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Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları ve İlaç-İlaç Etkileşimleri Yönetimi

Year 2019, Volume: 72 Issue: 1, 49 - 53, 13.06.2019
https://doi.org/10.4274/atfm.galenos.2019.63522

Abstract

Amaç: Bu çalışmanın amacı kronik hepatit C virüs (HCV) pozitif hemodiyaliz hastalarında paritaprevir/ritonavir/ombitasvir/dasabuvir (PROD),
ledipasvir/sofosbuvir (LDV/SOF) ve peginterferon (Peg-IFN) alfa-2a tedavilerinin HCV enfeksiyonu eliminasyonundaki başarısının ve direkt etkili
antiviral (DEA) alan hastaların eş zamanlı ilaç-ilaç etkileşimleri yönetiminin değerlendirilmesi amaçlanmıştır.

Gereç ve Yöntem: HCV genotip 1 ile enfekte 10 hastanın demografik özellikleri, komorbid hastalıkları, laboratuvar verileri ve aldıkları tedavi rejimi
ve süreleri hastane kayıt sisteminden retrospektif taranarak kaydedildi. Hastalar aldıkları tedavi rejimine göre 3 gruba ayrıldı: PROD, LDV/SOF ve
Peg-IFN. Tedavi süresince ve sonrasında virolojik yanıt, yan etkiler, biyokimyasal ve hematolojik parametreler ile ilgili veriler analiz edildi. Ayrıca DEA
tedavi rejimi alan hastalarda eş zamanlı ilaç kullanımı ve etkileşimi değerlendirildi.

Bulgular: Ortanca yaş 48 (aralık, 21-74) yıl, hastaların 5’i (%50) kadındı. Hastaların 2’si (%20) LED/SOF, 5’i (%50) PROD ve 3’ü (%30) Peg-IFN tedavisi
aldı. Hastaların 6’sı (%60) daha önce tedavi deneyimli olup Peg-IFN tedavisine yanıtsızlardı. Tüm hastalar kalıcı virolojik yanıt elde etti (%100).
Bir yıllık takip süresi sonunda hastaların hiçbirinde HCV reaktivasyonu gerçekleşmedi ve böylece HCV hemodiyaliz ünitemizden elimine edildi.
Hiçbir hasta tedavi süresince ilacın kesilmesine yol açan ciddi bir olumsuz olay yaşamadı. İlaç-ilaç etkileşimleri, DEA alan 7 hastanın 2’sinde tedavi
başlangıcı ile birlikte modifiye edildi.

Sonuç: Hemodiyaliz hastalarındaki çoklu ilaç kullanımı ve komorbiditeler göz önüne alındığında nefrolog liderliğindeki multidisipliner yaklaşım
tedaviye erişimin artması ve hastaların daha etkin yönetimini için çok önemlidir

Ethical Statement

Etik Kurul Onayı: Etik Kurul onayı alınmamıştır. Hasta Onayı: Tüm hastalardan verilerin kullanımı için onamları alınmıştır. Hakem Değerlendirmesi: Editörler kurulu ve editörler kurulu dışında olan kişiler tarafından değerlendirilmiştir. Finansal Destek: Yazar tarafından finansal destek alınmadığı bildirilmiştir.

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Thanks

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References

  • 1. Goodkin DA, Bieber B, Jadoul M, et al. Mortality, Hospitalization, and Quality of Life among Patients with Hepatitis C Infection on Hemodialysis. Clin J Am Soc Nephrol. 2017;12:287-297.
  • 2. Mohd Hanafiah K, Groeger J, Flaxman AD, et al. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013;57:1333-1342.
  • 3. Fabrizi F, Messa P. The epidemiology of HCV infection in patients with advanced CKD/ESRD: A global perspective. Semin Dial. 2019;32:93-98.
  • 4. National Nephrology, Dialysis and Transplantation Registry Report of Turkey 2017.
  • 5. Goodkin DA, Bieber B, Gillespie B, et al. Hepatitis C infection is very rarely treated among hemodialysis patients. Am J Nephrol. 2013;38:405-412.
  • 6. Peck-Radosavljevic M, Boletis J, Besisik F, et al. Low-dose peginterferon alfa-2a is safe and produces a sustained virologic response in patients with chronic hepatitis C and end-stage renal disease. Clin Gastroenterol Hepatol. 2011;9:242-248.
  • 7. Pagan J, Ladino M, Roth D. Treating hepatitis C virus in dialysis patients: How, when, and why? Semin Dial. 2019;32:152-158.
  • 8. Feld JJ, Moreno C, Trinh R, 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;64:301-307.
  • 9. Pockros PJ, Reddy KR, Mantry PS, et al. 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;150:1590-1598.
  • 10. Roth D, Nelson DR, Bruchfeld A, et al. Grazoprevir plus elbasvir in treatmentnaive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015;386:1537-1545.
  • 11. Abad S, Vega A, Hernández E, et al. Universal Sustained Viral Response to the Combination of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with/ without Ribavirin in Patients on Hemodialysis Infected with Hepatitis C Virus Genotypes 1 and 4. Am J Nephrol. 2017;45:267-272.
  • 12. Gane E, Lawitz E, Pugatch D, et al. Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment. N Engl J Med. 2017;377:1448- 1455.
  • 13. Ponziani FR, Siciliano M, Lionetti R, et al. Effectiveness of Paritaprevir/ Ritonavir/Ombitasvir/Dasabuvir in Hemodialysis Patients With Hepatitis C Virus Infection and Advanced Liver Fibrosis: Case Reports Am J Kidney Dis. 2017;70:297-300.
  • 14. Muñoz-Gómez R, Rincón D, Ahumada A, et al. Therapy with ombitasvir/ paritaprevir/ritonavir plus dasabuvir is effective and safe for the treatment of genotypes 1 and 4 hepatitis C virus (HCV) infection in patients with severe renal impairment: A multicentre experience. J Viral Hepat. 2017;24:464- 471.
  • 15. Surendra M, Raju SB, Sridhar N, et al. Ledipasvir and Sofosbuvir for untreated HCV genotype 1 infection in end stage renal disease patients: A prospective observational study. Hemodial Int. 2018;22:217-221.
  • 16. Sperl J, Kreidlova M, Merta D, et al. Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir Regimen in the Treatment of Genotype 1 Chronic Hepatitis C Infection in Patients with Severe Renal Impairment and End-Stage Renal Disease: a Real-Life Cohort Kidney Blood Press Res. 2018;43:594-605.
  • 17. Davis MI, Chute DF, Chung RT, et al. When and how can nephrologists treat hepatitis C virus infection in dialysis patients? Semin Dial. 2018;31:26-36.
  • 18. Kalkan İ, Çınar G, Çelen MK, et al. Drug-Drug Interaction Management in Hepatitis C Treatment. J Ankara Univ Fac Med 2018;71:174-176.
  • 19. Liverpool HEP Interactions. Availablefrom:https://www.hepdruginteractions. org/checker.
  • 20. European Association for the Study of Liver. Recommendation son treatment of hepatitis C 2016. J Hepatol. 2017;66:153-194.
  • 21. Aygen B, Demirtürk N, Türker N, et al. Management of Chronic Hepatitis C Virus Infection: A Consensus Report of the Study Group for Viral Hepatitis of the Turkish Society of Clinical Microbiology and Infectious Diseases-2017 Update. Klinik Dergisi 2017;30:2-36.
  • 22. Singh T, Guirguis J, Anthony S, et al. Sofosbuvir-based treatment is safe and effective in patients with chronic hepatitis C infection and end stage renal disease: a case series. Liver Int. 2016;36:802-806.
  • 23. Desnoyer A, Pospai D, Lê MP, et al. Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C. J Hepatol. 2016;65:40-47.
  • 24. Singh A, Kumari S, Kumar P, et al. Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency. J Viral Hepat. 2018;25:1501-1506.
  • 25. Jadoul M, Berenguer MC, Doss W, et al. Executive summary of the 2018 KDIGO Hepatitis C in CKD Guideline: welcoming advances in evaluation and management. Kidney Int. 2018;94:663-673.

Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları ve İlaç-İlaç Etkileşimleri Yönetimi

Year 2019, Volume: 72 Issue: 1, 49 - 53, 13.06.2019
https://doi.org/10.4274/atfm.galenos.2019.63522

Abstract

Objectives: The aim of this study was to evaluate the success of the paritaprevir/ritonavir/ombitasvir/dasabuvir (PROD), ledipasvir/sofosbuvir (LDV/
SOF) and peginterferon (Peg-IFN) alfa-2a in the elimination of chronic hepatitis C virus (HCV) infection in HCV positive hemodialysis patients, and
to assess the management of concomitant drug-drug interactions in patients receiving direct acting antiviral (DAA).

Materials and Methods: The demographical characteristics, comorbid diseases, laboratory data, and treatment regimen and duration of 10 patients
who were infected with HCV genotype 1 were retrospectively screened from the electronic hospital records. The patients were divided into 3 groups
according to treatment regimen: PROD, LDV/SOF and Peg-IFN. Data on virologic response, adverse events, and biochemical and hematological
parameters during and after therapy were analyzed. Also, concomitant drug use and drug-drug interactions were evaluated in patients receiving
DAA regimen.

Results: The median age was 48 (21-74) years, 5 (50%) of patients were female. 2 patients (20%) received LDV/SOF, 5 (50%) PROD and 3 (30%) Peg-
IFN. Six of patients (60%) were HCV treatment-experienced and were failed to previous Peg-IFN therapy. All patients achieved sustained virologic
response (100%). At the end of the one-year follow-up period, none of patients presented with HCV reactivation, and thus HCV was eliminated
from our hemodialysis unit. No patient experienced serious adverse event leading to medication discontinuation during the course of treatment.
Drug-drug interactions had to be modified with the treatment initiation in 2 out of 7 patients who received DAA.

Conclusion: When multidrug use and comorbidities in hemodialysis patients are considered, multidisciplinary approach led by nephrologist are very
important for increased access to treatment and more effective management of patients.

Project Number

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References

  • 1. Goodkin DA, Bieber B, Jadoul M, et al. Mortality, Hospitalization, and Quality of Life among Patients with Hepatitis C Infection on Hemodialysis. Clin J Am Soc Nephrol. 2017;12:287-297.
  • 2. Mohd Hanafiah K, Groeger J, Flaxman AD, et al. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013;57:1333-1342.
  • 3. Fabrizi F, Messa P. The epidemiology of HCV infection in patients with advanced CKD/ESRD: A global perspective. Semin Dial. 2019;32:93-98.
  • 4. National Nephrology, Dialysis and Transplantation Registry Report of Turkey 2017.
  • 5. Goodkin DA, Bieber B, Gillespie B, et al. Hepatitis C infection is very rarely treated among hemodialysis patients. Am J Nephrol. 2013;38:405-412.
  • 6. Peck-Radosavljevic M, Boletis J, Besisik F, et al. Low-dose peginterferon alfa-2a is safe and produces a sustained virologic response in patients with chronic hepatitis C and end-stage renal disease. Clin Gastroenterol Hepatol. 2011;9:242-248.
  • 7. Pagan J, Ladino M, Roth D. Treating hepatitis C virus in dialysis patients: How, when, and why? Semin Dial. 2019;32:152-158.
  • 8. Feld JJ, Moreno C, Trinh R, 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;64:301-307.
  • 9. Pockros PJ, Reddy KR, Mantry PS, et al. 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;150:1590-1598.
  • 10. Roth D, Nelson DR, Bruchfeld A, et al. Grazoprevir plus elbasvir in treatmentnaive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet. 2015;386:1537-1545.
  • 11. Abad S, Vega A, Hernández E, et al. Universal Sustained Viral Response to the Combination of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with/ without Ribavirin in Patients on Hemodialysis Infected with Hepatitis C Virus Genotypes 1 and 4. Am J Nephrol. 2017;45:267-272.
  • 12. Gane E, Lawitz E, Pugatch D, et al. Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment. N Engl J Med. 2017;377:1448- 1455.
  • 13. Ponziani FR, Siciliano M, Lionetti R, et al. Effectiveness of Paritaprevir/ Ritonavir/Ombitasvir/Dasabuvir in Hemodialysis Patients With Hepatitis C Virus Infection and Advanced Liver Fibrosis: Case Reports Am J Kidney Dis. 2017;70:297-300.
  • 14. Muñoz-Gómez R, Rincón D, Ahumada A, et al. Therapy with ombitasvir/ paritaprevir/ritonavir plus dasabuvir is effective and safe for the treatment of genotypes 1 and 4 hepatitis C virus (HCV) infection in patients with severe renal impairment: A multicentre experience. J Viral Hepat. 2017;24:464- 471.
  • 15. Surendra M, Raju SB, Sridhar N, et al. Ledipasvir and Sofosbuvir for untreated HCV genotype 1 infection in end stage renal disease patients: A prospective observational study. Hemodial Int. 2018;22:217-221.
  • 16. Sperl J, Kreidlova M, Merta D, et al. Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir Regimen in the Treatment of Genotype 1 Chronic Hepatitis C Infection in Patients with Severe Renal Impairment and End-Stage Renal Disease: a Real-Life Cohort Kidney Blood Press Res. 2018;43:594-605.
  • 17. Davis MI, Chute DF, Chung RT, et al. When and how can nephrologists treat hepatitis C virus infection in dialysis patients? Semin Dial. 2018;31:26-36.
  • 18. Kalkan İ, Çınar G, Çelen MK, et al. Drug-Drug Interaction Management in Hepatitis C Treatment. J Ankara Univ Fac Med 2018;71:174-176.
  • 19. Liverpool HEP Interactions. Availablefrom:https://www.hepdruginteractions. org/checker.
  • 20. European Association for the Study of Liver. Recommendation son treatment of hepatitis C 2016. J Hepatol. 2017;66:153-194.
  • 21. Aygen B, Demirtürk N, Türker N, et al. Management of Chronic Hepatitis C Virus Infection: A Consensus Report of the Study Group for Viral Hepatitis of the Turkish Society of Clinical Microbiology and Infectious Diseases-2017 Update. Klinik Dergisi 2017;30:2-36.
  • 22. Singh T, Guirguis J, Anthony S, et al. Sofosbuvir-based treatment is safe and effective in patients with chronic hepatitis C infection and end stage renal disease: a case series. Liver Int. 2016;36:802-806.
  • 23. Desnoyer A, Pospai D, Lê MP, et al. Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C. J Hepatol. 2016;65:40-47.
  • 24. Singh A, Kumari S, Kumar P, et al. Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency. J Viral Hepat. 2018;25:1501-1506.
  • 25. Jadoul M, Berenguer MC, Doss W, et al. Executive summary of the 2018 KDIGO Hepatitis C in CKD Guideline: welcoming advances in evaluation and management. Kidney Int. 2018;94:663-673.
There are 25 citations in total.

Details

Primary Language English
Subjects Nefroloji
Journal Section Research Article
Authors

Şiyar Erdoğmuş 0000-0003-3787-6754

Project Number -
Publication Date June 13, 2019
Published in Issue Year 2019 Volume: 72 Issue: 1

Cite

APA Erdoğmuş, Ş. (2019). Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları ve İlaç-İlaç Etkileşimleri Yönetimi. Ankara Üniversitesi Tıp Fakültesi Mecmuası, 72(1), 49-53. https://doi.org/10.4274/atfm.galenos.2019.63522
AMA Erdoğmuş Ş. Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları ve İlaç-İlaç Etkileşimleri Yönetimi. Ankara Üniversitesi Tıp Fakültesi Mecmuası. June 2019;72(1):49-53. doi:10.4274/atfm.galenos.2019.63522
Chicago Erdoğmuş, Şiyar. “Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları Ve İlaç-İlaç Etkileşimleri Yönetimi”. Ankara Üniversitesi Tıp Fakültesi Mecmuası 72, no. 1 (June 2019): 49-53. https://doi.org/10.4274/atfm.galenos.2019.63522.
EndNote Erdoğmuş Ş (June 1, 2019) Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları ve İlaç-İlaç Etkileşimleri Yönetimi. Ankara Üniversitesi Tıp Fakültesi Mecmuası 72 1 49–53.
IEEE Ş. Erdoğmuş, “Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları ve İlaç-İlaç Etkileşimleri Yönetimi”, Ankara Üniversitesi Tıp Fakültesi Mecmuası, vol. 72, no. 1, pp. 49–53, 2019, doi: 10.4274/atfm.galenos.2019.63522.
ISNAD Erdoğmuş, Şiyar. “Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları Ve İlaç-İlaç Etkileşimleri Yönetimi”. Ankara Üniversitesi Tıp Fakültesi Mecmuası 72/1 (June2019), 49-53. https://doi.org/10.4274/atfm.galenos.2019.63522.
JAMA Erdoğmuş Ş. Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları ve İlaç-İlaç Etkileşimleri Yönetimi. Ankara Üniversitesi Tıp Fakültesi Mecmuası. 2019;72:49–53.
MLA Erdoğmuş, Şiyar. “Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları Ve İlaç-İlaç Etkileşimleri Yönetimi”. Ankara Üniversitesi Tıp Fakültesi Mecmuası, vol. 72, no. 1, 2019, pp. 49-53, doi:10.4274/atfm.galenos.2019.63522.
Vancouver Erdoğmuş Ş. Hemodiyaliz Hastalarında Kronik Hepatit C Virüs Enfeksiyonu: Tedavi Sonuçları ve İlaç-İlaç Etkileşimleri Yönetimi. Ankara Üniversitesi Tıp Fakültesi Mecmuası. 2019;72(1):49-53.