affected by HIV. (English)
AIMS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
Concerns regarding negative drug-drug interactions (DDIs) between ART drugs and gender-affirming hormone therapy (GAHT), specifically feminizing hormone therapy (FHT), may contribute to the lower ART uptake by trans women with HIV compared with their cis counterparts. (English)
AIMS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
The aim of this study is to investigate the bidirectional pharmacokinetic effects of components of FHT regimens (oral oestradiol and androgen-suppressing medications) with the ART regimen (bictegravir/emtricitabine/tenofovir alafenamide [B/F/TAF)]. (English)
AIMS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
We present a protocol for a three-armed, parallel-group, longitudinal (6-month), DDI study. (English)
METHODS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
Group 1 includes 15 3trans women with HIV taking FHT and ART; group 2 includes 15 premenopausal cis women with HIV taking ART; group 3 includes 15 trans women without HIV taking FHT. (English)
METHODS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
Women with HIV must be on or switch to B/F/TAF at baseline and be virally suppressed for ≥3 months. (English)
METHODS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
Trans women must be taking a stable regimen of ≥2 mg daily oral oestradiol and an anti-androgen (pharmaceutical, and/or surgical, and/or medical) for ≥3 months. (English)
METHODS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
Plasma ART drug concentrations will be sampled at Month 2 and compared between groups 1 and 2. (English)
METHODS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
Serum oestradiol concentrations will be sampled at baseline and Month 2 visits and compared between groups 1 and 3. (English)
METHODS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
The primary outcomes are B/F/TAF pharmacokinetic parameters (C<sub>min</sub>, C<sub>max</sub> and AUC) and oestradiol concentrations (C<sub>min</sub>, C<sub>4h,</sub> C<sub>max</sub> and AUC) at month 2. (English)
METHODS (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
This study is of global importance as it provides critical information regarding safe coadministration of B/F/TAF and FHT, both of which are life-saving therapies for trans women with HIV. (English)
DISCUSSION (English)
© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. (English)
2024
Ashley (English)
Lacombe-Duncan (English)
A
Alice (English)
Tseng (English)
A
Kimberly K (English)
Scarsi (English)
KK
Tessa (English)
Senneker (English)
T
Hadas (English)
Kluger (English)
H
Yasmeen (English)
Persad (English)
Y
Angela (English)
Underhill (English)
A
V Logan (English)
Kennedy (English)
VL
Ian (English)
Armstrong (English)
I
Raymond (English)
Fung (English)
R
Amy (English)
Bourns (English)
A
Quang (English)
Nguyen (English)
Q
Susan (English)
Hranilovic (English)
S
Thea (English)
Weisdorf (English)
T
Louie (English)
Chan (English)
L
Hannah (English)
Kia (English)
H
Roberta (English)
Halpenny (English)
R
Harshita (English)
Iyer (English)
H
Nirubini (English)
Jeyarajah (English)
N
George (English)
Kovchazov (English)
G
Wangari (English)
Tharao (English)
W
Mona (English)
Loutfy (English)
M
23 October 2024
27 September 2024