Evidence map›Paper›PMID 35838919›Full record

ArticlePaediatric drugs2022

Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Treatment-Naïve Children without and with Comorbidities.

Othman AbouBakr, Mohammed Ezz El Regal, Amr Ali Sarhan, Maysaa El Sayed Zaki, Ahmed Noaman

Open access · hybridAbstract read
In one paragraph

Article in Paediatric drugs, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

5 authors at 1 institution in 1 country.

Othman AbouBakrPediatrics Department, Pediatric Gastroenterology, and Hepatology Unit, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt.
Mohammed Ezz El RegalPediatrics Department, Pediatric Gastroenterology, and Hepatology Unit, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt.
Amr Ali SarhanPediatrics Department, Pediatric Nephrology, and Dialysis Unit, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt.
Maysaa El Sayed ZakiClinical Pathology Department, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt.
Ahmed NoamanPediatrics Department, Pediatric Critical Care Unit, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt. ahmed_noaman@mans.edu.eg.ORCID http://orcid.org/0000-0002-3694-5773
Children's Hospital Mansoura University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic hepatitis C virus (HCV) infection represents a crucial health problem in children that greatly influences their quality of life. Many efforts have been directed toward investing in effective drugs with a high safety profile and oral administration for better compliance.

objectivesThis study aims to assess the safety of a fixed-dose combination of ledipasvir/sofosbuvir plus drug efficacy and sustained virologic response (SVR) at 12 weeks after treatment discontinuation.

methodOne tablet (90 mg ledipasvir, 400 mg sofosbuvir) was administered to treatment-naïve children aged 12-18 years weighing at least 35 kg with chronic HCV infection for 6 months, genotype 4. Patients were divided into 2 groups, (1) without comorbidities (24 patients) and (2) with comorbidities (26 patients).

resultsAt the end of the therapy, all patients (100%) had SVR and a significant reduction of liver enzymes with mild tolerable side effects.

conclusionLedipasvir/sofosbuvir fixed-dose combination is a safe and highly effective therapeutic option in Egyptian children aged ≥ 12 years, with chronic HCV infection, genotype 4, either without or with comorbidities.

Indexed as

Hepatitis C, ChronicSofosbuvirAntiviral AgentsBenzimidazolesChildDrug Therapy, CombinationFluorenesGenotypeHepacivirusHumansQuality of LifeTreatment OutcomeAntiviral AgentsBenzimidazolesFluorenesledipasvirSofosbuvir

Identifiers

PMID35838919
PMCPMC9439969
OpenAlexW4285589060

What OpenQuestion holds

Textmetadata
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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.