No known resistance with VEMLIDY treatment through 8 years1,2
on long-term treatment with VEMLIDY through 8 years (Week 384)1,2
Genotypic resistance analysis was performed in patients under the following criteria1,3:
In Trials 108 and 1101
- Virologic breakthrough (2 consecutive visits with HBV DNA ≥69 IU/mL [400 copies/mL] after having been <69 IU/mL, or ≥1.0-log10 increase in HBV DNA from nadir)
- Early discontinuation at or after Week 24 with HBV DNA ≥69 IU/mL
In Trial 40183
- HBV DNA ≥69 IU/mL at any study visit through Week 96
Proven in treatment-naïve and treatment-experienced adults with chronic hepatitis B and compensated liver disease starting VEMLIDY through 8 years1,2
(Pivotal trials 108 and 110)
Proven in virologically suppressed adults who switched from TDF to VEMLIDY through Week 961,3,4
(Switch trial 4018)
The 8-year analysis is not presented in the VEMLIDY full Prescribing Information.
TDF=tenofovir disoproxil fumarate.
Drug Interactions
- Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.
- Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.