Time to Viral Suppression Does Not Impact SVR in Patients Treated With Glecaprevir/Pibrentasvir for 8 Weeks
Bibliographic record
Abstract
Introduction: The pangenotypic direct-acting antivirals (DAAs) glecaprevir (developed by AbbVie and Enanta) coformulated with pibrentasvir (G/P) are approved as an 8-week regimen to treat chronic HCV infection for all six major genotypes (GT). An integrated analysis of patients treated with G/P for 8 weeks was performed to investigate factors impacting time to viral suppression, and whether lack of viral suppression by treatment week 4 was predictive of relapse. Methods: Data were pooled from five phase 2 or 3 clinical studies, and included patients with HCV GT 1-6 infection without cirrhosis who were either treatment naïve or experienced with IFN or pegIFN with or without ribavirin (RBV) or sofosbuvir and RBV with or without pegIFN. G/P (300 mg/120 mg) was orally dosed once-daily for 8 weeks. Patients lost to follow up or with missing SVR12 data (N = 13) were excluded from the analysis since the impact of viral suppression (HCV RNA below lower limit of quantification [LLOQ]) on response cannot be assessed in these patients. Two patients with on-treatment virologic failure were excluded since we sought to determine whether detectable HCV RNA at treatment week 4 was predictive of relapse. Results: The analysis included 950 patients; 63 (7%) were black, 171 (18%) had BMI ≥30, and 24% had baseline HCV RNA ≥6 million. The majority of patients were white, male, and HCV treatment-naïve. Among 942 patients with data, 906 (96%) had HCV RNA LLOQ at treatment week 4 (median baseline HCV RNA 6.7 log10IU/mL; range 5.2-7.6 log10 IU/mL), 100% (95% CI 90.4-100.0) achieved SVR12. Conclusion: In patients treated with G/P for 8 weeks,failure to suppress HCV RNA by treatment week 4 was not predictive of treatment outcome, suggesting that treatment extension in patients eligible for 8-week regimens based on this milestone is not warranted. Data will also be presented for patients with compensated cirrhosis treated with 12 or 16 weeks of G/P.1005 Figure 1 No Caption available.
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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".