ODEFSEY (emtricitabine, rilpivirine, tenofovir alafenamide), antiviral combination

VIROLOGY -VIROLOGY
Opinions on drugs - Posted on Mar 29 2017

Reason for request

Inclusion

No clinical benefit demonstrated for this second-line treatment in the management of HIV.

 

 

»  ODEFSEY has Marketing Authorisation in the treatment of adults and adolescents (aged 12 years and older, weighing at least 35 kg) infected with the human immunodeficiency virus type 1 (HIV-1) without any known mutations to be associated with resistance to the non-nucleoside class of reverse transcriptase inhibitors or to tenofovir or emtricitabine, and who present a viral load ≤ 100,000 copies/mL of HIV-1 RNA.

 

»  In adults, it is an alternative to EVIPLERA (emtricitabine, rilpivirine, tenofovir disoproxil fumarate).

 

»  In adolescents and patients with moderate renal failure (estimated creatinine clearance ≥ 30 mL/min), it is a therapeutic option only in cases in which it is not possible to prescribe first-line medicinal products that are not associated with a risk of kidney and bone damage.

 

»  It must be used alongside monitoring of renal function, calcium and phosphorus metabolism, and lipid parameters.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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