Trial reportHepatology (Baltimore, Md.)2020
Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study.
Trial report 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 40 papers, 2 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
40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 106 citations in OpenAlex.
- 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
- Population Pharmacokinetic Analysis of Glecaprevir and Pibrentasvir in Pediatric Patients ≥ 3 to < 18 Years of Age with Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection.Clinical pharmacokinetics · 2026Trial
- Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Children With Chronic HCV: Part 2 of the DORA Study.Hepatology (Baltimore, Md.) · 2021Trial
- Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan.Scientific reports · 2021Trial
- IMPAACT 2041: Designing the Study of Glecaprevir/Pibrentasvir Treatment During Pregnancy.Open forum infectious diseases · 2026Article
- Successful administration of glecaprevir/pibrentasvir via percutaneous endoscopic gastrostomy in a pediatric patient with chronic hepatitis C and spinal muscular atrophy receiving risdiplam.Clinical journal of gastroenterology · 2026Article
- Treatment of hepatitis C in children and adolescents: our experience to date, current status, and prospects.Clinical and experimental hepatology · 2026Review
- 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
- 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
- Effectiveness and Safety of Glecaprevir/Pibrentasvir in Italian Children and Adolescents With Chronic Hepatitis C: A Real-Word, Multicenter Study.Liver international : official journal of the International Association for the Study of the Liver · 2025Article
- Update on Pediatric Hepatitis C Infection.Current gastroenterology reports · 2025Review
- Recent advances in COVID-19-induced liver injury: causes, diagnosis, and management.Inflammopharmacology · 2024Review
- Hepatitis C in Children-An Asia-Pacific Concise Perspective.Pathogens (Basel, Switzerland) · 2024Review
- Hepatitis C Virus Infection in Europe.Pathogens (Basel, Switzerland) · 2024Review
- Updated Clinical Guidelines on the Management of Hepatitis C Infection in Children.Pathogens (Basel, Switzerland) · 2024Review
- Real-World Efficacy and Safety of an 8-Week Glecaprevir/Pibrentasvir Regimen in Children and Adolescents with Chronic Hepatitis C-Results of a Multicenter EpiTer-2 Study.Journal of clinical medicine · 2023Article
- Real-world efficacy and safety of glecaprevir/pibrentasvir in Japanese adolescents with chronic hepatitis C: a prospective multicenter study.Journal of gastroenterology · 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
18 authors at 8 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The pangenotypic regimen of glecaprevir and pibrentasvir (G/P) is approved to treat adults with chronic hepatitis C virus (HCV) infection and has yielded high cure rates in adults in clinical trials. Approved treatment options for pediatrics may include ribavirin. A pangenotypic regimen for pediatric patients remains an unmet need. DORA is an ongoing phase 2/3, nonrandomized, open-label study evaluating the pharmacokinetics (PK), safety, and efficacy of G/P in pediatric patients with chronic HCV. This analysis includes Part 1 of the study, conducted in adolescent patients 12-17 years of age given the adult regimen of G/P (300 mg/120 mg) once daily for 8-16 weeks according to the indication durations used in adults. Patients were either treatment naïve or experienced with interferon-based regimens. The primary PK endpoint was steady-state exposures for glecaprevir and pibrentasvir; the primary efficacy endpoint was sustained virologic response 12 weeks after treatment (SVR12). The secondary efficacy endpoints were on-treatment virologic failure, relapse, and reinfection. Safety and tolerability were monitored. Part 1 enrolled 48 adolescent patients infected with genotypes 1, 2, 3, or 4, of whom 47 were administered G/P. All 47 patients (100%) achieved SVR12. No on-treatment virologic failures or relapses occurred. PK exposures of glecaprevir and pibrentasvir were comparable to exposures in adults. No adverse events (AEs) led to treatment discontinuation, and no serious AEs occurred. Conclusion: Adolescent patients with chronic HCV infection treated with G/P achieved a comparable exposure to adults, 100% SVR12 rate, and safety profile consistent with that in adults. This pangenotypic regimen demonstrated 100% efficacy within the adolescent population in as little as 8 weeks of treatment.
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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.