P-11 REAL-WORLD DATA WITH PANGENOTYPIC DIRECT-ACTING ANTIVIRALS IN LATINAMERICA: PRELIMINARY RESULTS OF THE SVR10K STUDY
Bibliographic record
Abstract
Conflict of interest: Yes, Gilead-sponsored research Introduction and Objectives: A previous real-world data (RWD) analysis demonstrated high effectiveness of sofosbuvir/velpatasvir (SOF/VEL) without ribavirin in > 6,000 HCV patients from 12 clinical cohorts across Australia, Canada, Europe & USA. Expand this research initiative with the ongoing SVR10K study, to include even more patients from additional geographical areas, which will allow to show SOF/VEL effectiveness across multiple diverse populations, including Latin-American (LATAM) region. Patients / Materials and Methods: This RWD analysis includes patients ≥ 18 years treated with SOF/VEL without RBV for 12 weeks, as decided by the treating HCP, from 13 sites across Brazil, Colombia, Hong Kong, Mexico, Singapore, Sweden, Spain, Taiwan, and the United Arab Emirates. Age, sex, treatment experienced (TE), cirrhosis stage (no decompensated included), genotype, coinfections, time to treatment initiation (TTI) from HCV diagnosis, and SVR were analyzed for LATAM region. Results and Discussion: Overall, 7,027 patients have been included up to now, 13% (n=890) of them from four sites in the LATAM region (Table). There, median age was 54.5 [IQR 43.2-63.5], where males 51%, and age > 50 years in 62%. Genotype 3 was present in 14%, cirrhotic (CC) 34%, TE 8%, while HIV, HBV and HDV coinfection was reported in 7.2%, 0.3%, and 0.0%, respectively. The TTI was available in 94%, with 28% having ≤30 days (In Brazil 57%). In terms of effectiveness, SVR was achieved in 99.6% of the treated population (n=788); being 98.2% in GT3 patients (n=112), 99.6% in CC patients (n=279), and 97.4% in GT3 CC patients (n=38). Conclusions: Results on treatment effectiveness in LATAM region did not differ from RWD studies of patients in the North-Western countries, reinforcing that HCV treatment guidelines are globally applicable, and supporting the efficacy of panfibrotic, pangenotypic, and pangeographic DAA therapy. Although with positive signs, there is still a significant room for improvement in the time to treatment initiation in the LATAM region.
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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 | 0.005 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".