4 research outputs found
The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment
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, Lt
Erratum: SD1000: High Sustained Viral Response Rate in 1361 Patients with Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter Phase III Clinical Trial (Clin Infect Dis (2020) 70:10 (2206-2212) DOI: 10.1093/cid/ciz628)
Upon the original publication of this article Merat S. SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter Phase III Clinical Trial. Clin Infect Dis 2020;70(10):2206 2212. https://doi.org/10.1093/cid/ciz628, the members of SD1000 research team as shown in the Appendix were not correctly tagged with their affiliations under the SD1000 Research Team contributor group. The details have been corrected only in this erratum (as shown below) to preserve the published version of record. The publisher regrets this error. SD1000 Research Team Contributor Group:. © 2021 Oxford University Press. All rights reserved