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Interferon Free Therapy with and Without Ribavirin for Genotype 1 HCV Cirrhotic Patients in the Real World Experience

Dorota Zarębska-Michaluk 1 , * , Jerzy Jaroszewicz 2 , Ewa Janczewska 3 , Hanna Berak 4 , Andrzej Horban 4 , Marek Sitko 5 , Aleksander Garlicki 5 , Beata Dobracka 6 , Agnieszka Czauż-Andrzejuk 7 , Dorota Dybowska 8 , Waldemar Halota 8 , Małgorzata Pawłowska 8 , Magdalena Tudrujek-Zdunek 9 , Krzysztof Tomasiewicz 9 , Włodzimierz Mazur 10 , Zbigniew Deroń 11 , Teresa Belica-Wdowik 12 , Barbara Baka-Ćwierz 12 , Iwona Buczyńska 13 , Krzysztof Simon 13 , Anna Piekarska 14 , Jolanta Białkowska-Warzecha 15 , Beata Lorenc 16 , Rafał Krygier 17 , Agnieszka Staniaszek 18 , Jakub Klapaczyński 18 , Jolanta Citko 19 , Łukasz Socha 20 , Marta Wawrzynowicz-Syczewska 20 , Łukasz Laurans 20,21 and Robert Flisiak 7
Authors Information
1 Department of Infectious Disease, Voivodeship Hospital, Jan Kochanowski University, Kielce, Poland
2 Department of Infectious Diseases and Hepatology, Medical University of Silesia in Katowice, Bytom, Poland
3 Medical University of Silesia, School of Public Health in Bytom, Department of Basic Medical Sciences, Bytom; ID Clinic, Hepatology Outpatient Department, Mysłowice, Poland
4 Hospital for Infectious Diseases, Warsaw Medical University, Warszawa, Poland
5 Department of Infectious and Tropical Diseases, Collegium Medicum, Jagiellonian University, Kraków , Poland
6 Medical Center, MEDFIX, Wrocław, Poland
7 Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok , Poland
8 Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz , Poland
9 Department of Infectious Diseases, Medical University of Lublin, Lublin, Poland
10 Clinical Department of Infectious Diseases, Medical University of Silesia, Chorzów, Poland
11 Ward of Infectious Diseases and Hepatology, Biegański Regional Specialist Hospital, Łódź, Poland
12 Regional Center for Diagnosis and Treatment of Viral Hepatitis and Hepatology, John Paul II Hospital, Kraków, Poland
13 Department of Infectious Diseases and Hepatology, Wroclaw University of Medicine, Wrocław, Poland
14 Department of Infectious Diseases and Hepatology, Medical University of Lodz, Łódź, Poland
15 Department of Infectious and Liver Diseases, Medical University of Łódź, Łódź, Poland
16 Department of Infectious Diseases, Pomeranian Center of Infectious Diseases, Medical University of Gdańsk, Gdańsk, Poland
17 NZOZ Gemini, Infectious Diseases and Hepatology Outpatient Clinic, Żychlin, Poland
18 Department of Internal Medicine and Hepatology, Central Clinical Hospital of Internal Affairs and Administration, Warszawa, Poland
19 Regional Hospital, Olsztyn, Poland
20 Department of Infectious Diseases, Hepatology and Liver Transplantation, Pomeranian Medical University, Szczecin, Poland
21 Outpatient Department, Multidisciplinary Regional Hospital, Gorzów, Poland
Article information
  • Hepatitis Monthly: August 2018, 18 (8); e80761
  • Published Online: July 29, 2018
  • Article Type: Research Article
  • Received: June 12, 2018
  • Revised: July 8, 2018
  • Accepted: July 24, 2018
  • DOI: 10.5812/hepatmon.80761

To Cite: Zarębska-Michaluk D, Jaroszewicz J, Janczewska E, Berak H, Horban A, et al. Interferon Free Therapy with and Without Ribavirin for Genotype 1 HCV Cirrhotic Patients in the Real World Experience, Hepat Mon. 2018 ; 18(8):e80761. doi: 10.5812/hepatmon.80761.

Abstract
Copyright © 2018, Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.
1. Background
2. Objectives
3. Methods
4. Results
5. Discussion
References
  • 1. Xu F, Moorman AC, Tong X, Gordon SC, Rupp LB, Lu M, et al. All-Cause Mortality and Progression Risks to Hepatic Decompensation and Hepatocellular Carcinoma in Patients Infected With Hepatitis C Virus. Clin Infect Dis. 2016;62(3):289-97. doi: 10.1093/cid/civ860. [PubMed: 26417034].
  • 2. The Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2(3):161-76. doi: 10.1016/S2468-1253(16)30181-9. [PubMed: 28404132].
  • 3. Flisiak R, Pogorzelska J, Berak H, Horban A, Orlowska I, Simon K, et al. Prevalence of HCV genotypes in Poland - the EpiTer study. Clin Exp Hepatol. 2016;2(4):144-8. doi: 10.5114/ceh.2016.63871. [PubMed: 28856279]. [PubMed Central: PMC5497426].
  • 4. Bota S, Sporea I, Popescu A, Sirli R, Neghina AM, Danila M, et al. Response to standard of care antiviral treatment in patients with HCV liver cirrhosis-a systematic review. J Gastrointestin Liver Dis. 2011;20(3):293-8.
  • 5. Bota S, Sporea I, Sirli R, Popescu A, Neghina AM, Danila M, et al. Severe adverse events during antiviral therapy in hepatitis C virus cirrhotic patients: A systematic review. World J Hepatol. 2013;5(3):120-6. doi: 10.4254/wjh.v5.i3.120. [PubMed: 23556044]. [PubMed Central: PMC3612570].
  • 6. Somasundaram A, Venkataraman J. Antiviral treatment for cirrhosis due to hepatitis C: a review. Singapore Med J. 2012;53(4):231-5. [PubMed: 22511042].
  • 7. Silva GF, Villela-Nogueira CA, Mello CE, Soares EC, Coelho HS, Ferreira PR, et al. Peginterferon plus ribavirin and sustained virological response rate in HCV-related advanced fibrosis: a real life study. Braz J Infect Dis. 2014;18(1):48-52. doi: 10.1016/j.bjid.2013.05.007. [PubMed: 24055310].
  • 8. Pawlotsky JM, Aghemo A, Back D, Dusheiko G, Forns X, Puoti M, et al. EASL recommendations on treatment of hepatitis C 2015. J hepatol. 2015;63(1):199-236.
  • 9. European Association for The Study of The Liver. EASL recommendations on treatment of hepatitis C 2016. J hepatol. 2017;66(1):153.
  • 10. European Association for the Study of the Liver. EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. J hepatol. 2015;63(1):237-64.
  • 11. Backus LI, Belperio PS, Shahoumian TA, Mole LA. Impact of sustained virologic response with direct-acting antiviral treatment on mortality in patients with advanced liver disease. Hepatology. 2018. doi: 10.1002/hep.29408.
  • 12. Kutala BK, Guedj J, Asselah T, Boyer N, Mouri F, Martinot-Peignoux M, et al. Impact of treatment against hepatitis C virus on overall survival of naive patients with advanced liver disease. Antimicrob Agents Chemother. 2015;59(2):803-10. doi: 10.1128/AAC.04027-14. [PubMed: 25403673]. [PubMed Central: PMC4335837].
  • 13. Iacobellis A, Ippolito A, Andriulli A. Antiviral therapy in hepatitis C virus cirrhotic patients in compensated and decompensated condition. World J Gastroenterol. 2008;14(42):6467-72.
  • 14. Bruno S, Stroffolini T, Colombo M, Bollani S, Benvegnu L, Mazzella G, et al. Sustained virological response to interferon-alpha is associated with improved outcome in HCV-related cirrhosis: a retrospective study. Hepatology. 2007;45(3):579-87. doi: 10.1002/hep.21492. [PubMed: 17326216].
  • 15. Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS, et al. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. [PubMed: 25985734].
  • 16. Young J, Weis N, Hofer H, Irving W, Weiland O, Giostra E, et al. The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease. BMC Infect Dis. 2017;17(1):45. doi: 10.1186/s12879-016-2106-x. [PubMed: 28061762]. [PubMed Central: PMC5219681].
  • 17. 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 multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016;16(6):685-97. doi: 10.1016/S1473-3099(16)00052-9. [PubMed: 26907736].
  • 18. Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014;370(21):1973-82. doi: 10.1056/NEJMoa1402869. [PubMed: 24725237].
  • 19. Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, et al. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016;64(2):301-7. doi: 10.1016/j.jhep.2015.10.005. [PubMed: 26476290].
  • 20. Lawitz E, Makara M, Akarca US, Thuluvath PJ, Preotescu LL, Varunok P, et al. 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(4):971-80 e1. doi: 10.1053/j.gastro.2015.07.001. [PubMed: 26170136].
  • 21. Lawitz E, Matusow G, DeJesus E, Yoshida EM, Felizarta F, Ghalib R, et al. Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A phase 3 study (OPTIMIST-2). Hepatology. 2016;64(2):360-9. doi: 10.1002/hep.28422. [PubMed: 26704148]. [PubMed Central: PMC5297873].
  • 22. Halota W, Flisiak R, Boron-Kaczmarska A, Juszczyk J, Malkowski P, et al. Recommendations for the treatment of hepatitis C issued by the Polish Group of HCV Experts - 2016. Clin Exp Hepatol. 2016;2(2):27-33. doi: 10.5114/ceh.2016.59099. [PubMed: 28856269]. [PubMed Central: PMC5497405].
  • 23. Flisiak R, Flisiak-Jackiewicz M. Ombitasvir and paritaprevir boosted with ritonavir and combined with dasabuvir for chronic hepatitis C. Expert Rev Gastroenterol Hepatol. 2017;11(6):559-67. doi: 10.1080/17474124.2017.1309284. [PubMed: 28317409].
  • 24. Flisiak R, Janczewska E, Wawrzynowicz-Syczewska M, Jaroszewicz J, Zarebska-Michaluk D, Nazzal K, et al. Real-world effectiveness and safety of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C: AMBER study. Aliment Pharmacol Ther. 2016;44(9):946-56. doi: 10.1111/apt.13790. [PubMed: 27611776].
  • 25. Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, et al. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014;384(9954):1597-605. doi: 10.1016/S0140-6736(14)61059-X. [PubMed: 25078304].
  • 26. Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370(20):1889-98. doi: 10.1056/NEJMoa1402454. [PubMed: 24725239].
  • 27. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370(16):1483-93.
  • 28. Barone M, Iannone A, Shahini E, Ippolito AM, Brancaccio G, Morisco F, et al. A different perspective on sofosbuvir-ledipasvir treatment of patients with HCV genotype 1b cirrhosis: The ital-c network study. J Viral Hepat. 2018;25(1):56-62. doi: 10.1111/jvh.12765. [PubMed: 28787102].
  • 29. Marino Z, Pascasio-Acevedo JM, Gallego A, Diago M, Baliellas C, Morillas R, et al. High efficacy of Sofosbuvir plus Simeprevir in a large cohort of Spanish cirrhotic patients infected with genotypes 1 and 4. Liver Int. 2017;37(12):1823-32. doi: 10.1111/liv.13470. [PubMed: 28481460].
  • 30. Preda CM, Popescu CP, Baicus C, Voiosu TA, Manuc M, Pop CS, et al. Real-world efficacy and safety of ombitasvir, paritaprevir/r+dasabuvir+ribavirin in genotype 1b patients with hepatitis C virus cirrhosis. Liver Int. 2018;38(4):602-10. doi: 10.1111/liv.13550. [PubMed: 28816020].
  • 31. Hezode C. Treatment of hepatitis C: Results in real life. Liver Int. 2018;38:21-7.
  • 32. Lai JB, Witt MA, Pauly MP, Ready J, Allerton M, Seo S, et al. Eight-or 12-week treatment of hepatitis C with ledipasvir/sofosbuvir: real-world experience in a large integrated health system. Drugs. 2017;77(3):313-8.
  • 33. Louie V, Latt NL, Gharibian D, Sahota A, Yanny BT, Mittal R, et al. Real-World Experiences With a Direct-Acting Antiviral Agent for Patients With Hepatitis C Virus Infection. Perm J. 2017;21. doi: 10.7812/TPP/16-096. [PubMed: 28368787]. [PubMed Central: PMC5378486].
  • 34. Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Real-world effectiveness and predictors of sustained virological response with all-oral therapy in 21,242 hepatitis C genotype-1 patients. Antivir Ther. 2017;22(6):481-93. doi: 10.3851/IMP3117. [PubMed: 27934775].
  • 35. Bachofner J, Valli PV, Bergamin I, Kroger A, Kunzler P, Baserga A, et al. Excellent outcome of direct antiviral treatment for chronic hepatitis C in Switzerland. Swiss Med Wkly. 2018;148:w14560. doi: 10.4414/smw.2018.14560. [PubMed: 29376557].
  • 36. Chamorro-de-Vega E, Gimenez-Manzorro A, Rodriguez-Gonzalez CG, Escudero-Vilaplana V, De Lorenzo-Pinto A, Iglesias-Peinado I, et al. Twelve weeks of ombitasvir/paritaprevir/r and dasabuvir without ribavirin is effective and safe in the treatment of patients with HCV genotype 1b infection and compensated cirrhosis: results from a real-world cohort study. Expert Opin Drug Saf. 2018;17(3):235-41. doi: 10.1080/14740338.2018.1424829. [PubMed: 29325476].
  • 37. Calleja JL, Crespo J, Rincon D, Ruiz-Antoran B, Fernandez I, Perello C, et al. Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort. J Hepatol. 2017;66(6):1138-48. doi: 10.1016/j.jhep.2017.01.028. [PubMed: 28189751].
  • 38. Chang CY, Nguyen P, Le A, Zhao C, Ahmed A, Daugherty T, et al. Real-world experience with interferon-free, direct acting antiviral therapies in Asian Americans with chronic hepatitis C and advanced liver disease. Medicine (Baltimore). 2017;96(6). e6128. doi: 10.1097/MD.0000000000006128. [PubMed: 28178174]. [PubMed Central: PMC5313031].
  • 39. Fox DS, McGinnis JE, Tonnu-Mihara IQ, McCombs JS. Comparative treatment effectiveness of direct acting antiviral regimens for hepatitis C: Data from the Veterans administration. J Gastroenterol Hepatol. 2017;32(6):1136-42. doi: 10.1111/jgh.13652. [PubMed: 27869323].
  • 40. Reddy KR, Bourliere M, Sulkowski M, Omata M, Zeuzem S, Feld JJ, et al. Ledipasvir and sofosbuvir in patients with genotype 1 hepatitis C virus infection and compensated cirrhosis: An integrated safety and efficacy analysis. Hepatology. 2015;62(1):79-86. doi: 10.1002/hep.27826. [PubMed: 25846144].
  • 41. Ahmed H, Abushouk AI, Menshawy A, Mohamed A, Negida A, Loutfy SA, et al. Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysis. Clin Drug Investig. 2017;37(11):1009-23. doi: 10.1007/s40261-017-0565-5. [PubMed: 28871475].
  • 42. Ioannou GN, Beste LA, Chang MF, Green PK, Lowy E, Tsui JI, et al. Effectiveness of sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir and dasabuvir regimens for treatment of patients with hepatitis C in the Veterans Affairs National Health Care System. Gastroenterology. 2016;151(3):457-471. e5.
  • 43. Bourliere M, Bronowicki JP, De Ledinghen V, Hezode C, Zoulim F, Mathurin P, et al. 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(4):397-404.
  • 44. Trifan A, Stanciu C, Gheorghe L, Iacob S, Curescu M, Cijevschi Prelipcean C, et al. Efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for the treatment of HCV genotype 1b compensated cirrhosis in patients aged 70 years or older. Medicine (Baltimore). 2017;96(50). e9271. doi: 10.1097/MD.0000000000009271. [PubMed: 29390377]. [PubMed Central: PMC5815789].
  • 45. Welzel TM, Hinrichsen H, Sarrazin C, Buggisch P, Baumgarten A, Christensen S, et al. Real-world experience with the all-oral, interferon-free regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic hepatitis C virus infection in the German Hepatitis C Registry. J Viral Hepat. 2017;24(10):840-9. doi: 10.1111/jvh.12708. [PubMed: 28342229].
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