A189 TREATMENT OF CHORNIC HEPATITIS C GENOTYPE 1 IN CANADA: REAL WORLD EXPERIENCE WITH OMBITASVIR/PARITAPREVIR/R AND DASABUVIR WITH OR WITHOUT RIBAVIRIN
Bibliographic record
Abstract
The 3-direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir + dasabuvir (3D) +/- ribavirin (RBV) has been shown to be safe and effective for the treatment of chronic hepatitis C (CHC) in randomized controlled trials. However, data on real world treatment experience is limited. In Canada, the 3D regimen is approved to treat patients with CHC genotype (GT) 1 including compensated cirrhosis. The aim of this non-interventional study is to provide evidence of the effectiveness of the 3D regimen in a real world setting across broader clinical practice patient populations. The Canadian AMBER study is an ongoing, prospective, multi-center, observational cohort study aiming at enrolling 600 treatment-naïve and -experienced GT1 patients with and without compensated cirrhosis. The treatment course was at the discretion of the treating physician, according to the standard of care of the institution. All patients who started therapy from October 2015 up to March 31st, 2016 and for whom a treatment duration of 12 weeks was intended were included in this interim analysis. Effectiveness was defined as having achieved sustained virological response 12 weeks post-treatment (SVR12). The inclusion criteria for this analysis were met by 115 patients. Demographics: 70% male, mean age 55 (SD 10.7), 81% Caucasian, 7% Asian. Disease characteristics: Mode of HCV infection was i.v. drug use in 41%, blood transfusion in 17%, contaminated medical device in 6% and unknown in 28% of patients; GT1a 54%, GT1b 43%, GT1 subtype unknown 3%; 12% had failed previous therapy; 23% had cirrhosis, 8% transition to cirrhosis, Child Pugh B was present in 2 patients. Treatment: 74 (64%) patients had RBV added to their 12 week 3D regimen (96% of GT1a), 41 (36%) patients did not receive RBV (78% of GT1b). See table for co-morbidities. The data from this study may aid in better describing the medical profile of patients seeking care for CHC in real world. In contrast to development trials a broader population including patients with psychoactive substance dependency was enrolled. The effectiveness of new interferon-free regimens in such subpopulations is of particular interest. SVR12 data will be detailed in the poster. Patients (total n=115) with co-morbidities (n/%) Abbvie corporation
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.002 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 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 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".