Evidence map›Paper›PMID 26991780›Full record

ArticlePloS one2016

A Predictive Model for Selecting Patients with HCV Genotype 3 Chronic Infection with a High Probability of Sustained Virological Response to Peginterferon Alfa-2a/Ribavirin.

Tarik Asselah, Alex J Thompson, Robert Flisiak, Manuel Romero-Gomez, Diethelm Messinger, Georgios Bakalos, Mitchell L Shiffman

Abstract readValidation Study
In one paragraph

Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Tarik AsselahCentre de Recherche sur l'Inflammation (CRI), UMR 1149 Inserm, Université Paris Diderot, Service d'Hépatologie, AP-HP Hôpital Beaujon, Paris, France.
Alex J ThompsonDepartment of Gastroenterology, St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.
Robert FlisiakDepartment of Infectious Diseases and Hepatology, Medical University of Białystok, 15-540, Białystok, Poland.
Manuel Romero-GomezUCM Digestive Diseases and CIBERehd, Valme University Hospital, University of Seville, Seville, Spain.
Diethelm MessingerBiostatistics, PROMETRIS GmbH, 68219, Mannheim, Germany.
Georgios BakalosGlobal Product Development Medical Affairs, F. Hoffmann-La Roche Ltd, 4074, Basel, Switzerland.
Mitchell L ShiffmanLiver Institute of Virginia, Bon Secours Health System, Richmond and Newport News, Richmond, VA, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccess to direct-acting antiviral agents (DAAs) is restricted in some settings; thus, the European Association for the Study of the Liver recommends dual peginterferon/ribavirin (PegIFN/RBV) therapy wherever DAAs are unavailable. HCV genotype (GT) 3 infection is now the most difficult genotype to eradicate and PegIFN/RBV remains an effective option. The goal of this study was to devise a simple predictive score to identify GT3 patients with a high probability of achieving a sustained virologic response (SVR) with PegIFN alfa-2a/RBV therapy.

methodsRelationships between baseline characteristics and SVR were explored by multiple logistic regression models and used to develop a simple scoring system to predict SVR using data from 1239 treatment-naive GT3 patients who received PegIFN alfa-2a/RBV for 24 weeks in two large observational cohort studies.

resultsThe score was validated using a database of 473 patients. Scores were assigned for six factors as follows: age (years) (≤40: 2 points; >40 but ≤55: 1); bodyweight (kg) (<70: 2; ≥70 but <90: 1); no cirrhosis/transition to cirrhosis (2); ALT ≤2.5 x ULN (1); platelets (109/L) (>200: 2; ≥100 but <200: 1); HCV RNA (<400,000 IU/mL: 1). The points are summed to arrive at a score ranging from 0‒10 where higher scores indicate higher chances of SVR; 141, 123, 203, 249, 232, and 218 patients had total scores of 0‒4, 5, 6, 7, 8, and 9-10, respectively, among whom SVR rates were 45%, 62%, 72%, 76%, 84%, and 89%. Among 622 patients who had scores of 6‒10 and HCV RNA <50 IU/mL by treatment week 4 the SVR rate was 86% (532/622).

conclusionsA simple baseline scoring system involving age, bodyweight, cirrhosis status, ALT level, platelet count and HCV RNA level can be used to identify treatment-naive Caucasian patients with HCV GT3 infection with a high probability of SVR with PegIFN alfa-2a/RBV therapy.

Indexed as

GenotypeModels, TheoreticalAdolescentAdultAgedAntiviral AgentsFemaleHepacivirusHepatitis C, ChronicHumansInterferon-alphaMaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsRetrospective StudiesAntiviral AgentsInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirin

Identifiers

PMID26991780
PMCPMC4798721

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.