All treatments available in Iran for hepatitis C include sofosbuvir as a component. Unfortunately, sofosbuvir has not been cleared for use in patients with eGFR under 30 ml/min/1.73m2. The metabolite of sofosbuvir is renally excreted and levels up to 20 times higher than normal are reported among subjects with impaired renal function. Due to lack of data in these patients, sofosbuvir is not recommended for patients with renal impairment leaving these group of patients with no option. Nevertheless, out of despair, many patients with renal failure have been treated with sofosbuvir-containing regiments and no important adverse event has been reported.

We enrolled subjects with severely impaired renal function infected with hepatitis C from 13 centers. Patients were treated for 12 weeks with a single daily pill containing 400 mg sofosbuvir and 60 mg daclatasvir (Sovodak, Rojan Pharma, Tehran, Iran). Patients with cirrhosis were treated for 24 weeks. Subjects were followed weekly for the first month and then biweekly asking for possible adverse events. Response to treatment was evaluated 12 weeks after end of treatment (SVR12). ClinicalTrials.gov ID: NCT03063879.

By the time of this report 74 patients had finished the follow-up period. 54 patients (73%) were on hemodialysis. 31 (42%) had cirrhosis 7 of which were decompensated. 40 (54%) were genotype 1 and 22 patients (30%) had history of failed interferon-based treatment. Three patients died in which cause of death was not related to treatment. The remaining 71 patients all achieved SVR12 (100%). One case of diarrhea was report which was bearable and the patient continued treatment and achieved SVR. The diarrhea ceased after end of treatment. There were no other significant adverse events.

The combination of sofosbuvir and daclatasvir is an extremely effective and safe treatment for patients infected with all genotypes of hepatitis C who have severely impaired renal function, including hemodialysis patients.