VEMLIDY (tenofovir alafenamide), nucleotide analogue

INFECTIOUS DISEASES - New medicinal product
Opinions on drugs - Posted on Oct 24 2018

Reason for request

Inclusion

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

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Clinical Added Value

no clinical added value

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Therapeutic use

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