Plasma bictegravir/emtricitabine/tenofovir alafenamide concentrations in transgender women with HIV on oestrogen‐based gender‐affirming hormone therapy in comparison to cisgender women living with HIV
Notice bibliographique
Résumé
5 Background: Oestrogen-based gender-affirming hormone therapy (E-GAHT) typically consists of an oestrogen ± an anti-androgen and is essential for many transgender women. However, there is concern regarding drug–drug interactions (DDIs) between antiretroviral therapy (ART) and E-GAHT. This study's objective was to investigate the pharmacokinetics of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in transgender women taking E-GAHT compared to pre-menopausal cisgender women. Methods: We conducted a parallel group study in adult transgender women with HIV taking ART (transgender group) and cisgender women with HIV taking ART (control group). All participants were on suppressive ART for at least 6 months prior to and either taking or switched to BIC/FTC/TAF at entry. All participants in the transgender group were taking at least 2 mg/day of oral estradiol and anti-androgen therapy and could not have any E-GAHT medication changes for at least 3 months prior to entry. At the Month 2 visit, blood samples were collected prior to ART and E-GAHT dosing (if applicable) and then at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 h post-dose. BIC, FTC and TAF plasma concentrations were measured using a validated LC-MC/MS assay. Maximum (Cmax) and minimum (Cmin) concentrations were observed, and area under the concentration-time curve (AUC) over 24 h was calculated by non-compartmental methods. Data are presented as median (IQR) and compared between transgender and control groups by geometric mean ratio (GMR) with 90% confidence intervals (CI). Results: A total of 25 participants were enrolled, 10 transgender women and 15 cisgender women. E-GAHT consisted of a median estradiol dose of 4 mg (4, 4). Anti-androgen therapy included spironolactone (n = 6), cyproterone (n = 2), hypopituitarism (n = 1) and orchidectomy (n = 1). Median BIC Cmax, Cmin and AUC for the transgender group were 9.1 mcg/mL (8.1, 9.6), 2.6 mcg/mL (1.1, 3.1) and 119.5 h*mcg/mL (86.6, 141.2), respectively, compared to 7.2 mcg/mL (6.4, 9), 1.9 mcg/mL (1.4, 3.4) and 123.9 h*mcg/mL (79.7, 133.2), respectively, for the Control group. BIC PK parameters were similar between groups (GMR [90% CI]: 1.1 [0.9, 1.4], 1 [0.6, 1.7], and 1 [0.8, 1.3], respectively). Median FTC Cmax, Cmin and AUC for the transgender group were 2 mcg/mL (1.3, 2.5), 0.1 mcg/mL (0.1, 0.1) and 10.7 h*mcg/mL (8.7, 14), respectively, compared to 2 mcg/mL (1.6, 2.3), 0.1 mcg/mL (0.1, 0.1) and 11 h*mcg/mL (9.8, 15.6), respectively, for the control group. FTC PK parameters were similar between groups (GMR [90% CI]: 0.9 [0.8, 1.2], 1.1 [0.8, 1.5], and 1 [0.8, 1.2], respectively). Median TAF Cmax, Cmin and AUC for the transgender group were 164 ng/mL (90, 335), 0.5 ng/mL (0.5, 0.5) and 143 h*ng/mL (116, 320), respectively, compared to 250 ng/mL (132, 396), 0.5 ng/mL (0.5, 0.5) and 230 h*ng/mL (189, 394), respectively, for the control group. TAF PK parameters were similar between groups (GMR [90% CI]: 0.7 [0.4, 1.2], 1 [1, 1], and 0.7 [0.5, 1], respectively). All participants remained virally suppressed (HIV RNA < 200 copies/mL) throughout the study. Conclusion: BIC/FTC/TAF plasma pharmacokinetics were similar between groups, indicating no clinically significant effect of oral E-GAHT on BIC/FTC/TAF.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».