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 machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".