Evidence map›Paper›PMID 25238535›Full record

Trial reportPloS one2014

Predictive factors for sustained virological response after treatment with pegylated interferon α-2a and ribavirin in patients infected with HCV genotypes 2 and 3.

Claus Niederau, Stefan Mauss, Andreas Schober, Albrecht Stoehr, Tim Zimmermann, Michael Waizmann, Gero Moog, Stefan Pape, Bernd Weber, Konrad Isernhagen and 5 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02106156 (Noninterventional Study on the Quality Assurance of the Therapy of Chronic Hepatitis C With Peg-), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT02106156 completednot on this map

Noninterventional Study on the Quality Assurance of the Therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa-2a (Pegasys®) and Ribavirin (e.g. Copegus®) With Main Focus Gastroenterologists - a Project in BNG (Association of German Resident Gastroenterologists), Part III

TypeobservationalSponsorHoffmann-La RocheRan2008 to 2013Enrolled10,228ConditionsChronic Hepatitis CArmsPegylated interferon alfa-2a, Ribavirin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Observational
  2. Observational
  3. Article
  4. Observational
  5. Article
  6. Article
  7. Article
  8. Article
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

15 authors.

Claus NiederauClinic for Internal Medicine, St. Josef Hospital, Oberhausen, Germany.
Stefan MaussCenter for HIV and Hepatogastroenterology, Duesseldorf, Germany.
Andreas SchoberCenter of Gastroenterology, Goettingen, Germany.
Albrecht Stoehrifi-Institute for Interdisciplinary Medicine, Hamburg, Germany.
Tim Zimmermann1st Medical Clinic, Dept. Gastroenterology and Hepatology, Johannes Gutenberg University of Mainz, Mainz, Germany.
Michael WaizmannMedcenter Leipzig, Leipzig, Germany.
Gero MoogCenter of Gastroenterology, Kassel, Germany.
Stefan PapeCenter of Gastroenterology, Paderborn, Germany.
Bernd WeberCompetence Center for Addiction, Praxiszentrum Friedrichsplatz, Kassel, Germany.
Konrad IsernhagenPractice for general medicine, Koeln, Germany.
Petra SandowGeneral Practice, Berlin, Germany.
Bernd BokemeyerGastroenterology Practice, Minden, Germany.
Ulrich AlshuthVirology, Roche Pharma AG, Grenzach-Wyhlen, Germany.
Hermann SteffensPractice for internal Medicine, Berlin, Germany.
Dietrich HüppeCenter of Gastroenterology, Herne, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious trials have often defined genotype 2 and 3 patients as an "easy to treat" group and guidelines recommend similar management.

aimsThe present study looks for differences between the two genotypes and analyzes predictive factors for SVR.

methodsProspective, community-based cohort study involving 421 physicians throughout Germany. The analysis includes 2,347 patients with untreated chronic HCV genotype 2 (n = 391) and 3 (n = 1,956) infection treated with PEG-IFN α-2a plus ribavirin between August 2007 and July 2012.

resultsWhen compared with genotype 2 patients, those with genotype 3 were younger, had a shorter duration of infection, lower values of total cholesterol, LDL cholesterol and BMI, a higher frequency of drug use as infection mode and male gender (p<0.0001, respectively), and a higher APRI score (p<0.005). SVR was higher in genotype 2 when compared with genotype 3 (64.7% vs. 56.9%, p = 0.004). By multivariate analysis of genotype 2 patients, low baseline γ -GT and RVR predicted SVR. In genotype 3 age ≤45 years, cholesterol>130 mg/dl, a low APRI score, and a γ-GT ≥3-times ULN, RVR, and RBV starting dose were associated with SVR by multivariate analysis.

conclusionsThe present study corroborates that liver fibrosis is more pronounced in genotype 3 vs. 2. SVR is higher in genotype 2 versus genotype 3 partly because of follow-up problems in genotype 3 patients, in particular in those infected by drug use. Thus, subgroups of genotype 3 patients have adherence problems and need special attention also because they often have significant liver fibrosis.

trial registrationVerband Forschender Arzneimittelhersteller e.V., Berlin, Germany ML21645 ClinicalTrials.gov NCT02106156.

Indexed as

GenotypeAdultCohort StudiesFemaleGermanyHepacivirusHepatitis CHumansMaleMiddle Aged

Identifiers

PMID25238535
PMCPMC4169557

What OpenQuestion holds

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Registered trials

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.