Trial reportHepatology (Baltimore, Md.)2021
Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Children With Chronic HCV: Part 2 of the DORA Study.
Trial report in Hepatology (Baltimore, Md.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
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
28 citing papers in PubMed, 56 citations in OpenAlex.
- 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
- 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
- 2025 KASL clinical practice guidelines for management of hepatitis C.Clinical and molecular hepatology · 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
- Disparities in Linkage to Care Among Children With Hepatitis C Virus in the United States.Pediatrics · 2025Article
- 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
- Management of Pediatric Chronic Hepatitis C with Crushed or Split Glecaprevir/Pibrentasvir: A Case Series From East Jeddah Hospital, Saudi Arabia.International medical case reports journal · 2025Article
- 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
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- 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
- National viral hepatitis control program in India: Call for update.Journal of family medicine and primary care · 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
21 authors at 17 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsGlecaprevir/pibrentasvir (GLE/PIB) has shown high efficacy and safety in chronic HCV-infected adults and adolescents; data in children were limited. DORA part 2 is a phase 2/3, nonrandomized, open-label study evaluating the pharmacokinetics, efficacy, and safety of a pediatric formulation of GLE and PIB in children ages 3 to < 12 years. APPROACH AND
resultsChildren with chronic HCV infection, genotype 1-6, with or without compensated cirrhosis, were divided into three cohorts by age-cohort 2 (9 to < 12 years), cohort 3 (6 to < 9 years), and cohort 4 (3 to < 6 years)-and given weight-based doses of GLE and PIB for 8, 12, or 16 weeks. Primary endpoints were sustained virologic response at posttreatment week 12 (SVR12) and steady-state exposure; secondary endpoints were rates of persistent viremia, relapse, and reinfection. Safety and laboratory abnormalities were assessed. Final pediatric dosages determined to be efficacious were 250 mg GLE + 100 mg PIB (in children weighing ≥ 30 to < 45 kg), 200 mg GLE + 80 mg PIB (≥ 20 to < 30 kg), and 150 mg GLE + 60 mg PIB (12 to < 20 kg). Of 80 participants enrolled and dosed, 96% (77/80) achieved SVR12. One participant, on the initial dose ratio, relapsed by posttreatment week 4; no participants had virologic failures on the final dose ratio of GLE 50 mg/PIB 20 mg. Two nonresponders prematurely discontinued the study. Most adverse events (AEs) were mild; no drug-related serious AEs occurred. Pharmacokinetic exposures were comparable to those of adults.
conclusionsA pediatric formulation of GLE/PIB was highly efficacious and well tolerated in chronic HCV-infected children 3 to < 12 years old.
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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.