Evidence map›Paper›PMID 31515739›Full record

Observational studyHepatology international2019

Generic sofosbuvir/ledipasvir for the treatment of genotype 4 chronic hepatitis C in Egyptian children (9-12 years) and adolescents.

Hanaa A El-Araby, Behairy E Behairy, Mohamed A El-Guindi, Nermin M Adawy, Alif A Allam, Ahmad M Sira, Mohamed A Khedr, Ibrahim A Elhenawy, Gihan A Sobhy, Hosam El Din M Basiouny and 4 more

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Hepatology international, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Hepatitis C Elimination in Egypt: Story of Success.Pathogens (Basel, Switzerland) · 2024
    Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

14 authors at 1 institution in 1 country.

Hanaa A El-ArabyDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Behairy E BehairyDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Mohamed A El-GuindiDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Nermin M AdawyDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Alif A AllamDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Ahmad M SiraDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt. asira@liver.menofia.edu.eg.ORCID http://orcid.org/0000-0001-9813-4012
Mohamed A KhedrDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Ibrahim A ElhenawyDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Gihan A SobhyDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Hosam El Din M BasiounyDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Menan E SalemDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Samira A Abdel-AzizDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Ola A FouadDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Bassam A AyoubDepartment of Pediatric Hepatology, Gastroenterology, and Nutrition, National Liver Institute, Menofiya University, 32511 Shebin El-koom, Menofiya, Egypt.
Menoufia University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background/purpose of the studyWorldwide and national efforts are directed against eradication of HCV. The introduction of direct-acting antivirals (DAAs) has changed dramatically the outcome of HCV treatment. In spite of the Food and Drug Administration approval of the oral drugs sofosbuvir (SOF) and ledipasvir (LED) for the treatment of HCV in adolescents more than or equal to 12 years old, sufficient real-world experience is still lacking. The aim of this study was to assess the safety and efficacy of the generic SOF/LED fixed-dose combination 400/90 (400 mg SOF + 90 mg LED) for the treatment of adolescents and children (9-12 years) with chronic hepatitis C (CHC).

methodsIn this prospective observational study, 100 cases of genotype 4 CHC were recruited consecutively from those fulfilling the inclusion and exclusion criteria. All cases received the generic fixed-dose combination SOF/LED (400/90), one tablet daily for 12 weeks. All clinical, laboratory, and virologic characteristics were evaluated at base line, and week (W) 2, 4, 8, and 12 of therapy and W12 post-treatment (SVR12).

resultsRecruited children (9-12) and adolescents weighed 28-83 and 31-90 kg, respectively. Eighty cases were naïve and 20 cases were pegylated interferon/ribavirin treatment-experienced. Very rapid virologic response (vRVR) at W2 was 96%, while at W4 response rate was 100% and maintained till the end of treatment and at W12 post-treatment (SVR12). All reported side effects were mild and did not lead to treatment termination and disappeared at W12 post-treatment.

conclusionThe generic SOF/LED fixed-dose combination is safe and effective in children, 9-12 years, and adolescents with vRVR rate of 96%, 100% EOT response and SVR12.

Indexed as

Administration, OralAdolescentAdolescent Health ServicesAntiviral AgentsBenzimidazolesChildChild Health ServicesDrug Administration ScheduleEgyptFemaleFluorenesGenotypeHepatitis C, ChronicHumansMaleProspective StudiesAntiviral AgentsBenzimidazolesFluorenesledipasvir, sofosbuvir drug combinationSofosbuvirUridine MonophosphateChildrenHepatitis C virusLedipasvirSofosbuvir

Identifiers

PMID31515739
OpenAlexW2972496467

What OpenQuestion holds

Textmetadata
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.