Evidence map›Paper›PMID 23606708›Full record

Trial reportAnnals of the rheumatic diseases2014

Peg-IFNα/ribavirin/protease inhibitor combination in hepatitis C virus associated mixed cryoglobulinemia vasculitis: results at week 24.

David Saadoun, M Resche Rigon, V Thibault, M Longuet, S Pol, F Blanc, G Pialoux, A Karras, D Bazin-Karra, C Cazorla and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02825212 (Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia), which is not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT02825212 phase2 / phase3completednot on this mapstarted 2016, after this paper: background citation

Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia

TypeinterventionalSponsorIcahn School of Medicine at Mount SinaiRan2016 to 2019Enrolled10ConditionsHepatitis C, CryoglobulinemiaArmsHarvoni, Epclusa
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Treatment for hepatitis C virus-associated mixed cryoglobulinaemia.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Gastrointestinal aspects of vasculitides.Nature reviews. Gastroenterology & hepatology · 2017
    Review
  11. Review
  12. Treatment of Hepatitis C in Patients Undergoing Immunosuppressive Drug Therapy.Journal of clinical and translational hepatology · 2016
    Review
  13. Review
  14. Article
  15. New approaches in the treatment of hepatitis C.World journal of gastroenterology · 2016
    Review
  16. Vasculitic Neuropathies.Current treatment options in neurology · 2015
    Article
  17. Dermatologic Extrahepatic Manifestations of Hepatitis C.Journal of clinical and translational hepatology · 2015
    Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 2 countries.

David SaadounDepartment of Internal Medicine, Service de Médecine Interne, AP-HP, Groupe Hospitalier Pitié-Salpétrière, , Paris, France.
M Resche Rigon
V Thibault
M Longuet
S Pol
F Blanc
G Pialoux
A Karras
D Bazin-Karra
C Cazorla
D Vittecoq
L Musset
O Decaux
J M Ziza
O Lambotte
Patrice Cacoub
Sorbonne Université · FRBicêtre Hospital · FRDepartment of Virology · FRHôpital de la Croix-Rousse · FRHôpital Européen · FRHôpital Lapeyronie · FRHôpital Necker-Enfants Malades · FRHôpital Nord · FRHôpital Paul-Brousse · FRHôpital Saint-Louis · FRSpital Thurgau (Switzerland) · CHUniversité Jean Monnet · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe standard-of-care treatment of patients with hepatitis C virus (HCV)-mixed cryoglobulinemia (MC) vasculitis includes pegylated interferon α (PegIFN)-α plus ribavirin and/or rituximab. About 30-40% of patients are non-responders or relapsers to such combination.

objectiveTo analyse the safety and efficacy of Peg-IFNα/ribavirin/protease inhibitor combination in HCV-MC vasculitis. PATIENTS AND

methodsOpen-label, prospective, cohort study including 23 patients with HCV-MC vasculitis. Peg-IFNα/ribavirin was associated to telaprevir (375 mg three times daily, for 12 weeks, (n=15)) or boceprevir (800 mg three times daily, for 44 weeks, (n=8)) for 48 weeks.

resultsThe median age was 59 (52.5-66) years, with 48.8% women. Thirteen patients (56.5%) were complete clinical responders, and 10 (43.5%) were partial responders at week 24. The virological response (ie, HCV RNA negativation) was of 69.6% at week 24 (p=0.005). The cryoglobulin level decreased from 0.44 to 0.06 g/l (p=0.0006) and the C4 level increased from 0.09 to 0.15 g/l (p=0.045). Grades 3 and 4 adverse events (mainly anaemia, neutropenia and thrombocytopenia) were observed in 10 cases (43.5%). Twenty patients (87%) received erythropoietin, 9 (39.1%) had red cell transfusion, and 2 (8.7%) had granulocyte stimulating agents. Antiviral therapy discontinuation was required in 8 (34.7%) patients for virological non-response (n=5), virological relapse (n=2) and depression (n=1).

conclusionsPeg-IFNα/ribavirin/protease inhibitor combination seems highly effective in HCV-MC. Such therapeutic regimen should be administered cautiously considering the high rate of side effects.

Indexed as

AgedAntiviral AgentsCohort StudiesCryoglobulinemiaDrug Therapy, CombinationFemaleHepacivirusHepatitis C, ChronicHumansInterferon-alphaMaleMiddle AgedOligopeptidesPolyethylene GlycolsProlineProtease InhibitorsAntiviral AgentsInterferon-alphaN-(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-carboxamideOligopeptidespeginterferon alfa-2aPolyethylene GlycolsProlineProtease InhibitorsRecombinant ProteinsRibavirintelaprevir

Identifiers

PMID23606708
PMCPMC3995244
OpenAlexW2098086677

What OpenQuestion holds

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LicenceCC BY-NC
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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.