Research Article
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Year 2023, , 9 - 14, 29.01.2023
https://doi.org/10.46310/tjim.994659

Abstract

References

  • Calvaruso V, Craxi A. European Association of the Study of the Liver. 2011 European Association of the Study of the Liver hepatitis C virus clinical practice guidelines. Liver Int. 2012 Feb;32 Suppl 1:2-8. doi: 10.1111/j.1478-3231.2011.02703.x.
  • Memon MI, Memon MA. Hepatitis C: an epidemiological review. J Viral Hepat. 2002 Mar;9(2):84-100. doi: 10.1046/j.1365-2893.2002.00329.x.
  • Serdengeçti K, Süleymanlar G, Altıparmak MR, Seyahi N. Registry of The Nephrology, Dialysis and Transplantation in Turkey. Registry 2016. The Turkish Society of Nephrology. Ankara: Miki Matbaacılık; 2017. Available at: https://nefroloji.org.tr/uploads/folders/file/2016_REGISTRY.pdf. Accessed Sep 01, 2021.
  • Fabrizi F, Martin P, Dixit V, Bunnapradist S, Dulai G. Meta-analysis: Effect of hepatitis C virus infection on mortality in dialysis. Aliment Pharmacol Ther. 2004 Dec;20(11-12):1271-7. doi: 10.1111/j.1365-2036.2004.02290.x.
  • Pockros PJ, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski MS, Bernstein DE, Cohen DE, Shulman NS, Wang D, Khatri A, Abunimeh M, Podsadecki T, Lawitz E. Efficacy of direct-acting antiviral combination for patients with hepatitis c virus genotype 1 infection and severe renal impairment or end-stage renal disease. Gastroenterology. 2016 Jun;150(7):1590-8. doi: 10.1053/j.gastro.2016.02.078.
  • Beinhardt S, Al Zoairy R, Ferenci P, Kozbial K, Freissmuth C, Stern R, Stättermayer AF, Stauber R, Strasser M, Zoller H, Watschinger B, Schmidt A, Trauner M, Hofer H, Maieron A. DAA-based antiviral treatment of patients with chronic hepatitis C in the pre- and postkidney transplantation setting. Transpl Int. 2016 Sep;29(9):999-1007. doi: 10.1111/tri.12799.
  • Sovaldi (sofosbuvir) tablets, for oral use [package insert]. Foster City, CA: Gilead Sciences. Revised in August 2015. Available at: https://www.gilead.com/-/media/files/pdfs/medicines/liver-disease/sovaldi/sovaldi_patient_pi.pdf. Accessed Sep 01, 2021.
  • Harvoni (ledipasvir and sofosbuvir) tablets [package insert]. Foster City, CA: Gilead Sciences. Revised in March 2015. Available at: https://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf. Accessed Sep 01, 2021.
  • Lawitz E, Landis CS, Flamm SL, Bonacini M, Ortiz-Lasanta G, Huang J, Zhang J, Kirby BJ, De-Oertel S, Hyland RH, Osinusi AO, Brainard DM, Robson R, Maliakkal BJ, Gordon SC, Gane EJ. Sofosbuvir plus ribavirin and sofosbuvir plus ledipasvir in patients with genotype 1 or 3 hepatitis C virus and severe renal impairment: a multicentre, phase 2b, non-randomised, open-label study. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):918-26. doi: 10.1016/S2468-1253(19)30417-0.
  • Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, et al. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol 2019;71:660–665.
  • Cox-North P, Hawkins KL, Rossiter ST, Hawley MN, Bhattacharya R, Landis CS. Sofosbuvir-based regimens for the treatment of chronic hepatitis C in severe renal dysfunction. Hepatol Commun. 2017 Apr 18;1(3):248-255. doi: 10.1002/hep4.1035.
  • Desnoyer A, Pospai D, Lê MP, Gervais A, Heurgué-Berlot A, Laradi A, Harent S, Pinto A, Salmon D, Hillaire S, Fontaine H, Zucman D, Simonpoli AM, Muret P, Larrouy L, Bernard Chabert B, Descamps D, Yazdanpanah Y, Peytavin G. Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C. J Hepatol. 2016 Jul;65(1):40-7. doi: 10.1016/j.jhep.2016.02.044.
  • Saxena V, Koraishy FM, Sise ME, Lim JK, Schmidt M, Chung RT, Liapakis A, Nelson DR, Fried MW, Terrault NA; HCV-TARGET. Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function. Liver Int. 2016 Jun;36(6):807-16. doi: 10.1111/liv.13102.
  • Ouwerkerk-Mahadevan S, Beumont-Mauviel M, Mortier S, Peeters M, Verloes R, Truyers C, Mannens G, Wynant I, Simion A. Evaluation of the pharmacokinetics and renal excretion of simeprevir in subjects with renal impairment. Drugs R D. 2015 Sep;15(3):261-70. doi: 10.1007/s40268-015-0101-0.
  • Daklinza (daclatasvir) tablets, for oral use [package insert]. Princeton, NJ: Bristol-Myers Squibb. Revised in July 2015. Available at: https://packageinserts.bms.com/pi/pi_daklinza.pdf. Accessed Sep 01, 2021.
  • European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; Clinical Practice Guidelines Panel: Chair:; EASL Governing Board representative:; Panel members: EASL recommendations on treatment of hepatitis C: Final update of the series. J Hepatol. 2020 Nov;73(5):1170-218. doi: 10.1016/j.jhep.2020.08.018.
  • Lampertico P, Carrión JA, Curry M, Turnes J, Cornberg M, Negro F, Brown A, Persico M, Wick N, Porcalla A, Pangerl A, Crown E, Larsen L, Yu Y, Wedemeyer H. Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of patients with chronic HCV infection: A meta-analysis. J Hepatol. 2020 Jun;72(6):1112-21. doi: 10.1016/j.jhep.2020.01.025.
  • Gane E, Lawitz E, Pugatch D, Papatheodoridis G, Bräu N, Brown A, Pol S, Leroy V, Persico M, Moreno C, Colombo M, Yoshida EM, Nelson DR, Collins C, Lei Y, Kosloski M, Mensa FJ. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med. 2017 Oct 12;377(15):1448-55. doi: 10.1056/NEJMoa1704053.
  • Pol S, Pockros P, Pugatch D, Brau N, Landis C, Elkhashab M, Sasadeusz J, Tran A, Hu Y, Kosloski M, Mensa F. Safety and efficacy of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus infection genotype 1-6 and chronic kidney disease: an integrated analysis. J Hepatol. 2017;66(Suppl 1):S738. doi: 10.1016/s0168-8278(17)31967-0.
  • Atsukawa M, Tsubota A, Toyoda H, Takaguchi K, Nakamuta M, Watanabe T, Michitaka K, Ikegami T, Nozaki A, Uojima H, Fukunishi S, Genda T, Abe H, Hotta N, Tsuji K, Ogawa C, Tachi Y, Shima T, Shimada N, Kondo C, Akahane T, Aizawa Y, Tanaka Y, Kumada T, Iwakiri K. The efficacy and safety of glecaprevir plus pibrentasvir in 141 patients with severe renal impairment: a prospective, multicenter study. Aliment Pharmacol Ther. 2019 May;49(9):1230-41. doi: 10.1111/apt.15218.
  • Khatri A, Dutta S, Marbury TC, Preston RA, Rodrigues-Jr L, Wang H, Awni W, Menon R. The pharmacokinetics and safety of the direct-acting antiviral regimen of ABT-450/r, ombitasvir with/without dasabuvir in subjects with mild, moderate and severe renal impairment compared to subjects with normal renal function. The 65th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting 2014; Hepatology 2014 Oct;60(Suppl 1):320A. Avaliable at: https://aasldpubs.onlinelibrary.wiley.com/doi/epdf/10.1002/hep.27487. Accessed Sep 01, 2021.

The efficacy of the direct-acting antiviral combination in hemodialysis patients with chronic hepatitis C virus Genotype 1 infection

Year 2023, , 9 - 14, 29.01.2023
https://doi.org/10.46310/tjim.994659

Abstract

Background Interferon and ribavirin treatments previously used in treating chronic hepatitis C virus (HCV) infection cannot be used effectively in hemodialysis patients due to dose adjustment and drug-related side effects. Direct-acting antivirals (DAAs) therapies have been reported to be effective in hemodialysis patients. This study aimed to evaluate the effectiveness of DAAs in hemodialysis patients with chronic hepatitis C.
Material and Methods Twenty hemodialysis patients with chronic hepatitis C followed in the gastroenterology outpatient clinic between 2016 and 2018 were evaluated retrospectively.
Results Twelve of the 20 patients were male, and eight were female. The mean age of the patients was 50.7±8.6 years. Six patients had no treatment experience. Fourteen patients had been previously treated with interferon and/or ribavirin but did not achieve sustained virological response (SVR). Genotype 1b was detected in 14 patients, genotype 1a in 4 patients, and genotype 1 in 2 patients. Patients were treated with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) and dasabuvir (DSV) or ribavirin (RBV) for 12 or 24 weeks. Two patients were cirrhotic and had a Child-Pugh score of A. Treatment was discontinued in 2 patients due to thrombus formation in the arteriovenous fistula in the first month of DAAs treatment. SVR12 was evaluated in 14 of 18 patients and found to be 100%. One of the ten patients accepted as SVR24 had a relapse. This rate of SVR24 was similar to that in the general population.
Conclusions Our results supported that the OBV/PTV/r and DSV or RBV regimen was a safe and effective therapy for hemodialysis patients with chronic hepatitis C virus genotype 1.

References

  • Calvaruso V, Craxi A. European Association of the Study of the Liver. 2011 European Association of the Study of the Liver hepatitis C virus clinical practice guidelines. Liver Int. 2012 Feb;32 Suppl 1:2-8. doi: 10.1111/j.1478-3231.2011.02703.x.
  • Memon MI, Memon MA. Hepatitis C: an epidemiological review. J Viral Hepat. 2002 Mar;9(2):84-100. doi: 10.1046/j.1365-2893.2002.00329.x.
  • Serdengeçti K, Süleymanlar G, Altıparmak MR, Seyahi N. Registry of The Nephrology, Dialysis and Transplantation in Turkey. Registry 2016. The Turkish Society of Nephrology. Ankara: Miki Matbaacılık; 2017. Available at: https://nefroloji.org.tr/uploads/folders/file/2016_REGISTRY.pdf. Accessed Sep 01, 2021.
  • Fabrizi F, Martin P, Dixit V, Bunnapradist S, Dulai G. Meta-analysis: Effect of hepatitis C virus infection on mortality in dialysis. Aliment Pharmacol Ther. 2004 Dec;20(11-12):1271-7. doi: 10.1111/j.1365-2036.2004.02290.x.
  • Pockros PJ, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski MS, Bernstein DE, Cohen DE, Shulman NS, Wang D, Khatri A, Abunimeh M, Podsadecki T, Lawitz E. Efficacy of direct-acting antiviral combination for patients with hepatitis c virus genotype 1 infection and severe renal impairment or end-stage renal disease. Gastroenterology. 2016 Jun;150(7):1590-8. doi: 10.1053/j.gastro.2016.02.078.
  • Beinhardt S, Al Zoairy R, Ferenci P, Kozbial K, Freissmuth C, Stern R, Stättermayer AF, Stauber R, Strasser M, Zoller H, Watschinger B, Schmidt A, Trauner M, Hofer H, Maieron A. DAA-based antiviral treatment of patients with chronic hepatitis C in the pre- and postkidney transplantation setting. Transpl Int. 2016 Sep;29(9):999-1007. doi: 10.1111/tri.12799.
  • Sovaldi (sofosbuvir) tablets, for oral use [package insert]. Foster City, CA: Gilead Sciences. Revised in August 2015. Available at: https://www.gilead.com/-/media/files/pdfs/medicines/liver-disease/sovaldi/sovaldi_patient_pi.pdf. Accessed Sep 01, 2021.
  • Harvoni (ledipasvir and sofosbuvir) tablets [package insert]. Foster City, CA: Gilead Sciences. Revised in March 2015. Available at: https://www.gilead.com/~/media/files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf. Accessed Sep 01, 2021.
  • Lawitz E, Landis CS, Flamm SL, Bonacini M, Ortiz-Lasanta G, Huang J, Zhang J, Kirby BJ, De-Oertel S, Hyland RH, Osinusi AO, Brainard DM, Robson R, Maliakkal BJ, Gordon SC, Gane EJ. Sofosbuvir plus ribavirin and sofosbuvir plus ledipasvir in patients with genotype 1 or 3 hepatitis C virus and severe renal impairment: a multicentre, phase 2b, non-randomised, open-label study. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):918-26. doi: 10.1016/S2468-1253(19)30417-0.
  • Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, et al. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol 2019;71:660–665.
  • Cox-North P, Hawkins KL, Rossiter ST, Hawley MN, Bhattacharya R, Landis CS. Sofosbuvir-based regimens for the treatment of chronic hepatitis C in severe renal dysfunction. Hepatol Commun. 2017 Apr 18;1(3):248-255. doi: 10.1002/hep4.1035.
  • Desnoyer A, Pospai D, Lê MP, Gervais A, Heurgué-Berlot A, Laradi A, Harent S, Pinto A, Salmon D, Hillaire S, Fontaine H, Zucman D, Simonpoli AM, Muret P, Larrouy L, Bernard Chabert B, Descamps D, Yazdanpanah Y, Peytavin G. Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C. J Hepatol. 2016 Jul;65(1):40-7. doi: 10.1016/j.jhep.2016.02.044.
  • Saxena V, Koraishy FM, Sise ME, Lim JK, Schmidt M, Chung RT, Liapakis A, Nelson DR, Fried MW, Terrault NA; HCV-TARGET. Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function. Liver Int. 2016 Jun;36(6):807-16. doi: 10.1111/liv.13102.
  • Ouwerkerk-Mahadevan S, Beumont-Mauviel M, Mortier S, Peeters M, Verloes R, Truyers C, Mannens G, Wynant I, Simion A. Evaluation of the pharmacokinetics and renal excretion of simeprevir in subjects with renal impairment. Drugs R D. 2015 Sep;15(3):261-70. doi: 10.1007/s40268-015-0101-0.
  • Daklinza (daclatasvir) tablets, for oral use [package insert]. Princeton, NJ: Bristol-Myers Squibb. Revised in July 2015. Available at: https://packageinserts.bms.com/pi/pi_daklinza.pdf. Accessed Sep 01, 2021.
  • European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; Clinical Practice Guidelines Panel: Chair:; EASL Governing Board representative:; Panel members: EASL recommendations on treatment of hepatitis C: Final update of the series. J Hepatol. 2020 Nov;73(5):1170-218. doi: 10.1016/j.jhep.2020.08.018.
  • Lampertico P, Carrión JA, Curry M, Turnes J, Cornberg M, Negro F, Brown A, Persico M, Wick N, Porcalla A, Pangerl A, Crown E, Larsen L, Yu Y, Wedemeyer H. Real-world effectiveness and safety of glecaprevir/pibrentasvir for the treatment of patients with chronic HCV infection: A meta-analysis. J Hepatol. 2020 Jun;72(6):1112-21. doi: 10.1016/j.jhep.2020.01.025.
  • Gane E, Lawitz E, Pugatch D, Papatheodoridis G, Bräu N, Brown A, Pol S, Leroy V, Persico M, Moreno C, Colombo M, Yoshida EM, Nelson DR, Collins C, Lei Y, Kosloski M, Mensa FJ. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med. 2017 Oct 12;377(15):1448-55. doi: 10.1056/NEJMoa1704053.
  • Pol S, Pockros P, Pugatch D, Brau N, Landis C, Elkhashab M, Sasadeusz J, Tran A, Hu Y, Kosloski M, Mensa F. Safety and efficacy of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus infection genotype 1-6 and chronic kidney disease: an integrated analysis. J Hepatol. 2017;66(Suppl 1):S738. doi: 10.1016/s0168-8278(17)31967-0.
  • Atsukawa M, Tsubota A, Toyoda H, Takaguchi K, Nakamuta M, Watanabe T, Michitaka K, Ikegami T, Nozaki A, Uojima H, Fukunishi S, Genda T, Abe H, Hotta N, Tsuji K, Ogawa C, Tachi Y, Shima T, Shimada N, Kondo C, Akahane T, Aizawa Y, Tanaka Y, Kumada T, Iwakiri K. The efficacy and safety of glecaprevir plus pibrentasvir in 141 patients with severe renal impairment: a prospective, multicenter study. Aliment Pharmacol Ther. 2019 May;49(9):1230-41. doi: 10.1111/apt.15218.
  • Khatri A, Dutta S, Marbury TC, Preston RA, Rodrigues-Jr L, Wang H, Awni W, Menon R. The pharmacokinetics and safety of the direct-acting antiviral regimen of ABT-450/r, ombitasvir with/without dasabuvir in subjects with mild, moderate and severe renal impairment compared to subjects with normal renal function. The 65th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting 2014; Hepatology 2014 Oct;60(Suppl 1):320A. Avaliable at: https://aasldpubs.onlinelibrary.wiley.com/doi/epdf/10.1002/hep.27487. Accessed Sep 01, 2021.
There are 21 citations in total.

Details

Primary Language English
Subjects ​Internal Diseases
Journal Section Original Articles
Authors

Tuba Erürker Öztürk 0000-0002-3682-5851

Selim Gürel This is me 0000-0002-7279-2161

Ayşegül Oruç 0000-0002-0342-9692

Alparslan Ersoy 0000-0002-0710-0923

Publication Date January 29, 2023
Submission Date September 22, 2021
Acceptance Date November 18, 2022
Published in Issue Year 2023

Cite

EndNote Erürker Öztürk T, Gürel S, Oruç A, Ersoy A (January 1, 2023) The efficacy of the direct-acting antiviral combination in hemodialysis patients with chronic hepatitis C virus Genotype 1 infection. Turkish Journal of Internal Medicine 5 1 9–14.

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