Evidence map›Paper›PMID 24118693›Full record

Observational studyLiver international : official journal of the International Association for the Study of the Liver2014

Diabetes mellitus and advanced liver fibrosis are risk factors for severe anaemia during telaprevir-based triple therapy.

James F Crismale, Valérie Martel-Laferrière, Kian Bichoupan, Emily Schonfeld, Alexis Pappas, Christina Wyatt, Joseph A Odin, Lawrence U Liu, Thomas D Schiano, Ponni V Perumalswami and 3 more

Open access · greenAbstract readObservational Study
In one paragraph

Observational study in Liver international : official journal of the International Association for the Study of the Liver, 2014. 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
0.9field-weighted citation impact, top 26% of its field
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, 7 citations in OpenAlex.

  1. Predictors of early treatment discontinuation and severe anemia in a Brazilian cohort of hepatitis C patients treated with first-generation protease inhibitors.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2016
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 1 institution in 1 country.

James F CrismaleDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Valérie Martel-Laferrière
Kian Bichoupan
Emily Schonfeld
Alexis Pappas
Christina Wyatt
Joseph A Odin
Lawrence U Liu
Thomas D Schiano
Ponni V Perumalswami
Meena Bansal
Douglas T Dieterich
Andrea D Branch
Icahn School of Medicine at Mount Sinai · US

Funding

Optimizing Vitamin D Treatment in HIV/AIDS: An RCTR01DA031095 · NIDA · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BRANCH, ANDREA D., DIETERICH, DOUGLAS THOMAS · 2010 to 2014
$3.3M
Clinical Outcomes and the HCV Core GeneR01DK090317 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BRANCH, ANDREA D. · 2010 to 2014
$2.0M
NIDA NIH HHS DA031095NIDA NIH HHS R01 DA031095NIDDK NIH HHS DK090317NIDDK NIH HHS R01 DK090317
6 · The paper itself

Abstract

BACKGROUND &

aimsAdding telaprevir to pegylated-interferon and ribavirin increased both response rates and side effects of hepatitis C virus (HCV) treatment. We identified variables associated with severe anaemia during telaprevir-based triple therapy.

methodsAn observational study was performed on 142 HCV-infected patients between June 2011 and March 2012. All subjects completed 12 weeks of telaprevir-based triple therapy or discontinued early because of anaemia. Severe anaemia was defined by a haemoglobin≤8.9 g/dl; advanced fibrosis was determined by Fib-4≥3.25.

resultsThe 47 (33%) patients who developed severe anaemia were similar to those who did not in sex, race, and prior response to dual therapy, but they were more likely to have diabetes (23.4% vs. 6.3%, P<0.01), advanced fibrosis (46.8% vs. 29.5%, P=0.04) and a history of anaemia during previous dual therapy (29.7% vs. 11.4%, P=0.02). Patients developing severe anaemia were older (59 vs. 56 years, P=0.02), had lower baseline platelet counts (134 vs. 163×10(9) /L, P=0.04), haemoglobin (14.0 vs. 15.0 g/dl, P<0.01), estimated glomerular filtration rate (79 vs. 90 ml/min/1.73 m2, P=0.03) and a higher median ribavirin/weight ratio (14.9 vs. 13.2 mg/kg, P<0.01). In multivariable logistic regression, presence of diabetes (OR=5.61, 95% CI: 1.59-19.72), Fib-4≥3.25 (OR=3.09, 95% CI: 1.28-7.46), higher ribavirin/weight ratio (OR=1.31 per mg/kg, 95% CI: 1.13-1.52) and lower baseline haemoglobin (OR=0.57 per g/dl, 95% CI, 0.41-0.80) were independently associated with developing severe anaemia.

conclusionsSevere anaemia occurred in one-third of patients receiving telaprevir-based triple therapy. Risk was greater in patients with diabetes, advanced liver fibrosis, higher ribavirin/weight ratio and lower baseline haemoglobin.

Indexed as

AnemiaDiabetes Mellitus, Type 2Hepatitis CHumansInterferon-alphaLiver CirrhosisLogistic ModelsMultivariate AnalysisOdds RatioOligopeptidesPolyethylene GlycolsRecombinant ProteinsRibavirinRisk FactorsStatistics, NonparametricInterferon-alphaOligopeptidespeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirintelapreviranaemiadiabetes mellitushepatitis C viruspegylated-interferonribavirintelaprevirtriple therapy

Identifiers

PMID24118693
PMCPMC3972374
OpenAlexW1986480008

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.