The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment

Poustchi, H. and Majd Jabbari, S. and Merat, S. and Sharifi, A.-H. and Shayesteh, A.A. and Shayesteh, E. and Minakari, M. and Fattahi, M.R. and Moini, M. and Roozbeh, F. and Mansour-Ghanaei, F. and Afshar, B. and Mokhtare, M. and Amiriani, T. and Sofian, M. and Somi, M.-H. and Agah, S. and Maleki, I. and Latifnia, M. and Fattahi Abdizadeh, M. and Hormati, A. and Khoshnia, M. and Sohrabi, M. and Malekzadeh, Z. and Merat, D. and Malekzadeh, R. (2020) The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. Journal of Gastroenterology and Hepatology (Australia), 35 (9). pp. 1590-1594.

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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). 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

Item Type: Article
Additional Information: cited By 3
Uncontrolled Keywords: daclatasvir; peginterferon; ribavirin; sofosbuvir; sovodak; antivirus agent; daclatasvir; imidazole derivative; sofosbuvir, adult; Article; bedtime dosage; cause of death; diarrhea; drug efficacy; drug safety; female; follow up; genotype; glomerulus filtration rate; hemodialysis; hepatitis C; human; Iran; liver cirrhosis; major clinical study; male; priority journal; severe renal impairment; sustained virologic response; treatment response; combination drug therapy; complication; hepatitis C; kidney failure; safety; severity of illness index; treatment outcome; virology, Antiviral Agents; Drug Therapy, Combination; Female; Hepatitis C; Humans; Imidazoles; Liver Cirrhosis; Male; Renal Dialysis; Renal Insufficiency; Safety; Severity of Illness Index; Sofosbuvir; Sustained Virologic Response; Treatment Outcome
Subjects: WH Hemic and Lymphatic Systems
Depositing User: eprints admin
Date Deposited: 26 May 2021 07:25
Last Modified: 26 May 2021 07:25

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