Incidence of DAA failure and the clinical impact of retreatment in real-life patients treated in the advanced stage of liver disease: Interim evaluations from the PITER network

PLoS ONE

Volumn 12, Issue 10, 2017, Pages

  Kondili, Loreta A ^a   Gaeta, Giovanni Battista ^b   Brunetto, Maurizia Rossana ^c,d   Di Leo, Alfredo ^e   Iannone, Andrea ^e   Santantonio, Teresa Antonia ^f   Giammario, Adele ^f   Raimondo, Giovanni ^g   Filomia, Roberto ^g   Coppola, Carmine ^h   Amoruso, Daniela Caterina ^h   Blanc, Pierluigi ⁱ   Del Pin, Barbara ⁱ   Chemello, Liliana ^j   Cavalletto, Luisa ^j   Morisco, Filomena ^k   Donnarumma, Laura ^k   Rumi, Maria Grazia ^l   Gasbarrini, Antonio ^m   Siciliano, Massimo ^m   Massari, Marco ⁿ   Corsini, Romina ⁿ   Coco, Barbara ^c   Madonia, Salvatore ^o   Cannizzaro, Marco ^o   Zignego, Anna Linda ^p   Monti, Monica ^p   Russo, Francesco Paolo ^q   Zanetto, Alberto ^q   Persico, Marcello ^r   Masarone, Mario ^r   Villa, Erica ^s   Bernabucci, Veronica ^s   Taliani, Gloria ^t   Biliotti, Elisa ^t   Chessa, Luchino ^u   Pasetto, Maria Cristina ^u   Andreone, Pietro ^v   Margotti, Marzia ^v   Brancaccio, Giuseppina ^b   Ieluzzi, Donatella ^w   Borgia, Guglielmo ^k   Zappulo, Emanuela ^k   Calvaruso, Vincenza ^x   Petta, Salvatore ^x   Falzano, Loredana ^a   Quaranta, Maria Giovanna ^a   Weimer, Liliana Elena ^a   Rosato, Stefano ^a   Vella, Stefano ^a   Giannini, Edoardo Giovanni ^y   more..

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^b SECOND UNIVERSITY OF NAPLES   (Italy)

^c UNIVERSITY HOSPITAL OF PISA   (Italy)

^d UNIVERSITY OF PISA   (Italy)

^e UNIVERSITY OF BARI   (Italy)

^f UNIVERSITY OF FOGGIA   (Italy)

^g UNIVERSITY OF MESSINA   (Italy)

^h Hepatology and Intervenvetional US Unit Gragnano Hospital   (Italy)

ⁱ SANTA MARIA ANNUNZIATA HOSPITAL   (Italy)

^j UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^k UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^l UNIVERSITY OF MILAN   (Italy)

^m CATHOLIC UNIVERSITY   (Italy)

ⁿ S MARIA NUOVA HOSPITAL   (Italy)

^o VILLA SOFIA CERVELLO HOSPITAL   (Italy)

^p UNIVERSITY OF FLORENCE   (Italy)

^q UNIVERSITY OF PADOVA   (Italy)

^r UNIVERSITY OF SALERNO   (Italy)

^s UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^t SAPIENZA UNIVERSITY OF ROME   (Italy)

^u UNIVERSITY OF CAGLIARI   (Italy)

^v UNIVERSITY OF BOLOGNA   (Italy)

^w UNIVERSITY HOSPITAL OF VERONA   (Italy)

^x UNIVERSITY OF PALERMO   (Italy)

^y UNIVERSITY OF GENOA   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT; BILIRUBIN; DACLATASVIR; DASABUVIR PLUS OMBITASVIR PLUS PARITAPREVIR PLUS RITONAVIR; LEDIPASVIR; LEDIPASVIR PLUS SOFOSBUVIR; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; VIRUS RNA;

ADULT; AGED; ARTICLE; BILIRUBIN BLOOD LEVEL; CHILD PUGH SCORE; CHRONIC HEPATITIS C; CONTROLLED STUDY; DEATH; DISEASE SEVERITY; DRUG TREATMENT FAILURE; END STAGE LIVER DISEASE; FEMALE; FOLLOW UP; HEPATITIS C VIRUS GENOTYPE 3; HUMAN; LIVER CELL CARCINOMA; LIVER CIRRHOSIS; LIVER FAILURE; LIVER FIBROSIS; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PROSPECTIVE STUDY; RETREATMENT; SUSTAINED VIROLOGIC RESPONSE; THROMBOCYTE COUNT; VIRAL CLEARANCE; COMBINATION DRUG THERAPY; GENETICS; HEPATITIS C; INCIDENCE; LIVER DISEASES; MIDDLE AGED; PATHOLOGY; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; DRUG THERAPY, COMBINATION; FEMALE; HEPATITIS C; HUMANS; INCIDENCE; LIVER DISEASES; MALE; MIDDLE AGED; PROSPECTIVE STUDIES;

EID: 85030649396     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0185728     Document Type: Article

References (38)

1. WHO. Hepatitis C. Fact sheet updated April 2017. Available from: http://www.who.int/mediacentre/factsheets/fs164/en/
2. Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis 2005; 5: 558–567. https://doi.org/10.1016/S1473-3099(05)70216-4 PMID: 16122679
3. Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: A systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095–2128. https://doi.org/10.1016/S0140-6736(12)61728-0 PMID: 23245604
4. WHO. Global health sector strategy on viral hepatitis 2016–2021. Available from http://www.who.int/hepatitis/strategy2016-2021/ghss-hep/en/
5. George SL, Bacon BR, Brunt EM, Mihindukulasuriya KL,Hoffmann J, Di Bisceglie AM. Clinical, virologic, histologic, and biochemical outcomes after successful HCV therapy: a 5-year follow-up of 150 patients. Hepatology. 2009; 49:729–738. https://doi.org/10.1002/hep.22694 PMID: 19072828
6. D’Ambrosio R, Aghemo A, Rumi MG, Ronchi G, Donato MF, Paradis V, et al. A morphometric and immunohistochemical study to assess the benefit of a sustained virological response in hepatitis C virus patients with cirrhosis. Hepatology. 2012; 56: 532–543. https://doi.org/10.1002/hep.25606 PMID: 22271347
7. Petta S, Di Marco V, Bruno S, Enea M, Calvaruso V, Boccaccio V, et al. Impact of virus eradication in patients with compensated hepatitis C virus-related cirrhosis: competing risks and multistate model. Liver Int. 2016; 36: 1765–1773. https://doi.org/10.1111/liv.13156 PMID: 27164508
8. 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. https://doi.org/10.1001/jama.2014.12627 PMID: 25387192
9. Bruno S, Zuin M, Crosignani A, Rossi S, Zadra F, Roffi L, et al. Predicting mortality risk in patients with compensated HCV-induced cirrhosis: a long-term prospective study. Am J Gastroenterol. 2009; 104: 1147–1158. https://doi.org/10.1038/ajg.2009.31 PMID: 19352340
10. 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: 280–288. https://doi.org/10.1016/j.cgh.2009.11.018 PMID: 19948249
11. Backus LI, Boothroyd DB, Phillips BR, Belperio P, Halloran J, Mole LA. A sustained virologic response reduces risk of all-cause mortality in patients with hepatitis C.Clin Gastroenterol Hepatol. 2011; 9: 509–516. https://doi.org/10.1016/j.cgh.2011.03.004 PMID: 21397729
12. Simmons B, Saleem J,Heath K, Cooke GS, Hill A. Long-term treatment outcomes of patients infected with hepatitis C virus: a systematic review and meta-analysis of the survival benefit of achieving a sustained virological response. Clin Infect Dis. 2015; 61: 730–740. https://doi.org/10.1093/cid/civ396PMID: 25987643
13. AIFA Guidelines. Available from: http://www.agenziafarmaco.gov.it/content/aggiornamento-epatite-c
14. Rosen HR. "Hep C, where art thou": What are the remaining (fundable) questions in hepatitis C virus research? Hepatology. 2017; 65: 341–349. https://doi.org/10.1002/hep.28848 PMID: 27640881
15. Kondili LA, Vella S, PITER Collaborating Group. PITER: An ongoing nationwide study on the real-life impact of direct acting antiviral based treatment for chronic hepatitis C in Italy. Digest Liver Dis 2015; 47: 741–743.
16. Associazione Italiana per lo Studio del Fegato http://www.webaisf.org/media/38212/documento_hcv_13feb.2017.pdf (accessed March 14, 2017)
17. Casterà L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008; 48: 835–847. https://doi.org/10.1016/j.jhep.2008.02.008 PMID: 18334275
18. Ziol M, Handra-Luca A, Kettaneh A, Christidis C, Mal F, Kazemi F, et al. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005; 41: 48–54. https://doi.org/10.1002/hep.20506 PMID: 15690481
19. Bruix J, Sherman M. Management of hepatocellular carcinoma: an update. Hepatology. 2011; 53: 1020–1022. https://doi.org/10.1002/hep.24199 PMID: 21374666
20. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol. 2016; http://dx.doi.org/10.1016/j.jhep.2016.09.001
21. American Association for the Study of Liver Diseases (AASLD). Recommendations for testing, Managing and Treating Hepatitis C. http://hcvguidelines.org (accessed November 3 2016).
22. Omata M, Kanda T, Wei L, Yu ML, Chuang WL Ibrahim A et al. APASL consensus statements and recommendation on treatment of hepatitis C. Hepatol Int. 2016, 10:702–726. https://doi.org/10.1007/s12072-016-9717-6 PMID: 27130427
23. Veldt BJ, Heathcote EJ, Wedemeyer H, Reichen J, Hofmann WP, Zeuzem S, et al. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Ann Intern Med. 2007; 147: 677–684. PMID: 18025443
24. van der Meer AJ, Veldt BJ, Feld JJ Wedemeyer H, Dufour JF, Lammert F, 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. https://doi.org/10.1001/jama.2012.144878PMID: 23268517
25. Morgan TR, Ghany MG, Kim HY, Snow KK, Shiffman ML, De Santo JL, et al Outcome of sustained virological responders with histologically advanced chronic hepatitis C. Hepatology. 2010; 52: 833–844. https://doi.org/10.1002/hep.23744 PMID: 20564351
26. Di Marco V, Calvaruso V, Ferraro D, Bavetta MG, Cabibbo G, Conte E, et al. Effects of eradicating Hepatitis C virus infection in patients with cirrhosis differ with stage of portal hypertension. Gastroenterology. 2016; 151: 130–139. https://doi.org/10.1053/j.gastro.2016.03.036 PMID: 27039970
27. van der Meer AJ, Feld JJ, Hofer H, Almasio PL, Calvaruso V, Fernández-Rodríguez CM, et al. Risk of cirrhosis-related complications in patients with advanced fibrosis following hepatitis C virus eradication. J Hepatol. 2017; 66: 485–493. https://doi.org/10.1016/j.jhep.2016.10.017 PMID: 27780714
28. Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, et al. Ledipasvir and sofosbuvir plus ribavirin for treatment of HCV infection in patients with advanced liver disease. Gastroenterology. 2015; 149: 649–659. https://doi.org/10.1053/j.gastro.2015.05.010 PMID: 25985734
29. Deterding K,Honer Zu Siederdissen C, Port K, Solbach P, Sollik L, Kirschner J, et al. Improvement of liver function parameters in advanced HCV-associated liver cirrhosis by IFN-free antiviral therapies. Aliment Pharmacol Ther. 2015; 42: 889–901. https://doi.org/10.1111/apt.13343 PMID: 26250762
30. Modi AA, Nazario H, Trotter JF, Gautam M, Weinstein J, Mantry P, et al. Safety and efficacy of simeprevir plus sofosbuvir with or without ribavirin in patients with decompensated genotype 1 hepatitis C cirrhosis. Liver Transpl. 2016; 22: 281–286. https://doi.org/10.1002/lt.24324 PMID: 26335142
31. Saxena V, Nyberg L, Pauly M, Dasgupta A, Nyberg A, Piasecki B, et al. Safety and efficacy of simeprevir/sofosbuvir in hepatitis C-infected patients with compensated and decompensated cirrhosis. Hepatology. 2015; 62: 715–725. https://doi.org/10.1002/hep.27922 PMID: 26033798
32. Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, et al. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multi-centre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016; 16: 685–697. https://doi.org/10.1016/S1473-3099(16)00052-9 PMID: 26907736
33. Belli LS, Berenguer M, Cortesi PA, Strazzabosco M, Rockenschaub SR, Martini S, et al. Delisting of liver transplant candidates with chronic hepatitic C after viral eradication: a European study. J Hepatol. 2016; 65: 524–531. https://doi.org/10.1016/j.jhep.2016.05.010 PMID: 27212241
34. Conti F, Buonfiglioli F, Scuteri A, Crespi C, Bolondi L, Caraceni P, et al. Early occurrence and recurrence of hepatocellular carcinoma in HCV-related cirrhosis treated with direct-acting antivirals. J Hepatol. 2016; 65: 727–733. https://doi.org/10.1016/j.jhep.2016.06.015 PMID: 27349488
35. Pol S. Lack of evidence of an effect of Direct Acting Antivirals on the recurrence of hepatocellular carcinoma: The ANRS collaborative study group on hepatocellular carcinoma J Hepatol. 2016; 65: 734–740. https://doi.org/10.1016/j.jhep.2016.05.045 PMID: 27288051
36. Calvaruso V, Cabibbo G, Cacciola I, Petta S, Madonia S, Bellia A, et al. Occurrence of hepatocellular carcinoma in patients with hepatitis C virus related liver disease treated with direct-acting antivirals. EASL International Liver Congress. Amsterdam, April 19–23, 2017. Abstract PS-038.
37. Prenner S, VanWagner LB, Flamm SL, Salem R, Lewandowski RJ, Kulik L. Hepatocellular Carcinoma Decreases the Chance of Successful Hepatitis C Virus Therapy with Direct-Acting Antivirals. J Hepatol. 2017; https://doi.org/10.1016/j.jhep.2017.01.020 PMID: 28161470
38. Lu M, Li J, Rupp LB, Holmberg SD, Moorman AC, Spradling PR, et al Hepatitis C treatment failure is associated with increased risk of hepatocellular carcinoma. J Viral Hepat. 2016; 23: 718–729. https://doi.org/10.1111/jvh.12538 PMID: 27028626