Evidence map›Paper›PMID 26239732›Full record

ArticleBMC gastroenterology2015

Early virological response may predict treatment response in sofosbuvir-based combination therapy of chronic hepatitis c in a multi-center "real-life" cohort.

Niels Steinebrunner, Martin F Sprinzl, Tim Zimmermann, Marcus A Wörns, Thomas Zimmerer, Peter R Galle, Wolfgang Stremmel, Christoph Eisenbach, Kerstin Stein, Christoph Antoni and 2 more

Abstract readMulticenter Study
In one paragraph

Article in BMC gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. KASL clinical practice guidelines: management of hepatitis C.Clinical and molecular hepatology · 2016
    Guideline
  3. Trial
  4. Efficacy and safety of sofosbuvir-based therapy for chronic hepatitis C infection in "real-life" cohort.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2016
    Trial
  5. Article
  6. 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

12 authors.

Niels SteinebrunnerDepartment of Internal Medicine IV, University Hospital Heidelberg, Heidelberg, Germany. niels.steinebrunner@med.uni-heidelberg.de.
Martin F SprinzlDepartment of Internal Medicine I and Cirrhosis Center Mainz (CCM), University Medical Center Mainz, Mainz, Germany. martin.sprinzl@unimedizin-mainz.de.
Tim ZimmermannDepartment of Internal Medicine I and Cirrhosis Center Mainz (CCM), University Medical Center Mainz, Mainz, Germany. tim.zimmermann@unimedizin-mainz.de.
Marcus A WörnsDepartment of Internal Medicine I and Cirrhosis Center Mainz (CCM), University Medical Center Mainz, Mainz, Germany. marcus-alexander.woerns@unimedizin-mainz.de.
Thomas ZimmererDepartment of Internal Medicine II, University Hospital Mannheim, Mannheim, Germany. thomas.zimmerer@umm.de.
Peter R GalleDepartment of Internal Medicine I and Cirrhosis Center Mainz (CCM), University Medical Center Mainz, Mainz, Germany. peter.galle@unimedizin-mainz.de.
Wolfgang StremmelDepartment of Internal Medicine IV, University Hospital Heidelberg, Heidelberg, Germany. wolfgang.stremmel@med.uni-heidelberg.de.
Christoph EisenbachDepartment of Internal Medicine IV, University Hospital Heidelberg, Heidelberg, Germany. christoph.eisenbach@med.uni-heidelberg.de.
Kerstin SteinDepartment of Gastroenterology, Hepatology and Infectious Diseases, University Hospital of Magdeburg, Magdeburg, Germany. kerstin.stein@med.ovgu.de.
Christoph AntoniDepartment of Internal Medicine II, University Hospital Mannheim, Mannheim, Germany. christoph.antoni@umm.de.
Jörn M SchattenbergDepartment of Internal Medicine I and Cirrhosis Center Mainz (CCM), University Medical Center Mainz, Mainz, Germany. joern.schattenberg@unimedizin-mainz.de.
Anita PathilDepartment of Internal Medicine IV, University Hospital Heidelberg, Heidelberg, Germany. anita.pathil-warth@med.uni-heidelberg.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe combination of sofosbuvir (SOF), ribavirin (RBV) and peg-interferon-alfa-2a (peg-IFN-alfa-2a) as well as the combination of SOF and RBV for the treatment of patients infected with hepatitis c virus (HCV) has improved rates of sustained virological response (SVR) considerably in recent trials. However, there is only limited data concerning the efficacy and safety in a "real-life" cohort.

methodsWe analyzed a cohort of 119 patients with chronic HCV infection treated at four investigational sites in Germany. All patients received either a combination treatment of SOF, RBV and peg-IFN-alfa-2a or SOF and RBV.

resultsThe rates of SVR at 12 weeks after end of treatment (SVR 12) were as follows: Among 76 patients with genotype 1 infection the SVR 12 rate was 74% (n = 56), among 14 patients with genotype 2 infection the SVR 12 rate was 79% (n = 11), among 24 patients with genotype 3 infection the SVR 12 rate was 92% (n = 22) and among 5 patients with genotype 4 infection the SVR 12 rate was 80% (n = 4). Of all 26 patients with a relapse in our cohort, 69% (n = 18) of these patients presented with liver cirrhosis and 58% (n = 15) were treatment experienced. Notably, the level of HCV-RNA after 4 weeks of treatment was a significant predictor of treatment response in genotype 1 patients. Patients with HCV-RNA levels ≥ 12 IU ml-1 after 4 weeks of treatment achieved SVR 12 only in 30% (n = 17/56, p < 0.0001) of cases and treatment response was even lower with SVR 12 of 25% (n = 5/20, p = 0.0016) in the subgroup of patients with cirrhosis.

conclusionWe observed a high rate of SVR 12 with SOF-based treatment regimes, however probably due to the high number of patients with liver cirrhosis and prior treatment experience, treatment response rates were lower than in previously published trials. In genotype 1 patients the analysis of early virological response may predict treatment response in SOF-based combination therapies.

Indexed as

AdultAgedAntiviral AgentsDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHumansInterferon-alphaLiver CirrhosisLongitudinal StudiesMaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsRetreatmentAntiviral AgentsInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinRNA, ViralSofosbuvir

Identifiers

PMID26239732
PMCPMC4523924

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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.