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

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 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]). http://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.

Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial

“…The safety of sofosbuvir and daclatasvir has even been proven in patients with severely impaired renal function. 27 …”

COVID-19 therapeutics for low- and middle-income countries: a review of re-purposed candidate agents with potential for near-term use and impact

“…As cytokine mediators that trigger the cellular immune response to viral infections, 25 interferons have been used and studied as antiviral therapy for several viral infections 26 . SARS-CoV-2 particularly has been shown to induce particularly low levels of interferon-1 27 .…”

“…More recently, in silico studies have been carried out identifying both sofosbuvir and daclatasvir as potential inhibitors of SARS-CoV-2 56, 57, 58 . This combination offer well-established safety and tolerability as combination therapy and has been shown to be safe in patients with renal impairment 25 . Three small trials, sometimes in combination with ribavirin, have been published.…”

The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19

“…On the other hand, the safety of sofosbuvir/daclatasvir is well proven, even in advanced cases of renal failure. 13 , 14 So both the possible effectiveness of ribavirin against SARS-CoV-2 and the potential increased mortality due to its side effects might have impacted on our results. In the case of benefit from ribavirin, the observed relative advantage of sofosbuvir/daclatasvir would have been diminished.…”