Concise review: Interferon-free treatment of hepatitis C virus-Associated cirrhosis and liver graft infection

World Journal of Gastroenterology

Volumn 22, Issue 41, 2016, Pages 9044-9056

  Weiler, Nina ^a   Zeuzem, Stefan ^a   Welker, Martin Walter ^a  

^a UNIVERSITY HOSPITAL FRANKFURT   (Germany)

Author keywords

Cirrhosis; Direct antiviral agents; Hepatitis c; Interferon free antiviral treatment; Liver transplantation

Indexed keywords

ANTIVIRUS AGENT; DIRECT ACTING ANTIVIRAL AGENT; IMMUNOSUPPRESSIVE AGENT; INTERFERON; UNCLASSIFIED DRUG;

COHORT ANALYSIS; COMPENSATED LIVER CIRRHOSIS; DATA ANALYSIS; DECOMPENSATED LIVER CIRRHOSIS; DISEASE ASSOCIATION; DRUG APPROVAL; DRUG EFFICACY; DRUG RESPONSE; GRAFT INFECTION; GRAFT RECIPIENT; HEPATITIS C; HEPATITIS C VIRUS; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS GENOTYPE 2; HEPATITIS C VIRUS GENOTYPE 3; HEPATITIS C VIRUS GENOTYPE 4; HEPATITIS C VIRUS GENOTYPE 5; HEPATITIS C VIRUS GENOTYPE 6; HUMAN; LIVER GRAFT INFECTION; LIVER TRANSPLANTATION; MEDICAL RESEARCH; NONHUMAN; PROSPECTIVE STUDY; REVIEW; SCORING SYSTEM; TREATMENT PLANNING; VIRUS IDENTIFICATION; VIRUS VIRULENCE; ADVERSE EFFECTS; COMPLICATION; DRUG EFFECTS; DRUG INTERACTION; END STAGE LIVER DISEASE; GENETICS; GENOTYPE; HEPACIVIRUS; LIVER CIRRHOSIS; PATHOGENICITY; PATIENT SELECTION; RECURRENT DISEASE; RISK FACTOR; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME; VIROLOGY;

ANTIVIRAL AGENTS; DRUG INTERACTIONS; END STAGE LIVER DISEASE; GENOTYPE; HEPACIVIRUS; HEPATITIS C; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER CIRRHOSIS; LIVER TRANSPLANTATION; PATIENT SELECTION; RECURRENCE; RISK FACTORS; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME;

EID: 84995528415     PISSN: 10079327     EISSN: 22192840     Source Type: Journal    
DOI: 10.3748/wjg.v22.i41.9044     Document Type: Review

References (96)

1. Hepatitis C - Fact sheet N 164. In: Organisation WH, editor. World Health Organization, 2014.
2. Allison RD, Tong X, Moorman AC, Ly KN, Rupp L, Xu F, Gordon SC, Holmberg SD. Increased incidence of cancer and cancerrelated mortality among persons with chronic hepatitis C infection, 2006-2010. J Hepatol 2015; 63: 822-828 [PMID: 25937437 DOI:10.1016/j.jhep.2015.04.021].
3. van der Meer AJ, Wedemeyer H, Feld JJ, Dufour JF, Zeuzem S, Hansen BE, Janssen HL. Life expectancy in patients with chronic HCV infection and cirrhosis compared with a general population. JAMA 2014; 312: 1927-1928 [PMID: 25387192 DOI:10.1001/jama.2014.12627].
4. Adam R, Karam V, Delvart V, O'Grady J, Mirza D, Klempnauer J, Castaing D, Neuhaus P, Jamieson N, Salizzoni M, Pollard S, Lerut J, Paul A, Garcia-Valdecasas JC, Rodríguez FS, Burroughs A. Evolution of indications and results of liver transplantation in Europe. A report from the European Liver Transplant Registry (ELTR). J Hepatol 2012; 57: 675-688 [PMID: 22609307 DOI:10.1016/j.jhep.2012.04.015].
5. Degos F, Christidis C, Ganne-Carrie N, Farmachidi JP, Degott C, Guettier C, Trinchet JC, Beaugrand M, Chevret S. Hepatitis C virus related cirrhosis: Time to occurrence of hepatocellular carcinoma and death. Gut 2000; 47: 131-136 [PMID: 10861275 DOI:10.1136/gut.47.1.131].
6. Fattovich G. Progression of hepatitis B and C to hepatocellular carcinoma in Western countries. Hepatogastroenterology 1998; 45 Suppl 3: 1206-1213 [PMID: 9730376].
7. Chiba T, Matsuzaki Y, Abei M, Shoda J, Aikawa T, Tanaka N, Osuga T. Multivariate analysis of risk factors for hepatocellular carcinoma in patients with hepatitis C virus-related liver cirrhosis. J Gastroenterol 1996; 31: 552-558 [PMID: 8844477 DOI:10.1007/BF02355056].
8. Velosa J, Serejo F, Marinho R, Nunes J, Glória H. Eradication of hepatitis C virus reduces the risk of hepatocellular carcinoma in patients with compensated cirrhosis. Dig Dis Sci 2011; 56: 1853-1861 [PMID: 21374066 DOI:10.1007/s10620-011-1621-2].
9. Hsu CS, Chao YC, Lin HH, Chen DS, Kao JH. Systematic Review: Impact of Interferon-based Therapy on HCV-related Hepatocellular Carcinoma. Sci Rep 2015; 5: 9954 [PMID: 25963067 DOI:10.1038/srep09954].
10. Zhang L, Gwinn M, Hu DJ. Viral hepatitis C gets personal-The value of human genomics to public health. Public Health Genomics 2013; 16: 192-197 [PMID: 23859951 DOI:10.1159/000352014].
11. Friedrich-Rust M, Zeuzem S, Sarrazin C. Current therapy for hepatitis C. Int J Colorectal Dis 2007; 22: 341-349 [PMID: 16175369 DOI:10.1007/s00384-005-0038-9].
12. Peveling-Oberhag J, Zeuzem S, Hofmann WP. Antiviral therapy of chronic hepatitis C in patients with advanced liver disease and after liver transplantation. Med Microbiol Immunol 2010; 199: 1-10 [PMID: 19902246 DOI:10.1007/s00430-009-0131-8].
13. Levitsky J, Fiel MI, Norvell JP, Wang E, Watt KD, Curry MP, Tewani S, McCashland TM, Hoteit MA, Shaked A, Saab S, Chi AC, Tien A, Schiano TD. Risk for immune-mediated graft dysfunction in liver transplant recipients with recurrent HCV infection treated with pegylated interferon. Gastroenterology 2012; 142: 1132-1139.e1 [PMID: 22285805 DOI:10.1053/j.gastro.2012.01.030].
14. Han DS, Hahm B, Rho HM, Jang SK. Identification of the protease domain in NS3 of hepatitis C virus. J Gen Virol 1995; 76 (Pt 4): 985-993 [PMID: 9049347 DOI:10.1099/0022-1317-76-4-985].
15. Welzel TM, Dultz G, Zeuzem S. Interferon-free antiviral combination therapies without nucleosidic polymerase inhibitors. J Hepatol 2014; 61: S98-S107 [PMID: 25443350 DOI:10.1016/j.jhep.2014.08.014].
16. Sarrazin C, Hézode C, Zeuzem S, Pawlotsky JM. Antiviral strategies in hepatitis C virus infection. J Hepatol 2012; 56 Suppl 1: S88-S100 [PMID: 22300469 DOI:10.1016/S0168-8278(12)60010-5].
17. Abergel A, Asselah T, Metivier S, Kersey K, Jiang D, Mo H, Pang PS, Samuel D, Loustaud-Ratti V. Ledipasvir-sofosbuvir in patients with hepatitis C virus genotype 5 infection: An open-label, multicentre, single-Arm, phase 2 study. Lancet Infect Dis 2016; 16: 459-464 [PMID: 26803446].
18. Bourlière M, Bronowicki JP, de Ledinghen V, Hézode C, Zoulim F, Mathurin P, Tran A, Larrey DG, Ratziu V, Alric L, Hyland RH, Jiang D, Doehle B, Pang PS, Symonds WT, Subramanian GM, McHutchison JG, Marcellin P, Habersetzer F, Guyader D, Grangé JD, Loustaud-Ratti V, Serfaty L, Metivier S, Leroy V, Abergel A, Pol S. 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: 397-404 [PMID: 25773757 DOI:10.1016/S1473-3099(15)70050-2].
19. Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS, Fried MW, Terrault NA, O'Leary JG, Vargas HE, Kuo A, Schiff E, Sulkowski MS, Gilroy R, Watt KD, Brown K, Kwo P, Pungpapong S, Korenblat KM, Muir AJ, Teperman L, Fontana RJ, Denning J, Arterburn S, Dvory-Sobol H, Brandt-Sarif T, Pang PS, McHutchison JG, Reddy KR, Afdhal N. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology 2015; 149: 649-659 [PMID: 25985734 DOI:10.1053/j.gastro.2015.05.010].
20. Curry MP, O'Leary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, Reddy KR, Lawitz E, Flamm SL, Schiano T, Teperman L, Fontana R, Schiff E, Fried M, Doehle B, An D, McNally J, Osinusi A, Brainard DM, McHutchison JG, Brown RS, Charlton M. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med 2015; 373: 2618-2628 [PMID: 26569658 DOI:10.1056/NEJMoa1512614].
21. Curry MP, Forns X, Chung RT, Terrault NA, Brown R, Fenkel JM, Gordon F, O'Leary J, Kuo A, Schiano T, Everson G, Schiff E, Befeler A, Gane E, Saab S, McHutchison JG, Subramanian GM, Symonds WT, Denning J, McNair L, Arterburn S, Svarovskaia E, Moonka D, Afdhal N. Sofosbuvir and ribavirin prevent recurrence of HCV infection after liver transplantation: An open-label study. Gastroenterology 2015; 148: 100-107.e1 [PMID: 25261839 DOI:10.1053/j.gastro.2014.09.023].
22. Feld JJ, Jacobson IM, Hézode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med 2015; 373: 2599-2607 [PMID: 26571066 DOI:10.1056/NEJMoa1512610].
23. Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol 2016; 64: 301-307 [PMID: 26476290 DOI:10.1016/j.jhep.2015.10.005].
24. Forns X, Gordon SC, Zuckerman E, Lawitz E, Calleja JL, Hofer H, Gilbert C, Palcza J, Howe AY, DiNubile MJ, Robertson MN, Wahl J, Barr E, Buti M. Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-Acting antiviral agent. J Hepatol 2015; 63: 564-572 [PMID: 25895428 DOI:10.1016/j.jhep.2015.04.009].
25. Foster GR, Afdhal N, Roberts SK, Bräu N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourlière M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med 2015; 373: 2608-2617 [PMID: 26575258 DOI:10.1056/NEJMoa1512612].
26. Kumada H, Chayama K, Rodrigues L, Suzuki F, Ikeda K, Toyoda H, Sato K, Karino Y, Matsuzaki Y, Kioka K, Setze C, Pilot- Matias T, Patwardhan M, Vilchez RA, Burroughs M, Redman R. Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis. Hepatology 2015; 62: 1037-1046 [PMID: 26147154 DOI:10.1002/hep.27972].
27. Lawitz E, Matusow G, DeJesus E, Yoshida EM, Felizarta F, Ghalib R, Godofsky E, Herring RW, Poleynard G, Sheikh A, Tobias H, Kugelmas M, Kalmeijer R, Peeters M, Lenz O, Fevery B, De La Rosa G, Scott J, Sinha R, Witek J. Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A phase 3 study (OPTIMIST-2). Hepatology 2016; 64: 360-369 [PMID: 26704148 DOI:10.1002/hep.28422].
28. Lawitz E, Gane E, Pearlman B, Tam E, Ghesquiere W, Guyader D, Alric L, Bronowicki JP, Lester L, Sievert W, Ghalib R, Balart L, Sund F, Lagging M, Dutko F, Shaughnessy M, Hwang P, Howe AY, Wahl J, Robertson M, Barr E, Haber B. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): A randomised, open-label phase 2 trial. Lancet 2015; 385: 1075-1086 [PMID: 25467591 DOI:10.1016/S0140-6736(14)61795-5].
29. Lawitz E, Makara M, Akarca US, Thuluvath PJ, Preotescu LL, Varunok P, Morillas RM, Hall C, Mobashery N, Redman R, Pilot-Matias T, Vilchez RA, Hézode C. Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis. Gastroenterology 2015; 149: 971-80. e1 [PMID: 26170136 DOI:10.1053/j.gastro.2015.07.001].
30. Leroy V, Angus P, Bronowicki JP, Dore GJ, Hezode C, Pianko S, Pol S, Stuart K, Tse E, McPhee F, Bhore R, Jimenez-Exposito MJ, Thompson AJ. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+). Hepatology 2016; 63: 1430-1441 [PMID: 26822022 DOI:10.1002/hep.28473].
31. Manns M, Forns X, Samuel D, Denning J, Arterburn S, Brandt-Sarif T, Dvory-Sobol H, Pang P, McHutchison J, Gane E, Mutimer D. Ledipasvir/sofosbuvir with ribavirin is safe and efficacious in decompensated and post-liver transplant patients with HCV infection: preliminary results of the SOLAR-2 trial. Proceedings of the 50th Annual Meeting of the European Association for the Study of the Liver; 2015 April 18-22. Vienna, Austria, 2015.
32. Mizokami M, Yokosuka O, Takehara T, Sakamoto N, Korenaga M, Mochizuki H, Nakane K, Enomoto H, Ikeda F, Yanase M, Toyoda H, Genda T, Umemura T, Yatsuhashi H, Ide T, Toda N, Nirei K, Ueno Y, Nishigaki Y, Betular J, Gao B, Ishizaki A, Omote M, Mo H, Garrison K, Pang PS, Knox SJ, Symonds WT, McHutchison JG, Izumi N, Omata M. Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatmentnaive and previously treated Japanese patients with genotype 1 hepatitis C: An open-label, randomised, phase 3 trial. Lancet Infect Dis 2015; 15: 645-653 [PMID: 25863559 DOI:10.1016/S1473-3099(15)70099-X].
33. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes ZH, Harlan W, Ghalib R, Oguchi G, Thuluvath PJ, Ortiz-Lasanta G, Rabinovitz M, Bernstein D, Bennett M, Hawkins T, Ravendhran N, Sheikh AM, Varunok P, Kowdley KV, Hennicken D, McPhee F, Rana K, Hughes EA. 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; 61: 1127-1135 [PMID: 25614962 DOI:10.1002/hep.27726].
34. Omata M, Nishiguchi S, Ueno Y, Mochizuki H, Izumi N, Ikeda F, Toyoda H, Yokosuka O, Nirei K, Genda T, Umemura T, Takehara T, Sakamoto N, Nishigaki Y, Nakane K, Toda N, Ide T, Yanase M, Hino K, Gao B, Garrison KL, Dvory-Sobol H, Ishizaki A, Omote M, Brainard D, Knox S, Symonds WT, McHutchison JG, Yatsuhashi H, Mizokami M. Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: An open-label, phase 3 trial. J Viral Hepat 2014; 21: 762-768 [PMID: 25196837 DOI:10.1111/jvh.12312].
35. Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X, Lovell SS, Da Silva-Tillmann B, Collins CA, Campbell AL, Podsadecki T, Bernstein B. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med 2014; 370: 1973-1982 [PMID: 24725237 DOI:10.1056/NEJMoa1402869].
36. Poordad F, Schiff ER, Vierling JM, Landis C, Fontana RJ, Yang R, McPhee F, Hughes EA, Noviello S, Swenson ES. Daclatasvir, sofosbuvir, and ribavirin combination for HCV patients with advanced cirrhosis or post-Transplant recurrence: ALLY-1 phase 3 study. Proceedings of the 50th Annual Meeting of the European Association for the Study of the Liver; 2015 April 22-26. Vienna, Austria, 2015.
37. Poordad F, Bennett M, Sepe TE, Cohen E, Reindollar RW, Everson G, Phillips RW, Siddique A, Sullivan JG, Box TD, Fu B, Pilot-Mati T, Abunimeh M, Cohen DE, Younes Z. QUARTZ-I: Retreatment of HCV Genotype 1 DAA-failures With Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir Proceedings of the 66th Annual Meeting of the American Association for the Study of Liver Diseases; 2015 Nov 13-17. Boston, MA, United States, 2015.
38. Wyles D, Pockros P, Morelli G, Younes Z, Svarovskaia E, Yang JC, Pang PS, Zhu Y, McHutchison JG, Flamm S, Lawitz E. Ledipasvirsofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens. Hepatology 2015; 61: 1793-1797 [PMID: 25846014 DOI:10.1002/hep.27814].
39. Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hézode C, Esteban R. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 2014; 370: 1993-2001 [PMID: 24795201 DOI:10.1056/NEJMoa1316145].
40. Zeuzem S, Ghalib R, Reddy KR, Pockros PJ, Ben Ari Z, Zhao Y, Brown DD, Wan S, DiNubile MJ, Nguyen BY, Robertson MN, Wahl J, Barr E, Butterton JR. Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med 2015; 163: 1-13 [PMID: 25909356 DOI:10.7326/M15-0785].
41. Welzel TM, Herzer K, Ferenci P, Petersen J, Gschwantler M, Cornberg M, Berg T, Spengler U, Weiland O, Van der Valk M, Klinker H, Rockstroh J, Ingiliz P, Peck-Radosavljevic M, Jimenez- Exposito MJ, Zeuzem S. P0772: Daclatasvir plus sofosbuvir with or without ribavirin for the treatment of HCV in patients with severe liver disease: Interim results of a multicenter compassionate use program. J Hepatol 2015; 62: S619-S620 [DOI:10.1016/s0168-8278(15)30975-2].
42. Reddy KR, Bourlière M, Sulkowski M, Omata M, Zeuzem S, Feld JJ, Lawitz E, Marcellin P, Welzel TM, Hyland R, Ding X, Yang J, Knox S, Pang P, Dvory-Sobol H, Subramanian GM, Symonds W, McHutchison JG, Mangia A, Gane E, Mizokami M, Pol S, Afdhal N. Ledipasvir and sofosbuvir in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis: An integrated safety and efficacy analysis. Hepatology 2015; 62: 79-86 [PMID: 25846144 DOI:10.1002/hep.27826].
43. Saxena V, Nyberg L, Pauly M, Dasgupta A, Nyberg A, Piasecki B, Winston B, Redd J, Ready J, Terrault NA. Safety and Efficacy of Simeprevir/Sofosbuvir in Hepatitis C-Infected Patients With Compensated and Decompensated Cirrhosis. Hepatology 2015; 62: 715-725 [PMID: 26033798 DOI:10.1002/hep.27922].
44. Shiffman ML, James AM, Long AG, Alexander PC. Treatment of chronic HCV with sofosbuvir and simeprevir in patients with cirrhosis and contraindications to interferon and/or ribavirin. Am J Gastroenterol 2015; 110: 1179-1185 [PMID: 26215530 DOI:10.1038/ajg.2015.218].
45. Welzel TM, Petersen J, Ferenci P, Gschwantler M, Herzer K, Cornberg M, Schott E, Berg T, Spengler U, Weiland O, van der Valk M, Geier A, Rockstroh JK, Peck-Radosavljevic M, Zhao Y, Jimenez Exposito MJ, Zeuzem S. Safety and efficacy of daclatasvir plus sofosbuvir with or without ribavirin for the treatment of chronic HCV genotype 3 infection: Interim results of a multicenter European compassionate use program. Proceedings of the 66th Annual Meeting of the American Association for the Study of Liver Diseases; 2015 November 13-17. San Francisco, CA, USA, 2015.
46. Jensen D, ÒLeary J, Pockros P, Sherman K, Kwo P, Mailliard M, Kowdley K, Muir A, Dickson R, Ramani A, Manns M, Lok A, Akushevich L, Nelson D, Fried M, Group ftH-TS. Safety and efficacy of sofosbuvir-containing regimens for hepatitis C: realworld experience in a diverse, longitudinal observational cohort. [Abstract 45.]. Proceedings of the 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11. Boston, MA, USA, 2014.
47. Coilly A, Pageaux G, Houssel-Debry P, Duvoux C, Radenne S, de Ledinghen V, Botta-Fridlund D, Vallet-Pichard A, Anty R, Di Martino V, Conti F, Debette-Gratien M, Laurent Alric L, Abergel A, Besch C, Montialoux H, Lebray P, Dharancy S, Durand F, d' Alteroche L, Charier F, Chazouillères O, Dumortier J, Leroy V, Duclos-Vallee J. Improving liver function and delisting of patients awaiting liver transplantation for HCV cirrhosis: do we ask too much to DAA? Proceedings of the Annual Meeting of the American Association for the Study of Liver Diseases; 2015 November 13-17. San Francisco, USA, 2015.
48. Hezode C, de Ledinghen V, Fontaine H, Zoulim F, Lebray P, Boyer N, Larrey DG, Silvain C, Botta-Fridlund D, Leroy V, Bourlière M, d'Alteroche L, Fouchard-Hubert I, Guyader D, Rosa I, Nguyen-Khac E, Di Martino V, Carrat F, Fedchuk L, Akremi R, Bennai Y, Bronowicki J-P. Daclatasvir plus sofosbuvir with or without ribavirin in genotype 3 patients from a large French multicenter compassionate use program. Proceedings of the 66th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2015 November 13-17. San Francisco, California, USA, 2015.
49. Foster GR, Irving WL, Cheung MC, Walker AJ, Hudson BE, Verma S, McLauchlan J, Mutimer DJ, Brown A, Gelson WT, MacDonald DC, Agarwal K. Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis. J Hepatol 2016; 64: 1224-1231 [PMID: 26829205 DOI:10.1016/j.jhep.2016.01.029].
50. Cho Y, Cho EJ, Lee JH, Yu SJ, Yoon JH, Kim YJ. Sofosbuvirbased therapy for patients with chronic hepatitis C: Early experience of its efficacy and safety in Korea. Clin Mol Hepatol 2015; 21: 358-364 [PMID: 26770924 DOI:10.3350/cmh.2015.21.4.358].
51. Hézode C, Chevaliez S, Scoazec G, Soulier A, Varaut A, Bouvier- Alias M, Ruiz I, Roudot-Thoraval F, Mallat A, Féray C, Pawlotsky JM. Retreatment with sofosbuvir and simeprevir of patients with hepatitis C virus genotype 1 or 4 who previously failed a daclatasvir-containing regimen. Hepatology 2016; 63: 1809-1816 [PMID: 26853230 DOI:10.1002/hep.28491].
52. Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. 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. Lancet 2014; 383: 515-523 [PMID: 24209977 DOI:10.1016/S0140-6736(13)62121-2].
53. Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Bräu N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014; 370: 1889-1898 [PMID: 24725239 DOI:10.1056/NEJMoa1402454].
54. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014; 370: 1483-1493 [PMID: 24725238 DOI:10.1056/NEJMoa1316366].
55. Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, Shiffman ML, Schiff E, Ghalib R, Ryan M, Rustgi V, Chojkier M, Herring R, Di Bisceglie AM, Pockros PJ, Subramanian GM, An D, Svarovskaia E, Hyland RH, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Pound D, Fried MW. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014; 370: 1879-1888 [PMID: 24720702 DOI:10.1056/NEJMoa1402355].
56. Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, Weiland O, Aguilar H, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014; 370: 1594-1603 [PMID: 24720703 DOI:10.1056/NEJMoa1315722].
57. Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourlière M, Sulkowski MS, Wedemeyer H, Tam E, Desmond P, Jensen DM, Di Bisceglie AM, Varunok P, Hassanein T, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014; 370: 1604-1614 [PMID: 24720679 DOI:10.1056/NEJMoa1401561].
58. Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 2014; 370: 1983-1992 [PMID: 24795200 DOI:10.1056/NEJMoa1402338].
59. Hézode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot- Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. 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; 385: 2502-2509 [PMID: 25837829 DOI:10.1016/S0140-6736(15)60159-3].
60. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind- Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014; 370: 211-221 [PMID: 24428467 DOI:10.1056/NEJMoa1306218].
61. Alqahtani SA, Afdhal N, Zeuzem S, Gordon SC, Mangia A, Kwo P, Fried M, Yang JC, Ding X, Pang PS, McHutchison JG, Pound D, Reddy KR, Marcellin P, Kowdley KV, Sulkowski M. Safety and tolerability of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic hepatitis C virus genotype 1 infection: Analysis of phase III ION trials. Hepatology 2015; 62: 25-30 [PMID: 25963890 DOI:10.1002/hep.27890].
62. European Association for the Study of the Liver. EASL Clinical Practice Guidelines. Recommendations on treatment of hepatitis C. Geneva, Switzerland, 2015.
63. American Association for the Study of Liver Diseases. HCV guidelines. Alexandria, Virginia, USA, 2016.
64. Keating GM. Elbasvir/Grazoprevir: First Global Approval. Drugs 2016; 76: 617-624 [PMID: 26943930 DOI:10.1007/s40265-016-0558-3].
65. Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez- Torres M, Sulkowski MS, Shiffman ML, Lawitz E, Everson G, Bennett M, Schiff E, Al-Assi MT, Subramanian GM, An D, Lin M, McNally J, Brainard D, Symonds WT, McHutchison JG, Patel K, Feld J, Pianko S, Nelson DR. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013; 368: 1867-1877 [PMID: 23607593 DOI:10.1056/NEJMoa1214854].
66. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-1887 [PMID: 23607594 DOI:10.1056/NEJMoa1214853].
67. Dieterich D, Bacon B, Flamm S, Kowdley K, Milligan S, Tsai N, Younossi Z, Lawitz E. Evaluation of sofosbuvir and simeprevirbased regimens in the TRIO network - Academic and community treatment of a real-world, heterogeneous population. Proceedings of the AASLD; 2014 Nov 8-11. Boston, MA, USA, 2014.
68. Foster GR, Pianko S, Brown A, Forton D, Nahass RG, George J, Barnes E, Brainard DM, Massetto B, Lin M, Han B, McHutchison JG, Subramanian GM, Cooper C, Agarwal K. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-Alfa in patients with hepatitis C virus genotype 3 infection and treatmentexperienced patients with cirrhosis and hepatitis C virus genotype 2 infection. Gastroenterology 2015; 149: 1462-1470 [PMID: 26248087 DOI:10.1053/j.gastro.2015.07.043].
69. Ferenci P, Kozbial K, Mandorfer M, Hofer H. HCV targeting of patients with cirrhosis. J Hepatol 2015; 63: 1015-1022 [PMID: 26100497 DOI:10.1016/j.jhep.2015.06.003].
70. Flamm S, Everson G, Charlton M. Ledipasvir/Sofosbuvir with Ribavirin for the Treatment of HCV in Patients with Decompensated Cirrhosis: Preliminary Results of a Prospective, Multicenter Study. Proceedings of the 65th Annual Meeting of the American Association for the Study of Liver diseases; 2014 November 7-11. Boston, USA, 2014.
71. Welker MW, Luhne S, Lange CM, Vermehren J, Farnik H, Herrmann E, Welzel T, Zeuzem S, Sarrazin C. Lactic acidosis in patients with hepatitis C virus cirrhosis and combined ribavirin/sofosbuvir treatment. J Hepatol 2016; 64: 790-799 [PMID: 26658684 DOI:10.1016/j.jhep.2015.11.034].
72. Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Müllhaupt B, Agarwal K, Angus P, Yoshida EM, Colombo M, Rizzetto M, Dvory-Sobol H, Denning J, Arterburn S, Pang PS, Brainard D, McHutchison JG, Dufour JF, Van Vlierberghe H, van Hoek B, Forns X; SOLAR-2 investigators. 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: 685-697 [PMID: 26907736 DOI:10.1016/S1473-3099(16)00052-9].
73. Health USNIo. A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting. 2016.
74. Coilly A, Roche B, Duclos-Vallée JC, Samuel D. Optimal therapy in hepatitis C virus liver transplant patients with direct acting antivirals. Liver Int 2015; 35 Suppl 1: 44-50 [PMID: 25377540 DOI:10.1111/liv.12728].
75. Gugenheim J, Baldini E, Mazza D, Fabiani P, St Paul MC, Goubaux B, Ouzan D, Mouiel J. Recurrence of hepatitis C virus after liver transplantation. Transpl Int 1994; 7 Suppl 1: S224-S226 [PMID: 11271209 DOI:10.1111/j.1432-2277.1994.tb01352.x].
76. Dixon LR, Crawford JM. Early histologic changes in fibrosing cholestatic hepatitis C. Liver Transpl 2007; 13: 219-226 [PMID: 17205558 DOI:10.1002/lt.21011].
77. Brown RS, O'Leary JG, Reddy KR, Kuo A, Morelli GJ, Burton JR, Stravitz RT, Durand C, Di Bisceglie AM, Kwo P, Frenette CT, Stewart TG, Nelson DR, Fried MW, Terrault NA. Interferon-free therapy for genotype 1 hepatitis C in liver transplant recipients: Real-world experience from the hepatitis C therapeutic registry and research network. Liver Transpl 2016; 22: 24-33 [PMID: 26519873 DOI:10.1002/lt.24366].
78. Hanouneh IA, Miller C, Aucejo F, Lopez R, Quinn MK, Zein NN. Recurrent hepatitis C after liver transplantation: on-Treatment prediction of response to peginterferon/ribavirin therapy. Liver Transpl 2008; 14: 53-58 [PMID: 18161839 DOI:10.1002/lt.21312].
79. Fiel MI, Schiano TD. Plasma cell hepatitis (de-novo autoimmune hepatitis) developing post liver transplantation. Curr Opin Organ Transplant 2012; 17: 287-292 [PMID: 22498651 DOI:10.1097/MOT.0b013e3283536622].
80. Coilly A, Dumortier J, Botta-Fridlund D, Latournerie M, Leroy V, Pageaux GP, Agostini H, Giostra E, Moreno C, Roche B, Antonini TM, Guillaud O, Lebray P, Radenne S, Saouli AC, Calmus Y, Alric L, Debette-Gratien M, De Ledinghen V, Durand F, Duvoux C, Samuel D, Duclos-Vallée JC. Multicenter Experience with Boceprevir or Telaprevir to Treat Hepatitis C Recurrence after Liver Transplantation: When Present Becomes Past, What Lessons for Future? Plos One 2015; 10: e0138091 [PMID: 26394142 DOI:10.1371/journal.pone.0138091].
81. Coilly A, Furlan V, Roche B, Barau C, Noël C, Bonhomme- Faivre L, Antonini TM, Roque-Afonso AM, Samuel D, Taburet AM, Duclos-Vallée JC. Practical management of boceprevir and immunosuppressive therapy in liver transplant recipients with hepatitis C virus recurrence. Antimicrob Agents Chemother 2012; 56: 5728-5734 [PMID: 22908172 DOI:10.1128/AAC.01151-12].
82. Charlton M, Gane E, Manns MP, Brown RS, Curry MP, Kwo PY, Fontana RJ, Gilroy R, Teperman L, Muir AJ, McHutchison JG, Symonds WT, Brainard D, Kirby B, Dvory-Sobol H, Denning J, Arterburn S, Samuel D, Forns X, Terrault NA. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology 2015; 148: 108-117 [PMID: 25304641 DOI:10.1053/j.gastro.2014.10.001].
83. Reddy KR, Everson GT, Flamm SL, Denning JM, Arterburn S, Brandt-Sarif T, Pang PS, McHutchison JG, Curry MP, Charlton M. Ledipasvir/Sofosbuvir with Ribavirin for the Treatment of HCV in Patients with Post Transplant Recurrence: Preliminary Results of a Prospective, Multicenter Study. Proceedings of the 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11. Boston, MA, USA, 2014.
84. Kwo PY, Mantry PS, Coakley E, Te HS, Vargas HE, Brown R, Gordon F, Levitsky J, Terrault NA, Burton JR, Xie W, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Forns X. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med 2014; 371: 2375-2382 [PMID: 25386767 DOI:10.1056/NEJMoa1408921].
85. Forns X, Charlton M, Denning J, McHutchison JG, Symonds WT, Brainard D, Brandt-Sarif T, Chang P, Kivett V, Castells L, Prieto M, Fontana RJ, Baumert TF, Coilly A, Londoño MC, Habersetzer F. Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C after liver transplantation. Hepatology 2015 61: 1485-1494 [PMID: 25557906 DOI:10.1002/hep.27681].
86. Pungpapong S, Aqel B, Leise M, Werner KT, Murphy JL, Henry TM, Ryland K, Chervenak AE, Watt KD, Vargas HE, Keaveny AP. Multicenter experience using simeprevir and sofosbuvir with or without ribavirin to treat hepatitis C genotype 1 after liver transplant. Hepatology 2015; 61: 1880-1886 [PMID: 25722203 DOI:10.1002/hep.27770].
87. Pellicelli AM, Montalbano M, Lionetti R, Durand C, Ferenci P, D'Offizi G, Knop V, Telese A, Lenci I, Andreoli A, Zeuzem S, Angelico M. Sofosbuvir plus daclatasvir for post-Transplant recurrent hepatitis C: potent antiviral activity but no clinical benefit if treatment is given late. Dig Liver Dis 2014; 46: 923-927 [PMID: 24997638 DOI:10.1016/j.dld.2014.06.004].
88. Herzer K, Papadopoulos-Köhn A, Walker A, Achterfeld A, Paul A, Canbay A, Timm J, Gerken G. Daclatasvir, Simeprevir and Ribavirin as a Promising Interferon-Free Triple Regimen for HCV Recurrence after Liver Transplant. Digestion 2015; 91: 326-333 [PMID: 25999053 DOI:10.1159/000382075].
89. Saab S, Greenberg A, Li E, Bau SN, Durazo F, El-Kabany M, Han S, Busuttil RW. Sofosbuvir and simeprevir is effective for recurrent hepatitis C in liver transplant recipients. Liver Int 2015;35: 2442-2447 [PMID: 25913321 DOI:10.1111/liv.12856].
90. Punzalan CS, Barry C, Zacharias I, Rodrigues J, Mehta S, Bozorgzadeh A, Barnard GF. Sofosbuvir plus simeprevir treatment of recurrent genotype 1 hepatitis C after liver transplant. Clin Transplant 2015; 29: 1105-1111 [PMID: 26358816 DOI: 10.1111/ctr.12634].
91. Shiraga T, Matsuda H, Nagase K, Iwasaki K, Noda K, Yamazaki H, Shimada T, Funae Y. Metabolism of FK506, a potent immunosuppressive agent, by cytochrome P450 3A enzymes in rat, dog and human liver microsomes. Biochem Pharmacol 1994; 47: 727-735 [PMID: 7510480 DOI:10.1016/0006-2952(94)90136-8].
92. Cakaloglu Y, Tredger JM, Devlin J, Williams R. Importance of cytochrome P-450IIIA activity in determining dosage and blood levels of FK 506 and cyclosporine in liver transplant recipients. Hepatology 1994; 20: 309-316 [PMID: 7519161 DOI:10.1002/hep.1840200207].
93. Pichard L, Domergue J, Fourtanier G, Koch P, Schran HF, Maurel P. Metabolism of the new immunosuppressor cyclosporin G by human liver cytochromes P450. Biochem Pharmacol 1996; 51: 591-598 [PMID: 8615894 DOI:10.1016/S0006-2952(95)02175-2].
94. Kogiso T, Tokushige K, Hashimoto E, Taniai M, Omori A, Kotera Y, Egawa H, Yamamoto M, Shiratori K. Mycophenolate mofetil may induce prolonged severe anemia during pegylated-interferon/ribavirin/simeprevir therapy in liver transplant recipients. Clin J Gastroenterol 2015; 8: 156-161 [PMID: 25963122 DOI:10.1007/s12328-015-0570-2].
95. Afdhal N, Everson G, Calleja JL, McCaughan G, Symonds WT, Denning J, McNair L, McHutchison JG, Arterburn S, Charlton M, Reddy R, Asselah T, Gane E, Forns X. Sofosbuvir and Ribavirin for the treament of chronic HCV with cirrhosis and portal hypertension with and without decompensation: early virologic response and safety. J Hepatol 2014; 60: S28 [DOI:10.1016/S0168-8278(14)60070-2].
96. Wilder JM, Muir AJ. Strategies for treating chronic HCV infection in patients with cirrhosis: latest evidence and clinical outcomes. Ther Adv Chronic Dis 2015; 6: 314-327 [PMID: 26568808 DOI:10.1177/2040622315603642].