Evidence map›Paper›PMID 26402801›Full record

Observational studyMedicine2015

Effect of Peginterferon or Ribavirin Dosing on Efficacy of Therapy With Telaprevir in Treatment-Experienced Patients With Chronic Hepatitis C and Advanced Liver Fibrosis: A Multicenter Cohort Study.

Ewa Janczewska, Robert Flisiak, Dorota Zarebska-Michaluk, Dorota Kozielewicz, Hanna Berak, Beata Dobracka, Marta Librant-Suska, Wladyslaw Lojewski, Krzysztof Jurczyk, Joanna Musialik and 11 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Medicine, 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
1.0field-weighted citation impact, top 24% 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

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Observational
  2. Genotype 3-hepatitis C virus' last line of defense.World journal of gastroenterology · 2021
    Review
  3. Viral hepatitis C treatment shortening - what is the limit?Clinical and experimental hepatology · 2019
    Review
  4. Perspectives of hepatitis C virus (HCV) elimination in Poland.Clinical and experimental hepatology · 2019
    Article
  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

21 authors at 1 institution in 1 country.

Ewa JanczewskaFrom the ID Clinic, Myslowice, Poland (EJ, AP); Klinika Chorob Zakaznych i Hepatologii, Uniwersytet Medyczny, Białystok, Poland (RF, TL); Uniwersytet J. Kochanowskiego i Wojewodzki Szpital Zespolony, Kielce, Poland (DZ-M, WK); Department of Infectious Diseases and Hepatology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Toruń, Poland (DK); Hospital of Infectious Diseases, Warsaw, Poland (HB); Infectious Diseases Clinic, Wroclaw, Poland (BD, WD); Poradnia Wirusowych Zapalen Watroby SU, Kraków, Poland (ML-S); NZOZ Poradnia Chorob Watroby, Zielona Gora, Poland (WL); Department of Infectious Diseases, Hepatology, and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland (KJ); Department of Gastroenterology and Hepatology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland (JM); Department of Basic Biomedical Science, School of Pharmacy, Division of Laboratory, Medicine in Sosnowiec, Medical University of Silesia, Katowice, Poland (JM); Oddzial Obserwacyjno-Zakazny, Szpital im. Zeromskiego, Kraków, Poland (BP-K); Oddzial Obserwacyjno-Zakazny, Szpital Wojewodzki, Koszalin, Poland (JW); Oddzial Chorób Zakaznych, Walbrzych, Poland (KA); Klinika Chorob Infekcyjnych i Alergologii WIM, Warsaw, Poland (MD); Oddzial Obserwacyjno-Zakazny, Szpital Rejonowy, Raciborz, Poland (IO); Ośrodek Leczenia WZW, Centrum Medyczne, Lancut, Poland (AR); Warsaw Medical University and Hospital of Infectious Diseases, Warsaw, Poland (AH); and Faculty of Health Science, Medical University, Wroclaw, Poland (WD).
Robert Flisiak
Dorota Zarebska-Michaluk
Dorota Kozielewicz
Hanna Berak
Beata Dobracka
Marta Librant-Suska
Wladyslaw Lojewski
Krzysztof Jurczyk
Joanna Musialik
Barbara Postawa-Klosińska
Jacek Wroblewski
Krystyna Augustyniak
Marek Dudziak
Iwona Olszok
Agata Ruszala
Arkadiusz Pisula
Tadeusz Lapinski
Wieslaw Kryczka
Andrzej Horban
Witold Dobracki
Wojewódzki Szpital Zespolony · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We investigated the safety, efficacy, and impact of ribavirin and peginterferon dose reduction on complete early virologic response and sustained virologic response (SVR) to triple therapy with telaprevir in treatment-experienced patients with advanced liver fibrosis.Treatment was initiated for 211 patients who failed treatment with peginterferon and ribavirin, with bridging fibrosis (F3, n = 68) or cirrhosis (F4, n = 143), including 103 (49%) null-responders (NR), 30 (14%) partial responders (PR), and 78 (37%) relapsers (REL). Impaired liver function (ILF) platelets <100,000/mm or albumin <35 g/L were present in 40 patients. The distribution of hepatitis C virus subtypes was: 1a, 1b, or 1, with undetermined subtype for 10 (5%), 187 (89%), and 14 (6%) patients, respectively. Treatment was started with peginterferon alpha-2a or alpha-2b, ribavirin, and telaprevir at standard doses.The overall SVR24 rate was 56% and was lower in cirrhotic patients (NR: 35%, PR: 40%, and REL: 63%, respectively) than in patients with bridging fibrosis (NR: 50%, PR: 75%, and REL: 75%, respectively). The lowest probability of SVR24 was in NRs with ILF (26%). The SVR24 rate significantly decreased in NRs receiving <60% vs >60% of the total ribavirin dose (23% vs 44%, respectively) or <80% vs >80% of the total ribavirin dose (33% vs 48%, respectively). A significant SVR24 decrease was noted subsequent to a total peginterferon dose reduction, both when comparing patients who received <60% vs >60% of the total dose (NR: 0% vs 44%; REL: 33% vs 68%) and patients who received <80% vs >80% of the total dose (NR: 17% vs 50%; REL: 46% vs 71%).Serious adverse events were observed in 31 patients (15%). Deaths occurred in 4 patients. All of the deceased subjects were cirrhotic members of the ILF (baseline serum albumin level <35 g/L and/or platelet count <100,000/mm) group.Ribavirin dose reduction did not affect efficacy in REL but did in NR. Peginterferon dose reduction decreased the SVR24 rate for all groups, particularly in prior NR. ILF increased the risk of fatal complications with a low probability to achieve SVR24. One solution might be to provide wide and early access to novel, efficient, and safe interferon-free combinations to treatment-experienced patients, particularly those with liver cirrhosis.

Indexed as

Hepatitis C, ChronicInterferon-alphaLiver CirrhosisOligopeptidesPolyethylene GlycolsRibavirinAntiviral AgentsCohort StudiesDose-Response Relationship, DrugDrug CarriersDrug MonitoringDrug SubstitutionDrug Therapy, CombinationFemaleHumansInterferon alpha-2Antiviral AgentsDrug CarriersInterferon-alphaInterferon alpha-2Oligopeptidespeginterferon alfa-2apeginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsRibavirintelaprevir

Identifiers

PMID26402801
PMCPMC4635741
OpenAlexW2328569139

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.