Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection

Liver Transplantation

Volumn 22, Issue 4, 2016, Pages 446-458

  Fontana, Robert J ^a   Brown, Robert S ^b   Moreno Zamora, Ana ^c   Prieto, Martin ^d   Joshi, Shobha ^e   Londoño, Maria Carlota ^f   Herzer, Kerstin ^g   Chacko, Kristina R ^h   Stauber, Rudolf E ⁱ   Knop, Viola ^j   Jafri, Syed Mohammed ^k   Castells, Lluís ^l   Ferenci, Peter ^m   Torti, Carlo ⁿ   Durand, Christine M ^o   Loiacono, Laura ^p   Lionetti, Raffaella ^q   Bahirwani, Ranjeeta ^r   Weiland, Ola ^s   Mubarak, Abdullah ^t   Elsharkawy, Ahmed M ^u   Stadler, Bernhard ^v   Montalbano, Marzia ^q   Berg, Christoph ^w   Pellicelli, Adriano M ^x   Stenmark, Stephan ^y   Vekeman, Francis ^z   Ionescu Ittu, Raluca ^z   Emond, Bruno ^z   Reddy, K Rajender ^r   more..

^a UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^b New York Presbyterian Columbia University Medical Center   (United States)

^c HOSPITAL RAMÓN Y CAJAL   (Spain)

^d HOSPITAL UNIVERSITARIO LA FE   (Spain)

^e OCHSNER CLINIC FOUNDATION   (United States)

^f HOSPITAL CLÍNIC   (Spain)

^g UNIVERSITY HOSPITAL ESSEN   (Germany)

^h MONTEFIORE MEDICAL CENTER   (United States)

ⁱ UNIVERSITY OF GRAZ   (Austria)

^j GOETHE UNIVERSITY   (Germany)

^k HENRY FORD HOSPITAL   (United States)

^l UNIVERSITY OF BARCELONA   (Spain)

^m MEDICAL UNIVERSITY OF VIENNA   (Austria)

ⁿ UNIVERSITY MAGNA GRAECIA OF CATANZARO   (Italy)

^o DEPARTMENT OF PATHOLOGY   (United States)

^p MOLINETTE HOSPITAL   (Italy)

^q NATIONAL INSTITUTE FOR INFECTIOUS DISEASES L SPALLANZANI   (Italy)

^r HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^s KAROLINSKA INSTITUTE   (Sweden)

^t Physicians Medical Center of Dallas   (United States)

^u QUEEN ELIZABETH HOSPITAL   (United Kingdom)

^v Klinikum Wels Grieskirchen   (Austria)

^w UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^x SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^y UMEÅ UNIVERSITY   (Sweden)

^z INSTITUTE FOR RESEARCH IN IMMUNOLOGY AND CANCER   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; BILIRUBIN; CREATININE; DACLATASVIR; IMMUNOSUPPRESSIVE AGENT; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; VIRUS RNA; ANTIVIRUS AGENT; BMS-790052; IMIDAZOLE DERIVATIVE;

ADULT; ALKALINE PHOSPHATASE BLOOD LEVEL; ANTIVIRAL THERAPY; ARTICLE; BILIRUBIN BLOOD LEVEL; CHILD PUGH SCORE; CHOLANGITIS; CHOLESTATIC HEPATITIS; CHRONIC HEPATITIS C; COMPASSIONATE USE; CREATININE BLOOD LEVEL; DISEASE SEVERITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GRAFT RECIPIENT; HUMAN; KIDNEY FAILURE; LIVER BIOPSY; LIVER CIRRHOSIS; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MODEL FOR END STAGE LIVER DISEASE SCORE; NEUROTOXICITY; PRIORITY JOURNAL; RECURRENT INFECTION; RETROSPECTIVE STUDY; SIDE EFFECT; TREATMENT DURATION; AGED; COMBINATION DRUG THERAPY; COMPLICATION; GENETICS; GENOTYPE; HEPACIVIRUS; ISOLATION AND PURIFICATION; LIVER DISEASE; MIDDLE AGED; PATHOLOGY; PROCEDURES; RECURRENT DISEASE; TREATMENT OUTCOME; VIROLOGY;

AGED; ANTIVIRAL AGENTS; COMPASSIONATE USE TRIALS; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMIDAZOLES; LIVER CIRRHOSIS; LIVER DISEASES; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; RECURRENCE; RETROSPECTIVE STUDIES; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; TREATMENT OUTCOME;

EID: 84961741466     PISSN: 15276465     EISSN: 15276473     Source Type: Journal    
DOI: 10.1002/lt.24416     Document Type: Article

References (42)

1. Kim WR, Smith JM, Skeans MA, Schladt DP, Schnitzler MA, Edwards EB, et al., OPTN/SRTR 2012 annual data report: Liver. Am J Transplant 2014; 14 (suppl 1): 69-96.
2. Adam R, Karam V, Delvart V, O'Grady J, Mirza D, Klempnauer J, et al., 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.
3. Berenguer M, Schuppan D,. Progression of liver fibrosis in post-transplant hepatitis C: Mechanisms, assessment and treatment. J Hepatol 2013; 58: 1028-1041.
4. Forman LM, Lewis JD, Berlin JA, Feldman HI, Lucey MR,. The association between hepatitis C infection and survival after orthotopic liver transplantation. Gastroenterology 2002; 122: 889-896.
5. Thuluvath PJ, Guidinger MK, Fung JJ, Johnson LB, Rayhill SC, Pelletier SJ,. Liver transplantation in the United States, 1999-2008. Am J Transplant 2010; 10 (pt 2): 1003-1019.
6. Narang TK, Ahrens W, Russo MW,. Post-liver transplant cholestatic hepatitis C: A systematic review of clinical and pathological findings and application of consensus criteria. Liver Transpl 2010; 16: 1228-1235.
7. Verna EC, Abdelmessih R, Salomao MA, Lefkowitch J, Moreira RK, Brown RS Jr,. Cholestatic hepatitis C following liver transplantation: An outcome-based histological definition, clinical predictors, and prognosis. Liver Transpl 2013; 19: 78-88.
8. Sharma P, Hosmer A, Appelman H, McKenna B, Jafri MS, Sullivan P, et al., Immunological dysfunction during or after antiviral therapy for recurrent hepatitis C reduces graft survival. Hepatol Int 2013; 7: 990-999.
9. Selzner N, Guindi M, Renner EL, Berenguer M,. Immune-mediated complications of the graft in interferon-treated hepatitis C positive liver transplant recipients. J Hepatol 2011; 55: 207-217.
10. Picciotto FP, Tritto G, Lanza AG, Addario L, De Luca M, Di Costanzo GG, et al., Sustained virological response to antiviral therapy reduces mortality in HCV reinfection after liver transplantation. J Hepatol 2007; 46: 459-465.
11. Kwo PY, Mantry PS, Coakley E, Te HS, Vargas HE, Brown R Jr, et al., An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med 2014; 371: 2375-2382.
12. Charlton M, Gane E, Manns MP, Brown RS Jr, Curry MP, Kwo PY, et al., Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology 2015; 148: 108-117.
13. Forns X, Charlton M, Denning J, McHutchison JG, Symonds WT, Brainard D, et al., Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C after liver transplantation. Hepatology 2015; 61: 1485-1494.
14. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, et al.,; for AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014; 370: 211-221.
15. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al.,; for ALLY-3 Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology 2015; 61: 1127-1135.
16. Poordad F, Schiff ER, Vierling JM, Landis C, Fontana RJ, Yang R, et al., Daclatasvir, sofosbuvir, and ribavirin combination for HCV patients with advanced cirrhosis or posttransplant recurrence: Phase 3 ALLY-1 study. J Hepatol 2015; 62: S261-S262.
17. Pellicelli AM, Montalbano M, Lionetti R, Durand C, Ferenci P, D'Offizi G, et al., 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.
18. Fontana RJ, Hughes EA, Bifano M, Appelman H, Dimitrova D, Hindes R, Symonds WT,. Sofosbuvir and daclatasvir combination therapy in a liver transplant recipient with severe recurrent cholestatic hepatitis C. Am J Transplant 2013; 13: 1601-1605.
19. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed December 23, 2015.
20. European Medicines Agency. http://www.ema.europa.eu/ema/. Accessed December 23, 2015.
21. Wiesner RH, Sorrell M, Villamil F,; for International Liver Transplantation Society Expert Panel. Report of the first International Liver Transplantation Society expert panel consensus conference on liver transplantation for hepatitis C. Liver Transpl 2003; 9: S1-S9.
22. Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, et al.,; for SOLAR-1 Investigators. Ledipasvir and sofosbuvir plus ribavirin for treatment of HCV infection in patients with advanced liver disease. Gastroenterology 2015; 149: 649-659.
23. Londoño MC, Hezner K, Moreno C, Carrai P, Comadini UV, Lionetti RL, et al., Safety, efficacy and impact on liver function of simeprevir (SMV) in combination with daclatasvir (DCV) or sofosbuvir (SOF) in patients with severe hepatitis C recurrence after liver transplantation (LT): Results from compassionate use in Europe. J Hepatol 2015; 62: S275.
24. Coilly A, Fougerou C, De Ledinghen V, Houssel-Debry P, Duvoux C, Di Martino 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. J Hepatol 2015; 62: S236-S237.
25. Leroy V, Dumortier J, Coilly A, Sebagh M, Fougerou-Leurent C, Radenne S, et al., High rates of virological response and major clinical improvement during sofosbuvir and daclatasvir-based regimens for the treatment of fibrosing cholestatic HCV-recurrence after liver transplantation: The ANRS CO23 CUPILT study. Hepatology 2014; 60: 207A.
26. Welzel TM, Petersen J, Ferenci P, Gschwantler M, Herzer K, Cornberg M, et al., 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. Hepatology 2015; 62: 225A.
27. Forns X, Berenguer M, Herzer K, Sterneck M, Donato MF, Andreone P, 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. J Hepatol 2015; 62: S191-S192.
28. Gao M, Nettles RE, Belema M, Snyder LB, Nguyen VN, Fridell RA, et al., Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature 2010; 465: 96-100.
29. Hézode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, et al., Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: A randomised study. Gut 2015; 64: 948-956.
30. Nettles RE, Gao M, Bifano M, Chung E, Persson A, Marbury TC, et al., Multiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. Hepatology 2011; 54: 1956-1965.
31. Jacobson IM, Dore GJ, Foster GR, Fried MW, Radu M, Rafalsky VV, et al., Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): A phase 3, randomised, double-blind, placebo-controlled trial. Lancet 2014; 384: 403-413.
32. Nakamoto S, Kanda T, Wu S, Shirasawa H, Yokosuka O,. Hepatitis C virus NS5A inhibitors and drug resistance mutations. World J Gastroenterol 2014; 20: 2902-2912.
33. European Association for Study of Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol 2015; 63: 199-236.
34. Hezode C, de Ledinghen V, Fontaine H, Zoulim F, Lebray P, Boyer N, et al., Daclatasvir plus sofosbuvir with or without ribavirin in genotype 3 patients from a large French multicenter compassionate use program. Hepatology 2015; 62: 314A.
35. Wyles DL, Ruane P, Sulkowski MS, Dieterich D, Luetkemeyer AF, Morgan TR, et al., Daclatasvir plus sofosbuvir for treatment of HCV genotypes 1-4 in HIV-HCV coinfection: The ALLY-2 study. J Hepatol 2015; 62: S263.
36. Daklinza (daclatasvir) [summary of product characteristics]. Uxbridge, UK: Bristol-Myers Squibb Pharma; 2015.
37. Bifano M, Adamczyk R, Hwang C, Kan-doussi H, Marion AS, Bertz RJ,. Daclatasvir pharmacokinetics in healthy subjects: No clinically-relevant drug-drug interactions with cyclosporine or tacrolimus. Hepatology 2013; 58: 730A-731A.
38. Brayer SW, Reddy KR,. Ritonavir-boosted protease inhibitor based therapy: A new strategy in chronic hepatitis C therapy. Expert Rev Gastroenterol Hepatol 2015; 9: 547-558.
39. Olysio (simeprevir) [package insert]. Titusville, NJ: Janssen Therapeutics; 2015.
40. Ong JP, Younossi ZM, Gramlich T, Goodman Z, Mayes J, Sarbah S, Yen-Lieberman B,. Interferon alpha 2B and ribavirin in severe recurrent cholestatic hepatitis C. Transplantation 2001; 71: 1486-1487.
41. Firpi RJ, Abdelmalek MF, Soldevila-Pico C, Reed A, Hemming A, Howard R, et al., Combination of interferon alfa-2b and ribavirin in liver transplant recipients with histological recurrent hepatitis C. Liver Transpl 2002; 8: 1000-1006.
42. Leroy V, Dumortier J, Coilly A, Sebagh M, Fougerou-Leurent C, Radenne S, et al., Efficacy of sofosbuvir and daclatasvir in patients with fibrosing cholestatic hepatitis C after liver transplantation. Clin Gastro Hepatol 2015; 13: 1993-2001.