Glecaprevir Explained

Glecaprevir (INN,[1]) is a hepatitis C virus (HCV) nonstructural (NS) protein 3/4A protease inhibitor that was identified jointly by AbbVie and Enanta Pharmaceuticals.[2] It is being developed as a treatment of chronic hepatitis C infection in co-formulation with an HCV NS5A inhibitor pibrentasvir. Together they demonstrated potent antiviral activity against major HCV genotypes and high barriers to resistance in vitro.[3]

On 19 December 2016, AbbVie submitted a new drug application to the U.S. Food and Drug Administration for the glecaprevir/pibrentasvir (trade name Mavyret) regimen for the treatment of all major genotypes (1–6) of chronic hepatitis C. On 3 August 2017 the FDA approved the combination for hepatitis C treatment.[4] In Europe, it was approved on 17 August 2017 for the same indication, under the trade name Maviret.[5]

See also

Notes and References

  1. Web site: International Nonproprietary Names for Pharmaceutical Substances (INN). Recommended International Nonproprietary Names: List 76 . World Health Organization . 25 February 2017 . 503.
  2. News: ACS names its 2023 Heroes of Chemistry . August 14, 2023 . 101 . 26 . Chemical & Engineering News . Notman . Nina . 2024-04-04 . https://web.archive.org/web/20240316194612/https://cen.acs.org/acs-news/ACS-names-2023-Heroes-Chemistry/101/web/2023/07 . 2024-03-16.
  3. Lawitz EJ, O'Riordan WD, Asatryan A, Freilich BL, Box TD, Overcash JS, Lovell S, Ng TI, Liu W, Campbell A, Lin CW, Yao B, Kort J . 6 . Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection . Antimicrobial Agents and Chemotherapy . 60 . 3 . 1546–55 . December 2015 . 26711747 . 4775945 . 10.1128/AAC.02264-15 .
  4. News: AbbVie Submits New Drug Application to U.S. FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C. . 25 February 2017 . AbbVie Inc. North Chicago, Illinois, U.S.A. . December 19, 2016 . en . 20 August 2017 . https://web.archive.org/web/20170820203045/https://news.abbvie.com/news/abbvie-submits-new-drug-application-to-us-fda-for-its-investigational-regimen-glecaprevirpibrentasvir-gp-for-treatment-all-major-genotypes-chronic-hepatitis-c.htm . dead .
  5. Web site: Maviret: EPAR – Summary for the public. European Medicines Agency. 2017-08-17. 2017-10-20. 2017-10-19. https://web.archive.org/web/20171019163924/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/004430/WC500233680.pdf. dead.