HBV: FDA updates Vemlidy label for ESRD dosing

  • FDA

  • curated by Yael Waknine
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • The FDA has approved a labeling update for tenofovir alafenamide 25 mg tablets (TAF; Vemlidy) to include dosing information for hemodialysis-dependent adults with end-stage renal disease (ESRD).
  • TAF is indicated for the treatment of HBV in patients with compensated liver disease.

Key points

  • No dose adjustments required for patients with mild, moderate, or severe renal impairment; none are needed in hemodialysis-dependent ESRD (estimated creatinine clearance [CrCl]
  • TAF should be administered after hemodialysis is completed on hemodialysis day.
  • TAF should not be used in nonhemodialysis ESRD (CrCl
  • Safety is not established in this population.
  • Regular monitoring of serum creatinine, CrCl, urine glucose, and urine protein is recommended; serum phosphorus should be monitored in chronic kidney disease.
  • Supporting data

    • The FDA update was based on data from an open-label pharmacokinetics and safety study in 55 HIV-infected adults with hemodialysis-dependent ESRD.
    • Participants received elvitegravir/cobicistat/emtricitabine/TAF 150 mg/150 mg/200 mg/10 mg (Genvoya).
    • Results showed similar TAF exposure with the combination vs the 25 mg dose alone.
    • Safety profile was consistent with that expected in HIV-infected patients with hemodialysis-dependent ESRD.