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Canadian Journal of Gastroenterology and Hepatology
Volume 2017, Article ID 6468309, 8 pages
https://doi.org/10.1155/2017/6468309
Review Article

The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1, Who Have Cirrhosis and Have Failed Prior Therapy: A Systematic Review and Meta-Analysis

1Department of Medicine, University of Calgary, Foothills Medical Centre, 1403 29th St. NW, Calgary, AB, Canada T2N 2T9
2Department of Community Health Sciences, University of Calgary, Teaching, Research and Wellness Building, 3280 Hospital Drive NW, Calgary, AB, Canada T2N 4N1

Correspondence should be addressed to William Stokes; ac.num@sekotsw

Received 7 September 2016; Revised 13 January 2017; Accepted 26 January 2017; Published 6 March 2017

Academic Editor: Kevork M. Peltekian

Copyright © 2017 William Stokes et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. M. Trubnikov, P. Yan, and C. Archibald, “Estimated prevalence of Hepatitis C virus infection in Canada,” Canada Communicable Disease Report CCDR, vol. 40, no. 19, 2011. View at Google Scholar
  2. Liver Disease in Canada: A Crisis in the Making, http://www.liver.ca/files/PDF/Liver_Disease_Report_2013/Liver_Disease_in_Canada_-_E.pdf.
  3. R. Myers, M. Krajden, M. Bilodeau, K. Kaita, P. Marotta, and K. Peltekian, “Burden of disease and cost of chronic hepatitis C infection in Canada,” Canadian Journal of Gastroenterology and Hepatology, vol. 28, no. 5, pp. 243–250, 2014. View at Google Scholar
  4. R. P. Myers, A. Ramji, M. Bilodeau, S. Wong, and J. J. Feld, “An update on the management of chronic hepatitis C: consensus guidelines from the Canadian Association for the study of the liver,” Canadian Journal of Gastroenterology, vol. 26, no. 6, pp. 359–375, 2012. View at Publisher · View at Google Scholar · View at Scopus
  5. N. Afdhal, K. R. Reddy, D. R. Nelson et al., “Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection,” The New England Journal of Medicine, vol. 370, no. 16, pp. 1483–1493, 2014. View at Publisher · View at Google Scholar
  6. M. Bourlière, J.-P. Bronowicki, V. de Ledinghen 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),” The Lancet Infectious Diseases, vol. 15, no. 4, pp. 397–404, 2015. View at Publisher · View at Google Scholar · View at Scopus
  7. S. Chopra, A. Muir, A. Bisceglie, and A. Bloom, “Treatment regimens for chronic hepatitis C virus genotype 1,” UpToDate, 2015, http://www.uptodate.com/contents/treatment-regimens-for-chronic-hepatitis-c-virus-genotype-1-infection-in-adults.
  8. E. Lawitz, F. F. Poordad, P. S. Pang et al., “Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial,” The Lancet, vol. 383, no. 9916, pp. 515–523, 2014. View at Publisher · View at Google Scholar · View at Scopus
  9. E. J. Gane, C. A. Stedman, R. H. Hyland et al., “Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection,” Gastroenterology, vol. 146, no. 3, pp. 736.e1–743.e1, 2014. View at Publisher · View at Google Scholar · View at Scopus
  10. M. Mizokami, O. Yokosuka, T. Takehara et al., “Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial,” The Lancet Infectious Diseases, vol. 15, no. 6, pp. 645–653, 2015. View at Publisher · View at Google Scholar · View at Scopus
  11. L. Shamseer, D. Moher, M. Clarke et al., “Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation,” British Medical Journal, vol. 349, Article ID g7647, 2015. View at Publisher · View at Google Scholar
  12. J. O. Link, J. G. Taylor, L. Xu et al., “Discovery of ledipasvir (GS-5885): a potent, once-daily oral NS5A inhibitor for the treatment of hepatitis C virus infection,” Journal of Medicinal Chemistry, vol. 57, no. 5, pp. 2033–2046, 2014. View at Publisher · View at Google Scholar
  13. J. P. Higgins, D. G. Altman, P. C. Gotzsche et al., “The Cochrane Collaboration's tool for assessing risk of bias in randomised trials,” BMJ, vol. 343, Article ID d5928, 2011. View at Publisher · View at Google Scholar
  14. C. B. Begg and M. Mazumdar, “Operating characteristics of a rank correlation test for publication bias,” Biometrics, vol. 50, no. 4, pp. 1088–1101, 1994. View at Publisher · View at Google Scholar
  15. J. E. Bekelman, Y. Li, and C. P. Gross, “Scope and impact of financial conflicts of interest in biomedical research. A systematic review,” JAMA, vol. 289, no. 4, pp. 454–465, 2003. View at Publisher · View at Google Scholar
  16. J. Lexchin, L. A. Bero, B. Djulbegovic, and O. Clark, “Pharmaceutical industry sponsorship and research outcome and quality: systematic review,” British Medical Journal, vol. 326, no. 7400, pp. 1167–1170, 2003. View at Publisher · View at Google Scholar · View at Scopus
  17. A. Lundh, S. Sismondo, J. Lexchin, O. A. Busuioc, and L. Bero, “Industry sponsorship and research outcome,” Cochrane Database of Systematic Reviews, vol. 12, 2012. View at Google Scholar · View at Scopus
  18. WHO, Adherence to Long-Term Therapies: Evidence for Action, WHO, Geneva, Switzerland, 2003, http://apps.who.int/medicinedocs/pdf/s4883e/s4883e.pdf.
  19. W. C. Blackwelder, “‘Proving the null hypothesis’ in clinical trials,” Controlled Clinical Trials, vol. 3, no. 4, pp. 345–353, 1982. View at Publisher · View at Google Scholar
  20. M. Buti, S. C. Gordon, E. Zuckerman et al., “Grazoprevir, elbasvir, and ribavirin for chronic hepatitis C virus genotype 1 infection after failure of pegylated interferon and ribavirin with an earlier-generation protease inhibitor: final 24-week results from C-SALVAGE,” Clinical Infectious Diseases, vol. 62, no. 1, pp. 32–36, 2016. View at Publisher · View at Google Scholar · View at Scopus
  21. L. Boglione, S. M. Pinna, C. S. Cardellino et al., “Treatment with daclatasvir and sofosbuvir for 24 weeks without ribavirin in cirrhotic patients who failed first-generation protease inhibitors,” Infection, vol. 45, no. 1, pp. 103–106, 2017. View at Publisher · View at Google Scholar
  22. Hepatitis C treatment Epclusa approved in Canada—key information, CATIE—Canada's Source for HIV and Hepatitis C Information, http://www.catie.ca/en/catienews/2016-07-20/hepatitis-c-treatment-epclusa-approved-canada-key-information.
  23. “Epclusa Recommended by CADTH Canadian Drug Expert Committee If,” 2017, http://www.hepctip.ca/drug-pipeline-2/epclusa-recommended-canadian-drug-expert-committee/.
  24. “Harvoni generic entry, patent expiration dates | GILEAD SCIENCES INC: ledipasvir; sofosbuvir,” 2017, https://www.drugpatentwatch.com/p/tradename/HARVONI.
  25. “Sofosbuvir; velpatasvir generic drug entry, pharmaceutical patent expiration and FTO,” 2017, https://www.drugpatentwatch.com/p/generic-api/SOFOSBUVIR%3B+VELPATASVIR.
  26. D. Moher, A. Liberati, J. Tetzlaff, D. G. Altman, and The PRISMA Group, “Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement,” PLoS Medicine, vol. 6, no. 7, Article ID e1000097, 2009. View at Publisher · View at Google Scholar