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Sofosbuvir safe, effective in patients with chronic kidney disease, HCV

Sofosbuvir-based direct-acting antiviral therapy was safe and effective for patients with chronic kidney disease and hepatitis C, particularly for patients with advanced chronic kidney disease, according to a recently published study.

“We found that direct-acting antivirals were reasonably well tolerated, with only 8% of patients discontinuing therapy due to side effects,” Meghan E. Sise, MD, MS, from Massachusetts General Hospital, and colleagues wrote. “While adverse effects are common, serious adverse effects and treatment discontinuations are rare. Kidney function remained stable on therapy. Significant [acute kidney injury] events were rare and all resolved, except in one patient who died from causes unrelated to direct-acting antiviral treatment.”

The researchers analyzed clinical data of 98 patients with stage 1, 2 or 3 CKD disease and HCV who received a sofosbuvir-based direct-acting antiviral regimen. Mean patient age was 62 years.

Patients with more advanced CKD were more likely to achieve sustained virologic response with DAA therapy. For each decline of 10 mL/min/1.73 m² from baseline estimated glomerular filtration rate (eGFR), patients were 1.7 times more likely to achieve SVR (95% CI, 1.3-2.4).

Ninety-three patients had at least one serum creatinine measured while receiving DAA therapy. Seven patients had creatinine levels rise 1.5 times or more from baseline during therapy, only one of whom had advanced CKD. Creatinine levels improved to within 0.3 mg/dL of baseline after treatment for all patients except one who died from hepatic encephalopathy.

Patients with eGFR less than 60 mL/min/1.73 m² at baseline improved by an average of 9.3 mL/min/1.72 m² after treatment (95% CI, 0.44-18).

Among patients with stage 3 CKD and diabetes, the researchers observed a continued decline of eGFR despite DAA therapy compared with an average increase of 4.5 mL/min/1.73 m² in patients without diabetes over the same period (P = .006).

Seventy-nine patients reported at least one new or worsened adverse event during treatment or within 4 weeks posttreatment; however, the researchers associated the coadministration of ribavirin with the increased odds for adverse events during treatment.

“Sofosbuvir-based therapy may be useful in the management of subjects with CKD and HCV genotypes 1 and 4,” Richard J. Johnson, MD, from the University of Colorado, and Michiko Shimada, MD, PhD, from the Hirosaki University Graduate School of Medicine, Japan, wrote in a related editorial.

Johnson and Shimada voiced concern regarding sofosbuvir’s effects in patients with kidney disease, stating that they would like to see more studies investigating the potential nephrotoxicity of sofosbuvir. “Furthermore,” they wrote, “this ... regimen is not FDA-approved in the United States in the patient with CKD at this time. Alternative therapies are becoming available that may be safer and more effective. We predict that HCV, like hepatitis B virus and HIV, will slowly disappear as a major medical problem for patients with renal disease.” – by Talitha Bennett

Disclosure: Sise reports she received research grant funding from Gilead Sciences, AbbVie and Merck, and is a scientific advisory board participant for AbbVie and Merck. Please see the full study for the other researchers’ relevant financial disclosures.