Evidence map›Paper›PMID 25373453›Full record

ArticleDigestive diseases and sciences2015

Hepatic decompensation likely attributable to simeprevir in patients with advanced cirrhosis.

Jonathan G Stine, Nicolas Intagliata, Neeral L Shah, Curtis K Argo, Stephen H Caldwell, James H Lewis, Patrick G Northup

Open access · greenAbstract readCase Reports
In one paragraph

Article in Digestive diseases and sciences, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
6.0field-weighted citation impact, top 3% 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

22 citing papers in PubMed, 61 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. CClEvidence-based complementary and alternative medicine : eCAM · 2019
    Article
  8. Article
  9. Article
  10. Drug Hepatotoxicity: Environmental Factors.Clinics in liver disease · 2017
    Review
  11. Chronic Cholestatic Liver Injury Attributable to Vedolizumab.Journal of clinical and translational hepatology · 2016
    Article
  12. Review
  13. Possible Simeprevir/Sofosbuvir-Induced Hepatic Decompensation With Acute Kidney Failure.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2016
    Article
  14. Review
  15. Observational
  16. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Jonathan G StineDivision of Gastroenterology and Hepatology, University of Virginia, JPA and Lee Street, MSB 2145, PO Box 800708, Charlottesville, VA, 22908-0708, USA, jgs9f@virginia.edu.
Nicolas Intagliata
Neeral L Shah
Curtis K Argo
Stephen H Caldwell
James H Lewis
Patrick G Northup
University of Virginia · USGeorgetown University · US

Funding

RESEARCH TRAINING IN DIGESTIVE DISEASEST32DK007769 · NIDDK · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI COHN, STEVEN M · 1999 to 2014
$2.1M
NIDDK NIH HHS T32 DK007769
6 · The paper itself

Abstract

backgroundHyperbilirubinemia is a common side effect of protease inhibitors used to treat chronic hepatitis C (HCV), and most patients do not experience without clinically overt hepatotoxicity. The safety of second-wave protease inhibitors, including simeprevir, has not been well studied in patients with advanced cirrhosis. MATERIALS &

methodsWe report two cases of suspected drug-induced liver injury leading to hepatic decompensation in patients with advanced HCV cirrhosis treated with the combination of simeprevir and sofosbuvir on a compassionate basis. Both patients developed marked hyperbilirubinemia out of proportion to their aminotransferases, despite clearance of hepatitis C RNA. RUCAM scoring was probable and possible, respectively. While other factors may have contributed to the liver injury, including infection and concurrent administration of other medications, we believe that the potentially deleterious hepatic effects of simeprevir on transporters or other key functional components were the main reason for their decompensation.

conclusionsProtease inhibitors should be used with caution, if at all, in patients with cirrhosis, especially in those with the most advanced disease. We await newer, safer, direct-acting antiviral therapies for such patients, especially those on our transplant list.

Indexed as

AdultChemical and Drug Induced Liver InjuryHepatitis C, ChronicHeterocyclic Compounds, 3-RingHumansLiver CirrhosisMaleMiddle AgedProtease InhibitorsSimeprevirSulfonamidesHeterocyclic Compounds, 3-RingProtease InhibitorsSimeprevirSulfonamides

Identifiers

PMID25373453
PMCPMC6600814
OpenAlexW2004009551

What OpenQuestion holds

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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.