ODEFSEY (emtricitabine, rilpivirine, tenofovir alafenamide), antiviral combination
Reason for request
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 |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |