A176 SOFOSBUVIR/VELPATASVIR-BASED REGIMENS ARE ASSOCIATED WITH EXCELLENT EFFICACY AND A SIGNIFICANT IMPROVEMENT OF PATIENTS-REPORTED OUTCOMES ACROSS PATIENT POPULATIONS: FROM NON-CIRRHOTICS TO COMPENSATED CIRRHOTICS TO DECOMPENSATED CIRRHOTICS
Bibliographic record
Abstract
Our aim was to assess the impact SOF/VEL±ribavirin (RBV) on patient-reported outcomes (PROs) in HCV patients with and without decompensated cirrhosis. Four PRO questionnaires (SF-36, CLDQ-HCV, FACIT-F, WPAI:HCV) were collected in 4 phase 3 trials of SOF/VEL (ASTRAL-1,2, 3 and 4). The baseline PROs and treatment-emergent changes in PROs were compared among 3 groups (no cirrhosis, compensated cirrhosis, decompensated cirrhosis) while receiving +/- RBV-containing regimens. 1,701 patients received SOF/VEL or SOF/VEL+RBV or SOF+RBV for 12 or 24 weeks: 1,112 without cirrhosis, 338 with compensated cirrhosis, 251 with decomp cirrhosis; 488 received RBV-containing regimens [SOF+RBV (N=401) and SOF/VEL+RBV (N=87)] and 1,213 received RBV-free SOF/VEL. Decomp cirrhotics were older, more commonly male and less treatment-naive, and had more pre-treatment depression, anxiety, type 2 diabetes, fatigue and insomnia (all p<0.002). SVR-12 was 84.7% (SOF/VEL in decomp cirrhosis, all GTs), 98.5% (SOF/VEL non-cirrhotics, all GTs), 66.3% (SOF+RBV in GT3 cirrhotics), 94.7% (SOF+RBV in non-GT3 cirrhotics) and 94.3% (SOF/VEL+RBV in decomp cirrhotics, all GTs). Cirrhotic patients had significantly lower baseline PRO scores (up to -33.5 points on a universal 0–100 PRO scale in patients with decomp cirrhosis in comparison to patients without cirrhosis; p<0.05 for all but three PRO domains). By the end of treatment with RBV+ regimens, changes in PROs were similar across 3 groups (all p>0.01) and included moderate improvements in some PROs (up to +11.8, p<0.05 for 8/26 PRO scores) and moderate decrements in others (up to -7.1, p<0.05 for 6 mental health-related PRO scores). After treatment cessation, improvements from baseline (up to +12.6 points by post-treatment week 4, up to +14.2 by week 12, +17.1 by week 24) were again similar in all patients regardless of cirrhosis status (all p>0.01). By SVR-12 follow-up, PRO improvements were sustained in patients with decompensated cirrhosis: average across PROs +5.8 vs. +4.1 in compensated cirrhosis or no cirrhosis, p<0.05 for 7/26 PROs. In multivariate analysis, compensated cirrhosis was associated with additional +2.3 to +5.0 points improvement of treatment-emergent PRO (all p<0.05), decompensated cirrhosis – with +5.5 to 9.1 points (all p<0.002) in SOF/VEL regimen. HCV patients with decompensated cirrhosis experience the greatest improvement of their PRO scores during treatment with SOF/VEL regimen. SVR is associated with significant improvements in PROs, especially in patients with decompensated cirrhosis. Gilead Sciences, Inc.
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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 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".