Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
The Food and Drug Administration (FDA) has approved updated labeling for Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to include updated information regarding treatment of patients with hepatitis C virus (HCV) who have severe renal impairment including those with end stage renal disease (ESRD) who are on dialysis.
The prescribing information for all 3 agents now states that no dosage adjustment is recommended in patients with any degree of renal impairment including patients on dialysis. The update was based on pharmacokinetic data obtained from studies involving HCV-infected patients with ESRD requiring dialysis.
Results from these studies showed that the pharmacokinetics of sofosbuvir, GS-331007 (the predominant circulating metabolite of sofosbuvir), velpatasvir, and ledipasvir were consistent with those observed in HCV-negative patients with ESRD requiring dialysis. While not studied in ESRD patients, voxilaprevir exposure is not expected to be meaningfully altered in HCV patients with ESRD requiring dialysis.
Epclusa is a fixed-dose combination of sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, or in combination with ribavirin in patients with decompensated cirrhosis.
Harvoni is a fixed-dose combination of ledipasvir, an HCV NS5A inhibitor, and sofosbuvir, and is indicated for the treatment of chronic HCV in adults and pediatric patients 3 years of age and older with genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis; genotype 1 infection with decompensated cirrhosis, in combination with ribavirin; and genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
Vosevi is a fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir, an HCV NS3/4A protease inhibitor, and is indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor; and genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.
For more information visit gilead.com.
