#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Sofosbuvir-based regimen for genotype 2 HCV infected patients in Taiwan: A real world experience


Autoři: Wei-Lun Tsai aff001;  Chih-Feng Wang aff001;  Jin-Shiung Cheng aff001;  Wen-Chi Chen aff001;  Ming-Jong Bair aff003;  Ching-Chu Lo aff002
Působiště autorů: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan aff001;  School of Medicine, National Yang-Ming University, Taipei, Taiwan aff002;  Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan aff003;  Mackay Medical College, New Taipei City, Taiwan aff004;  Division of Gastroenterology and Hepatology, Department of Internal Medicine, St. Martin De Porres Hospital, Chiayi, Taiwan aff005;  Chung-Jen junior College of Nursing, Health Sciences and Management, Chiayi, Taiwan aff006
Vyšlo v časopise: PLoS ONE 15(1)
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pone.0227424

Souhrn

Background

Sofosbuvir (SOF)-based regimens achieve excellent efficacy and safety in the treatment of chronic hepatitis C (CHC) with various genotypes. There are few real-world instances of the use of SOF-based regimens to treat genotype 2 CHC. This study determines the effectiveness and safety of SOF/Ribavirn (RBV), SOF/Daclatasvir (DCV) and SOF/DCV/RBV in the treatment of genotype 2 CHC patients in Taiwan.

Material and methods

Patients with genotype 2 CHC were treated for 12 weeks with SOF/RBV, SOF/DCV or SOF/DCV/RBV under the National Health Insurance reimbursement program in three hospitals in Taiwan. The sustained virological response at 12 weeks (SVR12) was determined. Adverse events were recorded for a safety analysis.

Results

A total of 467 genotype 2 CHC patients were enrolled from January to October 2018. One hundred and eleven patients (24%) had cirrhosis, including 10 patients (2.1%) with hepatic decompensation. Fifty-five patients (12%) had already experienced interferon-alpha/RBV treatment. Forty-two patients (9%) had a history of hepatocellular carcinoma (HCC) in the baseline. Three hundred and fifty-five patients received SOF/RBV, forty-seven patients received SOF/DCV and sixty-two patients received SOF/DCV/RBV. The SOF/DCV group featured a greater HCV viral load than the SOF/RBV or SOF/DCV/RBV groups. SVR12 was achieved in 94.6% of the SOF/RBV group, 95.7% of the SOF/DCV group and 96.8% of then SOF/DCV/RBV group (P = NS). Thirteen out of 352 patients (3.7%) in the SOF/RBV group, 1 out of 62 patients (1.6%) in the SOF/DCV/RBV group and 1 out of 47 patients (2.1%) in the SOF/DCV group developed virological failure. There are no differences in virological failure between the three groups (P = NS). Multi-variate analysis shows that history of HCC is an independent factor that is associated with the failure of treatment in the SOF/RBV group (odds ratio:4.905, 95% confidence interval (CI): 1.321–18.205, P = 0.017). Hemoglobin levels at 12 weeks are significantly lower in the SOF/RBV and the SOF/RBV/DCV group than in the SOF/DCV group (P<0.05). Serious adverse events (SAE) occurred in six patients (1.6%) in the SOF/RBV group and in one patient (1.6%) in the SOF/RBV/DCV group. No patients in the SOF/DCV group experienced SAE.

Conclusions

SOF/RBV, SOF/DCV or SOF/DCV/RBV for 12 weeks all achieve very high SVR rates and are equally effective in the treatment of genotype 2 CHC patients in the real world in Taiwan. Patients in the SOF/RBV group who have a history of HCC exhibit a lower SVR rate.

Klíčová slova:

Hemoglobin – Hepatitis C virus – Cirrhosis – Adverse events – Hepatocellular carcinoma – Taiwan – Liver fibrosis – anémia


Zdroje

1. Kao J.H.; Chen D.S. Changing disease burden of hepatocellular carcinoma in the Far East and Southeast Asia. Liver international. 2005, 25, 696–703. https://www.ncbi.nlm.nih.gov/pubmed/15998418 doi: 10.1111/j.1478-3231.2005.01139.x 15998418

2. Heimbach J.; Kulik L.M.; Finn R.; Sirlin C.B.; Abecassis M.; Roberts L.R.; Zhu A.; Murad M.H.; Marrero J. Aasld guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2017 Jan 28. https://www.ncbi.nlm.nih.gov/pubmed/28130846 doi: 10.1002/hep.29086 28130846

3. Fattovich G.; Stroffolini T.; Zagni I.; Donato F. Hepatocellular carcinoma in cirrhosis: incidence and risk factors. Gastroenterology. 2004, 127, suppl 1. S35–50. https://www.ncbi.nlm.nih.gov/pubmed/15508101 doi: 10.1053/j.gastro.2004.09.014 15508101

4. Welsch C.; Zeuzem S. Will Interferon-Free Regimens Prevail? Gastroenterology. 2012, 142, 1351–1355. https://www.ncbi.nlm.nih.gov/pubmed/22537442 doi: 10.1053/j.gastro.2011.12.062 22537442

5. Schaefer, eak.; Chung R.T. Anti_Hepatitis C Virus Drugs in Development. Gastroenterology. 2012, 142, 1340–1350. https://www.ncbi.nlm.nih.gov/pubmed/22537441 doi: 10.1053/j.gastro.2012.02.015 22537441

6. AASLD-IDSA HCV Guidance Panel. Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Clinical Infectious Diseases. 2018, 67(10), 1477–92. https://www.ncbi.nlm.nih.gov/pubmed/30215672 doi: 10.1093/cid/ciy585 30215672

7. Manns M.P.; Buti M.; Gane E.; Pawlotsky J.M.; Razavi H.; Terrault N.; et al. Hepatitis C virus infection. Nat Rev Dis Prim. 2017, 3, 17006. https://www.ncbi.nlm.nih.gov/pubmed/28252637 doi: 10.1038/nrdp.2017.6 28252637

8. Van Der Meer A.J.; Veldt B.J.; Feld J.J.; Wedemeyer H.; Dufour J.F.; 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, 2584–93. https://www.ncbi.nlm.nih.gov/pubmed/23268517 doi: 10.1001/jama.2012.144878 23268517

9. Falade-Nwulia O.; Suarez-Cuervo C.; Nelson D.R.; Fried M.W.; Segal J.B.; Sulkowski M.S. Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review. Ann Intern Med. 2017 May 2, 166(9), 637–648. https://www.ncbi.nlm.nih.gov/pubmed/28319996 doi: 10.7326/M16-2575 28319996

10. Cheung M.C.M.; Walker A.J.; Hudson B.E. Verma S.; McLauchlan J.; Mutimer D.J.; et al. Outcomes after successful direct-acting antiviral therapy for patients with chronic hepatitis C and decompensated cirrhosis. J Hepatol. 2016, 65, 741–7. https://www.ncbi.nlm.nih.gov/pubmed/27388925 doi: 10.1016/j.jhep.2016.06.019 27388925

11. Jacobson I.M.; Gordon S.C.; Kowdley K.V.; et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013, 368, 1867–1877. https://www.ncbi.nlm.nih.gov/pubmed/23607593 doi: 10.1056/NEJMoa1214854 23607593

12. Zeuzem S.; Dusheiko G.M.; Salupere R.; et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014, 370, 1993–2001. https://www.ncbi.nlm.nih.gov/pubmed/24795201 doi: 10.1056/NEJMoa1316145 24795201

13. Omata M.; Nishiguchi S.; Ueno Y.; Mochizuki H.; Izumi N,; Ikeda F. et al. Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: an open-label, phase 3 trial. J Viral Hepat. 2014 Nov, 21(11), 762–8. https://www.ncbi.nlm.nih.gov/pubmed/25196837 doi: 10.1111/jvh.12312 25196837

14. Kao J.H.; Chien R.N.; Chang T.T.; Peng C.Y.; Hu T.H.; Lo G.H, et al. A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection. Liver Int. 2016 Aug, 36(8), 1101–7. https://www.ncbi.nlm.nih.gov/pubmed/26835876 doi: 10.1111/liv.13082 26835876

15. Tacke F.; Günther R.; Buggisch P.; Klinker H.; Schober A.; John C. et al., Treatment of HCV genotype 2 with sofosbuvir and ribavirin results in lower sustained virological response rates in real life than expected from clinical trials. Liver Int. 2017 Feb, 37(2), 205–211. https://www.ncbi.nlm.nih.gov/pubmed/27428297 doi: 10.1111/liv.13206 27428297

16. Akahane T.; Kurosaki M.; Itakura J.; Tsuji K.; Joko K.; Kimura H. et al. Real-world efficacy and safety of sofosbuvir + ribavirin for hepatitis C genotype 2: A nationwide multicenter study by the Japanese Red Cross Liver Study Group. Hepatol Res. 2019 Mar, 49(3), 264–270. https://www.ncbi.nlm.nih.gov/pubmed/30171740 doi: 10.1111/hepr.13246 30171740

17. Welzel T.M.; Nelson D.R.; Morelli G.; Di Bisceglie A.; Reddy R.K.;. HCV-TARGET Study Group. Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study. Gut. 2017 Oct, 66(10), 1844–1852. https://www.ncbi.nlm.nih.gov/pubmed/27418632 doi: 10.1136/gutjnl-2016-311609 27418632

18. Mangia A.; Susser S.; Piazzolla V.; Agostinacchio E.; De Stefano G.; Palmieri V. et al., Sofosbuvir and ribavirin for genotype 2 HCV infected patients with cirrhosis: A real life experience. J Hepatol. 2017 Apr, 66(4), 711–717. https://www.ncbi.nlm.nih.gov/pubmed/27965158 doi: 10.1016/j.jhep.2016.12.002 27965158

19. Kanda T1.; Nakamura M2.; Yasui S3.; Haga Y4.; Tawada A5.; Suzuki E6. Et al., Treatment of Real-World HCV Genotype 2-Infected Japanese Patients with Sofosbuvir plus Ribavirin. Biology (Basel). 2017 May 9, 6(2), pii: E30. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5485477/ doi: 10.3390/biology6020030 28486403

20. Sulkowski MS.; Gardiner DF.; Rodriguez-Torres M.; Reddy K.R.; Hassanein T.; Jacobson I, et al., Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16, 370(3), 211–21, doi: 10.1056/NEJMoa1306218 https://www.nejm.org/doi/full/10.1056/NEJMoa1306218 24428467

21. Zhou N.; Han Z.; Hartman-Neumann S.; DeGray B.; Ueland J.; Vellucci V.; Hernandez D.; McPhee F. Characterization of NS5A polymorphisms and their impact on response rates in patients with HCV genotype 2 treated with daclatasvir-based regimens. J Antimicrob Chemother. 2016 Dec, 71(12), 3495–3505 https://www.ncbi.nlm.nih.gov/pubmed/27605597 doi: 10.1093/jac/dkw336 27605597

22. Mangia A.; Arleo A.; Copetti M.; Miscio M.; Piazzolla V.; Santoro R. Squillante MM The combination of daclatasvir and sofosbuvir for curing genotype 2 patients who cannot tolerate ribavirin. Liver Int. 2016 Jul, 36(7), 971–6. https://www.ncbi.nlm.nih.gov/pubmed/26786792 doi: 10.1111/liv.13069 26786792

23. Wang J.H.; Changchien C.S.; Hung C.H.; Eng H.L.; Tung W.C.; Kee K.M.; et al. FibroScan and ultrasonography in the prediction of hepatic fibrosis in patients with chronic viral hepatitis. J Gastroenterol. 2009, 44, 439–46. https://www.ncbi.nlm.nih.gov/pubmed/19308312 doi: 10.1007/s00535-009-0017-y 19308312

24. Sterling R.K.; Lissen E.; Clumeck N.; Sola R.; Correa M.C.; Montaner J.; et. al. Development of a simple noninvasive index to predict significant fibrosis patients with HIV/HCV co-infection. Hepatology. 2006, 43, 1317–1325. https://www.ncbi.nlm.nih.gov/pubmed/16729309 doi: 10.1002/hep.21178 16729309

25. Bedossa P.; Poynard T. An algorithm for the grading of activity in chronic hepatitis C. The METAVIR Cooperative Study Group. Hepatology. 1996, 24, 289–293. https://www.ncbi.nlm.nih.gov/pubmed/8690394 doi: 10.1002/hep.510240201 8690394

26. Lin D.Y.; Sheen I.S.; Chiu C.T.; Lin S.M.; Kuo Y.C.; Liaw Y.F. Ultrasonographic changes of early liver cirrhosis in chronic hepatitis B: a longitudinal study. J Clin Ultrasound. 1993 Jun, 21(5), 303–8. https://www.ncbi.nlm.nih.gov/pubmed/8514896 doi: 10.1002/jcu.1870210502 8514896

27. Heimbach J.K.; Kulik L.M.; Finn R.S.; Sirlin C.B.; Abecassis M.M.; Roberts L.R.; et al. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018, 67, 358–80. https://www.ncbi.nlm.nih.gov/pubmed/28130846 doi: 10.1002/hep.29086 28130846

28. Omata M.; Cheng A.L.; Kokudo N.; Kudo M.; Lee J.M.; Jia J.; et al. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017, 11, 317–70. https://www.ncbi.nlm.nih.gov/pubmed/28620797 doi: 10.1007/s12072-017-9799-9 28620797

29. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018, 69, 182–236. https://www.ncbi.nlm.nih.gov/pubmed/29628281 doi: 10.1016/j.jhep.2018.03.019 29628281.

30. Kumar M, Jindal A, Sharma BC, Hamid SS, Dokmeci AK, Mamun-Al-Mahtab, et al.,. APASL consensus statements and recommendation on treatment of hepatitis C.Omata M1,2, Kanda T3, Wei L4, Yu ML5, Chuang WL6, Ibrahim A7, Lesmana CR8, Sollano J910 Hepatol Int. 2016 Sep;10(5):702–26. https://www.ncbi.nlm.nih.gov/pubmed/2713047 doi: 10.1007/s12072-016-9717-6 27130427.

31. EASL Recommendations on Treatment of Hepatitis C 2018.European Association for the Study of the Liver. J Hepatol. 2018 Aug, 69(2), 461–511. https://easl.eu/wp-content/uploads/2018/10/HepC-English-report.pdf doi: 10.1016/j.jhep.2018.03.026 29650333

32. Backus L.I.; Belperio P.S.; Shahoumian T.A.; Loomis T.P.; Mole L.A. Effectiveness of sofosbuvir-based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 U.S. Veterans. Aliment Pharmacol Ther. 2015, 42, 559–73. https://www.ncbi.nlm.nih.gov/pubmed/26113432 doi: 10.1111/apt.13300 26113432

33. Zeuzem S.; Dusheiko G.M.; Salupere R.; Mangia A.; Flisiak R.; Hyland R.H.; et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 2014, 370, 1993–2001. doi: 10.1056/NEJMoa1316145 24795201

34. Foster G.R.; Pianko S.; Brown A.; Forton D.; Nahass R.G.; George J.; 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, 1462–70. https://www.ncbi.nlm.nih.gov/pubmed/26248087 doi: 10.1053/j.gastro.2015.07.043 26248087

35. Cheng P.N.; Chiu Y.C,; Chien S.C.; Chiu H.C. Real-world effectiveness and safety of sofosbuvir plus daclatasvir with or without ribavirin for genotype 2 chronic hepatitis C in Taiwan. J Formos Med Assoc. 2019 May, 118(5), 907–913. https://www.ncbi.nlm.nih.gov/pubmed/30316677 doi: 10.1016/j.jfma.2018.09.016 30316677

36. Wu S.H.; Chu C.J.; Su C.W.; Lin C.C.; Lee S.D.; Wang Y.J, et al., Daclatasvir plus sofosbuvir, with or without ribavirin, is highly effective for all kinds of genotype-2 chronic hepatitis-C infection in Taiwan. J Chin Med Assoc. 2019 in press. https://www.ncbi.nlm.nih.gov/pubmed/31356562 doi: 10.1097/JCMA.0000000000000148 31356562

37. Belperio P.S.; Shahoumian T.A.; Loomis T.P.; Mole L.A.; Backus L.I. Real-world effectiveness of daclatasvir plus sofosbuvir and velpatasvir/sofosbuvir in hepatitis C genotype 2 and 3. J Hepatol. 2019 Jan, 70(1), 15–23. https://www.ncbi.nlm.nih.gov/pubmed/30266283 doi: 10.1016/j.jhep.2018.09.018 30266283

38. Swallow E.; Song J.; Yuan Y.; Kalsekar A.; Kelley C.; Peeples M, et al.,Daclatasvir and Sofosbuvir Versus Sofosbuvir and Ribavirin in Patients with Chronic Hepatitis C Coinfected with HIV: A Matching-adjusted Indirect Comparison. Clin Ther. 2016 Feb, 38(2), 404–12. https://www.ncbi.nlm.nih.gov/pubmed/26839044 doi: 10.1016/j.clinthera.2015.12.017 26839044

39. Prenner S.B.; VanWagner L.B.; Flamm S.L.; Salem R.; Lewandowski R.J.; Kulik L. Hepatocellular carcinoma decreases the chance of successful hepatitis C virus therapy with direct-acting antivirals. J Hepatol. 2017 Jun, 66(6), 1173–1181. doi: 10.1016/j.jhep.2017.01.020 Epub 2017 Feb 2. https://www.ncbi.nlm.nih.gov/pubmed/28161470 28161470

40. Beste L.A.; Green P.K.; Berry K.; Kogut M.J.; Allison S.K.; Ioannou G.N. Effectiveness of hepatitis C antiviral treatment in a USA cohort of veteran patients with hepatocellular carcinoma. J Hepatol. 2017 Jul, 67(1), 32–39. https://www.ncbi.nlm.nih.gov/pubmed/28267622 doi: 10.1016/j.jhep.2017.02.027 28267622

41. Yen Y.H.; et al. Active hepatocellular carcinoma is an independent risk factor of direct-acting antiviraltreatment failure: a retrospective study with prospectively collected data. Plos one. 2019 in press. https://www.ncbi.nlm.nih.gov/pubmed/31581209 doi: 10.1371/journal.pone.0222605 31581209

42. Huang CF, Yeh ML, Huang CI, Liang PC, Lin YH, Hsieh MY, et al., Equal treatment efficacy of direct-acting antivirals in patients with chronic hepatitis C and hepatocellular carcinoma? A prospective cohort study.BMJ Open. 2019 May 5;9(5):e026703. https://www.ncbi.nlm.nih.gov/pubmed/6501994 doi: 10.1136/bmjopen-2018-026703 31061041

43. Liu C.H.; Sun H.Y.; Liu C.J.; et al. Generic velpatasvir plus sofosbuvir for hepatitis C virus infection in patients with or without human immunodeficiency virus coinfection. Aliment Pharmacol Ther. 2018, 47, 1690–8. https://www.ncbi.nlm.nih.gov/pubmed/29665069 doi: 10.1111/apt.14647 29665069


Článok vyšiel v časopise

PLOS One


2020 Číslo 1
Najčítanejšie tento týždeň
Najčítanejšie v tomto čísle
Kurzy

Zvýšte si kvalifikáciu online z pohodlia domova

Získaná hemofilie - Povědomí o nemoci a její diagnostika
nový kurz

Eozinofilní granulomatóza s polyangiitidou
Autori: doc. MUDr. Martina Doubková, Ph.D.

Všetky kurzy
Prihlásenie
Zabudnuté heslo

Zadajte e-mailovú adresu, s ktorou ste vytvárali účet. Budú Vám na ňu zasielané informácie k nastaveniu nového hesla.

Prihlásenie

Nemáte účet?  Registrujte sa

#ADS_BOTTOM_SCRIPTS#