Drugs

pp 1–8 | Cite as

Glecaprevir/Pibrentasvir: First Global Approval

AdisInsight Report

Abstract

A fixed-dose combination tablet of the hepatitis C virus (HCV) NS3/4A protease inhibitor (PI) glecaprevir and the HCV NS5A inhibitor pibrentasvir [glecaprevir/pibrentasvir; MAVIRET™ (EU); MAVYRET™ (USA)] has been developed by AbbVie. Oral glecaprevir/pibrentasvir 300 mg/120 mg (three 100 mg/40 mg tablets) taken once daily has been approved by the EMA for the treatment of all major genotypes (genotypes 1–6) of chronic HCV infection in adults. It has also been approved by the US FDA for the treatment of adult patients with chronic HCV genotype 1–6 infection without cirrhosis and with compensated cirrhosis, and for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing either an HCV NS5A inhibitor or an NS3/4A PI, but not both. This article summarizes the milestones in the development of glecaprevir/pibrentasvir leading to its first global approval in the EU and subsequent approval in the USA for chronic HCV infection.

References

  1. 1.
    AbbVie. European Commission grants AbbVie’s MAVIRET® (glecaprevir/pibrentasvir) marketing authorisation for the treatment of chronic hepatitis C in all major genotypes (GT1-6) [media release]. 2017. http://www.abbvie.co.uk/.
  2. 2.
    AbbVie Ltd. Maviret (glecaprevir/pibrentasvir) 100 mg/40 mg film-coated tablets: summary of product characteristics. 2017. http://ec.europa.eu/. Accessed 6 Sept 2017.
  3. 3.
    AbbVie Inc. MAVYRET™ (glecaprevir and pibrentasvir) tablets, for oral use. 2017. http://www.rxabbvie.com/. Accessed 6 Sept 2017.
  4. 4.
    AbbVie. AbbVie recieves U.S. FDA approval of MAVYRET™ (glecaprevir/pibrentasvir) for the treatment of chronic hepatitis C in all major genotypes (GT 1-6) in as short as 8 weeks [media release]. 2017. http://news.abbvie.com/.
  5. 5.
    AbbVie. AbbVie’s MAVIRET™ approved by Health Canada for the treatment of chronic hepatitis C in all major genotypes [media release]. 2017. http://www.abbvie.com/.
  6. 6.
    AbbVie. Patient medication information: MAVIRET (glecaprevir/pibrentasvir tablets). 2017. http://www.abbvie.ca/. Accessed 6 Sept 2017.
  7. 7.
    Enanta Pharmaceuticals. Enanta announces Japanese Ministry of Health, Labour and Welfare grants priority review for AbbVies investigational HCV regimen of glecaprevir/ pibrentasvir (G/P) for the treatment of all major genotypes of chronic hepatitis C [media release]. 2017. http://www.enanta.com/.
  8. 8.
    AbbVie. AbbVie receives CHMP positive opinion for MAVIRET™ (glecaprevir/ pibrentasvir) for the treatment of chronic hepatitis C in all major genotypes (GT1-6) [media release]. 2017. http://www.abbvie.com/.
  9. 9.
    Enanta Pharmaceuticals. Form 10-Q. 2017. http://ir.enanta.com/. Accessed 6 Sept 2017.
  10. 10.
    Krishnan P, Schnell G, Tripathi R, et al. Pooled resistance analysis in HCV genotype 1–6-infected patients treated with glecaprevir/pibrentasvir in phase 2 and 3 clinical trials [abstract no. FRI-205]. J Hepatol. 2017;66(1 Suppl):S500.CrossRefGoogle Scholar
  11. 11.
    Lin CW, Liu W, Asatryan A, et al. Steady-state pharmacokinetics and safety of coadministration of pan-genotypic, direct acting protease inhibitor, ABT-493 with pan-genotypic NS5A inhibitor, ABT-530, in healthy adult subjects [abstract no. P0715]. J Hepatol. 2015;62(Suppl. 2):S592.CrossRefGoogle Scholar
  12. 12.
    Gane E, Poordad F, Valdes J, et al. Pharmacokinetics and safety of glecaprevir/pibrentasvir in adults with chronic genotype 1–6 hepatitis C virus infection and compensated cirrhosis: an integrated analysis [abstract no. THU-263 ]. J Hepatol. 2017;66(1 Suppl):S306.CrossRefGoogle Scholar
  13. 13.
    Asselah T, Hezode C, Zadeikis N, et al. ENDURANCE-4: efficacy and safety of ABT-493/ABT-530 treatment in patients with chronic HCV genotype 4, 5, or 6 infection [abstract and poster no. 114]. Hepatology. 2016;64(1 Suppl.):63A.Google Scholar
  14. 14.
    Forns X, Lee SS, Valdes J, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single, open-label, multicentre phase 3 trial. Lancet Infect Dis. 2017;. doi:10.1016/S1473-3099(17)30496-6.PubMedGoogle Scholar
  15. 15.
    Foster GR, Gane E, Asatryan A, et al. ENDURANCE-3: safety and efficacy of glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in treatment-naïve HCV genotype 3-infected patients without cirrhosis [abstract no. GS-007]. J Hepatol. 2017;66(1 Suppl):S33.CrossRefGoogle Scholar
  16. 16.
    Gane E, Lawitz EJ, Pugatch D, et al. EXPEDITION-IV: safety and efficacy of GLE/PIB in adults with renal impairment and chronic hepatitis C virus genotype 1–6 infection [abstract and poster no. LB-11]. Hepatology. 2016;64(6 Suppl.):1125A.Google Scholar
  17. 17.
    Kowdley KV, Colombo M, Zadeikis N, et al. ENDURANCE-2: safety and efficacy of ABT-493/ABT-530 in hepatitis C virus genotype 2-infected patients without cirrhosis, a randomized, double-blind, placebo-controlled study [abstract and poster no. 73]. Hepatology. 2016;64(1 Suppl.):39A.Google Scholar
  18. 18.
    Poordad F, Felizarta F, Asatryan A, et al. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology. 2017;66(2):389–97.CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Zeuzem S, Feld JJ, Wang S, et al. ENDURANCE-1: efficacy and safety of 8- versus 12-week treatment with ABT-493/ABT-530 in patients with chronic HCV genotype 1 infection [abstract and poster no. 253]. Hepatology. 2016;64(1 Suppl.):132A–3A.Google Scholar
  20. 20.
    Gane E, Poordad F, Wang S, et al. High efficacy of ABT-493 and ABT-530 treatment in patients with HCV genotype 1 or 3 infection and compensated cirrhosis. Gastroenterology. 2016;151(4):651–9.CrossRefPubMedGoogle Scholar
  21. 21.
    Kwo PY, Poordad F, Asatryan A, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1–6 without cirrhosis. J Hepatol. 2017;67(2):263–71.CrossRefPubMedGoogle Scholar
  22. 22.
    Puoti M, Foster G, Wang S, et al. High SVR rates with eight and twelve weeks of pangenotypic glecaprevir/pibrentasvir: integrated efficacy and safety analysis of genotype 1–6 patients without cirrhosis [abstract no. SAT-233]. J Hepatol. 2017;66(1 Suppl):S721.CrossRefGoogle Scholar
  23. 23.
    Pol S, Pockros P, Pugatch D, et al. Safety and efficacy of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus infection genotype 1–6 and chronic kidney disease: an integrated analysis [abstract no. SAT-273 ]. J Hepatol. 2017;66(1 Suppl):S738.CrossRefGoogle Scholar
  24. 24.
    Rockstroh J, Lacombe K, Viani RM, et al. Efficacy and safety of glecaprevir/pibrentasvir in patients co-infected with hepatitis C virus and human immunodeficiency virus-1: the EXPEDITION-2 study [abstract and poster no. LBP-522]. J Hepatol. 2017;66(1 Suppl):S102–3.CrossRefGoogle Scholar
  25. 25.
    Chayama K, Suzuki F, Karino Y, et al. CERTAIN-1: efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 1 hepatitis C virus infection with and without cirrhosis [abstract and poster no. FRI-262]. J Hepatol. 2017;66(1 Suppl):S527.CrossRefGoogle Scholar
  26. 26.
    Chayama K, Suzuki F, Sato K, et al. Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection with and without cirrhosis [abstract and poster no. FRI-263]. J Hepatol. 2017;66(1 Suppl):S528.CrossRefGoogle Scholar
  27. 27.
    Reau N, Kwo PY, Rhee S, et al. MAGELLAN-2: safety and efficacy of glecaprevir/pibrentasvir in liver or renal transplant adults with chronic hepatitis C genotype 1–6 infection [abstract and poster no. LBO-03]. J Hepatol. 2017;66(1 Suppl):S90–1.CrossRefGoogle Scholar
  28. 28.
    Poordad F, Pol S, Asatryan A, et al. MAGELLAN-1, part 2: glecaprevir and pibrentasvir for 12 or 16 weeks in patients with chronic hepatitis C virus genotype 1 or 4 and prior direct-acting antiviral treatment failure [abstract no. PS-156]. J Hepatol. 2017;66(1 Suppl):S83–4.CrossRefGoogle Scholar
  29. 29.
    Hassanein T, Wyles D, Wang S, et al. SURVEYOR-II, part 4: glecaprevir/pibrentasvir demonstrates high SVR rates in patients with HCV genotype 2, 4, 5, or 6 infection without cirrhosis following an 8-week treatment duration [abstract and poster no. LB-15]. In: American Association for the Study of Liver Diseases (AASLD). 2016.Google Scholar
  30. 30.
    Dufour JF, Zuckerman E, Zadeikis N, et al. Safety of glecaprevir/pibrentasvir in adults with chronic genotype 1–6 hepatitis C virus infection: an integrated analysis [abstract no. FRI-238]. J Hepatol. 2017;66(1 Suppl):S515.CrossRefGoogle Scholar

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations