Evidence map›Paper›PMID 26394142›Full record

Observational studyPloS one2015

Multicenter Experience with Boceprevir or Telaprevir to Treat Hepatitis C Recurrence after Liver Transplantation: When Present Becomes Past, What Lessons for Future?

Audrey Coilly, Jérôme Dumortier, Danielle Botta-Fridlund, Marianne Latournerie, Vincent Leroy, Georges-Philippe Pageaux, Hélène Agostini, Emiliano Giostra, Christophe Moreno, Bruno Roche and 13 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

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.

  1. Review
  2. Anti-hepatitis C virus drugs and kidney.World journal of hepatology · 2016
    Review
  3. Review
  4. Review
  5. Review
  6. Review
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

23 authors.

Audrey CoillyAP-HP Hôpital Paul-Brousse, Centre Hépato-Biliaire, Villejuif, F-94800, France, Université Paris-Sud, UMR-S 785, Villejuif, F-94800, France, Inserm, Unité 785, Villejuif, F-94800, France, Hepatinov, Villejuif, F-94800, France.
Jérôme DumortierDepartment of Digestive Diseases, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France.
Danielle Botta-FridlundAssistance Publique-Hôpitaux de Marseille, Centre Hospitalo-Universitaire Conception, Service d'Hépato-Gastro-Entérologie, Marseille, France.
Marianne LatournerieCHU Rennes, Liver Disease Unit, Rennes, France.
Vincent LeroyService d'hépato-gastro-entérologie, hôpital A.-Michallon, 38700, La Tronche, France.
Georges-Philippe PageauxFédération médico-chirurgicale des maladies de l'appareil digestif, hôpital Saint-Eloi, 34295, Montpellier, France.
Hélène AgostiniAP-HP, Hôpital Bicêtre, Unité de recherche clinique Paris-Sud, Kremlin-Bicêtre, France.
Emiliano GiostraDepartment of Gastroenterology and Hepatology, Geneva University Hospital, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva, 14, Switzerland.
Christophe MorenoLiver unit, Department of Gastroenterology, Hepatopancreatology and Digestive oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.
Bruno RocheAP-HP Hôpital Paul-Brousse, Centre Hépato-Biliaire, Villejuif, F-94800, France, Université Paris-Sud, UMR-S 785, Villejuif, F-94800, France, Inserm, Unité 785, Villejuif, F-94800, France, Hepatinov, Villejuif, F-94800, France.
Teresa Maria AntoniniAP-HP Hôpital Paul-Brousse, Centre Hépato-Biliaire, Villejuif, F-94800, France, Université Paris-Sud, UMR-S 785, Villejuif, F-94800, France, Inserm, Unité 785, Villejuif, F-94800, France, Hepatinov, Villejuif, F-94800, France.
Olivier GuillaudDepartment of Digestive Diseases, Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France.
Pascal LebrayAssistance Publique Hôpitaux de Paris (AP-HP), Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
Sylvie RadenneService d'hépatologie, HCL, hôpital de la Croix-Rousse, 69205, Lyon, France.
Anne-Catherine SaouliHepato-Bilio-Pancreatic Surgery and Liver Transplantation Center, Université de Strasbourg, Strasbourg, France.
Yvon CalmusDepartment of Hepatobiliary and Liver Transplantation Surgery, Hopital Saint Antoine, Assistance publique-Hopitaux de Paris, 184 rue du Faubourg Saint-Antoine, 75012, Paris Cedex, France.
Laurent AlricInternal medecine-Digestive department UMR 152 IRD Toulouse 3 University, Toulouse, France.
Maryline Debette-GratienService d'Hépato-gastroentérologie, CHU de Limoges, 2 avenue Martin-Luther-King, 87042, Limoges, France, Inserm UMR 1092, Faculté de médecine de Limoges, Université de Limoges, Limoges, France.
Victor De LedinghenUniversity of Bordeaux, Bordeaux, France.
François DurandService d'hépatologie, hôpital Beaujon, AP-HP, 92118, Clichy, France.
Christophe DuvouxService d'hépatologie, hôpital Henri-Mondor, AP-HP, 94000, Créteil, France.
Didier SamuelAP-HP Hôpital Paul-Brousse, Centre Hépato-Biliaire, Villejuif, F-94800, France, Université Paris-Sud, UMR-S 785, Villejuif, F-94800, France, Inserm, Unité 785, Villejuif, F-94800, France, Hepatinov, Villejuif, F-94800, France.
Jean-Charles Duclos-ValléeAP-HP Hôpital Paul-Brousse, Centre Hépato-Biliaire, Villejuif, F-94800, France, Université Paris-Sud, UMR-S 785, Villejuif, F-94800, France, Inserm, Unité 785, Villejuif, F-94800, France, Hepatinov, Villejuif, F-94800, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsFirst generation protease inhibitors (PI) with peg-interferon (PEG-IFN) and ribavirin (RBV) have been the only therapy available for hepatitis C virus (HCV) genotype 1 infection in most countries for 3 years. We have investigated the efficacy and tolerance of this triple therapy in transplanted patients experiencing a recurrence of HCV infection on the liver graft. PATIENTS: This cohort study enrolled 81 liver transplant patients (Male: 76%, mean age: 55.8±9.7 years) with severe HCV recurrence (F3 or F4: n = 34 (42%), treatment experienced: n = 44 (54%)), treated with boceprevir (n = 36; 44%) or telaprevir (n = 45; 56%). We assessed the percentages of patients with sustained virological responses 24 weeks after therapy (SVR24), and safety.

resultsThe SVR24 rate was 47% (telaprevir: 42%; boceprevir: 53%, P = ns). At baseline, a normal bilirubin level (p = 0.0145) and albumin level >35g/L (p = 0.0372) and an initial RBV dosage of ≥800 mg/day (p = 0.0033) predicted SVR24. During treatment, achieving an early virological response after 12 weeks was the strongest independent factor to predict SVR24 (p<0.0001). A premature discontinuation of anti-HCV therapy due to a serious adverse event (SAE) was observed in 22 patients (27%). Hematological toxicity, infections and deaths were observed in 95%, 28% and 7% of patients, respectively. A history of post-LT antiviral therapy and thrombocytopenia (<50G/L) during treatment were both independent predictors of the occurrence of infections or SAE (p = 0.0169 and p = 0.011).

conclusionsThe use of first generation PI after liver transplantation enabled an SVR24 rate of 47% in genotype 1 patients, but induced a high rate of SAE. The identification of predictive factors for a response to treatment, and the occurrence of SAE, have enabled us to establish limits for the use of this anti-HCV therapy in the transplant setting.

Indexed as

AdultAgedAnemiaAntiviral AgentsCombined Modality TherapyDrug Therapy, CombinationFemaleGenotypeHepacivirusHepatitis CHost-Pathogen InteractionsHumansInterferon-alphaLiver TransplantationMaleMiddle AgedAntiviral 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 Proteinstelaprevir

Identifiers

PMID26394142
PMCPMC4578772

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