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Comparison of first- and second-wave DAAs for HCV GT1: efficacy, safety, tolerability, and regimen complexity

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References

  1. Lavanchy D. The global burden of hepatitis C. Liver Int 2009;29(Suppl 1):74–81

    Article  PubMed  Google Scholar 

  2. 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;144(7):1450–1455

    Article  PubMed  Google Scholar 

  3. PegIntron® (Peginterferon alfa-2b). Injection, powder for solution for subcutaneous use [prescribing information]. Whitehouse Station, NJ: Schering Corporation: Whitehouse Station; 2001, 2013. NJ

  4. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347(13):975–982

    Article  CAS  PubMed  Google Scholar 

  5. 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;358(9286):958–965

    Article  CAS  PubMed  Google Scholar 

  6. McHutchison JG, Lawitz EJ, Shiffman ML, et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med 2009;361(6):580–593

    Article  CAS  PubMed  Google Scholar 

  7. Volk ML, Tocco R, Saini S, Lok AS. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology 2009;50(6):1750–1755

    Article  PubMed  Google Scholar 

  8. Poenisch M, Bartenschlager R. New insights into structure and replication of the hepatitis C virus and clinical implications. Semin Liver Dis 2010;30(4):333–347

    Article  CAS  PubMed  Google Scholar 

  9. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364(25):2405–2416

    Article  CAS  PubMed  Google Scholar 

  10. Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med 2011;364(25):2417–2428

    Article  CAS  PubMed  Google Scholar 

  11. Sherman KE, Flamm SL, Afdhal NH, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med 2011;365(11):1014–1024

    Article  CAS  PubMed  Google Scholar 

  12. Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364(13):1195–1206

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  13. Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011;364(13):1207–1217

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  14. Kwo PY, Lawitz EJ, McCone J, et al. Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial. Lancet 2010;376(9742):705–716

    Article  CAS  PubMed  Google Scholar 

  15. Ghany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology 2011;54(4):1433–1444

    Article  PubMed Central  PubMed  Google Scholar 

  16. Aghemo A, Degasperi E, Colombo M. Directly acting antivirals for the treatment of chronic hepatitis C: unresolved topics from registration trials. Dig Liver Dis 2013;45(1):1–7

    Article  PubMed  Google Scholar 

  17. Aghemo A, De FR. New horizons in hepatitis C antiviral therapy with direct-acting antivirals. Hepatology 2013;58(1):428–438

    Article  CAS  PubMed  Google Scholar 

  18. Sarrazin C, Hézode C, Zeuzem S, Pawlotsky JM. Antiviral strategies in hepatitis C virus infection. J Hepatol 2012;56(Suppl 1):S88–S100

    Article  CAS  PubMed  Google Scholar 

  19. Kiser JJ, Burton JR, Anderson PL, Everson GT. Review and management of drug interactions with boceprevir and telaprevir. Hepatology 2012;55(5):1620–1628

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  20. Holmberg SD, Spradling PR, Moorman AC, Denniston MM. Hepatitis C in the United States. N Engl J Med 2013;368(20):1859–1861

    Article  CAS  PubMed  Google Scholar 

  21. Jacobson IM, Kowdley KV, Kwo PY. Anemia management in the era of triple combination therapy for chronic HCV. Gastroenterol Hepatol (N Y) 2012;8(9 Suppl 6):1–16

    PubMed Central  Google Scholar 

  22. Poordad F, Lawitz E, Reddy KR, et al. Effects of ribavirin dose reduction vs erythropoietin for boceprevir-related anemia in patients with chronic HCV genotype 1 infection: a randomized trial. Gastroenterology 2013;145(5):1035–1044.

    Article  CAS  PubMed  Google Scholar 

  23. Sulkowski MS, Poordad F, Manns MP, et al. Anemia during treatment with peginterferon Alfa-2b/ribavirin and boceprevir: analysis from the serine protease inhibitor therapy 2 (SPRINT-2) trial. Hepatology 2013;57(3):974–984

    Article  CAS  PubMed  Google Scholar 

  24. Poynard T, McHutchison J, Manns M, et al. Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C. Gastroenterology 2002;122(5):1303–1313

    Article  CAS  PubMed  Google Scholar 

  25. Bruno S, Crosignani A, Facciotto C, et al. Sustained virologic response prevents the development of esophageal varices in compensated, Child-Pugh class A hepatitis C virus-induced cirrhosis. A 12-year prospective follow-up study. Hepatology 2010;51(6):2069–2076

    Article  CAS  PubMed  Google Scholar 

  26. Singal AG, Volk ML, Jensen D, Di Bisceglie AM, Schoenfeld PS. A sustained viral response is associated with reduced liver-related morbidity and mortality in patients with hepatitis C virus. Clin Gastroenterol Hepatol 2010;8(3):280–288

    Article  PubMed  Google Scholar 

  27. Hézode C, Fontaine H, Dorival C, et al. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French early access programme (ANRS CO20-CUPIC) - NCT01514890. J Hepatol 2013;59(3):434–441

    Article  PubMed  Google Scholar 

  28. Belperio PS, Hwang EW, Thomas IC, Mole LA, Cheung RC, Backus LI. Early virologic responses and hematologic safety of direct-acting antiviral therapies in veterans with chronic hepatitis C. Clin Gastroenterol Hepatol 2013;11(8):1021–1027

    Article  CAS  PubMed  Google Scholar 

  29. Fried MW, Buti M, Dore GJ, et al. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-Naive genotype 1 hepatitis C: the randomized PILLAR study. Hepatology 2013;58(6):1918–1929

    Article  CAS  PubMed  Google Scholar 

  30. Poordad F, Fried MW, Zeuzem S, Ferenci P, Lenz O, Sinha R, et al. Efficacy and tolerability of TMC435 150 mg once daily with peginterferon 〈-2a and ribavirin for treatment of HCV genotype 1 infection in patients with Metavir score F3 and F4 (PILLAR and ASPIRE trials). Hepatology 2013;56(Suppl 4):233A

    Google Scholar 

  31. Jacobson IM, Dore GJ, Foster GR, et al. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve patients: efficacy in difficult-to-treat patient sub-populations in the QUEST-1 and 2 Phase III trials. Presented at: the American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; November 1–5, 2013.

  32. Manns M, Marcellin P, Poordad FF, et al. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype-1 infection in treatment-naïve patients: results from QUEST-2, a Phase III trial. J Hepatol 2013;58:S567–S577

    Google Scholar 

  33. Jacobson I, Dore GJ, Foster GR, et al. Simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype-1 infection in treatment-naïve patients: results from QUEST-1, a Phase III trial. J Hepatol 2013;58:S567–S577.

    Google Scholar 

  34. Olysio [prescribing information]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP; 2013.

  35. Forns X, Lawitz E, Zeuzem S, Gane E, Bronowicki JP, Andreone P, et al. Simeprevir (TMC435) with peg-interferon á-2a/ribavirin for treatment of chronic HCV genotype 1 infection in patients who relapsed after previous interferon-based therapy: efficacy and safety in patient sub-populations in the PROMISE phase III trial. Presented at the American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; November 1–5, 2013.

  36. Lawitz E, Forns X, Zeuzem S, et al. Simeprevir (TMC435) With Peginterferon/Ribavirin for Treatment of Chronic HCV Genotype 1 Infection in Patients Who Relapsed After Previous Interferon-Based Therapy: results From PROMISE, a Phase III Trial. Gastroenterology 2013;77:S151

    Google Scholar 

  37. Sulkowski MS, Asselah T, Lalezari J, Ferenci P, Fainboim H, Leggett B, et al. Faldaprevir combined with peginterferon alfa-2a and ribavirin in treatment-naive patients with chronic genotype-1 HCV: sILEN-C1 trial. Hepatology 2013;57(6):2143–2154

    Article  CAS  PubMed  Google Scholar 

  38. Sulkowski MS, Bourliere M, Bronowicki JP, et al. Faldaprevir combined with peginterferon alfa-2a and ribavirin in chronic HCV genotype-1 patients with prior nonresponse: sILEN-C2 trial. Hepatology 2013;57(6):2155–2163

    Article  CAS  PubMed  Google Scholar 

  39. Jensen DM, Asselah T, Dieterich D, et al. A pooled analysis of two randomized, double-blind placebo-controlled Phase III trials (STARTVerso1&2) of faldaprevir plus pegylated interferon alfa-2a and ribavirin in treatment-naïve patients with chronic hepatitis C genotype-1 infection. Presented at: The American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; Nov 1–5, 2013.

  40. Jacobson IM, Asselah T, Ferenci P, t al. STARTVerso 3: A randomized, double-blind, placebo-controlled phase III trial of faldaprevir in combination with pegylated interferon á-2a and ribavirin in treatment-experienced patients with chronic HCV genotype-1 infection. Presented at: The American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; Nov 1–5, 2013.

  41. Rockstroh J, Nelson M, Soriano V, et al. STARTVerso 4 Phase III Trial of faldaprevir once-daily plus peg interferon alfa-2a and ribavirin (PR) in patients with HIV and HCV genotype 1 coinfection: end of treatment Response (ETR). Presented at: The American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; Nov 1–5, 2013.

  42. Vermehren J, Sarrazin C. The role of resistance in HCV treatment. Best Pract Res Clin Gastroenterol 2012;26(4):487–503

    Article  CAS  PubMed  Google Scholar 

  43. Scheel TK, Rice CM. Understanding the hepatitis C virus life cycle paves the way for highly effective therapies. Nat Med 2013;19(7):837–849

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  44. De Meyer S, Dierynck I, Ghys A, et al. Characterization of telaprevir treatment outcomes and resistance in patients with prior treatment failure: results from the REALIZE trial. Hepatology 2012;56(6):2106–2115

    Article  PubMed  Google Scholar 

  45. Janssen Therapeutics. Simeprevir (TMC435) treatment of patients with chronic hepatitis C. 2013 http://www.fdagov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371624.pdf. Accessed 24 Oct 2013.

  46. Berger KL, Triki I, Cartier M, et al. Baseline HCV NS3 polymorphisms and their Impact on treatment response in clinical studies of the HCV NS3 protease inhibitor faldaprevir. Antimicrob Agents Chemother 2013;58(2):698–705

    Article  PubMed  Google Scholar 

  47. You DM, Pockros PJ. Simeprevir for the treatment of chronic hepatitis C. Expert Opin Pharmacother 2013;14(18):2581–2589

    Article  CAS  PubMed  Google Scholar 

  48. Simmonds P. Genetic diversity and evolution of hepatitis C virus—15 years on. J Gen Virol 2004;85(Pt 11):3173–3188

    Article  CAS  PubMed  Google Scholar 

  49. Pawlotsky JM. Treatment failure and resistance with direct-acting antiviral drugs against hepatitis C virus. Hepatology 2011;53(5):1742–1751

    Article  CAS  PubMed  Google Scholar 

  50. Hézode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009;360(18):1839–1850

    Article  PubMed  Google Scholar 

  51. Kieffer TL, Sarrazin C, Miller JS, et al. Telaprevir and pegylated interferon-alpha-2a inhibit wild-type and resistant genotype 1 hepatitis C virus replication in patients. Hepatology 2007;46(3):631–639

    Article  CAS  PubMed  Google Scholar 

  52. Pawlotsky JM. Mechanisms of antiviral treatment efficacy and failure in chronic hepatitis C. Antiviral Res 2003;59(1):1–11

    Article  CAS  PubMed  Google Scholar 

  53. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Sustained virological response with daclatasvir plus sofosbuvir ± ribavirin (RBV) in chronic HCV genotype (GT) 1-infected patients who previously failed telaprevir (TVR) or boceprevir (BOC). Presented at: The 48th Annual Meeting of the European Association for the Study of the Liver; Amsterdam, The Netherlands; April 24–28, 2013.

  54. Sovaldi [prescribing information]. Foster City, CA: Gilead Sciences. 2013.

  55. Kowdley KV, Lawitz E, Crespo I, et al. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for tre-atment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet 2013;381(9883):2100–2107

    Article  CAS  PubMed  Google Scholar 

  56. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013;368(20):1878–1887

    Article  CAS  PubMed  Google Scholar 

  57. Izumi N, Lataillade M, Chayama K, et al. First report of peginterferon lambda/ribavirin in combination with either daclatasvir or asunaprevir in HCV genotype 1 Japanese patients: early sustained virologic response (SVR4) results from the D-LITE Japanese substudy. Presented at: The 63rd Annual Meeting of the American Association for the Study of Liver Diseases; Boston, MA; November; Boston, MA; November 9–13, 2012.

  58. Lok AS, Gardiner DF, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012;366(3):216–224

    Article  CAS  PubMed  Google Scholar 

  59. Lawitz E, Poordad F, Kowdley KV, et al. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1. J Hepatol 2013;59(1):18–23

    Article  CAS  PubMed  Google Scholar 

  60. Poordad F, Lawitz E, Kowdley KV, et al. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med 2013;368(1):45–53

    Article  CAS  PubMed  Google Scholar 

  61. Kowdley K, Lawitz E, Poordad F, et al. A 12-week interferon-free treatment regimen with ABT-450/r, ABT 267, ABT-333, and ribavirin achieves SVR12 rates (observed data) of 99 % in treatment-naïve patients and 93 % in prior null responders with HCV genotype 1 Infection. Presented at: The 63rd Annual Meeting of the American Association for the Study of Liver Diseases; Boston, MA; November; Boston, MA; November 9–13, 2012.

  62. Cohen D, Xie W, Larsen L, et al. Safety of ribavirin-containing regimens of ABT- 450/r, ABT-333, and ABT-267 for the treatment of HCV genotype 1 infection and efficacy in subjects with ribavirin dose reductions. Presented at: The American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; Nov 1–5, 2013.

  63. Poordad F, Hezode C, trinh R, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis c with cirrhosis. New Engl J Med 2014;. doi:10.14056/NEJMoa1402869.

    Google Scholar 

  64. Feld JJ, Kowdley KY, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. New Engl J Med 2015;. doi:10.1056/NEJMoa1315722.

    Google Scholar 

  65. Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. New Engl J Med 2014;. doi:10.1056/NEJMoa1401561.

    Google Scholar 

  66. AbbVie. A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in People With Chronic Hepatitis C. In: ClinicalTrials gov Bethesda (MD): National Library of Medicine 2014. Available from: URL: http://ClinicalTrials.gov/show/NCT01674725. Accessed 1 July 2014.

  67. AbbVie. A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection. In: ClinicalTrials gov Bethesda (MD): National Library of Medicine 2014. Available from: URL: http://ClinicalTrials.gov/show/NCT01767116. Accessed 1 July 2014.

  68. AbbVie. A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection. In: ClinicalTrials gov Bethesda (MD): National Library of Medicine 2014. Available from: URL: http://ClinicalTrials.gov/show/NCT01833533. Accessed 1 July 2014.

  69. Gane E, Stedman C, Anderson J, Hyland R, Hindes R, Symonds W. 100 % rapid virologic response for PSI-7977 + ribavirin in genotype 1 null responders (ELECTRON): Early viral decline similar to that observed in genotype 1 and genotype 2/3 treatment-naïve patients. Presented at: 19th Conference on Retroviruses and Opportunistic Infections (CROI); Seattle, WA;March 5–8, 2012.

  70. Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013;368(20):1867–1877

    Article  CAS  PubMed  Google Scholar 

  71. Zeuzem S, Dusheiko G, Salupere R, et al. Sofosbuvir + Ribavirin for 12 or 24 Weeks for Patients with HCV Genotype 2 or 3: the VALENCE trial. In: Presented at: The American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; bNov 1–5, 2013.

  72. Gane EJ, Stedman CA, Hyland RH, et al. ELECTRON: Once daily PSI-7977 plus RBV in HCV GT1/2/3. J Hepatol 2012;56(Suppl 2):S438–S439

    Article  Google Scholar 

  73. Osinusi A, Meissner EG, Lee Y. Sofosbuvir and ribavirin for hepatitis c genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA 2013;310(8):804–811

    Article  CAS  PubMed  Google Scholar 

  74. Gane E, Stedman CA, Hyland RH, Ding X, Pang PS, Symonds W. ELECTRON: 100% SVR rates for once-daily sofosbuvir plus ledipasvir plus ribavirin given for 12 weeks in treatment-naive and previously treated patients with HCV genotype 1. Presented at: 20th Conference on Retroviruses and Opportunistic Infections; Atlanta, GA; March 3–6, 2013.

  75. Gane E, Stedman C, Hyland R, et al. Once Daily Sofosbuvir/Ledipasvir Fixed Dose Combination with or without Ribavirin: the ELECTRON trial. Presented at: The American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; Nov 1–5, 2013.

  76. Afhdal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. New Engl J Med 2014;. doi:10.1056/NEJMoa1402454.

    Google Scholar 

  77. Afhdal N, reddy KR, Nelson, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. New Engl J Med 2014;370:1483–1493 doi:10.1056/NEJMoa1402355.

    Article  Google Scholar 

  78. Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. New Engl J Med 2014;370(20):1879–1888

    Article  PubMed  Google Scholar 

  79. Jacobson IM, Ghalib R, Rodriguez-Torres M, et al. SVR results of a once-daily regimen of simeprevir (SMV, TMC435) plus sofosbuvir (SOF, GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study. Presented at: The American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; Nov 1–5, 2013.

  80. Suzuki Y, Ikeda K, Suzuki F, et al. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol 2013;58(4):655–662.

    Article  CAS  PubMed  Google Scholar 

  81. Chayama K, Suzuki Y, Ikeda K, et al. All-oral combination of daclatasvir plus asunaprevir in interferon ineligible naive/intolerant and nonresponder Japanese patients chronically infected with HCV genotype 1b: results from a phase 3 trial. In: Presented at: The American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC; Nov 1–5, 2013.

  82. Everson GT, Sims KD, Rodriguez-Torres M, et al. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology 2014;146:420–429

    Article  CAS  PubMed  Google Scholar 

  83. Fattovich G, Giustina G, Degos F, et al. Morbidity and mortality in compensated cirrhosis type C: a retrospective follow-up study of 384 patients. Gastroenterology 1997;112(2):463–472

    Article  CAS  PubMed  Google Scholar 

  84. Thomas DL, Seeff LB. Natural history of hepatitis C. Clin Liver Dis 2005;9(3):383–98, vi.

  85. Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH. Pathogenesis, natural history, treatment, and prevention of hepatitis C. Ann Intern Med 2000;132(4):296–305

    Article  CAS  PubMed  Google Scholar 

  86. Vezali E, Aghemo A, Colombo M. A review of the treatment of chronic hepatitis C virus infection in cirrhosis. Clin Ther 2010;32(13):2117–2138

    Article  CAS  PubMed  Google Scholar 

  87. Afdhal N, Jacobson I, Brown RS, et al. The effect of liver fibrosis and cirrhosis on SVR in 4913 patients with hepatitis C: results From The WIN-R Trial. Presented at: Digestive Disease Week; Los Angeles, CA; May 21–24, 2006.

  88. Iacobellis A, Siciliano M, Annicchiarico BE, et al. Sustained virological responses following standard anti-viral therapy in decompensated HCV-infected cirrhotic patients. Aliment Pharmacol Ther 2009;30(2):146–153

    Article  CAS  PubMed  Google Scholar 

  89. Fabrizi F, Dixit V, Martin P, Messa P. Combined antiviral therapy of hepatitis C virus in dialysis patients: meta-analysis of clinical trials. J Viral Hepat 2011;18(7):e263–e269

    Article  CAS  PubMed  Google Scholar 

  90. Tsoulfas G, Goulis I, Giakoustidis D, Akriviadis E, Agorastou P, Imvrios G, et al. Hepatitis C and liver transplantation. Hippokratia 2009;13(4):211–215

    CAS  PubMed Central  PubMed  Google Scholar 

  91. Ciesek S, Wedemeyer H. Immunosuppression, liver injury and post-transplant HCV recurrence. J Viral Hepat 2012;19(1):1–8

    Article  CAS  PubMed  Google Scholar 

  92. Cheng WS, Roberts SK, McCaughan G, et al. Low virological response and high relapse rates in hepatitis C genotype 1 patients with advanced fibrosis despite adequate therapeutic dosing. J Hepatol 2010;53(4):616–623

    Article  PubMed  Google Scholar 

  93. Toniutto P, Fabris C, Bitetto D, et al. Antiviral treatment in patients with hepatitis C virus-related cirrhosis awaiting liver transplantation. Ther Clin Risk Manag 2008;4(3):599–603

    CAS  PubMed Central  PubMed  Google Scholar 

  94. Burton JR, Everson G. Initial experience with telaprevir for treating hepatitis C virus in liver recipients: virologic response, safety, and tolerability. Presented at: American Transplant Congress; Boston, MA; June 2–6, 2012.

  95. Kwo PY, Tector AJ. Oral direct-acting antiviral therapy to prevent reinfection of the liver graft after liver transplantation for hepatitis C virus-related cirrhosis. Liver Transpl 2013;19(7):780–781

    Article  PubMed  Google Scholar 

  96. Curry M, Forns X, Raymond T, Terrault N, et al. Pretransplant sofosbuvir and ribavirin to prevent recurrence of HCV infection after liver transplantation. Presented at: The American Association for the Study of Liver Diseases 64th Annual Meeting; Washington, DC;Nov 1-5, 2013.

  97. Duarte-Rojo A, Budhraja V, Veldt BJ, et al. Interleukin-28B and fibrosing cholestatic hepatitis in posttransplant hepatitis C: a case-control study and literature review. Liver Transpl 2013;19(12):1311–1317

    Article  PubMed  Google Scholar 

  98. Picciotto FP, Tritto G, Lanza AG, et al. Sustained virological response to antiviral therapy reduces mortality in HCV reinfection after liver transplantation. J Hepatol 2007;46(3):459–465

    Article  CAS  PubMed  Google Scholar 

  99. Berenguer M. Systematic review of the treatment of established recurrent hepatitis C with pegylated interferon in combination with ribavirin. J Hepatol 2008;49(2):274–287.

    Article  CAS  PubMed  Google Scholar 

  100. Carrion JA, Navasa M, Garcia-Retortillo M, et al. Efficacy of antiviral therapy on hepatitis C recurrence after liver transplantation: a randomized controlled study. Gastroenterology 2007;132(5):1746–1756

    Article  CAS  PubMed  Google Scholar 

  101. Yee HS, Chang MF, Pocha C, et al. Update on the management and treatment of hepatitis C virus infection: recommendations from the Department of Veterans Affairs Hepatitis C Resource Center Program and the National Hepatitis C Program Office. Am J Gastroenterol 2012;107(5):669–689

    Article  CAS  PubMed  Google Scholar 

  102. de Oliveira Pereria A, Shin H, Safdar A. Post liver transplant therapy with telaprevir for recurrent hepatitis C. Presented at: American Transplant Congress; Boston, MA; June 2–6 2012.

  103. Kwo PY, Ghabril M, Lacerda M, Vet al. Use of telaprevir plus PEG interferon/ribavirin for null responders post OLT with advanced fibrosis/cholestatic hepatitis C. J Hepatol 2012;56 (Suppl.).

  104. Verna EC, Burton JR, O’Leary JG, et al. J A multicenter study of protease inhibitor-triple therapy in HCV-infected liver transplant recipients: report from the CRUSH-C group. J Hepatol 2013;58(Suppl 1):20–21

    Google Scholar 

  105. Charlton MR, Gane E, Manns M, Brown RS, Curry M, Kwo PY. Sofosbuvir and ribavirin for the treatment of established recurrent hepatitis c infection after liver transplantation: preliminary results of a prospective, multicenter study. Presented at: The 64th Annual Meeting of the American Association for the Study of Liver Diseases; Washington, DC; November 1–5, 2013.

  106. Fabrizi F, Dixit V, Messa P, Martin P. Pegylated interferon monotherapy of chronic hepatitis C in dialysis patients: meta-analysis of clinical trials. J Med Virol 2010;82(5):768–775

    Article  CAS  PubMed  Google Scholar 

  107. Shiratori Y, Imazeki F, Moriyama M, et al. Histologic improvement of fibrosis in patients with hepatitis C who have sustained response to interferon therapy. Ann Intern Med 2000;132(7):517–524

    Article  CAS  PubMed  Google Scholar 

  108. Sclair SN, Patel A, Junaidi O, et al. Telaprevir or boceprevir therapy in chronic hepatitis C patients with end stage renal disease on hemodialysis is safe, tolerable and feasible. Presented at: The 48th Annual Meeting of the European Association for the Study of the Liver; Amsterdam, The Netherlands; April 24–28, 2013.

  109. Basu P, Siriki R, Shah N, et al. Telaprevir with adjusted dose of ribavirin in naïve CHC-G1: Efficacy and treatment in CHC in hemodialysis population. TARGET C (RCT). Presented at: The 48th Annual Meeting of the European Association for the Study of the Liver; msterdam, The Netherlands; April 24–28, 2013.

  110. Tapper EB, Afdhal NH. Is 3 the new 1: perspectives on virology, natural history, and treatment for hepatitis C genotype 3. J Viral Hepat 2014;20:669–677

    Article  Google Scholar 

  111. Lawitz E, Poordad F, Brainard DM, et al. Sofosbuvir in combination with PegIFN and ribavirin for 12 weeks provides high SVR rates in HCV-infected genotype 2 or 3 treatment-experienced patients with and without compenssated cirrhosis: Results from the LONESTAR-2 Study. Presented at The 64th Annual Meeting of the American Assication for the Study of Liver Diseases; Washington, DC: November 1–5, 2013. Abstract LB-4.

  112. Hagan LM, Yang Z, Ehteshami M, et al. All oral interferon-free treatment for chronic hepatitis C: case effectiveness analysis. J Viral Hepat 2014;20:847–857

    Article  Google Scholar 

  113. Mohd HK, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology 2013;57(4):1333–1342

    Article  Google Scholar 

  114. Gilead Sciences. Sovaldi registration in the developubg world. 2014 gilead com 2014Available from: URL: http://www.gilead.com/~/media/Files/pdfs/other/Sovaldi%20Registration%20-%20April%202014.pdf. Accessed 12 May 2014.

  115. Incivek [prescribing information]. Cambridge, MA: Vertex Pharmaceuticals Incorporated; 2013.

  116. Victrelis [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; 2013.

  117. Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Mullhaupt B, et al. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med 2013;369(7):630–639

    Article  CAS  PubMed  Google Scholar 

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Acknowledgement

Dr. Kowdley has received grants from AbbVie, Beckman, BMS, Boeringer Ingelheim, Gilead, Ikaria, Intercept, Janssen, Merck, Mochida, and Vertex; provided scientific consulting for Novartis and Tekmira Pharmaceuticals; and participated on the advisory boards of AbbVie, Boeringer Ingelheim, Gilead, Ikaria, Janssen, Merck, and Trio Health. Scientific consulting and advisory board participation honoraria were payable to his institution. Dr. Kwo has received consulting fees from Abbvie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Janssen, Merck, Novartis, and Vertex; has received fees for non-CME/CE services from Merck; and has received funds for research support from Abbvie, Bristol-Myers Squibb, Gilead Sciences, Merck, Roche, and Vertex.

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Dr. Burman has nothing to declare.

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Correspondence to Kris V. Kowdley.

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The authors meet criteria for authorship as recommended by the International committee of Medical Journal Editors (ICMJE). This project was supported in part by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), with editorial support provided by Dominic Sloane, PhD, of Adelphi Communications and subsequently independently developed by the authors.

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Burman, B.E., Kwo, P.Y. & Kowdley, K.V. Comparison of first- and second-wave DAAs for HCV GT1: efficacy, safety, tolerability, and regimen complexity. Hepatol Int 8, 352–364 (2014). https://doi.org/10.1007/s12072-014-9552-6

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