Sword 1 and 2: Subgroup Analysis of 48 Week Results by Age, Race and Gender
Notice bibliographique
Résumé
Abstract Background Switching to the 2-drug regimen (2DR) of DTG+RPV was proven non-inferior to continuing a suppressive PI-, INI- or NNRTI- based current antiretroviral regimen (CAR) at Week 48. This analysis evaluated the efficacy and safety of switching from CAR to DTG+RPV by age, race and gender subgroups. Methods Two identically designed, open-label, multicenter, global, phase III, non-inferiority studies compared the efficacy and safety of switching from a 3 or 4-drug CAR to DTG + RPV once daily in HIV-1-infected adults, with HIV-1 RNA<50 c/mL. Primary endpoint was proportion of patients with VL<50 c/mL at Wk48 using FDA Snapshot. Additional analysis were performed to summarize efficacy base on age, race and gender subgroups for each individual study and pooled. Results 1024 patients were randomized and exposed (DTG+RPV 513; CAR 511), across both studies. Treatment arms were well matched for demographic and baseline characteristics. Median age across both arms was 43.4 years, with 29% and 28% ≥ 50 years in DTG+RPV and CAR, respectively. 23% and 21% were female while 18% and 22% were non-white for DTG+RPV and CAR. For the pooled studies and for SWORD-1 and SWORD-2 individually, switching to DTG+RPV was non-inferior to CAR at Wk48. Similar response rates were observed in the DTG+RPV arm compared with CAR across subgroups (Table 1). More AEs were reported in the DTG+/RPV arm across all subgroups except Asian race; no unexpected AEs were identified for either drug. Conclusion Switch to a novel, once daily 2DR of DTG+RPV in patients with a suppressed viral load, was an effective and well tolerated treatment option across age, race, and gender subgroups which were consistent with overall results. Disclosures S. Walmsley, Merck: Board Member, Consultant, Grant Investigator, Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Grant recipient, Research grant and Speaker honorarium; ViiV Healthcare: Board Member, Consultant, Grant Investigator, Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Grant recipient, Research grant and Speaker honorarium; Gilead Sciences: Board Member, Consultant, Grant Investigator, Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Grant recipient, Research grant and Speaker honorarium; GSK: Board Member, Consultant, Grant Investigator, Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Grant recipient, Research grant and Speaker honorarium; Janssen: Board Member, Consultant, Grant Investigator, Investigator, Scientific Advisor and Speaker’s Bureau, Grant recipient, Research grant and Speaker honorarium; BMS: Grant Investigator, Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Grant recipient, Research grant and Speaker honorarium; G. Richmond, Viiv Healthcare: Investigator, Research support; F. Bredeek, ViiV Healthcare: Investigator and Scientific Advisor, Consulting fee and Research support; M. Ramgopal, viiv: Investigator, Consulting fee; C. C. Hung, Gilead Sciences: Board Member and Speaker’s Bureau, Consulting fee and Speaker honorarium; ViiV: Board Member and Investigator, Consulting fee and Research support; Abbvie: Board Member and Investigator, Consulting fee and Research grant; Bristol-Myers Squibb: Investigator, Research support; Jassen: Board Member and Investigator, Consulting fee and Research support; E. Blair, ViiV Healthcare: Employee and Shareholder, Salary; L. Kahl, ViiV Healthcare: Employee and Shareholder, Salary; M. Underwood, ViiV Healthcare: Employee, Salary; K. Angelis, GlaxoSmithKline: Employee, Salary; K. Vandermeulen, Jansen: Employee, Salary; B. Wynne, ViiV Healthcare: Employee, Salary; M. Aboud, ViiV Healthcare: Employee, Salary
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 | 0,011 | 0,010 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,004 | 0,012 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,004 | 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 ».