RSS-Feed abonnieren
DOI: 10.1055/s-0042-107360
Empfehlungen zur antiviralen Therapie der chronischen Hepatitis C bei Patienten auf der Warteliste und nach Transplantation
Expert recommendations: Hepatitis C and transplantationPublikationsverlauf
03. März 2016
19. April 2016
Publikationsdatum:
18. Juli 2016 (online)
Zusammenfassung
Mit der Zulassung der neuen direkt antiviral wirksamen Substanzen (DAA) wurden die Therapiemöglichkeiten der chronischen Hepatitis C-Virus(HCV)-Infektion bei Patienten vor und nach Lebertransplantation (LTx) durch effektive, interferonfreie und nebenwirkungsarme Kombinationstherapien deutlich erweitert. Da bislang nur wenige Daten zu Patienten mit höhergradig eingeschränkter Leberfunktion sowie nach LTx vorliegen, ist die klinische Erfahrung mit einer DAA-basierten HCV-Behandlung in diesen speziellen Patientenpopulationen limitiert. Die nachstehenden Empfehlungen zur Therapie der Hepatitis C im Rahmen der LTx wurden in einer Expertenrunde als Stellungnahme erarbeitet und geben den Kenntnisstand der recherchierten Literatur, verfügbaren Fachinformationen sowie klinischen Erfahrungen der beteiligten Autoren wieder. Sie sollen hinsichtlich der Entscheidungsfindung bei antiviraler Therapie vor und nach LTx als Orientierungshilfe dienen.
Abstract
With the approval of new direct acting antiviral agents (DAA), therapeutic options for patients with chronic hepatitis C virus (HCV) infection are now generally available before and after liver transplantation (LT). Interferon-free DAA regimens are highly effective therapies and provide a good safety profile. However, the body of clinical evidence in this patient population is limited and the best treatment strategies for patients on the waiting list with (de)compensated cirrhosis and after LT are not well defined. The following recommendations for antiviral therapy in the context of LT are based on the currently available literature and clinical experience of experts in the field, and have been discussed in an expert meeting. The aim of this article is to guide clinicians in the decision making when treating patients before and after LT with DAAs.
-
Literatur
- 1 Sarrazin C, Berg T, Buggisch P et al. S3 guideline hepatitis C addendum. Zeitschrift fur Gastroenterologie 2015; 53: 320-334
- 2 Gane EJ, Manns MP, McCaughan G et al. High efficacy of ledipasvir/sofosbuvir with ribavirin in patients with decompensated cirrhosis or liver transplantation and HCV infection: combined efficacy from the SOLAR-1 and SOLAR-2 trials. Hepatology 2015; 62: 722a-723a
- 3 Manns M, Forns X, Samuel D et al. Ledipasvir/Sofosbuvir with Ribavirin Is Safe and Efficacious in Decompensated and Post Liver Transplantation Patients with Hcv Infection: Preliminary Results of the Prospective Solar 2 Trial. Journal of Hepatology 2015; 62: S187-S188
- 4 EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol 2015; 63: 199-236
- 5 Poordad F, Schiff E, Vierling J et al. Daclatasvir, sofosbuvir, and ribavirin combination for HCV patients with advanced cirrhosis or post-transplant recurrence: phase 3 ALLY-1 study. J Viral Hepatitis 2015; 22: 30-31
- 6 Afdhal N, Everson GT, Calleja JL et al. Effect of long term viral suppression with Sofosbuvir plus Ribavirin on hepatic venous pressure gradient in HCV-Infected patients with cirrhosis and portal hypertension. Journal of Hepatology 2015; 62: S269-S270
- 7 Lens S, Rincon D, Garcia-Retortillo M et al. Association Between Severe Portal Hypertension and Risk of Liver Decompensation in Patients With Hepatitis C, Regardless of Response to Antiviral Therapy. Clinical Gastroenterology and Hepatology – the Official Clinical Practice Journal of the American Gastroenterological Association 2015; 13: 1846-1853 e1841
- 8 El-Serag HB. Hepatocellular carcinoma. The New England Journal of Medicine 2011; 365: 1118-1127
- 9 http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index3.html
- 10 Greten TF, Malek NP, Schmidt S et al. Diagnosis of and therapy for hepatocellular carcinoma. Zeitschrift fur Gastroenterologie 2013; 51: 1269-1326
- 11 Skowasch M, Schneider J, Otto G et al. Midterm follow-up after DC-BEAD-TACE of hepatocellular carcinoma (HCC). European journal of radiology 2012; 81: 3857-3861
- 12 van der Meer AJ, Veldt BJ, Feld JJ et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. Jama 2012; 308: 2584-2593
- 13 Poordad F, Hezode C, Trinh R et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. The New England Journal of Medicine 2014; 370: 1973-1982
- 14 Afdhal N, Zeuzem S, Kwo P et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. The New England Journal of Medicine 2014; 370: 1889-1898
- 15 Bourliere MSM, Omata M et al. An Integrated Safety and Efficacy Analysis of > 500 Patients with Compensated Cirrhosis Treated with Ledipasvir/Sofosbuvir with or without Ribavirin. Hepatology 2014; 60: 239A
- 16 Feld JJ, Moreno C, Trinh R et al. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol 2015; DOI: 10.1016/j.jhep.2015.10.005.
- 17 Lawitz E, Sulkowski MS, Ghalib R 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; 384: 1756-1765
- 18 Lawitz E, Matusow G, DeJesus E et al. A Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of 12 Weeks of Simeprevir (Smv) Plus Sofosbuvir (Sof) in Treatment-Naive or -Experienced Patients with Chronic Hcv Genotype 1 Infection and Cirrhosis: Optimist-2. Journal of Hepatology 2015; 62: S264-S265
- 19 Lawitz E, Mangia A, Wyles D et al. Sofosbuvir for previously untreated chronic hepatitis C infection. The New England Journal of Medicine 2013; 368: 1878-1887
- 20 Jacobson IM, Gordon SC, Kowdley KV et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. The New England Journal of Medicine 2013; 368: 1867-1877
- 21 Zeuzem S, Dusheiko GM, Salupere R et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. The New England Journal of Medicine 2014; 370: 1993-2001
- 22 Foster GR, Pianko S, Brown A et al. 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; 149: 1462-1470
- 23 Nelson DR, Cooper JN, Lalezari JP et al. 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
- 24 Leroy V, Angus P, Bronowicki JP et al. Daclatasvir, Sofosbuvir, and Ribavirin for Hepatitis C Virus Genotype 3 and Advanced Liver Disease: A Randomized Phase III Study (ALLY-3+). Hepatology 2016; DOI: 10.1002/hep.28473.
- 25 Kapoor R, Kohli A, Sidharthan S et al. All Oral Treatment for Genotype 4 Chronic Hepatitis C Infection with Sofosbuvir and Ledipasvir: Interim Results from the NIAID SYNERGY Trial. Hepatology 2014; 60: 321a-321a
- 26 Abergel A, Loustaud-Ratti V, Metivier S et al. Ledipasvir/Sofosbuvir Treatment Results in High Svr Rates in Patients with Chronic Genotype 4 and 5 Hcv Infection. Journal of Hepatology 2015; 62: S219-S220
- 27 El RazikyM, Gamil M, Hammad R et al. Treatment of Hepatitis C Genotype 4 patients with Simeprevir and Sofosbuvir: Preliminary Results from a Phase IIa, Partially Randomised, Open-label Trial conducted in Egypt (OSIRIS). Hepatology 2015; 62: 784a-784a
- 28 Gane EJ, Hyland RH, An D et al. High Efficacy of LDV/SOF Regimens for 12 Weeks for Patients with HCV Genotype 3 or 6 Infection. Hepatology 2014; 60: 1274a-1275a
- 29 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: 649-659
- 30 Flamm SL, Everson GT, Charlton M et al. Ledipasvir/Sofosbuvir with Ribavirin for the Treatment of HCV in Patients with Decompensated Cirrhosis: Preliminary Results of a Prospective, Multicenter Study. Hepatology 2014; 60: 320a-321a
- 31 Lawitz E, Poordad F, Gutierrez J et al. Simeprevir (Smv) Plus Daclatasvir (Dcv) and Sofosbuvir (Sof) in Treatment-Naive and -Experienced Patients with Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease: Interim Results from the Phase Ii Impact Study. Journal of Hepatology 2015; 62: S266-S267
- 32 Mantry PS, Hanson J, Trinh R et al. Ombitasvir/Paritaprevir/r and Dasabuvir with Ribavirin for HCV Genotype 1 Patients with Decompensated Cirrhosis. Hepatology 2015; 62: 568a-569a
- 33 Welker MW, Luhne S, Lange CM et al. Lactic acidosis in patients with hepatitis C virus related cirrhosis and combined ribavirin/sofosbuvir treatment. J Hepatol 2015; DOI: S0168-8278(15)00792-8 [pii]10.1016/j.jhep.2015.11.034.
- 34 Peng CY, Chien RN, Liaw YF. Hepatitis B virus-related decompensated liver cirrhosis: benefits of antiviral therapy. J Hepatol 2012; 57: 442-450
- 35 Liaw YF, Sheen IS, Lee CM et al. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology 2011; 53: 62-72
- 36 Morgan RL, Baack B, Smith BD et al. Eradication of hepatitis C virus infection and the development of hepatocellular carcinoma: a meta-analysis of observational studies. Annals of internal medicine 2013; 158: 329-337
- 37 Koh C, Heller T, Haynes-Williams V et al. Long-term outcome of chronic hepatitis C after sustained virological response to interferon-based therapy. Alimentary pharmacology & therapeutics 2013; 37: 887-894
- 38 McCombs J, Matsuda T, Tonnu-Mihara I et al. The risk of long-term morbidity and mortality in patients with chronic hepatitis C: results from an analysis of data from a Department of Veterans Affairs Clinical Registry. JAMA Internal Medicine 2014; 174: 204-212
- 39 Aleman S, Rahbin N, Weiland O et al. A risk for hepatocellular carcinoma persists long-term after sustained virologic response in patients with hepatitis C-associated liver cirrhosis. Clinical infectious diseases – an official publication of the Infectious Diseases Society of America 2013; 57: 230-236
- 40 Sarrazin C, Berg T, Ross RS et al. Prophylaxis, diagnosis and therapy of hepatitis C virus (HCV) infection: the German guidelines on the management of HCV infection. Zeitschrift fur Gastroenterologie 2010; 48: 289-351
- 41 Morgan TR, Ghany MG, Kim HY et al. Outcome of sustained virological responders with histologically advanced chronic hepatitis C. Hepatology 2010; 52: 833-844
- 42 Yu ML, Lin SM, Lee CM et al. A simple noninvasive index for predicting long-term outcome of chronic hepatitis C after interferon-based therapy. Hepatology 2006; 44: 1086-1097
- 43 Casado JL, Quereda C, Moreno A et al. Regression of liver fibrosis is progressive after sustained virological response to HCV therapy in patients with hepatitis C and HIV coinfection. J Viral Hepat 2013; 20: 829-837
- 44 Poynard T, Moussalli J, Munteanu M et al. Slow regression of liver fibrosis presumed by repeated biomarkers after virological cure in patients with chronic hepatitis C. J Hepatol 2013; 59: 675-683
- 45 Bernuth S, Yagmur E, Schuppan D et al. Early changes in dynamic biomarkers of liver fibrosis in hepatitis C virus-infected patients treated with sofosbuvir. Digestive and liver disease – official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 2016; 48: 291-297
- 46 Olufade TOWL, Devine S et al. Sustained Virologic Response and the Risk of Liver Decompensation in HCV and HIV/HCV Patients. Poster 641, CROI 2014, Boston 2014.
- 47 Deterding K, Honer Zu Siederdissen C, Port K et al. Improvement of liver function parameters in advanced HCV-associated liver cirrhosis by IFN-free antiviral therapies. Alimentary Pharmacology & Therapeutics 2015; 42: 889-901
- 48 Ruiz I, Feray C, Pawlotsky JM et al. Patient with decompensated hepatitis C virus-related cirrhosis delisted for liver transplantation after successful sofosbuvir-based treatment. Liver Transplantation – Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society 2015; 21: 408-409
- 49 Coilly A, Pageaux GP, Houssel-Debry P et al. Improving liver function and delisting of patients awaiting liver transplantation for HCV cirrhosis: do we ask too much to DAA?. Hepatology 2015; 62: 257a-257a
- 50 Curry MP, Forns X, Chung RT et al. Sofosbuvir and ribavirin prevent recurrence of HCV infection after liver transplantation: an open-label study. Gastroenterology 2015; 148: 100-107 e101
- 51 Terrault N, Shrestha R, Satapathy SK et al. Novel Approach for the Prevention of Recurrent Hepatitis C in Liver Transplant Recipients: Preliminary Results from Ongoing Phase Iii Trial with Civacir (R). Journal of Hepatology 2015; 62: S271-S272
- 52 NCT02485080. Safety, Tolerability, Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Pre-liver Transplant Chronic Hepatitis C Genotype 1.
- 53 Manns M, Forns X, Samuel D et al. Ledipasvir/Sofosbuvir with Ribavirin Is Safe and Efficacious in Decompensated and Post Liver Transplantation Patients with Hcv Infection: Preliminary Results of the Prospective Solar 2 Trial. Transplant International 2015; 28: 21-21
- 54 Forns X, Mutimer D, Manns M et al. Ledipasvir/Sofosbuvir with Ribavirin for the Treatment of Fibrosing Cholestatic Hepatitis C after Liver Transplantation. Journal of Hepatology 2015; 62: S623-S623
- 55 Foster GR, McLauchlan J, Irving W et al. Treatment of Decompensated Hcv Cirrhosis in Patients with Diverse Genotypes: 12 Weeks Sofosbuvir and Ns5a Inhibitors with/without Ribavirin Is Effective in Hcv Genotypes 1 and 3. Journal of Hepatology 2015; 62: S190-S191
- 56 Garcia-Retortillo M, Forns X, Feliu A et al. Hepatitis C virus kinetics during and immediately after liver transplantation. Hepatology 2002; 35: 680-687
- 57 Zimmermann TOG, Schuchmann M. Managing hepatitis C in liver transplant patients with recurrent infection. Transplant Research and Risk Management 2009; I: 1-14
- 58 Forman LM, Lewis JD, Berlin JA et al. The association between hepatitis C infection and survival after orthotopic liver transplantation. Gastroenterology 2002; 122: 889-896
- 59 Gane EJ. The natural history of recurrent hepatitis C and what influences this. Liver transplantation – official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society 2008; 14 (Suppl. 02) S36-S44
- 60 Berenguer M, Ferrell L, Watson J et al. HCV-related fibrosis progression following liver transplantation: increase in recent years. J Hepatol 2000; 32: 673-684
- 61 Zimmermann T, Otto C, Hoppe-Lotichius M et al. Risk factors in patients with rapid recurrent hepatitis C virus-related cirrhosis within 1 year after liver transplantation. Transplantation proceedings 2009; 41: 2549-2556
- 62 Berenguer M, Palau A, Aguilera V et al. Clinical benefits of antiviral therapy in patients with recurrent hepatitis C following liver transplantation. Am J Transplant 2008; 8: 679-687
- 63 Dumortier J, Salame E, Roche B et al. Severe fibrosis in patients with recurrent hepatitis C after liver transplantation: a French experience on 250 patients over 15 years (the Orfevre study). Clinics and Research in Hepatology and Gastroenterology 2014; 38: 292-299
- 64 Gallegos-Orozco JF, Yosephy A, Noble B et al. Natural history of post-liver transplantation hepatitis C: A review of factors that may influence its course. Liver transplantation – official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society 2009; 15: 1872-1881
- 65 Charlton M, Gane E, Manns MP et al. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology 2015; 148: 108-117
- 66 Kwo PY, Mantry PS, Coakley E et al. An interferon-free antiviral regimen for HCV after liver transplantation. The New England Journal of Medicine 2014; 371: 2375-2382
- 67 Forns X, Berenguer M, Herzer K et al. On-Treatment Virologic Response and Tolerability of Simeprevir, Daclatasvir and Ribavirin in Patients with Recurrent Hepatitis C Virus Genotype 1b Infection after Orthotopic Liver Transplantation (Olt): Interim Data from the Phase Ii Saturn Study. Journal of Hepatology 2015; 62: S191-S192
- 68 Coilly A, Fougerou C, De Ledinghen V et al. The Association of Sofosbuvir and Daclatasvir for Treating Severe Recurrence of Hcv Infection after Liver Transplantation: Results from a Large French Prospective Multicentric Anrs Co23 Cupilt Cohort. Journal of Hepatology 2015; 62: S236-S237
- 69 Pungpapong S, Aqel B, Leise M et al. Multicenter experience using simeprevir and sofosbuvir with or without ribavirin to treat hepatitis C genotype 1 after liver transplant. Hepatology 2015; 61: 1880-1886
- 70 Leroy V, Dumortier J, Coilly A et al. Efficacy of Sofosbuvir and Daclatasvir in Patients With Fibrosing Cholestatic Hepatitis C After Liver Transplantation. Clinical gastroenterology and hepatology – the official clinical practice journal of the American Gastroenterological Association 2015; 13: 1993-2001 e1992
- 71 Kwo PY, Badshah MB. New hepatitis C virus therapies: drug classes and metabolism, drug interactions relevant in the transplant settings, drug options in decompensated cirrhosis, and drug options in end-stage renal disease. Current Opinion in Organ Transplantation 2015; 20: 235-241
- 72 Höner Zu Siederdissen C, Maasoumy B, Marra F et al. Drug-Drug Interactions With Novel All Oral Interferon-Free Antiviral Agents in a Large Real-World Cohort. Clinical infectious diseases – an official publication of the Infectious Diseases Society of America 2016; 62: 561-567
- 73 Burgess S, Partovi N, Yoshida EM et al. Drug Interactions With Direct-Acting Antivirals for Hepatitis C: Implications for HIV and Transplant Patients. The Annals of Pharmacotherapy 2015; 49: 674-687
- 74 Pellicelli AM, Montalbano M, Lionetti R et al. Sofosbuvir plus daclatasvir for post-transplant recurrent hepatitis C: potent antiviral activity but no clinical benefit if treatment is given late. Digestive and liver disease – official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 2014; 46: 923-927
- 75 Furihata T, Matsumoto S, Fu Z et al. Different interaction profiles of direct-acting anti-hepatitis C virus agents with human organic anion transporting polypeptides. Antimicrob Agents Chemother 2014; 58: 4555-4564
- 76 Gambato M, Lens S, Navasa M et al. Treatment options in patients with decompensated cirrhosis, pre- and post-transplantation. Journal of Hepatology 2014; 61: S120-S131
- 77 Johnson RJ, Gretch DR, Yamabe H et al. Membranoproliferative glomerulonephritis associated with hepatitis C virus infection. The New England Journal of Medicine 1993; 328: 465-470
- 78 Davda R, Peterson J, Weiner R et al. Membranous glomerulonephritis in association with hepatitis C virus infection. American journal of kidney diseases – the official journal of the National Kidney Foundation 1993; 22: 452-455
- 79 Zacks SL, Fried MW. Hepatitis B and C and renal failure. Infectious Disease Clinics of North America 2001; 15: 877-899
- 80 Husing A, Kabar I, Schmidt HH et al. Hepatitis C in Special Patient Cohorts: New Opportunities in Decompensated Liver Cirrhosis, End-Stage Renal Disease and Transplant Medicine. International Journal of Molecular Sciences 2015; 16: 18033-18053
- 81 Gane EJ, Robson RA, Bonacini M et al. Safety, Anti-Viral Efficacy and Pharmacokinetics (PK) of Sofosbuvir (SOF) in Patients with Severe Renal Impairment. Hepatology 2014; 60: 667a-667a
- 82 Bhamidimarri KR, Gutierrez JA, Grigorian A et al. Urgent Treatment With Sofosbuvir Based Regimen For Hepatitis C Genotype 1 Patients With Severe Renal Insufficiency (GFR < 30ml/min). Hepatology 2014; 60: 688a-689a
- 83 Bhamidimarri KR, Czul F, Peyton A et al. Safety, efficacy and tolerability of half-dose sofosbuvir plus simeprevir in treatment of Hepatitis C in patients with end stage renal disease (vol 63, pg 763, 2015). Journal of Hepatology 2015; 63: 1542-1542
- 84 Nazario HE, Ndungu M, Modi A. Safety and efficacy of Sofosbuvir plus Simeprevir without Ribavirin in hepatitis C genotype 1-infected patients with end-stage renal disease or GFR < 30 mL/min. Journal of Hepatology 2015; 62: S635-S635
- 85 Saxena V, Koraishy FM, Sise M et al. Safety and Efficacy of Sofosbuvir-Containing Regimens in Hepatitis C Infected Patients with Reduced Renal Function: Real-World Experience from Hcv-Target. Journal of Hepatology 2015; 62: S267-S267
- 86 Singh T, Guirguis J, Anthony S et al. Sofosbuvir based treatment is safe and effective in patients with chronic hepatitis C infection and end-stage renal disease: a case series. Liver Int 2016; DOI: 10.1111/liv.13078.
- 87 Hundemer GL, Sise ME, Wisocky J et al. Use of sofosbuvir-based direct-acting antiviral therapy for hepatitis C viral infection in patients with severe renal insufficiency. Infect Dis-Nor 2015; 47: 924-929
- 88 Kitzman G, Davis E, Monico J et al. Sofosbuvir is well tolerated and effective in chronic hepatitis C patients with advanced renal disease and/or on hemodialysis. Hepatology 2015; 62: 792a-792a
- 89 Faisal N, Renner EL, Bilodeau M et al. Impact of Sofosbuvir-Based Regimens on Renal Function in Liver Transplant Recipients: Results of a Multicenter Study. Hepatology 2015; 62: 312a-313a
- 90 Almarzooqi S, Klair JS, Karkada JG et al. Frequency of Renal Impairment in Patients With Hepatitis C Infection Treated With Sofosbuvir-based Antiviral Regimens. Hepatology 2015; 62: 750a-751a
- 91 Pockros PJ, Reddy KR, Mantry PS et al. Safety of Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir for Treating Hcv Gt1 Infection in Patients with Severe Renal Impairment or End-Stage Renal Disease: The Ruby-I Study. Journal of Hepatology 2015; 62: S257-S257
- 92 Pockros PJ, Reddy KR, Mantry PS et al. RUBY-I: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir +/- Ribavirin in Non-cirrhotic HCV Genotype 1-infected Patients With Severe Renal Impairment or End-Stage Renal Disease. Hepatology 2015; 62: 716a-717a
- 93 Roth D, Nelson DR, Bruchfeld A et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet 2015; 386: 1537-1545
- 94 Rifai K, Wedemeyer H, Rosenau J et al. Longer survival of liver transplant recipients with hepatitis virus coinfections. Clinical transplantation 2007; 21: 258-264
- 95 Collins JM, Raphael KL, Terry C et al. Hepatitis B Virus Reactivation During Successful Treatment of Hepatitis C Virus With Sofosbuvir and Simeprevir. Clinical infectious diseases – an official publication of the Infectious Diseases Society of America 2015; 61: 1304-1306
- 96 Perrillo RP, Gish R, Falck-Ytter YT. American Gastroenterological Association Institute technical review on prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy. Gastroenterology 2015; 148: 221-244 e223
- 97 Di Bisceglie AM, Lok AS, Martin P et al. Recent US Food and Drug Administration warnings on hepatitis B reactivation with immune-suppressing and anticancer drugs: just the tip of the iceberg?. Hepatology 2015; 61: 703-711
- 98 Miro JM, Stock P, Teicher E et al. Outcome and management of HCV/HIV coinfection pre- and post-liver transplantation. A 2015 update. J Hepatol 2015; 62: 701-711
- 99 Sulkowski MS, Naggie S, Lalezari J et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. Jama 2014; 312: 353-361
- 100 Basu P, Shah NJ, Aloysius M. Simeprevir and Sofosbuvir with modified doses of Ribavirin (RBV) therapy on Telaprevir experienced Co infected (with HIV) cirrhotics with chronic hepatitis C (CHC) A randomized open label clinical pilot study: STOP C. Hepatology 2014; 60: 682a-683a
- 101 Wyles DL, Sulkowski MS, Eron JJ et al. TURQUOISE-I: 94% SVR12 in HCV/HIV-1 Coinfected Patients Treated with ABT-450/r/Ombitasvir, Dasabuvir and Ribavirin. Hepatology 2014; 60: 1136a-1137a
- 102 Osinusi A, Townsend K, Kohli A et al. Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and HIV co-infection. Jama 2015; 313: 1232-1239
- 103 Wyles DL, Ruane PJ, Sulkowski MS et al. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. The New England Journal of Medicine 2015; 373: 714-725
- 104 Osinusi A, Kohli A, Marti MM et al. Re-treatment of chronic hepatitis C virus genotype 1 infection after relapse: an open-label pilot study. Annals of internal medicine 2014; 161: 634-638
- 105 Lawitz E, Flamm S, Yang JC et al. Retreatment of Patients Who Failed 8 or 12 Weeks of Ledipasvir/Sofosbuvir- Based Regimens with Ledipasvir/Sofosbuvir for 24 Weeks. Journal of Hepatology 2015; 62: S192-S192
- 106 Wilson E, Kattakuzhy S, Sims Z et al. Highly Successful Retreatment with Ledipasvir (LDV) and Sofosbuvir (SOF) in HCV GT-1 Patients Who Failed Initial Short Course Therapy with Combination DAA Regimens (NIH SYNERGY Trial). Hepatology 2015; 62: 255a-255a
- 107 Pungpapong S, Leise MD, Watt KD et al. Multicenter Experience using Sofosbuvir/Ledipasvir with or without Ribavirin to Treat Hepatitis C Genotype 1 Relapsers after Simeprevir and Sofosbuvir Treatment. Hepatology 2015; 62: 716a-716a
- 108 Gonzales GR, Gonzalez SA, Nazario HE et al. Efficacy of Ledipasvir plus Sofosobuvir with or without ribavirin in hepatitis C genotype 1 patients who failed previous treatment with Simeprevir plus Sofosbuvir. Hepatology 2015; 62: 775a-775a
- 109 Hezode C, Chevaliez S, Scoazec G et al. Retreatment with sofosbuvir and simeprevir of patients with HCV GT1 or 4 who previously failed a daclatasvir-containing regimen. Hepatology 2016; DOI: 10.1002/hep.28491.
- 110 Poordad F, Bennett M, Sepe TE et al. Retreatment of HCV Genotype 1 DAA-failures with Ombitasvir/Paritaprevir/r, Dasabuvir, and Sofosbuvir. Hepatology 2015; 62: 1392a-1392a
- 111 Ellingson K, Seem D, Nowicki M et al. Estimated risk of human immunodeficiency virus and hepatitis C virus infection among potential organ donors from 17 organ procurement organizations in the United States. Am J Transplant 2011; 11: 1201-1208
- 112 Marroquin CE, Marino G, Kuo PC et al. Transplantation of hepatitis C-positive livers in hepatitis C-positive patients is equivalent to transplanting hepatitis C-negative livers. Liver transplantation – official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society 2001; 7: 762-768
- 113 Coilly A, Samuel D. Pros and Cons: Usage of organs from donors infected with hepatitis C virus – Revision in the direct-acting antiviral era. J Hepatol 2016; 64: 226-231
- 114 Velidedeoglu E, Desai NM, Campos L et al. The outcome of liver grafts procured from hepatitis C-positive donors. Transplantation 2002; 73: 582-587
- 115 Burr AT, Li Y, Tseng JF et al. Survival after liver transplantation using hepatitis C virus-positive donor allografts: case-controlled analysis of the UNOS database. World journal of surgery 2011; 35: 1590-1595
- 116 Northup PG, Argo CK, Nguyen DT et al. Liver allografts from hepatitis C positive donors can offer good outcomes in hepatitis C positive recipients: a US National Transplant Registry analysis. Transplant international – official journal of the European Society for Organ Transplantation 2010; 23: 1038-1044
- 117 Lai JC, O'Leary JG, Trotter JF et al. Risk of advanced fibrosis with grafts from hepatitis C antibody-positive donors: a multicenter cohort study. Liver transplantation – official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society 2012; 18: 532-538
- 118 Terrault NA, Roland ME, Schiano T et al. Outcomes of liver transplant recipients with hepatitis C and human immunodeficiency virus coinfection. Liver transplantation – official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society 2012; 18: 716-726
- 119 Kucirka LM, Alexander C, Namuyinga R et al. Viral nucleic acid testing (NAT) and OPO-level disposition of high-risk donor organs. Am J Transplant 2009; 9: 620-628
- 120 Patwardhan VR, Curry MP. Reappraisal of the hepatitis C virus-positive donor in solid organ transplantation. Current opinion in organ transplantation 2015; 20: 267-275
- 121 Alpers C, Bloom RD, Fabrizi F et al. KDIGO clinical practice guidelines for the prevention, diagnosis, evaluation, and treatment of hepatitis C in chronic kidney disease – Introduction. Kidney Int 2008; 73: S6-S99
- 122 Pereira BJ, Levey AS. Hepatitis C virus infection in dialysis and renal transplantation. Kidney Int 1997; 51: 981-999
- 123 Su Y, Norris JL, Zang C et al. Incidence of hepatitis C virus infection in patients on hemodialysis: a systematic review and meta-analysis. Hemodialysis international International Symposium on Home Hemodialysis 2013; 17: 532-541
- 124 Fabrizi F, Lunghi G, Finazzi S et al. Decreased serum aminotransferase activity in patients with chronic renal failure: impact on the detection of viral hepatitis. American journal of kidney diseases – the official journal of the National Kidney Foundation 2001; 38: 1009-1015
- 125 Trevizoli JE, de Paula MenezesR, Ribeiro VelascoLF et al. Hepatitis C is less aggressive in hemodialysis patients than in nonuremic patients. Clinical journal of the American Society of Nephrology 2008; 3: 1385-1390
- 126 Aslinia FM, Wasan SK, Mindikoglu AL et al. End-stage renal disease and African American race are independent predictors of mild liver fibrosis in patients with chronic hepatitis C infection. J Viral Hepat 2012; 19: 371-376
- 127 Fabrizi F, Martin P, Dixit V et al. Meta-analysis: Effect of hepatitis C virus infection on mortality in dialysis. Alimentary pharmacology & therapeutics 2004; 20: 1271-1277
- 128 Kalantar-Zadeh K, McAllister CJ, Miller LG. Clinical characteristics and mortality in hepatitis C-positive haemodialysis patients: a population based study. Nephrology, dialysis, transplantation – official publication of the European Dialysis and Transplant Association – European Renal Association 2005; 20: 1662-1669
- 129 Scott DR, Wong JK, Spicer TS et al. Adverse impact of hepatitis C virus infection on renal replacement therapy and renal transplant patients in Australia and New Zealand. Transplantation 2010; 90: 1165-1171
- 130 Fabrizi F, Dixit V, Messa P. Impact of hepatitis C on survival in dialysis patients: a link with cardiovascular mortality?. J Viral Hepat 2012; 19: 601-607
- 131 Ingsathit A, Kamanamool N, Thakkinstian A et al. Survival advantage of kidney transplantation over dialysis in patients with hepatitis C: a systematic review and meta-analysis. Transplantation 2013; 95: 943-948
- 132 Baid-Agrawal S, Pascual M, Moradpour D et al. Hepatitis C virus infection and kidney transplantation in 2014: what's new?. Am J Transplant 2014; 14: 2206-2220
- 133 Cano O, Almenar L, Martinez-Dolz L et al. Course of patients with chronic hepatitis C virus infection undergoing heart transplantation. Transplantation proceedings 2007; 39: 2353-2354
- 134 Lee I, Localio R, Brensinger CM et al. Decreased post-transplant survival among heart transplant recipients with pre-transplant hepatitis C virus positivity. The Journal of heart and lung transplantation – the official publication of the International Society for Heart Transplantation 2011; 30: 1266-1274
- 135 Kim EY, Ko HH, Yoshida EM. A concise review of hepatitis C in heart and lung transplantation. Canadian journal of gastroenterology – Journal canadien de gastroenterologie 2011; 25: 445-448
- 136 Fong TL, Hou L, Hutchinson IV et al. Impact of hepatitis C infection on outcomes after heart transplantation. Transplantation 2009; 88: 1137-1141
- 137 Carreno MC, Piedad UG, Maite L et al. Hepatitis C virus infection after lung transplantation: dim prognosis. The Journal of heart and lung transplantation – the official publication of the International Society for Heart Transplantation 2001; 20: 224
- 138 Cotler SJ, Jensen DM, Kesten S. Hepatitis C virus infection and lung transplantation: a survey of practices. The Journal of heart and lung transplantation – the official publication of the International Society for Heart Transplantation 1999; 18: 456-459
- 139 Fong TL, Cho YW, Hou L et al. Outcomes after lung transplantation and practices of lung transplant programs in the United States regarding hepatitis C seropositive recipients. Transplantation 2011; 91: 1293-1296
- 140 Pawlotsky JM, Feld JJ, Zeuzem S et al. From non-A, non-B hepatitis to hepatitis C virus cure. J Hepatol 2015; 62: S87-99
- 141 Poordad F, Lawitz E, Gutierrez JA et al. C-SWIFT: Grazoprevir/Elbasvir plus Sofosbuvir in cirrhotic and noncirrhotic, treatment-naive patients with hepatitis C virus genotype 1 infection, for durations of 4, 6 OR 8 weeks and genotype 3 infection for durations of 8 or 12 weeks. Journal of hepatology 2015; 62: S192-S193
- 142 Feld JJ, Jacobson IM, Hezode C et al. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. The New England Journal of Medicine 2015; DOI DOI: 10.1056/NEJMoa1512610.
- 143 Foster GR, Afdhal N, Roberts SK et al. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. The New England Journal of Medicine 2015; DOI: 10.1056/NEJMoa1512612.
- 144 Pianko S, Flamm SL, Shiffman ML et al. High Efficacy of Treatment with Sofosbuvir+GS-5816 +/- Ribavirin for 12 Weeks in Treatment Experienced Patients with Genotype 1 or 3 HCV Infection. Hepatology 2014; 60: 297a-298a
- 145 Muir AJ, Poordad F, Lalezari J et al. Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis. Jama 2015; 313: 1736-1744