Month 12 outcomes of switching to long-acting cabotegravir + rilpivirine with an oral lead-in versus continuing bictegravir/emtricitabine/tenofovir alafenamide in the Phase 3b randomized SOLAR study
Bibliographic record
Abstract
Cabotegravir + rilpivirine (CAB + RPV) dosed every 2 months (Q2M) is the only complete long-acting (LA) regimen for maintaining HIV-1 virologic suppression. In some regions, prescribing information mandates a 4-week oral lead-in (OLI) before initiating CAB + RPV LA. To support clinical decision-making in these areas, we report a pre-specified analysis in adults living with HIV-1 who switched to CAB + RPV LA with an OLI versus continuing daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) for maintaining virologic suppression in the Phase 3b, randomized, open-label, SOLAR study. In SOLAR, participants with HIV-1 RNA <50 copies/mL were randomized (2:1) to either intramuscular CAB + RPV LA Q2M, with a 1-month optional once-daily OLI of CAB + RPV, or to continue daily oral BIC/FTC/TAF. Month 12 endpoints included virologic response, safety, and patient-reported outcomes. Of 670 participants, 173 (39 %) switched to CAB + RPV LA with OLI, 274 (61 %) switched to CAB + RPV LA starting directly with injections, and 223 (33 %) continued BIC/FTC/TAF. At Month 12, the proportions of participants with HIV-1 RNA ≥50 copies/mL (CAB + RPV LA OLI, 1 % [n = 2/173]; BIC/FTC/TAF, <1 % [n = 1/223]) and HIV-1 RNA <50 copies/mL (CAB + RPV LA OLI, 87 % [n = 151/173]; BIC/FTC/TAF, 93 % [n = 207/223]) were similar between arms. Excluding injection site reactions, adverse events were comparable between arms; however, more participants in the CAB + RPV LA OLI arm had adverse events leading to withdrawal (5 % [n = 8/173] versus <1 % [n = 2/227]). Overall, 87 % (n = 142/163) of participants who switched preferred CAB + RPV LA OLI to BIC/FTC/TAF. Switching to CAB + RPV LA OLI demonstrated comparable efficacy to continuing BIC/FTC/TAF, was well tolerated and preferred by most participants who switched. ClinicalTrials.gov; NCT04542070 (https://clinicaltrials.gov/study/NCT04542070).
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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 | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.000 |
| 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".