638. Safety, Efficacy, and Durability of Long-Acting CAB and RPV as Maintenance Therapy for HIV-1 Infection: LATTE-2 Week 256 Results
Notice bibliographique
Résumé
Abstract Background Long-acting (LA) injectable suspensions of cabotegravir (CAB) & rilpivirine (RPV) are in phase III development. LATTE-2 W160 results demonstrated high rates of virologic response & overall tolerability. This W256 analysis evaluated long-term efficacy, safety, & tolerability of every 8-week (Q8W) & 4-week (Q4W) intramuscular (IM) dosing. Methods LATTE-2 is a phase IIb, multicenter, parallel arm, open-label study in antiretroviral therapy–naive adults with HIV. After a 20-week Induction Period on oral CAB+abacavir/lamivudine, participants (pts) with plasma HIV-1 RNA< 50c/mL were randomized 2:2:1 to IM CAB LA+RPV LA Q8W, Q4W, or continue oral (PO) regimen in the Maintenance Period (MP). After W96, pts on IM regimens continued their current MP regimen. Pts randomized to PO in MP chose a Q8W or Q4W IM regimen in the Extension Period (EP). W256 analysis of MP & EP included virologic success with HIV-1 RNA< 50 c/mL (Food & Drug Administration Snapshot analysis), protocol-defined virologic failure (PDVF), & safety (intention-to-treat–Maintenance Exposed population). Results At W256, 88% (101/115; Q8W) & 74% (85/115; Q4W) of randomized IM pts had HIV-1 RNA< 50 c/mL, as did 93% (41/44) of PO to IM pts. No pt developed PDVF after W48. In the randomized IM arm (MP & EP), excluding injection-site reactions (ISRs), nasopharyngitis (45%), diarrhea (28%), & headache (24%) were the most common adverse events (AEs), with 34% (39/115; Q8W) & 33% (38/115; Q4W) of pts reporting AEs ≥grade 3, of which 12% (14/115; Q8W) & 11% (13/115; Q4W) were drug related. 3% (3/115; Q8W) & 17% (20/115; Q4W) of pts had AEs leading to withdrawal. 22% (25/115; Q8W) & 23% (27/115; Q4W) reported serious AEs (3 were drug related). In the PO to IM arm (EP only), most common AEs excluding ISRs were nasopharyngitis (25%), influenza (23%), & back pain (18%). 23% (10/44) reported AEs ≥grade 3 & 5% (2/44) had AEs leading to withdrawal. Majority of ISRs were mild/moderate pain & discomfort. < 1% of ISRs were severe, with 5 pts discontinuing due to ISRs. Table 1 Table 2 Conclusion CAB+RPV LA injectable therapy, administered Q8W or Q4W, demonstrated high rates of virologic response & tolerability through 5 years. W256 results add to previous results & demonstrate long-term durability of CAB+RPV LA for people living with HIV. Disclosures Keith Henry, MD, Gilead (Research Grant or Support, Paid to institution)GSK/ViiV (Research Grant or Support, Paid to institution)Janssen (Research Grant or Support, Paid to institution)Merck (Research Grant or Support, Paid to institution) Daniel Podzamczer, MD, PhD, Gilead (Grant/Research Support, Advisor or Review Panel member)Janssen Pharmaceutica (Grant/Research Support, Advisor or Review Panel member)Merck Sharp & Dohme (Grant/Research Support, Advisor or Review Panel member)ViiV Healthcare (Grant/Research Support, Advisor or Review Panel member) Mar Masiá, MD, PhD, Janssen Pharmaceutica (Consultant, Other Financial or Material Support, Travel/accommodations/meeting expenses)Merck Sharp & Dohme (Consultant, Other Financial or Material Support, Travel/accommodations/meeting expenses)ViiV Healthcare (Consultant, Other Financial or Material Support, Travel/accommodations/meeting expenses) Hans Jaeger, MD, Abbvie (Consultant, Speaker’s Bureau)Gilead Sciences (Consultant, Speaker’s Bureau)Janssen (Consultant, Speaker’s Bureau)MSD Sharp & Dohme (Consultant, Speaker’s Bureau)ViiV Healthcare (Consultant, Research Grant or Support, Speaker’s Bureau) Marie-Aude Khuong-Josses, MD, Viiv HC (Advisor or Review Panel member) Kenneth Sutton, MA, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Cynthia C. McCoig, MD, ViiV Healthcare (Employee) Kati Vandermeulen, MSC, Janssen Pharmaceutica (Employee, Shareholder) Rodica Van Solingen-Ristea, MD, Janssen R&D (Employee) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)
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 distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 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) | 0,000 | 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 tête enseignante, 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 ».