1586. Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy and Safety Outcomes Through Week 96 by Race
Notice bibliographique
Résumé
Abstract Background Long-acting cabotegravir + rilpivirine (CAB + RPV LA) administered monthly or every 2 months is the first and only complete LA regimen recommended by treatment guidelines for the maintenance of HIV-1 virologic suppression. This post hoc analysis summarizes pooled outcomes for participants in the FLAIR and ATLAS-2M global Phase 3/3b studies through Week (W) 96 by race. Methods Data from participants randomized to receive CAB + RPV LA every 4 weeks (Q4W) or 8 weeks (Q8W) in the FLAIR and ATLAS-2M studies were pooled and stratified by race (Black or African American, White, Asian, Other race). Key efficacy endpoints were the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL and HIV-1 RNA < 50 copies/mL at W96 (FDA Snapshot). Incidence of confirmed virologic failure (CVF; two consecutive HIV-1 RNA measurements of ≥200 copies/mL), safety, and treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs]) were also assessed. Results 937 participants received CAB + RPV LA (Q8W, n=327; Q4W, n=610). Overall, 76% (n=711) of participants were White, 16% (n=149) were Black or African American, 4% (n=41) were Asian, and 4% (n=36) were Other race. The median age (range) was 39 years (19–83), and 23% (n=211) were female (sex at birth) (Table 1). At W96, rates of virologic non-response (HIV-1 RNA ≥50 copies/mL) and suppression (HIV-1 RNA < 50 copies/mL) with CAB + RPV LA ranged 0–3% and 83–94%, respectively, across races (Table 2). Rates of CVF ranged 0–2% across races. Excluding injection site reactions (ISRs), drug-related Grade ≥3 adverse events (AEs) occurred in 2% (n=17/937) of participants, ranging 0–3% across races. Drug-related serious AEs occurred in 5 (< 1%) participants (White, < 1% [n=4]; Other race, 3% [n=1]). Overall, 99% (n=8357/8453) of ISR events were Grade 1 or 2; 2% (n=20) of participants withdrew for injection-related reasons. Mean changes in HIVTSQs total scores increased from baseline to W96 across all races, ranging 0.9–3.0. Conclusion CAB + RPV LA demonstrated high efficacy and was well tolerated, with increases in participant satisfaction reported from baseline, irrespective of race. These data support CAB + RPV LA as a complete regimen for the maintenance of virologic suppression in individuals with HIV-1. Disclosures Parul Patel, MSW, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare Ltd: Employee Emilie Elliot, MD, ViiV Healthcare Ltd: Employee Ronald D’Amico, D.O., MSc, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare Ltd: Employee Louise Garside, PhD, GlaxoSmithKline: Stocks/Bonds Jeremy Roberts, MSc, GlaxoSmithKline: Employee|GlaxoSmithKline: Stocks/Bonds Joseph W. Polli, PhD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare Ltd: Employee Moti Ramgopal, MD, FACP, FIDSA, AbbVie: Grant/Research Support|Gilead Sciences Inc.: Advisor/Consultant|Gilead Sciences Inc.: Grant/Research Support|Gilead Sciences Inc.: Honoraria|Gilead Sciences Inc.: Stocks/Bonds|GlaxoSmithKline: Advisor/Consultant|GlaxoSmithKline: Grant/Research Support|GlaxoSmithKline: Honoraria|GlaxoSmithKline: Stocks/Bonds|Janssen Research & Development LLC: Advisor/Consultant|Janssen Research & Development LLC: Grant/Research Support|Janssen Research & Development LLC: Honoraria|Janssen Research & Development LLC: Stocks/Bonds|Merck: Advisor/Consultant|Merck: Grant/Research Support|Merck: Honoraria|Merck: Stocks/Bonds|Shionogi: Grant/Research Support|ViiV: Advisor/Consultant|ViiV: Grant/Research Support Princy N. Kumar, MD, American Gene Technologies: Grant/Research Support|BioHaven: Grant/Research Support|Eli Lilly: Grant/Research Support|Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Gilead: Stocks/Bonds|GSK: Grant/Research Support|GSK: Stocks/Bonds|Johnson&Johnson: Advisor/Consultant|Johnson&Johnson: Stocks/Bonds|Merck: Advisor/Consultant|Merck: Grant/Research Support|Merck: Stocks/Bonds|Moderna: Stocks/Bonds|Pfizer: Stocks/Bonds|Regeneron: Grant/Research Support|TheraTechnologies: Advisor/Consultant|ViiV: Advisor/Consultant Olayemi Osiyemi, MD, Gilead: Advisor/Consultant|gsk: Advisor/Consultant|viiv: Advisor/Consultant Bryan Baugh, MD, Janssen Research & Development LLC: Employee|Janssen Research & Development LLC: Stocks/Bonds Jean A. van Wyk, MB,ChB; MFPM, ViiV Healthcare Limited: I am an employee of ViiV Healthcare|ViiV Healthcare Limited: Stocks/Bonds.
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 | 0,007 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,006 | 0,001 |
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 ».