Trial reportGastroenterology2011
The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C.
Trial report in Gastroenterology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00100659 (Pegylated Interferon +/- Ribavirin for Children With Hepatitis C), which is not on this map. Cited by 33 papers, 4 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.
Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
Who cites it
33 citing papers in PubMed, 4 syntheses or guidelines pooled it, 136 citations in OpenAlex.
- 2017 KASL clinical practice guidelines management of hepatitis C: Treatment of chronic hepatitis C.Clinical and molecular hepatology · 2018Guideline
- KASL clinical practice guidelines: management of hepatitis C.Clinical and molecular hepatology · 2016Guideline
- KASL clinical practice guidelines: management of hepatitis C.Clinical and molecular hepatology · 2014Guideline
- Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children: recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics.The Pediatric infectious disease journal · 2013Guideline
- Safety and efficacy of Hansenula-derived PEGylated-interferon alpha-2a and ribavirin combination in chronic hepatitis C Egyptian children.World journal of gastroenterology · 2014Trial
- Population pharmacokinetics of peginterferon alfa-2b in pediatric patients with chronic hepatitis C.European journal of clinical pharmacology · 2013Trial
- Autoantibodies and autoimmune disease during treatment of children with chronic hepatitis C.Journal of pediatric gastroenterology and nutrition · 2013Trial
- Pegylated interferon for chronic hepatitis C in children affects growth and body composition: results from the pediatric study of hepatitis C (PEDS-C) trial.Hepatology (Baltimore, Md.) · 2012Trial
- Treatment of hepatitis C in children and adolescents: how far have we reached?World journal of pediatrics : WJP · 2023Review
- Hepatitis B and C.Pediatric clinics of North America · 2017Review
- Hepatitis C virus infection in children and adolescents.Hepatology communications · 2017Review
- The Role of Direct-acting Antivirals in the Treatment of Children with Chronic Hepatitis C.Journal of clinical and translational hepatology · 2017Review
- Hepatitis B and C in Children.Indian journal of pediatrics · 2016Review
- Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016.Journal of clinical and experimental hepatology · 2016Review
- Use of an integrated modelling and simulation approach to develop a simplified peginterferon alfa-2a dosing regimen for children with hepatitis C.British journal of clinical pharmacology · 2016Article
- Interferon-α plus ribavirin yields 98 % sustained virologic response in children aged 1-5 years with iatrogenic chronic hepatitis C.Hepatology international · 2015Article
- Chronic Hepatitis C Infection in Children: Current Treatment and New Therapies.Journal of clinical and translational hepatology · 2015Review
- Treating HCV infection in children.Clinical liver disease · 2015Review
- Treatment of Hepatitis C Virus Infection in Children Less than 12 Years of Age in Developing Countries.Journal of clinical and translational hepatology · 2014Review
- New treatments for chronic hepatitis C: an overview for paediatricians.World journal of gastroenterology · 2014Review
Corrections and comments
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Authors and funding
18 authors at 16 institutions in 2 countries.
Funding
Abstract
BACKGROUND &
aimsAlthough randomized trials of adults infected with hepatitis C virus (HCV) have shown that ribavirin increases the efficacy of pegylated interferon (PEG), such trials have not been performed in children. We conducted a randomized controlled trial of PEG and ribavirin, compared with PEG and placebo, in children 5 to 17 years old with chronic hepatitis C.
methodsHCV RNA-positive children from 11 university medical centers were randomly assigned to receive either PEG alfa-2a (PEG-2a; 180 μg/1.73 m(2) body surface area, subcutaneously each week; n = 55) and ribavirin (15 mg/kg orally in 2 doses daily) or PEG-2a and placebo (n = 59) for 48 weeks. The primary end point was sustained virologic response (SVR; lack of detectable HCV RNA at least 24 weeks after stopping therapy).
resultsSVR was achieved in 53% of children treated with PEG-2a and ribavirin, compared with 21% of children who received PEG-2a and placebo (P < .001). Early virologic response (HCV RNA reduction >2 log(10) IU at 12 weeks) had a negative predictive value of only 0.89 in children with genotype 1, indicating that these children might benefit from 24 weeks of therapy before stopping treatment. Side effects, especially neutropenia, led to dose modification in 40% of children. Eighty-two percent of the PEG/ribavirin and 86% of the PEG/placebo group were in compliance with the year 2 follow-up visit; the durability of virologic response was 100% in both groups.
conclusionsThe combination of PEG and ribavirin is superior to PEG and placebo as therapy for chronic hepatitis C in children and adolescents.
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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.