EVIPLERA (rilpivirine, emtricitabine, tenofovir disoproxil fumarate), antiviral combination
TRANSPARENCY COMMITTEE OPINION
Opinions on drugs -
Posted on
Jan 18 2016
Reason for request
Inclusion conditions modification
- EVIPLERA has Marketing Authorisation in the treatment of adult patients infected with the human immunodeficiency virus type 1 (HIV‑1) without any known mutations associated with resistance to the non-nucleoside class of reverse transcriptase inhibitors (NNRTI) or to tenofovir or emtricitabine, and who present a viral load ≤ 100 000 copies/ml of HIV‑1 RNA.
- EVIPLERA is a second-line treatment option because of:
- its renal toxicity and toxic effects on calcium and phosphorus metabolism (due to tenofovir disoproxil fumarate), and its neurological toxicity (due to rilpivirine),
- the low genetic barrier to resistance of rilpivirine and the absence of demonstrated superiority in terms of efficacy by comparison with the efavirenz/emtricitabine/tenofovir DF combination,
- the existence of treatment alternatives with a better efficacy and/or safety profile, and with a higher genetic barrier to resistance, such as the combinations based on integrase inhibitors (INI) or protease inhibitors/ritonavir (PI/r),
- and must be used alongside monitoring of renal function and of calcium and phosphorus metabolism. Good compliance with treatment is, moreover, advisable, on account of the low genetic barrier of rilpivirine.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |
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