Evidence map›Paper›PMID 29672891›Full record

Trial reportHepatology (Baltimore, Md.)2018

Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection.

Nancy Reau, Paul Y Kwo, Susan Rhee, Robert S Brown, Kosh Agarwal, Peter Angus, Edward Gane, Jia-Horng Kao, Parvez S Mantry, David Mutimer and 12 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 70 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 1 pooled it
16.6field-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.

NCT02692703 phase3completednot on this map

A Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (MAGELLAN-2)

TypeinterventionalSponsorAbbVieRan2016 to 2017Enrolled100ConditionsChronic Hepatitis C, HCV, Hepatitis C VirusArmsglecaprevir/pibrentasvir
NCT03801707 phase2 / phase3completednot on this mapstarted 2019, after this paper: background citation

An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient

TypeinterventionalSponsorOhio State UniversityRan2019 to 2021Enrolled54ConditionsKidney Transplant, Hepatitis C, HCVArmsSofosbuvir / Velpatasvir Oral Tablet [Epclusa], Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]
NCT04614142 phase4withdrawnnot on this mapstarted 2020, after this paper: background citation

Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access

TypeinterventionalSponsorMassachusetts General HospitalRan2020 to 2021Enrolled0ConditionsEnd Stage Renal Disease, Chronic Hepatitis cArmsGlecaprevir / Pibrentasvir Oral Tablet [Mavyret]
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 1 synthesis or guideline pooled it, 179 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Efficacy and safety of glecaprevir/pibrentasvir in patients with HCV genotype 5/6: An integrated analysis of phase 2/3 studies.Liver international : official journal of the International Association for the Study of the Liver · 2020
    Trial
  4. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Prophylactic 2-week glecaprevir/pibrentasvir in hepatitis C positive-to-negative kidney transplantation.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Article
  11. Review
  12. Renal Manifestations of Chronic Hepatitis C: A Review.Journal of clinical medicine · 2024
    Review
  13. Review
  14. Review
  15. SASLT guidelines: Update in treatment of hepatitis C virus infection, 2024.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
    Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article

10 more citing papers are in PubMed but not listed here.

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

22 authors at 10 institutions in 6 countries.

Nancy ReauRush University Medical Center, Chicago, IL.ORCID 0000-0003-2290-4580
Paul Y KwoStanford University School of Medicine, Palo Alto, CA.
Susan RheeAbbVie Inc., North Chicago, IL.
Robert S BrownCenter for Liver Disease and Transplantation, Weill Cornell Medical College, New York, NY.
Kosh AgarwalInstitute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK.ORCID 0000-0002-4754-828X
Peter AngusUniversity of Melbourne, Melbourne, Australia.
Edward GaneNew Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.
Jia-Horng KaoNational Taiwan University Hospital, Taipei, Taiwan.
Parvez S MantryThe Liver Institute at Methodist Dallas, Dallas, TX.
David MutimerQueen Elizabeth Hospital and NIHR Liver Biomedical Research Unit, Birmingham, UK.
K Rajender ReddyUniversity of Pennsylvania, Philadelphia, PA.ORCID 0000-0002-4898-7778
Tram T TranCedars Sinai Medical Center, Los Angeles, CA.
Yiran B HuAbbVie Inc., North Chicago, IL.
Abhishek GulatiAbbVie Inc., North Chicago, IL.
Preethi KrishnanAbbVie Inc., North Chicago, IL.
Emily O DumasAbbVie Inc., North Chicago, IL.
Ariel PorcallaAbbVie Inc., North Chicago, IL.
Nancy S ShulmanAbbVie Inc., North Chicago, IL.
Wei LiuAbbVie Inc., North Chicago, IL.
Suvajit SamantaAbbVie Inc., North Chicago, IL.
Roger TrinhAbbVie Inc., North Chicago, IL.
Xavier FornsLiver Unit, Hospital Clinic, CIBEREHD, IDIBAPS, University of Barcelona, Barcelona, Spain.
AbbVie (United States) · USRush University Medical Center · USAuckland City Hospital · NZCedars-Sinai Medical Center · USCornell University · USKing's College Hospital NHS Foundation Trust · GBNational Taiwan University Hospital · TWPalo Alto University · USThe University of Melbourne · AUUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Well-tolerated, ribavirin-free, pangenotypic hepatitis C virus (HCV) treatments for transplant recipients remain a high priority. Once-daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response at 12 weeks posttreatment (SVR12) across all major HCV genotypes (GTs). This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. MAGELLAN-2 was a phase 3, open-label trial conducted in patients who were ≥3 months posttransplant. Patients without cirrhosis who were HCV treatment-naive (GT1-6) or treatment-experienced (GT1, 2, 4-6; with interferon-based therapy with or without sofosbuvir, or sofosbuvir plus ribavirin) received glecaprevir/pibrentasvir (300/120 mg) once daily for 12 weeks. The primary endpoint compared the percentage of patients receiving glecaprevir/pibrentasvir with SVR12 to a historic SVR12 rate based on the standard of care. Safety of glecaprevir/pibrentasvir was assessed. In total, 80 liver transplant and 20 kidney transplant patients participated in the trial. Most patients had no or minimal fibrosis (80% had fibrosis scores F0-F1) and were infected with HCV GT1 (57%) or GT3 (24%). The overall SVR12 was 98% (n/N = 98/100; 95% confidence interval, 95.3%-100%), which exceeded the prespecified historic standard-of-care SVR12 threshold of 94%. One patient experienced virologic failure. One patient discontinued because of an adverse event considered to be unrelated to treatment; this patient achieved SVR12. Adverse events were mostly mild in severity, and laboratory abnormalities were infrequent.

conclusionOnce-daily glecaprevir/pibrentasvir for 12 weeks is a well-tolerated and efficacious, ribavirin-free treatment for patients with chronic HCV GT1-6 infection who have received a liver or kidney transplant. (ClinicalTrials.gov NCT02692703.) (Hepatology 2018; 00:000-000).

Indexed as

Kidney TransplantationLiver TransplantationAdultAgedAminoisobutyric AcidsBenzimidazolesCyclopropanesDose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationFemaleGraft RejectionGraft SurvivalHepatitis C, ChronicHumansInternationalityAminoisobutyric AcidsBenzimidazolesCyclopropanesglecaprevirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamides

Identifiers

PMID29672891
PMCPMC6220874
OpenAlexW2800563576

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.