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GARNET: High SVR Rates Following Eight-Week Treatment with Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir for Patients with HCV Genotype 1b Infection

2016· article· en· W2978270911 on OpenAlexaff
Tania M. Welzel, Stefan Zeuzem, Emily O. Dumas, Tarik Asselah, David Shaw, Rawi Hazzan, Xavier Forns, Wenjing Lü, Daniel E. Cohen, Jordan J. Feld

Bibliographic record

VenueThe American Journal of Gastroenterology · 2016
Typearticle
Languageen
FieldMedicine
TopicHepatitis C virus research
Canadian institutionsToronto Liver CentreUniversity of Toronto
Fundersnot available
KeywordsOmbitasvirDasabuvirParitaprevirMedicineRitonavirRibavirinInternal medicineHepatitis CRegimenGastroenterologyHepatitis C virusVirologyViral loadVirus

Abstract

fetched live from OpenAlex

Introduction: Ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-administered with ritonavir, and dasabuvir comprise the 3 direct-acting antiviral (DAA; 3D) regimen OBV/PTV/r + DSV approved for hepatitis C virus (HCV) genotype (GT) 1 infection. Previous data reported high rates of sustained virologic response (HCV RNA <LLOQ; SVR) at post-treatment week 12 (PTW12; SVR12) following 8 and 12 weeks of 3D treatment with and without ribavirin (RBV), respectively. This is the first study evaluating an 8-week treatment duration of 3D without RBV in HCV GT1b-infected patients without cirrhosis. Methods: GARNET is a multicenter, open-label, single-arm study investigating the safety and efficacy of an 8-week treatment duration of once-daily OBV/PTV/r (25/150/100 mg) + twice-daily DSV (250 mg) in treatment-naive patients with chronic HCV GT1b infection without cirrhosis. Safety and available rates of HCV RNA <LLOQ at end of treatment (EOT) and at PTW4 (SVR4) are reported. Results: The study enrolled166 patients across 20 sites. Select baseline demographics, safety, and laboratory abnormalities are presented in Table 1. To date, 164/166 (99%) patients with available data had HCV RNA <LLOQ at EOT or a subsequent visit. Of the 70 patients that have reached PTW4, 100% achieved SVR4. Two patients did not achieve HCV RNA

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 imitation

Not 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.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.001
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Non-randomized trial · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.002
Threshold uncertainty score0.007

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0010.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.001
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0020.000

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.

Opus teacher head0.015
GPT teacher head0.285
Teacher spread0.270 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNon-randomized trial
Domainnot available
GenreEmpirical

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".

Quick stats

Citations3
Published2016
Admission routes1
Has abstractyes

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