S1419 The Effect of Race on Treatment Response to Terlipressin in Patients with Hepatorenal Syndrome: A Pooled Analysis of 3 Phase III Clinical Studies
Bibliographic record
Abstract
Introduction: Owing to its ability to reverse hepatorenal syndrome (HRS)—a form of acute kidney injury—terlipressin is recommended (in combination with albumin) as a first-line therapy for adult patients with HRS. The efficacy and safety of terlipressin treatment for patients with HRS has been examined in 3 placebo-controlled North American Phase III clinical studies. Notably, across these clinical studies, most patients were White. Therefore, this study used a pooled dataset of patients with HRS to examine whether there is any impact of race (White vs non-White) on treatment response to terlipressin. Methods: The pooled intent-to-treat dataset included data from 3 clinical studies (ie, OT-0401, REVERSE, and CONFIRM) that examined terlipressin treatment in adult patients with HRS, defined as a rapidly progressive worsening of kidney function to a serum creatine (SCr) ≥ 2.25 mg/dL (CONFIRM) or ≥ 2.5 mg/dL (OT-0401 and REVERSE). HRS reversal, defined as the proportion of patients achieving a SCr level of ≤ 1.5 mg/dL while on treatment, including up to 24 hours after the last dose of study drug, was examined by race (ie, White vs non-White). Race was assessed for the potential to predict treatment response (ie, HRS reversal) by univariate logistic regression analysis. Results: These 3 clinical studies were conducted at large tertiary centers in the US and Canada and enrolled 608 patients in total. Most patients evaluable for the race group (n = 603) were White (terlipressin, 313/348 [89.9%]; placebo, 235/255 [92.2%]). Among White patients (n = 548), more patients achieved HRS reversal with terlipressin than with placebo (34.5% vs 17.0%; P < .001). Similarly, among non-White patients (n = 55), more patients achieved HRS reversal with terlipressin (22.9%) than with placebo (10.0%); however, statistical significance was not reached (P = .297) (Table 1). Race (White vs non-White) was not significantly associated with HRS reversal (odds ratio [95% CI]: terlipressin, 1.778 [0.781 – 4.048], P = .170; placebo, 1.846 [0.412 – 8.273], P = .423). Conclusion: Race was not significantly associated with the odds of achieving HRS reversal for patients in the terlipressin group. Therefore, race is unlikely to influence the clinical response to terlipressin treatment among patients with HRS. Table 1. - Incidence of HRS reversal by race HRS reversal, n/N (%) Terlipressin Placebo P valuea White 108/313 (34.5) 40/235 (17.0) <.001 Non-White 8/35 (22.9) 2/20 (10.0) .297 aFrom a Chi-square/Fisher’s exact test. HRS, hepatorenal syndrome.
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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) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| 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".