Sofosbuvir Deemed Safe in Patients with Chronic Kidney Disease

Sofosbuvir-based direct-acting antiviral therapy was deemed safe and effective in patients co-infected with chronic kidney disease (CKD) and hepatitis C virus (HCV), according to a recent study.

The link between HCV and kidney disease is well documented, with approximately 130 million to 150 million individuals infected with HCV and CKD prevalence of 10% to 16% worldwide.

Although this once-daily medication successfully targets and eliminates HCV, there are concerns about the safety of sofosbuvir in patients with CKD.

In a study published in the Clinical Journal of the American Society of Nephrology, investigators sought to determine the safety and efficacy of sofosbuvir in patients with CKD. The investigators examined a retrospective observational cohort of 98 patients with stages 1-3 CKD who received sofosbuvir-based therapy in a large health care system.

The results of the study showed the overall sustained virologic response was 81% and the average kidney function during treatment was stable. Patients with advanced CKD were more likely to be cured of HCV compared with patients with mild CKD.

Furthermore, patients with advanced CKD who were cured of HCV experienced an improvement in kidney function following treatment.

Adverse events (AEs) were common, occurring in 81% of participants; however, serious AEs and treatment conditions were less common and occurred in 17% and 8% of participants, respectively.

“The use of direct-acting antiviral therapy in patients with hepatitis C infection has transformed the illness into a curable one,” said investigator Meghan Sise, MD, MS. “This study shows that these medications can be safely and effectively used in patients with stage 1-3 kidney disease.”

Although the findings show promise, larger studies are needed to determine if curing HCV with direct-acting antiviral therapy slows or prevents the progression of end stage renal disease in patients with CKD and HCV, according to the authors.

In an accompanying editorial, Richard Johnson, MD, and Michiko Shimada, MD, PhD, mentioned that there are other effective antiviral drugs available for patients with CKD and HCV, and are not eliminated by the kidneys.

More research needs to be done to examine the effects of various antivirals in patients with CKD, according to the authors.

“We predict that HCV, like hepatitis B virus and HIV, will slowly disappear as a major medical problem for patients with renal disease,” Johnson and Shimada wrote.