Premium
The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment
Author(s) -
Poustchi Hossein,
Majd Jabbari Sara,
Merat Shahin,
Sharifi AmirHoushang,
Shayesteh Ali Akbar,
Shayesteh Elahe,
Minakari Mohammad,
Fattahi Mohammad Reza,
Moini Maryam,
Roozbeh Fatemeh,
MansourGhanaei Fariborz,
Afshar Behrooz,
Mokhtare Marjan,
Amiriani Taghi,
Sofian Masoomeh,
Somi MohammadHossein,
Agah Shahram,
Maleki Iradj,
Latifnia Maryam,
Fattahi Abdizadeh Mojtaba,
Hormati Ahmad,
Khoshnia Masoud,
Sohrabi Masoudreza,
Malekzadeh Zeinab,
Merat Dorsa,
Malekzadeh Reza
Publication year - 2020
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.14994
Subject(s) - daclatasvir , sofosbuvir , medicine , gastroenterology , hepatitis c , virology , intensive care medicine , hepatitis c virus , ribavirin , virus
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/1.73m 2 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.