1,000
Views
16
CrossRef citations to date
0
Altmetric
Drug Evaluation

Pharmacokinetics and pharmacodynamics of sofosbuvir and ledipasvir for the treatment of hepatitis C

, &
Pages 105-112 | Received 08 Aug 2016, Accepted 28 Oct 2016, Published online: 14 Nov 2016

References

  • Stanaway JD, Flaxman AD, Naghavi M, et al. The global burden of viral hepatitis from 1990 to 2013: findings from the global burden of disease study 2013. Lancet. 2016;388:1081–1088. DOI:10.1016/S0140-6736(16)30579-7
  • Arends JE, Lieveld FI, Boeijen LL, et al. Natural history and treatment of HCV/HIV coinfection: is it time to change paradigms? J Hepatol. 2015;63(5):1254–1262.
  • Thein HH, Yi Q, Dore GJ, et al. Estimation of stage-specific fibrosis progression rates in chronic hepatitis C virus infection: a meta-analysis and meta-regression. Hepatology. 2008;48(2):418–431.
  • Recommendations for Testing, Managing, and Treating Hepatitis C of the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA). Available from: http://www.hcvguidelines.org [ cited 2016 Jun 5]
  • European Association for the Study of the Liver (EASL) Recommendations on Treatment of Hepatitis C 2014. Available from: http://www.easl.eu/research/our-contributions/clinical-practice-guidelines/detail/recommendations-on-treatment-of-hepatitis-c-2015 [cited 2016 Jun 5]
  • Pearlman BL. Protease inhibitors for the tratment of chronic hepatitis C genotype-1 infection: the new standard of care. Lancet Infect Dis. 2012;12(9):717–728.
  • Incorporated VP. INCIVEKTM (telaprevir) film coated tablets. US prescribing information. Cambridge: Vertex Pharmaceuticals Incorporated; 2013.
  • Merck & Co Inc.. VICTRELIS® (boceprevir) Capsules for oral use. U.S Prescribing Information. Whitehouse Station: cited 2013 Sep.
  • González-Grande R, Jiménez-Pérez M1, González Arjona C1, et al. New approaches in the treatment of hepatitis C. World J Gastroenterol. 2016;22(4):1421–1432.
  • HARVONI® (ledipasvir and sofosbuvir) tablets, for oral use. US prescribing information. Foster City: Gilead Sciences, Inc.; 2016.
  • Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370(20):1889–1898.
  • Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370(16):1483–1493.
  • Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370(20):1879–1888.
  • Naggie S, Cooper C, Saag M, et al. Ledipasvir and Sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373(8):705–713.
  • Bourlière M, Bronowicki JP, De Ledinghen V, et al. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis. 2015;15(4):397–404.
  • Charlton M, Everson GT, Flamm SL, et al. Ledipasvir and sofosbuvir plus ribavirin for treatment of HCV infection in patients with advanced liver disease. Gastroenterology. 2015;149(3):649–659.
  • Manns M, Samuel D, Gane EJ, et al. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016;16(6):685–697.
  • Gane EJ, Hyland RH, An D, et al. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015;149(6):1454–1461.
  • Abergel A, Asselah T, Metivier S, et al. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5infection: an open-label, multicentre, single-arm, phase 2 study. Lancet Infect Dis. 2016;16(4):459–464.
  • Chemistry Review. Food and Drugs Administration (FDA). Chemistry Review. NDA: 205834. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000Approv.pdf
  • Babusis D, Curry MP, Denning JM, et al. Translational studies to understand the mechanism of liver delivery by sofosbuvir. 15th international workshop on clinical pharmacology of HIV and hepatitis therapy. 2014 May 19-21. Washington D. C., USA: Abstract O–12.
  • Clinical pharmacology and biopharmaceutics review. Food and Drugs Administration (FDA). NDA: 205834. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000ClinPharmR.pdf
  • Pharmacology review. Food and Drugs Administration (FDA). NDA: 205834. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000PharmR.pdf
  • Link J, Bannister R, Beilke L, et al. Nonclinical profile and phase I results in healthy volunteers of the novel and potent HCV NS5A inhibitor GS-5885. 61st annual meeting of the American Association for the Study of Liver Diseases (AASLD). 2010 Oct 30; Nov 2. Boston (MA), USA: Abstract 1883.
  • German P, Yang J, West S, et al. Effect of food and acid reducing agents on the relative bioavailability and pharmacokinetics of ledipasvir/sofosbuvir fixed dose combination tablet. 15th international workshop on clinical pharmacology of HIV and hepatitis therapy. 2014 May 19-21. Washington D. C., USA: Abstract P–15.
  • Cornpropst M, Denning J, Clemons D, et al. The effect of renal impairment and end stage renal disease on the single-dose pharmacokinetics of GS-7977. 47th Annual Meeting of the European Association for the Study of the Liver (EASL). Barcelona, Spain; 2012 Apr 18–22; p. Abstract 1101.
  • Mogalian E, Mathias A, Yang J, et al. The pharmacokinetics of ledipasvir, an HCV-specific NS5A inhibitor, in HCV-uninfected subjects with severe renal impairment. The 65th annual meeting of the American Association for the Study of Liver Diseases: the liver meeting (AASLD). Boston, USA; 2014 Nov 7-11; p. Abstract 1952.
  • German P, Mathias A, Yang J, et al. Pharmacokinetics of ledipasvir, an HCV-specific NS5A inhibitor, in HCV-uninfected subjects with moderate or severe hepatic impairment. 64th annual meeting of the American Association for the Study of Liver Diseases (AASLD). Washington, DC, USA; 2013 Nov 1–5; p. Abstract 467.
  • Murakami E, Tolstykh T, Bao H, et al. Mechanism of activation of PSI-7851 and its diastereoisomer PSI-7977. J Biol Chem. 2010;285(45):34337–34347.
  • Kirby B, Gordi T, Symonds WT, et al. Population pharmacokinetics of sofosbuvir and its major metabolite (GS- 331007) in healthy and HCV-infected adult subjects. 64th annual meeting of the American Association for the Study of Liver Diseases (AASLD). Washington, DC, USA; Nov 1–5 2013. p. Abstract 1106.
  • Lawitz E, Rodriguez-Torres M, Cornpropst M, et al. The effect of hepatic impairment on the safety, pharmacokinetics, and antiviral activity of GS-7977 in hepatitis C infected subjects treated for seven days. Annual Meeting of the European Association for the Study of the Liver (EASL). Barcelona, Spain; 2012 Apr 18–22; p. Abstract 1130.
  • Lawitz E, Rodriguez-Torres M, Denning J, et al. All-oral therapy with nucleotide inhibitors sofosbuvir and GS-0938 for 14 days in treatment-naive genotype 1 hepatitis C (NUCLEAR). J Viral Hepat. 2013;20(10):699–707.
  • Rodriguez-Torres M, Lawitz E, Kowdley KV, et al. Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: A randomized, 28-day, dose- ranging trial. J Hepatol. 2013;58(4):663–668.
  • Kirby B, Hanbin L, Kearney BP, et al. Population pharmacoki- netics analysis of ledipasvir (GS-5885) in healthy and hepatitis C virus-infected subjects. 15th international workshop on clinical pharmacology of HIV and hepatitis therapy. Washington D. C., USA; 2014 May 19-21; p. Abstract P–33.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.