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)
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VEMLIDY has been granted marketing authorisation for the treatment of chronic hepatitis B in adults and adolescents aged > 12 years.
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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).
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Overall, its efficacy and safety profile is comparable to that of TDF, though data for patients with a risk of poor response are limited.
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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).
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When used, renal function, phosphate-calcium metabolism and lipid parameters should be monitored.
Clinical Benefit
| Substantial |
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Clinical Added Value
| no clinical added value |
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Therapeutic use
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