A172 C-EDGE CO-STAR: RISK OF REINFECTION FOLLOWING SUCCESSFUL THERAPY WITH ELBASVIR (EBR) AND GRAZOPREVIR (GZR) IN PERSONS WHO INJECT DRUGS (PWID) RECEIVING OPIOD AGONIST THERAPY (OAT)
Bibliographic record
Abstract
The fixed-dose combination of EBR 50 mg, an NS5A inhibitor, and GZR 100 mg, an NS3/4 protease inhibitor (EBR/GZR), is a highly effective and well-tolerated all-oral, once-daily regimen in diverse populations of hepatitis C virus (HCV) genotype (GT)1-, 4-, or 6-infected patients, including PWID on OAT. However, data on HCV reinfection rates after successful treatment are limited. To determing the rate of reinfections following sucessful HCV therapy with EBR and GZR in PWID receiving OAT The double-blind, placebo-controlled CO-STAR study evaluated the efficacy of EBR/GZR for 12 weeks in treatment-naïve HCV GT1-/4-/6-infected patients receiving OAT. Patients were randomized 2:1 to an immediate treatment group (ITG) or a deferred treatment group. HCV reinfection was evaluated among ITG patients with undetectable HCV RNA at end of treatment (EOT). In patients with recurrent viremia following EOT, population sequencing and phylogenetic analysis were performed on baseline and post-treatment samples to distinguish relapse from reinfection. Three hundred one patients were randomized, with 201 in the ITG (76% GT1a; 20% cirrhotic; 8% HIV+). Baseline OAT included methadone (81%) and buprenorphine (19%), and 46% had detectable illicit drugs, excluding marijuana. Post-treatment viremia was detected in 18 patients, with 12 virologic failures and 6 probable reinfections (5 through follow-up week (FW)12 and 1 at FW24). Three patients identified as reinfections had subsequent clearance of HCV RNA. Estimated reinfection incidence per 100 person-years from EOT through FW12 is 10.5 (95% CI: 3.42, 24.6), and from EOT through FW24 is 3.4 (95% CI: 1.3,7.5). Follow-up analysis to determine if any probable reinfections were due to relapse of nondominant baseline variants rather than reinfection will be presented. Several HCV reinfection cases were detected among PWID on OAT following successful EBR/GZR therapy. Further follow-up is required to determine the natural course of HCV reinfection in the setting of interferon-free HCV treatment and the impact of viral persistence following reinfection on long-term response rates in this population. Merck Pharmaceuticals
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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 | 0.002 | 0.001 |
| 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 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 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".