Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts
Bibliographic record
Abstract
Abstract Chronic hepatitis C virus (HCV) infection has the greatest health impact in patients with advanced liver disease. The direct‐acting antiviral (DAA) regimen glecaprevir/pibrentasvir (G/P) is approved for treatment of HCV‐infected patients without cirrhosis and with compensated cirrhosis. However, events of liver decompensation/failure have been reported in patients treated with protease‐inhibitor–containing DAA regimens, often in patients with advanced liver disease. This study examines the safety of on‐label G/P treatment in patients with compensated cirrhosis (F4 at baseline) with markers of advanced liver disease. Patients with cirrhosis were categorized into 4 subgroups, based on different noninvasive markers of advanced liver disease identified using laboratory measures: platelet count < or ≥ 100 × 10 9 /L, and Child‐Pugh score 5 or 6. Separate analyses were performed using pooled data from clinical trials and from real‐world post‐marketing observational studies. G/P was well tolerated in patients with platelet count ≥100 × 10 9 /L ( n = 800), platelet count <100 × 10 9 /L ( n = 215), a Child‐Pugh score of 5 ( n = 915) and a Child‐Pugh score of 6 ( n = 95). In the clinical trial and real‐world cohorts two patients and no patients experienced a serious adverse event (AE) possibly related to study drug, respectively; three patients and no patients experienced an AE of special interest for hepatic decompensation and hepatic failure. This analysis reaffirms G/P's safety profile in indicated patients with compensated cirrhosis, including those with markers of more advanced liver disease. Increasing the number of patients treated with short‐duration G/P therapy may contribute to meeting HCV elimination targets.
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".