ArticleHepatology (Baltimore, Md.)2020
Ledipasvir-Sofosbuvir for 12 Weeks in Children 3 to <6 Years Old With Chronic Hepatitis C.
Article in Hepatology (Baltimore, Md.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 93 citations in OpenAlex.
- Poor-tasting pediatric medicines: Part 1. A scoping review of their impact on patient acceptability, medication adherence, and treatment outcomes.Frontiers in drug delivery · 2025Pooled it
- High SVR12 With 8-Week Course of Direct-Acting Antivirals in Adolescents and Children With Chronic Hepatitis C: A Comprehensive Analysis.Frontiers in medicine · 2021Pooled it
- Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases-Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection.Hepatology (Baltimore, Md.) · 2020Guideline
- Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Children With Chronic HCV: Part 2 of the DORA Study.Hepatology (Baltimore, Md.) · 2021Trial
- Real-world treatment of pediatric Hepatitis C: A Florida experience.Journal of pediatric gastroenterology and nutrition · 2026Article
- Efficacy and safety of sofosbuvir-based therapies for treating HCV in children: observations from a real-world setting.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Article
- Histopathological features and eight-week split-tablet sofosbuvir/velpatasvir treatment in young children with acute hepatitis C: a case-series study.BMC infectious diseases · 2026Article
- Observational
- To treat or not to treat young children with hepatitis C?--real-life experience.European journal of pediatrics · 2025Article
- Hepatitis C virus in childhood and pregnancy.Infectious diseases & immunity · 2025Review
- Pediatric and Adolescent Hepatitis C Care Cascade and Real-World Treatment Outcomes Utilizing an Integrated Health System Specialty Pharmacy Model.Journal of the Pediatric Infectious Diseases Society · 2025Observational
- Update on Pediatric Hepatitis C Infection.Current gastroenterology reports · 2025Review
- Hepatitis C Virus-Pediatric and Adult Perspectives in the Current Decade.Pathogens (Basel, Switzerland) · 2024Review
- Hepatitis C in Children-An Asia-Pacific Concise Perspective.Pathogens (Basel, Switzerland) · 2024Review
- Updated Clinical Guidelines on the Management of Hepatitis C Infection in Children.Pathogens (Basel, Switzerland) · 2024Review
- Should they wait? Two children under 3 years old infected by HCV 1b successfully treated by ledipasvir/sofosbuvir: A report of two cases.Liver research (Beijing, China) · 2023Article
- A Synopsis of Hepatitis C Virus Treatments and Future Perspectives.Current issues in molecular biology · 2023Review
- Real-world efficacy and safety of glecaprevir/pibrentasvir in Japanese adolescents with chronic hepatitis C: a prospective multicenter study.Journal of gastroenterology · 2023Article
- Elbasvir/grazoprevir in children aged 3-18 years with chronic HCV genotype 1 or 4 infection: a pharmacokinetic modeling study.Hepatology communications · 2023Article
- [A case of chronic hepatitis C treated with sofosbuvir/velpatasvir combined with ribavirin among 3-year-old children with low body weight].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 12 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
For children under 12 years of age who have chronic hepatitis C virus (HCV) infection, there are currently no approved treatments with direct-acting antiviral agents. We therefore evaluated the safety and efficacy of ledipasvir-sofosbuvir in HCV-infected children aged 3 to <6 years. In an open-label study, patients 3 to <6 years old chronically infected with HCV genotype 1 (n = 33) or 4 (n = 1) received weight-based doses of combined ledipasvir-sofosbuvir as granules (33.75 mg/150 mg for weights <17 kg or 45 mg/200 mg for weights ≥17 kg) for 12 weeks. The primary endpoint was sustained virological response 12 weeks after treatment (SVR12). For the first 14 patients, intensive pharmacokinetic sampling was done on day 10 of treatment. All patients had been infected through perinatal transmission and were treatment naïve. No patients had known cirrhosis. Ten patients (29%) weighed <17 kg. SVR12 was achieved in 97% of patients (33 of 34); the patient who did not achieve SVR12 was 3 years old and discontinued treatment after 5 days because of an adverse event "abnormal drug taste." The most common adverse events were vomiting (24% of patients), cough (21%), and pyrexia (21%). No patients experienced a serious adverse event. Intensive pharmacokinetic analysis of 13 patients for whom data were evaluable confirmed that the doses selected were appropriate. Conclusion: Ledipasvir-sofosbuvir was well tolerated and highly effective in children 3 to <6 years old with chronic HCV infection.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.