1311: TERLIPRESSIN IMPROVES OUTCOMES IN PATIENTS WITH HRS AND ALCOHOLIC HEPATITIS: THE CONFIRM STUDY
Bibliographic record
Abstract
Introduction: Alcoholic hepatitis (AH) may lead to liver cirrhosis, hepatorenal syndrome (HRS) and subsequently acute-on-chronic liver failure (ACLF). Terlipressin (terli) is FDA-approved to treat HRS, with greater benefit if treatment is initiated when serum creatinine (SCr) is < 5 mg/dL; patients (pts) with ACLF grade 0–2 have a lower risk of respiratory failure. In pts with AH complicated by HRS, terli is associated with a greater rate of HRS reversal versus placebo (pbo). This post hoc analysis of the pbo-controlled CONFIRM study evaluated the efficacy of terli in the subgroup of pts with HRS, ACLF grade 0–2 and SCr < 5 mg/dL, excluding any pts with contraindications or warnings (i.e., ACLF grade 3 or SCr >5 mg/dL) as listed in the US prescribing information (USPI). Methods: The incidence of verified HRS reversal—defined as 2 consecutive SCr values ≤1.5 mg/dL at least 2 hours apart while on treatment and alive without RRT for at least 10 days—and HRS reversal—defined as SCr ≤1.5 mg/dL while on treatment, overall survival up to 90 days, and renal replacement therapy (RRT)-free survival up to Day 90 were assessed. Statistical analyses were performed using a Cochran-Mantel-Haenszel test or a 2-sample log-rank test to compare treatment arms. Results: From the CONFIRM intent-to-treat population (N=300), 117 pts had HRS associated with AH, ACLF grade 0–2, and SCr < 5 mg/dL (terli n=78; pbo n=39). Baseline demographics were comparable across treatment arms. The incidence of verified HRS reversal was significantly higher in pts treated with terli (25/78 [32%]) versus pbo (3/39 [8%], P=0.004), as was the incidence of HRS reversal (terli: 29/78 [37%] vs pbo: 4/39 [10.3%], P=0.002). Overall survival up to 90 days was similar between the terli and pbo arms (log rank P=0.450). The number of pts alive at Day 90 was also similar (37/78 [47%] vs 18/39 [46%]. RRT-free survival was numerically longer in the terli arm compared with pbo (median RRT-free survival: 21 days vs 12 days, log rank P=0.110). Conclusions: In CONFIRM, the largest prospective pbo-controlled study of terli to date, pts with AH and HRS, who met the current USPI criteria (i.e., ACLF grade 0–2 and SCr < 5 mg/dL) had a significantly better response rate than pbo, highlighting the utility of terli in reversing acute kidney injury in pts with AH.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| 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) | 0.004 | 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 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".