What are the treatment regimens for hepatitis C virus (HCV) genotype 4 in treatment-naïve patients?

1. Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr. 49(4):1335-74. [Medline].

2. Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31. 364(13):1195-206. [Medline].

3. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23. 364(25):2405-16. [Medline].

4. Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31. 364(13):1207-17. [Medline]. [Full Text].

5. Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23. 364(25):2417-28. [Medline].

6. Chen J, Florian J, Carter W, et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology. 2013 Jun. 144(7):1450-1455.e2. [Medline].

7. Foster GR, Pianko S, Brown A,et al, for the BOSON Study Group. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with hepatitis C virus genotype 3 infection and treatment-experienced patients with cirrhosis and hepatitis C virus genotype 2 infection. Gastroenterology. 2015 Nov. 149 (6):1462-70. [Medline].

8. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26. 347(13):975-82. [Medline].

9. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22. 358(9286):958-65. [Medline].

10. Olysio (simeprevir) [package insert]. Titusville, NJ: Janssen Therapeutics. 2013. Available at [Full Text].

11. Sovaldi (sofosbuvir) [package insert]. Foster City, CA: Gilead Sciences, Inc. 2013. Available at [Full Text].

12. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17. 370(16):1483-93. [Medline]. [Full Text].

13. Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15. 370(20):1889-98. [Medline]. [Full Text].

14. Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014 May 15. 370(20):1879-88. [Medline]. [Full Text].

15. Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM, Corregidor A, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014 Jul 26. [Medline].

16. Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24. 370(17):1594-603. [Medline].

17. Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24. 370(17):1604-14. [Medline].

18. Andreone P, Colombo MG, Enejosa JV,et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology. 2014 Aug. 147(2):359-365.e1. [Medline].

19. Ferenci P, Bernstein D, Lalezari J, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014 May 22. 370(21):1983-92. [Medline].

20. Poordad F, Hezode C, Trinh R, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014 May 22. 370(21):1973-82. [Medline].

21. Viekira Pak [package insert]. North Chicago, IL: AbbVie Inc. October 2015. Available at [Full Text].

22. US Food and Drug Administration. FDA approves Technivie for treatment of chronic hepatitis C genotype 4 [news release]. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455857.htm. July 24, 2015; Accessed: July 29, 2015.

23. Hezode C, Asselah T, Reddy KR, et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20. 385 (9986):2502-9. [Medline].

24. US Food and Drug Administration. FDA approves new treatment for chronic hepatitis C genotype 3 infections [news release]. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm. July 24, 2015; Accessed: July 29, 2015.

25. Nelson DR, Cooper JN, Lalezari JP, et al, for the ALLY-3 study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015 Apr. 61 (4):1127-35. [Medline]. [Full Text].

26. Leroy V, Angus PW, Bronowicki J-P, et al. All-oral treatment with daclatasvir (DCV) plus sofosbuvir (SOF) plus ribavirin (RBV) for 12 or 16 weeks in HCV genotype (GT) 3-infected patients with advanced fibrosis or cirrhosis: the ALLY-3+ phase 3 study [abstract LB-3]. Presented at: 2015 Annual Meeting of the American Association for the Study of Liver Diseases; November 13-17, 2015; San Francisco, California.

27. US Food and Drug Administratoin. FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4 [press release]. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-zepatier-treatment-chronic-hepatitis-c-genotypes-1-and-4. January 28, 2016; Accessed: February 28, 2016.

28. [Guideline] American Association for the Study of Liver Diseases, Infectious Diseases Society of America. Recommendations for testing, managing and treating hepatitis C. Available at http://www.hcvguidelines.org. Accessed: December 9, 2020.

29. Zepatier (elbasvir/grazoprevir) [package insert]. Whitehouse Station, NJ: Merck & Co, Inc. June 2018. Available at [Full Text].

30. Mavyret (glecaprevir/pibrentasvir) [package insert]. North Chicago, IL: AbbVie, Inc. September 2019. Available at [Full Text].

31. Harvoni (ledipasvir/sofosbuvir) [package insert]. Foster City, CA: Gilead Sciences, Inc. September 2019. Available at [Full Text].

32. Epclusa (sofosbuvir/velpatasvir) [package insert]. Foster City, CA: Gilead Sciences, Inc. September 2019. Available at [Full Text].

33. Vosevi (sofosbuvir/velpatasvir/voxilaprevir) [package insert]. Foster City, CA: Gilead Sciences, Inc. September 2019. Available at [Full Text].

34. Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir + ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial (abstract 1085). Presented at: 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 2013; Washington, DC. 526. [Full Text].

35. Daklinza [package insert]. Princeton, NJ: Bristol-Myers Squibb Co. July 2015. Available at [Full Text].

36. Sulkowski MS, Rodriguez-Torres M, Lalezari J, et al. All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients with coinfected with HIV (PHOTON-1) [abstract 212]. Presented at: 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 2013; Washington, DC. 106. [Full Text].

37. Moreno C, Hezode C, Marcellin P, et al. Efficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4. J Hepatol. 2015 May. 62 (5):1047-55. [Medline].

David C Wolf, MD, FACP, FACG, AGAF, FAASLD Medical Director of Liver Transplantation, Westchester Medical Center; Professor of Clinical Medicine, Division of Gastroenterology and Hepatobiliary Diseases, Department of Medicine, New York Medical College

David C Wolf, MD, FACP, FACG, AGAF, FAASLD is a member of the following medical societies: American Association for the Study of Liver Diseases, American College of Gastroenterology, American College of Physicians, American Gastroenterological Association

Disclosure: Serve(d) as a speaker or a member of a speakers bureau for: Salix; Gilead; Abbvie; Intercept; Merck.

Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.

Michael Stuart Bronze, MD David Ross Boyd Professor and Chairman, Department of Medicine, Stewart G Wolf Endowed Chair in Internal Medicine, Department of Medicine, University of Oklahoma Health Science Center; Master of the American College of Physicians; Fellow, Infectious Diseases Society of America; Fellow of the Royal College of Physicians, London

Michael Stuart Bronze, MD is a member of the following medical societies: Alpha Omega Alpha, American College of Physicians, American Medical Association, Association of Professors of Medicine, Infectious Diseases Society of America, Oklahoma State Medical Association, Southern Society for Clinical Investigation

Disclosure: Nothing to disclose.