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The Combination of Sofosbuvir and Daclatasvir Is Effective and Safe in Treating Patients With Hepatitis C and Severe Renal Impairment Publisher Pubmed



Poustchi H1 ; Majd Jabbari S1 ; Merat S1 ; Sharifi AH1 ; Shayesteh AA2 ; Shayesteh E2 ; Minakari M3 ; Fattahi MR4 ; Moini M4 ; Roozbeh F5 ; Mansourghanaei F6 ; Afshar B7 ; Mokhtare M8 ; Amiriani T9 Show All Authors
Authors
  1. Poustchi H1
  2. Majd Jabbari S1
  3. Merat S1
  4. Sharifi AH1
  5. Shayesteh AA2
  6. Shayesteh E2
  7. Minakari M3
  8. Fattahi MR4
  9. Moini M4
  10. Roozbeh F5
  11. Mansourghanaei F6
  12. Afshar B7
  13. Mokhtare M8
  14. Amiriani T9
  15. Sofian M10
  16. Somi MH11
  17. Agah S8
  18. Maleki I12
  19. Latifnia M13
  20. Fattahi Abdizadeh M14
  21. Hormati A15, 16
  22. Khoshnia M1, 9
  23. Sohrabi M16
  24. Malekzadeh Z1
  25. Merat D1
  26. Malekzadeh R1
Show Affiliations
Authors Affiliations
  1. 1. Liver and Pancreatobiliary Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
  3. 3. Department of Gastroenterology and Hepatology, Isfahan University of Medical Sciences, Isfahan, Iran
  4. 4. Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
  5. 5. Department of Gastroenterology and Hepatology, Mazandaran University of Medical Sciences, Sari, Iran
  6. 6. Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran
  7. 7. Department of Gastroenterology and Hepatology, Hamadan University of Medical Sciences, Hamadan, Iran
  8. 8. Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran
  9. 9. Golestan Research Center for Gastroenterology and Hepatology, Golestan University of Medical Science, Gorgan, Iran
  10. 10. Infectious Disease Research Center, Arak University of Medical Science, Arak, Iran
  11. 11. Department of Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz, Iran
  12. 12. Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran
  13. 13. Department of Gastroenterology and Hepatology, Sabzevar University of Medical Sciences, Sabzevar, Iran
  14. 14. Cellular and Molecular Research Center, Sabzevar University of Medical Sciences, Sabzevar, Iran
  15. 15. Gastroenterology and Hepatology Disease Research Center, Qom University of Medical Science, Qom, Iran
  16. 16. Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences, Tehran, Iran

Source: Journal of Gastroenterology and Hepatology (Australia) Published:2020


Abstract

Background and Aim: Many of the treatment regimens available for hepatitis C include sofosbuvir. Unfortunately, sofosbuvir has not been recommended for use in patients with severe renal impairment leaving these group of patients with very few options. Nevertheless, there are many reports in which these patients have been treated with sofosbuvir-containing regiments without important adverse events. This study aims at determining the safety and effectiveness of a sofosbuvir-based treatment in patients with severe renal impairment, including those on hemodialysis. Method: We enrolled subjects with hepatitis C and estimated glomerular filtration rate under ml/min/1.73m2 from 13 centers in Iran. Patients were treated for 12 weeks with a single daily pill containing 400-mg sofosbuvir and 60-mg daclatasvir. Patients with cirrhosis were treated for 24 weeks. Response to treatment was evaluated 12 weeks after end of treatment (sustained viral response [SVR]). ClinicalTrials.gov identifier: NCT03063879. Results: A total of 103 patients were enrolled from 13 centers. Seventy-five patients were on hemodialysis. Thirty-nine had cirrhosis and eight were decompensated. Fifty-three were Genotype 1, and 27 Genotype 3. Twenty-seven patients had history of previous failed interferon-based treatment. Three patients died in which cause of death was not related to treatment. Six patients were lost to follow-up. The remaining 94 patients all achieved SVR. No adverse events leading to discontinuation of medicine was observed. Conclusions: The combination of sofosbuvir and daclatasvir is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis. © 2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd
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