Bibliographic record
Abstract
Background: Cenicriviroc (CVC), an oral chemokine receptor CCR2/5 antagonist, has potent anti-inflammatory and antifibrotic activity in animal models of acute and chronic liver diseases.Its efficacy and safety as a treatment for non-alcoholic steatohepatitis (NASH) and liver fibrosis are being evaluated in adults at increased risk of progression to cirrhosis (CEN-TAUR; NCT02217475).Methods: Phase 2b, randomized, double-blind, placebo-controlled, ongoing 2-year multinational study; primary analysis at Year 1. Subjects with histologically defined NASH, a non-alcoholic fatty liver disease activity score (NAS) ≥4, liver fibrosis (stages 1-3 NASH CRN), and diabetes or metabolic syndrome (MetS) were randomized to CVC 150 mg QD or placebo.NAS, resolution of steatohepatitis, and fibrosis stage were assessed on Year 1 liver biopsies.Markers of systemic inflammation, treatment-emergent adverse events (TEAEs), and laboratory abnormalities were evaluated.Results: 289 subjects were randomized: 53% female; 52% diabetes; 72% MetS; 74% NAS ≥5; 67% fibrosis stage 2-3.Mean BMI (SD) was 34 kg/m 2 (6.5).A similar proportion in each group achieved the NAS and resolution of steatohepatitis endpoints (Table).Improvement in fibrosis by ≥1 stage and no worsening of steatohepatitis was obtained in significantly more CVC-treated subjects than placebo overall (p=0.023) and in subgroups with histologically advanced disease char-acteristics.Improvement in fibrosis by 2 stages was observed in 11 subjects (8 CVC; 3 placebo).Seven subjects progressed to cirrhosis (2 CVC; 5 placebo).IL-6, hs-CRP, and fibrinogen levels were significantly decreased with CVC vs. placebo.Drug-related, clinical TEAEs of Grade ≥2 severity occurring in ≥2% of subjects were fatigue (2.8%) and diarrhea (2.1%) for CVC; headache (3.5%) for placebo.There were no differences in laboratory abnormalities or premature discontinuations between CVC and placebo.Conclusions: In the ITT population, CVC was well tolerated and resulted in twice as many subjects achieving ≥1 stage improvement in fibrosis and no worsening of steatohepatitis vs. placebo, after only 1 year of treatment.Importantly, greater treatment benefits were observed in subjects with higher disease activity and stage.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.014 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.009 | 0.004 |
| Open science | 0.002 | 0.004 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.848 | 0.759 |
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".