IDDF2019-ABS-0211 Efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 5 or 6 infection: an integrated analysis of phase 2 and 3 studies
Bibliographic record
Abstract
Background The pangenotypic direct-acting antivirals (DAAs) glecaprevir (identified by AbbVie and Enanta) coformulated with pibrentasvir (G/P) are approved for the treatment of chronic HCV genotype (GT) 1–6 infection. However, the efficacy and safety data of G/P are limited in patients infected with HCV GT5 and GT6. Methods The data analysis integrated data from 10 Phase 2b, 3a (registrational) and 3b (post-registrational) studies. The patient population comprised adults with chronic HCV GT5 or GT6 infection and compensated liver disease (with or without cirrhosis) who were treatment-naïve or experienced with regimens containing interferon (IFN) or pegylated IFN (pegIFN) ± ribavirin or sofosbuvir + ribavirin ± pegIFN. Patients received 8 or 12 weeks of G/P (300 mg/120 mg) depending on the design of the original study. Efficacy was evaluated as the rate of sustained virologic response (SVR) at post-treatment week (PTW) 12 (SVR12). HCV subtype was identified by phylogenetic analysis. Results Data from 181 patients were included in this integrated analysis, including 56 (30.9%) with HCV GT5 and 125 (69.1%) with HCV GT6 infection. Overall, 102 (56.4%) patients were treated for 8 weeks and 79 (43.6%) for 12 weeks, irrespective of the presence of cirrhosis. Most patients were male (54.1%), Asian (64.6%), < 65 years of age (72.4%), treatment-naïve (87.8%), with F0-F1 fibrosis (68%), and non-cirrhotic (non-F4, 84.5%). Overall, 1% (1/102) of patients on 8-week treatment and no (0/76) patient on 12-week treatment experienced a relapse. SVR12 rates by cirrhosis status and treatment duration are shown in (Abstract IDDF2019-ABS-0211 Figure 1). Treatment-emergent adverse events (AEs) were mostly mild or moderate in severity (175/181, 96.7%). Most common AEs in at least 10% of patients were fatigue (29/181, 16%) and headache (27/181, 14.9%). Conclusions HCV GT5- and GT6-infected patients without cirrhosis or with compensated cirrhosis treated with G/P for 8 or 12 weeks achieved high rates of SVR12. There were no added efficacy benefits when treatment was extended from 8 to 12 weeks, even in patients with compensated cirrhosis. The G/P regimen was well-tolerated.
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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 | 0.009 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| 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".