Sofosbuvir easy on the kidneys

Use of sofosbuvir-based direct-acting antiviral (DAA) regimens for treating hepatitis C virus (HCV) in clinical trial participants with chronic kidney disease (CKD) does not appear to worsen estimated glomerular filtration rate (eGFR) levels, according to a study. Furthermore, the drug does not appear to contribute to an increased risk of end-stage renal disease (ESRD) among HCV patients with CKD treated in clinical practice.

The analysis included 4,642 HCV-infected patients with stage 2 CKD at baseline (eGFR 30–89 mL/min/1.73 m²) and 682 HCV-infected patients with stage 3 CKD (eGFR 30–89 mL/min/1.73 m²) who were treated with sofosbuvir in 76 phase II/III trials. EGFR was evaluated at each study visit.

Another retrospective analysis was separately conducted using an administrative claims database. The goal was to compare the incidence rate and relative risk of ESRD between HCV patients with CKD who received sofosbuvir (n=2,042) and non-sofosbuvir (n=431) regimens using propensity score methods.

In the first analysis, there was no decline in eGFR noted. Moreover, mean eGFR improved from baseline to 4 weeks post-treatment both in the stage 2 (0.7 ml/min/1.73 m²) and stage 3 CKD (2.6 ml/min/1.73 m²) groups (p<0.001 each).

In the second analysis, there was no significant between-group difference in the risk of ESRD between sofosbuvir and non-sofosbuvir DAA regimens (adjusted hazard ratio, 0.85, 95 percent confidence interval, 0.51–1.42).