Evidence map›Paper›PMID 36457986›Full record

ArticleArchives of medical science : AMS2022

Efficacy of 8- versus 12-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C patients eligible for 8-week regimen in a real-world setting.

Dorota Zarębska-Michaluk, Anna Piekarska, Jerzy Jaroszewicz, Jakub Klapaczyński, Marek Sitko, Magdalena Tudrujek-Zdunek, Krzysztof Tomasiewicz, Teresa Belica-Wdowik, Paweł Pabjan, Beata Lorenc and 17 more

Open access · goldAbstract read
In one paragraph

Article in Archives of medical science : AMS, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 36% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Viral hepatitis C treatment shortening - what is the limit?Clinical and experimental hepatology · 2019
    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

27 authors at 17 institutions in 1 country.

Dorota Zarębska-MichalukDepartment of Infectious Diseases, Voivodeship Hospital and Jan Kochanowski University, Kielce, Poland.
Anna PiekarskaDepartment of Infectious Diseases and Hepatology, Medical University of Lodz, Lodz, Poland.
Jerzy JaroszewiczDepartment of Infectious Diseases and Hepatology, Medical University of Silesia in Katowice, Bytom, Poland.
Jakub KlapaczyńskiDepartment of Internal Medicine and Hepatology, Central Clinical Hospital of Internal Affairs and Administration, Warsaw, Poland.
Marek SitkoDepartment of Infectious and Tropical Diseases, Jagiellonian University Medical College, Krakow, Poland.
Magdalena Tudrujek-ZdunekDepartment of Infectious Diseases, Medical University of Lublin, Lublin, Poland.
Krzysztof TomasiewiczDepartment of Infectious Diseases, Medical University of Lublin, Lublin, Poland.
Teresa Belica-WdowikRegional Center for Diagnosis and Treatment of Viral Hepatitis and Hepatology, John Paul II Hospital, Krakow, Poland.
Paweł PabjanDepartment of Infectious Diseases, Voivodeship Hospital and Jan Kochanowski University, Kielce, Poland.
Beata LorencDepartment of Infectious Diseases, Pomeranian Center of Infectious Diseases, Medical University of Gdansk, Gdansk, Poland.
Agnieszka Czauż-AndrzejukDepartment of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.
Olga TroninaDepartment of Transplantation Medicine, Nephrology, and Internal Diseases, Medical University of Warsaw, Warsaw, Poland.
Rafał KrygierState University of Applied Sciences, Konin, Poland.
Witold DobrackiMED-FIX Wroclaw, Poland.
Iwona BuczyńskaDepartment of Infectious Diseases and Hepatology, Wroclaw University of Medicine, Wroclaw, Poland.
Krzysztof A SimonDepartment of Infectious Diseases and Hepatology, Wroclaw University of Medicine, Wroclaw, Poland.
Dorota DybowskaDepartment of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland.
Waldemar HalotaDepartment of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland.
Małgorzata PawłowskaDepartment of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland.
Jolanta CitkoMedical Practice of Infections, Regional Hospital, Olsztyn, Poland.
Łukasz LauransOutpatient Department, Multidisciplinary Regional Hospital, Gorzow Wielkopolski, Poland.
Włodzimierz MazurClinical Department of Infectious Diseases, Specialist Hospital in Chorzow, Medical University of Silesia in Katowice, Poland.
Ewa JanczewskaDepartment of Basic Medical Sciences, School of Public Health in Bytom, Medical University of Silesia in Katowice, Poland.
Łukasz SochaDepartment of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland.
Zbigniew DerońBiegański Regional Specialist Hospital, Lodz, Poland.
Hanna BerakHospital of Infectious Diseases, Medical University of Warsaw, Warsaw, Poland.
Robert FlisiakDepartment of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.
Nicolaus Copernicus University · PLJan Kochanowski University · PLMedical University of Białystok · PLMedical University of Lodz · PLMedical University of Lublin · PLMedical University of Warsaw · PLUniversity of Silesia in Katowice · PLWroclaw Medical University · PLCentral Clinical Hospital · PLGdańsk Medical University · PLJagiellonian University · PLJohn Paul II Hospital · PLMedical University of Silesia · PLMeditest · PLPomeranian Medical University · PLState University of Applied Sciences in Konin · PLUniversity of Computer Sciences and Economics in Olsztyn · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Non-cirrhotic treatment-naive hepatitis C patients infected with genotype 1 can be treated with ledipasvir/sofosbuvir (LDV/SOF) for 8 weeks, but in practice this regimen is frequently extended up to 12 weeks at least in part due to insufficient real-world data supporting shortening of treatment. The aim of our study was to compare 8- and 12-week regimens' efficacy in patients eligible for 8-week therapy in a real-world setting. Material and methods: Data of HCV genotype 1 infected patients treated with LDV/SOF between 2015 and 2018 included in the EpiTer-2 database were analyzed with respect to patients' characteristics and length of treatment. Results: Among a total of 1718 patients treated with LDV/SOF, 679 were included in the analysis, 238 (35%) received 8-week regimen, whereas 441 were treated for 12 weeks although they fulfilled the criteria for a shorter course. The majority of patients were infected with genotype 1b (89%) and demonstrated minimal fibrosis (55%). The 12-week regimen was assigned significantly more frequently to patients with comorbidities, concomitant medications and advanced liver fibrosis. The sustained virologic response rate was similar after 8 (98%) and 12 (97%) weeks of therapy according to intent-to-treat analysis and reached 99% in both groups after exclusion of patients lost to follow-up. Conclusions: We confirmed high effectiveness regardless of treatment duration with LDV/SOF in non-cirrhotics infected with HCV genotype 1 eligible for the 8-week regimen according to the current label. This real-world study also demonstrated no need for addition of ribavirin (RBV) in this population and showed that shortening of treatment significantly improves the safety profile of LDV/SOF medication.

Indexed as

genotype 1hepatitis Cledipasvirsofosbuvirtreatment-naïve

Identifiers

PMID36457986
PMCPMC9710286
OpenAlexW2969696875

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.