Evidence map›Paper›PMID 31222783›Full record

ArticleHepatology (Baltimore, Md.)2020

Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection.

Philip Rosenthal, Kathleen B Schwarz, Regino P Gonzalez-Peralta, Chuan-Hao Lin, Deidre A Kelly, Scott Nightingale, William F Balistreri, Sanjay Bansal, Maureen M Jonas, Benedetta Massetto and 11 more

Abstract read
In one paragraph

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 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

21 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. 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 · 2026
    Article
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  10. [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 · 2023
    Article
  11. Review
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  17. [From treatable to curable to eliminated ---- a decade of research progress in the diagnosis and treatment of hepatitis C].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2021
    Article
  18. Article
  19. Review
  20. Article
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

21 authors.

Philip RosenthalUniversity of California San Francisco, San Francisco, CA.
Kathleen B SchwarzJohns Hopkins University School of Medicine, Baltimore, MD.
Regino P Gonzalez-PeraltaUniversity of Florida College of Medicine and Shands Children's Hospital, Gainesville, FL.
Chuan-Hao LinChildren's Hospital Los Angeles, Los Angeles, CA.
Deidre A KellyBirmingham Children's Hospital, Birmingham, United Kingdom.
Scott NightingaleUniversity of Newcastle and John Hunter Children's Hospital, Australia.
William F BalistreriCincinnati Children's Hospital Medical Center, Cincinnati, OH.
Sanjay BansalKings College Hospital, London, United Kingdom.
Maureen M JonasBoston Children's Hospital, Boston, MA.
Benedetta MassettoGilead Sciences, Inc., Foster City, CA.
Diana M BrainardGilead Sciences, Inc., Foster City, CA.
Chia-Hsiang HsuehGilead Sciences, Inc., Foster City, CA.
Jiang ShaoGilead Sciences, Inc., Foster City, CA.
Bandita ParhyGilead Sciences, Inc., Foster City, CA.
Suzanne DavisonLeeds Children's Hospital, Leeds, United Kingdom.
Cornelia Feiterna-SperlingCharité - Universitaetsmedizin Berlin, Berlin, Germany.
Lynette A GillisMonroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN.
Giuseppe IndolfiMeyer Children's University Hospital, Florence, Italy.
Etienne M SokalCliniques Universitaires St. Luc, Université Catholique de Louvain, Brussels, Belgium.ORCID 0000-0001-5597-4708
Karen F MurrayUniversity of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA.
Stefan WirthHelios Medical Center, Witten/Herdecke University, Wuppertal, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Currently, the only approved hepatitis C virus (HCV) treatment for children aged <12 years is pegylated interferon plus ribavirin. In an open-label study, we evaluated the safety and efficacy of sofosbuvir plus ribavirin for 12 weeks in children aged 3 to <12 years chronically infected with genotype 2 or for 24 weeks in patients with genotype 3. Patients aged 3 to <6 years weighing <17 kg received sofosbuvir 150 mg, and patients aged 3 to <6 years weighing ≥17 kg and all patients aged 6 to <12 years received sofosbuvir 200 mg once daily. Intensive pharmacokinetic sampling conducted in each age group confirmed the appropriateness of sofosbuvir doses. For all patients, ribavirin dosing was determined by baseline weight (up to 1,400 mg/day, two divided doses). The primary efficacy endpoint was sustained virologic response 12 weeks after therapy (SVR12). Fifty-four patients were enrolled (41 aged 6 to <12 years and 13 aged 3 to <6 years). Most were treatment naïve (98%) and infected perinatally (94%). All but one patient achieved SVR12 (53/54, 98%; 95% confidence interval, 90%-100%). The patient who did not achieve SVR12 was a 4-year-old who discontinued treatment after 3 days because of "abnormal drug taste." The most commonly reported adverse events in patients aged 6 to <12 years were vomiting (32%) and headache (29%), and those in patients aged 3 to <6 years were vomiting (46%) and diarrhea (39%). One 3-year-old patient had a serious adverse event of accidental ribavirin overdose requiring hospitalization for monitoring; this patient completed treatment and achieved SVR12. Conclusion: Sofosbuvir plus ribavirin was well tolerated and highly effective in children aged 3 to <12 years with chronic HCV genotype 2 or 3 infection.

Indexed as

Antiviral AgentsChildChild, PreschoolDrug CombinationsFemaleGenotypeHepacivirusHepatitis C, ChronicHumansMaleRibavirinSofosbuvirSustained Virologic ResponseTreatment OutcomeAntiviral AgentsDrug CombinationsRibavirinSofosbuvir

Identifiers

PMID31222783
PMCPMC7004103

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.