1029. Long-Term Patient Adherence and Management of Treatment Interruptions With Long-Acting Injectable Cabotegravir + Rilpivirine for Maintenance Therapy in Phase IIb/III Studies
Notice bibliographique
Résumé
Abstract Background Cabotegravir (CAB) and rilpivirine (RPV) are under development as a novel long-acting (LA) regimen for maintenance of HIV virologic suppression. Pooled data from pivotal phase III trials demonstrated noninferiority of CAB + RPV LA given as gluteal intramuscular injections vs current antiretroviral regimen (CAR) on the primary endpoint of HIV-1 ribonucleic acid (RNA) ≥50c/mL at Week 48, with high levels of adherence. Long-term adherence to dosing visits and outcomes after use of oral CAB+RPV to cover planned missed injections in FLAIR through Week 96 and in LATTE-2 through Week 256 is reported here. Methods Virologically suppressed participants (HIV-1 RNA < 50c/mL) were randomized to switch to CAB+RPV LA or to continue CAR. On-time injections occurred every 4 weeks or every 8 weeks (LATTE-2 only) within a ±7-day dosing window of the projected dosing date. Adherence to LA therapy was calculated as the number of on-time injection visits divided by the number of expected dosing visits through the period of follow up. Injection visits outside the prespecified window and missed injection visits with or without use of oral dosing were characterized. Results Of 6005 expected injection visits through Week 96 in FLAIR, 97% of injections were given within the allowed ±7-day dosing window, with 43% on the projected dosing date. 45 (< 1%) injection visits were early and 107 (2%) were late. Adherence to 9803 expected injection visits in LATTE-2, through Week 256, was similarly high, with 96% of injections given within the allowed ±7-day dosing window and 39% on the projected dosing date. For 31 missed injection visits in 18 participants across both trials, 30 were covered with oral CAB+RPV, with all participants maintaining HIV-1 RNA < 50c/mL through the last study visit. In those participants who used oral CAB + RPV for planned treatment interruptions, 3 had repeat use on ≥2 separate occasions. Conclusion Participants maintained high levels of long-term adherence to CAB+RPV LA, through 2-5 years of follow up, with 97% of injections given within the ±7-day dosing window in the FLAIR and LATTE-2 clinical trials. Oral CAB+RPV to cover planned missed visits provides an effective strategy to maintain virologic suppression during short periods of LA treatment interruption. Disclosures Paula Teichner, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sterling Wu, PhD, GlaxoSmithKline (Employee, Shareholder) David Dorey, MMATH, GlaxoSmithKline Inc. (Employee, Shareholder) Ronald D’Amico, DO, MSc, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sandy Griffith, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Kenneth Sutton, MA, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Cynthia C. McCoig, MD, ViiV Healthcare (Employee) Joseph Polli, PhD, FAAPS, ViiV Healthcare (Employee) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Rodica Van Solingen-Ristea, MD, Janssen R&D (Employee) Kati Vandermeulen, M.SC., Janssen Pharmaceutica (Employee, Shareholder) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) Parul Patel, PharmD, ViiV Healthcare (Employee)
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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 | 0,000 |
| 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 ».