VEMLIDY (tenofovir alafenamide), nucleotide analogue
Reason for request
High clinical benefit in chronic hepatitis B, though no demonstrated clinical advantage over VIREAD (tenofovir disoproxil fumarate)
VEMLIDY has been granted marketing authorisation for the treatment of chronic hepatitis B in adults and adolescents aged > 12 years.
Tenofovir alafenamide (TAF) is a tenofovir prodrug developed to reduce plasma tenofovir levels in order to improve the nephrotoxicity and bone toxicity observed with tenofovir disoproxil fumarate (TDF).
Overall, its efficacy and safety profile is comparable to that of TDF, though data for patients with a risk of poor response are limited.
It is a first-line option whose use is justified when BARACLUDE (entecavir) or VIREAD (TDF) cannot be used (particularly in the event of resistance to entecavir, renal impairment or bone risk).
When used, renal function, phosphate-calcium metabolism and lipid parameters should be monitored.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |