Evidence map›Paper›PMID 25218788›Full record

Observational studyJournal of hepatology2015

Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET.

Stuart C Gordon, Andrew J Muir, Joseph K Lim, Brian Pearlman, Curtis K Argo, Ananthakrishnan Ramani, Benedict Maliakkal, Imtiaz Alam, Thomas G Stewart, Monika Vainorius and 5 more

Open access · greenAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of hepatology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
9.4field-weighted citation impact, top 1% 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

39 citing papers in PubMed, 95 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Viral proteases as therapeutic targets.Molecular aspects of medicine · 2022
    Review
  5. Article
  6. Breakthroughs in hepatitis C research: from discovery to cure.Nature reviews. Gastroenterology & hepatology · 2022
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Observational
  13. Safety and Effectiveness of Ledipasvir and Sofosbuvir, With or Without Ribavirin, in Treatment-Experienced Patients With Genotype 1 Hepatitis C Virus Infection and Cirrhosis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018
    Observational
  14. Article
  15. Article
  16. Observational
  17. Article
  18. Observational
  19. Article
  20. 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 at 10 institutions in 1 country.

Stuart C GordonDepartment of Internal Medicine, Division of Gastroenterology-Hepatology, Henry Ford Hospital, Detroit, MI, USA. Electronic address: sgordon3@hfhs.org.
Andrew J MuirGastroenterology and Hepatology Research Group, Duke Clinical Research Institute, Durham, NC, USA.
Joseph K LimYale Liver Center, Yale University School of Medicine, New Haven, CT, USA.
Brian PearlmanCenter for Hepatitis C, Atlanta Medical Center, Atlanta, GA, USA.
Curtis K ArgoUniversity of Virginia, Charlottesville, VA, USA.
Ananthakrishnan RamaniColumbia Memorial Hospital, Hudson, NY, USA.
Benedict MaliakkalStrong Memorial Hospital/University of Rochester, Rochester, NY, USA.
Imtiaz AlamAustin Hepatitis Center, Austin, TX, USA.
Thomas G StewartUNC Liver Center, University of North Carolina, Chapel Hill, NC, USA.
Monika VainoriusUNC Liver Center, University of North Carolina, Chapel Hill, NC, USA.
Joy PeterUniversity of Florida, Division of Gastroenterology, Hepatology and Nutrition, Gainesville, FL, USA.
David R NelsonUniversity of Florida, Division of Gastroenterology, Hepatology and Nutrition, Gainesville, FL, USA.
Michael W FriedUNC Liver Center, University of North Carolina, Chapel Hill, NC, USA.
K Rajender ReddyUniversity of Pennsylvania, Philadelphia, PA, USA. Electronic address: rajender.reddy@uphs.upenn.edu.
HCV-TARGET study group
University of North Carolina at Chapel Hill · USUniversity of Florida · USAtlanta Medical Center · USClinical Research Institute · USHenry Ford Health System · USHepatitis B Foundation · USMemorial Hospital of South Bend · USStrong Memorial Hospital · USUniversity of Virginia · USYale Cancer Center · US

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
Yale Liver CenterP30DK034989 · NIDDK · YALE UNIVERSITY · PI MICHAEL H NATHANSON, Mario Strazzabosco · 1986 to 2026
$31.1M
UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
Mentoring Junior Faculty: Viral hepatitis Clinical ResearchK24DK066144 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRIED, MICHAEL W · 2004 to 2014
$1.5M
NCATS NIH HHS 1UL1TR001111NCATS NIH HHS UL1 TR000064NCATS NIH HHS UL1TR000064NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR002489NIDDK NIH HHS K24 DK066144NIDDK NIH HHS P30 DK034989
6 · The paper itself

Abstract

BACKGROUND &

aimsThe safety profiles of boceprevir and telaprevir in the treatment of chronic hepatitis C, administered in academic and community centres across the United States, were evaluated.

methodsIn 90 medical centres, patients with chronic HCV received pegylated interferon, ribavirin, and either telaprevir or boceprevir per local standard of care. Demographic, adverse event, clinical, and virological data were collected during treatment and follow-up.

resultsA total of 2084 patients (97% HCV genotype 1) received at least one dose of a protease inhibitor. At baseline, 38% of patients had cirrhosis, and 57% had received at least one prior treatment for hepatitis C. Serious adverse events occurred in 12% of patients receiving protease inhibitor therapy. Overall, 66% of patients experienced anaemia, leading to frequent ribavirin dose reductions (42%) and erythropoietin use (37%); 11% received blood transfusion. More than 90% of patients had adverse events that led to a prescription, treatment, or dosage change, and 39% of patients discontinued treatment early, most commonly because of adverse events (18%) or lack of efficacy (16%). Hepatic decompensation events occurred in 3% of all patients. Age, female gender, cirrhosis, HCV genotype 1 subtype, creatinine clearance, platelet levels, albumin levels and haemoglobin levels were independent predictors of anaemia. Five deaths occurred. Overall, 52% of all patients achieved a sustained virologic response.

conclusionsIn academic and community centres, where chronic hepatitis C patients commonly have advanced liver disease, triple therapy was associated with a high rate of adverse events and involved frequent treatment modifications and adverse event management.

Indexed as

AdolescentAdultAgedAntiviral AgentsDNA, ViralDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFollow-Up StudiesGenotypeHepacivirusHepatitis C, ChronicHumansMaleMiddle AgedOligopeptidesAntiviral AgentsDNA, ViralN-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamideOligopeptidesProlinetelaprevirAnaemiaBoceprevirCirrhosisHepatic decompensationHepatitis CTelaprevir

Identifiers

PMID25218788
PMCPMC4586075
OpenAlexW1974027259

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.