Patients Followed in an Addiction Medicine Clinic Are Less Likely to Be Eligible to Hepatitis C Drug Studies Regardless of Drug Use
Bibliographic record
Abstract
Phase 3 trials evaluating direct-acting antivirals (DAA) consistently report high sustained virologic responses (SVR). The strict eligibility criteria applied to these studies may affect the reproducibility in clinical practice. It has been demonstrated that drug use generally does not affect SVR. This retrospective cohort study sought to estimate the proportion of patients followed in a tertiary addiction clinic that would meet eligibility criteria for clinical trials, if drug use was not considered as a rejection criteria. The sample population consists of patients with active HCV genotypes (GT) 1-3, seen at the clinic between 01/2013 and 09/2015. Information from clinical charts was retrieved to examine how participants would meet the eligibility criteria of 14 studies. Individual patient’s data were compared with the studies’ eligibility criteria. A total of 234 patients met the inclusion criteria (GT 1: 58.1%; GT 2: 8.5%, GT 3: 34.2%; experienced: 16.2%; cirrhotic: 14.5%) and 53% (124/234) of patients could have been included in at least one study. Table shows individual study results. The most inclusive study was COSMOS (31/49; 63%). The most frequent exclusion criteria were the presence of significant diseases (cardiac, pulmonary, hepatic, porphyria or other), contraindicated medication and haemoglobin level. Even without considering drug use, only half of the patients of the addiction clinic would have been eligible for at least one study. This under-representation stems from strict eligibility criteria that promote a healthier population. Our study suggests that the DAA might prove less effective when administered to infected populations followed in specialized clinics for drug. J. Bruneau, Gilead: Consultant, Consulting fee. Merck: Consultant, Consulting fee. V. Martel-Laferrière, Gilead Inc.: Consultant and Grant Investigator, Consulting fee and Research grant. Abbvie: Grant Investigator, Research grant Merck: Consultant, Consulting fee
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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 | 0.001 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.008 | 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 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".