<scp>ALT</scp> flares during nucleotide analogue therapy are associated with <scp>HB</scp>sAg loss in genotype A <scp>HB</scp>eAg‐positive chronic hepatitis B
Bibliographic record
Abstract
Abstract Background Alanine aminotransferase ( ALT ) flares during NA therapy are uncommon but occur. Evaluation of ALT flares during nucleos(t)ide analogue ( NA ) therapy is important as new immunomodulatory therapies for hepatitis B virus ( HBV ) are developed. We evaluated the association between ALT flares and HB sAg loss during long‐term therapy for genotype A CHB . Methods This analysis included genotype A subjects from a phase III study of tenofovir vs adefovir in HB eAg‐positive HBV . ALT flare was defined as (i) a rise in ALT >2x ULN from normal ALT levels; or (ii) a rise in ALT >2x baseline ALT level. HB sAg response at week 384 was recorded as one of HB sAg loss vs HB sAg decline (≥1 log 10 IU /mL decline) vs non‐response. The primary analysis evaluated the association between ALT flare and HB sAg response. Results 54 subjects were included. 23/54 (43%) subjects experienced an on‐treatment ALT flare. 45% achieved an HB sAg reduction ≥1 log 10 IU / mL , and of these 67% achieved HB sAg loss at a median of 102 weeks [ IQR : 64‐156]. Flare was associated with HB sAg decline vs non‐response (67% vs 23%, P = .002), and were more common in subjects who achieved HB sAg loss vs non‐response (56% vs 23%), P = .049). There was a median delay of 56 weeks [ IQR : 40‐80] between a flare and HB sAg loss. Conclusion In genotype A subjects undergoing long‐term NA therapy, ALT flares predict for HB sAg response. The delay between ALT flare and HB sAg loss has implications for clinical trial design for early phase development of immunomodulatory strategies aiming for HB sAg loss.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 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".