VH3810109 Efficacy, Safety, Pharmacokinetics, and Incidence of Antidrug Antibodies in Adults With HIV-1 Naive to Antiretroviral Therapy: BANNER Study Results
Bibliographic record
Abstract
BACKGROUND: VH3810109 (N6LS) is a CD4-binding site antibody with broad and potent neutralizing activity in vitro. Here, we present efficacy, safety, and pharmacokinetic results from the phase 2a BANNER study in people with HIV-1. METHODS: BANNER was a randomized, open-label, 2-part, multicenter study of N6LS in adults naive to antiretroviral therapy (ART) with HIV-1 RNA ≥5000 copies/mL. N6LS was evaluated during monotherapy after a single intravenous (IV) infusion at various doses or subcutaneous (SC) injection, followed by 48 weeks of standard-of-care ART. Antiviral activity, safety, pharmacokinetics, and antidrug antibodies (ADAs) were evaluated. RESULTS: Sixty-two participants completed the monotherapy phase and 58 completed the standard-of-care phase. Most participants were male (94%), Hispanic (82%), and White (61%). Virologic response (reduction in HIV-1 RNA ≥0.5 log10 copies/mL from baseline) was achieved in 8/8 (100%; 40 mg/kg IV), 14/15 (93%; 700 mg IV), 5/6 (83%; 280 mg IV), 7/16 (44%; 70 mg IV), and 8/16 (50%; 700 mg SC) participants. Administered IV or SC, N6LS was well tolerated with few drug-related adverse events (n = 13) and no serious adverse events reported during monotherapy. Pharmacokinetic parameters increased proportionally with dose. Incidence of ADAs was dose-dependent and ranged from 6% to 83% in the IV groups; incidence was 19% in the SC group, with no indication that route of administration impacts incidence of ADAs. CONCLUSIONS: N6LS was efficacious and generally safe, supporting further development of N6LS dosed IV or SC for the treatment of HIV-1 (ClinicalTrials.gov, NCT04871113).
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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 | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".