Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

  1. Cornberg, Markus ORCID logo
  2. Ahumada, Adriana
  3. Aghemo, Alessio
  4. Andreoni, Massimo
  5. Bhagat, Abhi
  6. Butrymowicz, Isabel
  7. Carmiel, Michal
  8. Chodick, Gabriel
  9. Conway, Brian
  10. Song, Yanna
  11. Gasbarrini, Antonio
  12. Hüppe, Dietrich
  13. Plaza, Francisco Jorquera
  14. Lampertico, Pietro
  15. Alonso, Maria Luisa Manzano
  16. Myles, Lindsay
  17. Persico, Marcello
  18. Ramji, Alnoor
  19. Sarrazin, Christoph
  20. Villa, Erica
  21. Weil, Clara
  22. Otano, Juan Isidro Uriz

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1000 Titel
  • Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study
1000 Autor/in
  1. Cornberg, Markus |
  2. Ahumada, Adriana |
  3. Aghemo, Alessio |
  4. Andreoni, Massimo |
  5. Bhagat, Abhi |
  6. Butrymowicz, Isabel |
  7. Carmiel, Michal |
  8. Chodick, Gabriel |
  9. Conway, Brian |
  10. Song, Yanna |
  11. Gasbarrini, Antonio |
  12. Hüppe, Dietrich |
  13. Plaza, Francisco Jorquera |
  14. Lampertico, Pietro |
  15. Alonso, Maria Luisa Manzano |
  16. Myles, Lindsay |
  17. Persico, Marcello |
  18. Ramji, Alnoor |
  19. Sarrazin, Christoph |
  20. Villa, Erica |
  21. Weil, Clara |
  22. Otano, Juan Isidro Uriz |
1000 Verlag
  • Springer Healthcare
1000 Erscheinungsjahr 2022
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2022-05-11
1000 Erschienen in
1000 Quellenangabe
  • 39(7):3146-3158
1000 Copyrightjahr
  • 2022
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1007/s12325-022-02158-6 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9239949/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Introduction!#!In clinical trials with hepatitis C virus-infected treatment-naïve (TN) patients with compensated cirrhosis (CC), glecaprevir/pibrentasvir (G/P), a fixed-dose, once-daily, pangenotypic regimen, has demonstrated sustained virologic response at posttreatment Week 12 (SVR12) > 95%. We evaluated the real-world safety and effectiveness of 8-week G/P therapy in TN patients with CC, including certain subgroups of interest.!##!Methods!#!The CREST study is a real-world, noninterventional, multicenter study retrospectively assessing data from Canada, Germany, Israel, Italy, and Spain. The full analysis set (FAS) designated all patients in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 data. The primary endpoint was SVR12; safety endpoints were also assessed.!##!Results!#!A total of 386 patients were included in the FAS, 375 patients completed the study, and 325 patients were included in the MAS; 51 patients had missing SVR12 data. Overall, in the MAS and FAS, SVR12 was achieved in 99.1% and 84.2% of patients, respectively. In subgroups of interest, the percentage of patients achieving SVR12 in the MAS (and FAS) was: genotype (GT)3: 97.5% (80.6%); FibroScan!##!Conclusion!#!In this real-world cohort, 8 weeks of G/P therapy was well tolerated in TN patients with CC. SVR12 rates were similar to clinical trials, supporting 8-week treatment in TN patients with CC, including those with signs of advanced liver disease and GT3 infection.
1000 Sacherschließung
lokal Liver Cirrhosis/complications [MeSH]
lokal Cyclopropanes [MeSH]
lokal Sustained Virologic Response [MeSH]
lokal Quinoxalines [MeSH]
lokal Aminoisobutyric Acids [MeSH]
lokal Hepacivirus/genetics [MeSH]
lokal Hepatitis C, Chronic/genetics [MeSH]
lokal Real world
lokal Compensated cirrhosis
lokal Benzimidazoles [MeSH]
lokal Hepatitis C, Chronic/drug therapy [MeSH]
lokal Original Research
lokal Pyrrolidines/therapeutic use [MeSH]
lokal Sulfonamides [MeSH]
lokal Lactams, Macrocyclic [MeSH]
lokal Antiviral Agents/adverse effects [MeSH]
lokal Humans [MeSH]
lokal Retrospective Studies [MeSH]
lokal Treatment-naïve
lokal Hepatitis C, Chronic/complications [MeSH]
lokal Leucine/analogs
lokal Direct-acting antivirals
lokal Medical and Health Sciences
lokal Hepatitis C/drug therapy [MeSH]
lokal Genotype [MeSH]
lokal Liver Cirrhosis/drug therapy [MeSH]
lokal Proline/analogs
lokal Hepatitis C virus
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-9141-8001|https://frl.publisso.de/adhoc/uri/QWh1bWFkYSwgQWRyaWFuYQ==|https://frl.publisso.de/adhoc/uri/QWdoZW1vLCBBbGVzc2lv|https://frl.publisso.de/adhoc/uri/QW5kcmVvbmksIE1hc3NpbW8=|https://frl.publisso.de/adhoc/uri/QmhhZ2F0LCBBYmhp|https://frl.publisso.de/adhoc/uri/QnV0cnltb3dpY3osIElzYWJlbA==|https://frl.publisso.de/adhoc/uri/Q2FybWllbCwgTWljaGFs|https://frl.publisso.de/adhoc/uri/Q2hvZGljaywgR2FicmllbA==|https://frl.publisso.de/adhoc/uri/Q29ud2F5LCBCcmlhbg==|https://frl.publisso.de/adhoc/uri/U29uZywgWWFubmE=|https://frl.publisso.de/adhoc/uri/R2FzYmFycmluaSwgQW50b25pbw==|https://frl.publisso.de/adhoc/uri/SMO8cHBlLCBEaWV0cmljaA==|https://frl.publisso.de/adhoc/uri/UGxhemEsIEZyYW5jaXNjbyBKb3JxdWVyYQ==|https://frl.publisso.de/adhoc/uri/TGFtcGVydGljbywgUGlldHJv|https://frl.publisso.de/adhoc/uri/QWxvbnNvLCBNYXJpYSBMdWlzYSBNYW56YW5v|https://frl.publisso.de/adhoc/uri/TXlsZXMsIExpbmRzYXk=|https://frl.publisso.de/adhoc/uri/UGVyc2ljbywgTWFyY2VsbG8=|https://frl.publisso.de/adhoc/uri/UmFtamksIEFsbm9vcg==|https://frl.publisso.de/adhoc/uri/U2FycmF6aW4sIENocmlzdG9waA==|https://frl.publisso.de/adhoc/uri/VmlsbGEsIEVyaWNh|https://frl.publisso.de/adhoc/uri/V2VpbCwgQ2xhcmE=|https://frl.publisso.de/adhoc/uri/T3Rhbm8sIEp1YW4gSXNpZHJvIFVyaXo=
1000 Hinweis
  • DeepGreen-ID: b175b58877ad4dea8326f29b3c9f2db7 ; metadata provieded by: DeepGreen (https://www.oa-deepgreen.de/api/v1/), LIVIVO search scope life sciences (http://z3950.zbmed.de:6210/livivo), Crossref Unified Resource API (https://api.crossref.org/swagger-ui/index.html), to.science.api (https://frl.publisso.de/), ZDB JSON-API (beta) (https://zeitschriftendatenbank.de/api/), lobid - Dateninfrastruktur für Bibliotheken (https://lobid.org/resources/search)
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1000 Erstellt am 2024-10-03T01:54:12.531+0200
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1000 Zuletzt bearbeitet 2024-10-04T16:40:40.187+0200
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