Evidence map›Paper›PMID 28543053›Full record

Trial reportHepatology (Baltimore, Md.)2017

Sofosbuvir and ribavirin in adolescents 12-17 years old with hepatitis C virus genotype 2 or 3 infection.

Stefan Wirth, Philip Rosenthal, Regino P Gonzalez-Peralta, Maureen M Jonas, William F Balistreri, Chuan-Hao Lin, Winita Hardikar, Kathryn Kersey, Benedetta Massetto, Bittoo Kanwar and 7 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
10.7field-weighted citation impact, top 1% of its field
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.

NCT02175758 phase2completednot on this map

A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

TypeinterventionalSponsorGilead SciencesRan2014 to 2018Enrolled106ConditionsHepatitis C Virus InfectionArmsSOF, RBV
NCT03764345 nacompletednot on this mapstarted 2018, after this paper: background citation

Sofosbovir/Ledipasvir in HCV Infected Children Aged From 4 to 10 Years

TypeinterventionalSponsorNational Liver Institute, EgyptRan2018 to 2019Enrolled30ConditionsHepatitis C, Chronic, Children, OnlyArmsSofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. [Guideline for the prevention and treatment of hepatitis C (2022 version)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2022
    Guideline
  2. Pooled it
  3. Guideline
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. [Use of sofosbuvir-based regimens in the treatment of adolescents and children with chronic hepatitis C].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2021
    Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. [Guidelines for the prevention and treatment of hepatitis C (2019 version)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2019
    Article
  19. Observational
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 3 countries.

Stefan WirthHelios Medical Center, Witten/Herdecke University, Wuppertal, Germany.
Philip RosenthalUniversity of California San Francisco, San Francisco, CA.
Regino P Gonzalez-PeraltaUniversity of Florida College of Medicine and Shands Children's Hospital, Gainesville, FL.
Maureen M JonasBoston Children's Hospital, Boston, MA.
William F BalistreriCincinnati Children's Hospital Medical Center, Cincinnati, OH.
Chuan-Hao LinChildren's Hospital Los Angeles, Los Angeles, CA.
Winita HardikarThe Royal Children's Hospital Melbourne, Parkville, VIC, Australia.
Kathryn KerseyGilead Sciences, Inc, Foster City, CA.
Benedetta MassettoGilead Sciences, Inc, Foster City, CA.
Bittoo KanwarGilead Sciences, Inc, Foster City, CA.
Diana M BrainardGilead Sciences, Inc, Foster City, CA.
Jiang ShaoGilead Sciences, Inc, Foster City, CA.
Evguenia SvarovskaiaGilead Sciences, Inc, Foster City, CA.
Brian KirbyGilead Sciences, Inc, Foster City, CA.
Ronen ArnonThe Mount Sinai Hospital, New York, NY.
Karen F MurrayUniversity of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA.
Kathleen B SchwarzJohns Hopkins University School of Medicine, Baltimore, MD.
Gilead Sciences (United States) · USWitten/Herdecke University · DEBoston Children's Hospital · USChildren's Hospital of Los Angeles · USCincinnati Children's Hospital Medical Center · USFlorida College · USMount Sinai Hospital · USRoyal Children's Hospital · AUUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Children with chronic hepatitis C virus infection have limited treatment options. We evaluated the all-oral combination of sofosbuvir and ribavirin in adolescents aged 12-17 with hepatitis C virus genotype 2 or 3 (ClinicalTrials.gov NCT02175758). Fifty-two patients received sofosbuvir 400 mg once daily and weight-based ribavirin twice daily for 12 (genotype 2) or 24 (genotype 3) weeks. The pharmacokinetics of sofosbuvir and its metabolite GS-331007 were evaluated by intensive plasma sampling at day 7 in the first 10 patients enrolled and by sparse sampling in all patients throughout treatment. The primary efficacy endpoint was the percentage of patients with a sustained virologic response 12 weeks after treatment (SVR12). The median age of patients was 15 years, and 75% had genotype 3. Eighty-three percent of patients were treatment-naive, and 73% were infected by vertical transmission. Forty percent were assessed as not having cirrhosis; the remainder did not have a cirrhosis determination. Overall, SVR12 was achieved by 98% of patients (51/52; 95% confidence interval, 90%-100%). SVR12 rates were 100% (13/13) for patients with genotype 2 and 97% (38/39) for those with genotype 3. The single patient who did not achieve SVR12 was lost to follow-up after achieving SVR4. The most commonly reported adverse events were nausea (27%) and headache (23%). When compared with the exposure in adults treated in phase 2 and 3 sofosbuvir studies, the area under the curve and maximum concentration for sofosbuvir and GS-331007 in adolescents were within predefined pharmacokinetic equivalence boundaries of 50%-200%.

conclusionSofosbuvir and ribavirin was safe and highly effective in adolescents with chronic hepatitis C virus genotype 2 or 3 infection. (Hepatology 2017;66:1102-1110).

Indexed as

AdolescentAntiviral AgentsChildFemaleHepacivirusHepatitis C, ChronicHumansMaleRibavirinSofosbuvirSustained Virologic ResponseAntiviral AgentsRibavirinSofosbuvir

Identifiers

PMID28543053
OpenAlexW2620318023

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.