- 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.
- 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.
- 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.