1586. Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy and Safety Outcomes Through Week 96 by Race
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".