The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment
Hossein Poustchi, Sara Majd Jabbari, Shahin Merat, Amir‐Houshang Sharifi, Ali Akbar Shayesteh, Elahe Shayesteh, Mohammad Minakari, Mohammad Reza Fattahi, Maryam Moini, Fatemeh Roozbeh, Fariborz Mansour‐Ghanaei, Behrooz Afshar, Marjan Mokhtare, Taghi Amiriani, Masoomeh Sofian, Mohammad Hossein Somi, Shahram Agah, Iradj Maleki, Maryam Latifnia, Mojtaba Fattahi Abdizadeh, Ahmad Hormati, Masoud Khoshnia, Masoudreza Sohrabi, Zeinab Malekzadeh, Dorsa Merat, Reza Malekzadeh
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: 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.