1587. SOLAR 12-Month North American Results: Randomized Switch Trial of CAB+RPV LA vs. Oral BIC/FTC/TAF
Bibliographic record
Abstract
Abstract Background Cabotegravir + rilpivirine (CAB+RPV) administered monthly or every 2 months (Q2M) is the only complete long-acting (LA) regimen for maintaining HIV-1 suppression and may address challenges associated with daily oral therapy. In the Phase 3b SOLAR study, switching to CAB+RPV LA Q2M was noninferior to continuing daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). We present results for North American (NA; United States and Canada) participants. Methods SOLAR (NCT04542070) is the first randomized (2:1), open-label, multicenter, noninferiority study assessing switching virologically suppressed adults to CAB+RPV LA Q2M (with oral lead-in or starting with injections) vs. continuing BIC/FTC/TAF. The primary analysis was based on the prespecified modified intention-to-treat exposed (mITT-E) population (n=11 from 1 study site excluded from the ITT-E population for protocol deviation) at Month (M) 12. The primary endpoint was the proportion with plasma HIV-1 RNA ≥50 c/mL. Other endpoints were the proportion with plasma HIV-1 RNA < 50 c/mL, incidence of confirmed virologic failure (CVF; 2 consecutive HIV-1 RNA ≥200 c/mL), safety and tolerability (ITT-E), and treatment satisfaction (HIV Treatment Satisfaction Questionnaire status version [HIVTSQs]). Results Of 670 participants (mITT-E), 325 were from North America; 66% (n=216/325) switched to LA and 34% (n=109/325) continued BIC/FTC/TAF. Baseline (BL) characteristics were similar between arms (Table 1). At M12, 1 participant in each arm had HIV-1 RNA ≥50 c/mL (Table 2). No NA participant had CVF in the mITT-E population; 1 (0.3%) NA participant excluded from the mITT-E population due to protocol violation had CVF (LA arm). Adverse events (AEs), excluding injection site reactions (ISRs), were similar between the LA (74% [n=164/223]) and BIC/FTC/TAF arms (73% [n=83/113]). More participants in the LA vs. BIC/FTC/TAF arm withdrew due to AEs (8% [n=17/223] vs. < 1% [n=1/113]). Mean adjusted HIVTSQs scores improved significantly (p< 0.001) from BL to M12 for LA (+3.40) vs. BIC/FTC/TAF (–1.07) participants. Conclusion Consistent with the overall SOLAR study population, switching to CAB+RPV LA from BIC/FTC/TAF was efficacious and well tolerated, with improved treatment satisfaction, in NA participants. Disclosures Mehri McKellar, MD, Gilead Sciences, Inc: Grant/Research Support Paula Teichner, PharmD, GlaxoSmithKline: Stocks/Bonds|ViiV Healthcare: Employment Jonathan Angel, MD, Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Gilead: Honoraria|Merck: Grant/Research Support|ViiV Canada: Advisor/Consultant|ViiV Canada: Grant/Research Support|ViiV Canada: Honoraria Lori A. Gordon, PharmD, ViiV Healthcare: Stocks/Bonds Kenneth Sutton, MA, ViiV Healthcare: Employment|ViiV Healthcare: Stocks/Bonds Denise Sutherland-Phillips, MD, ViiV Healthcare: Employment|ViiV Healthcare: Stocks/Bonds Christine L. Talarico, M.S., ViiV Healthcare: Stocks/Bonds Rimgaile Urbaityte, MSc, GSK: Employment|GSK: Stocks/Bonds Rodica Van Solingen-Ristea, MD, Janssen R&D: Employee Bryan Baugh, MD, Johnson & Johnson: Stocks/Bonds Ronald D'Amico, DO, MSc, ViiV Healthcare Ltd: Stocks/Bonds Jean A. van Wyk, MBChB, MFPM, ViiV Healthcare Ltd: 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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 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".