GENVOYA (emtricitabine, cobicistat, elvitegravir and tenofovir alafenamide), antiviral combination

VIROLOGY - New medicinal product
Opinions on drugs - Posted on May 26 2016

Reason for request

Inclusion

Second-line treatment in the management of HIV.

  • GENVOYA has the Marketing Authorisation in the treatment of type 1 human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 and older, weighing at least 35 kg) who are infected with HIV-1 without any known mutations associated with resistance to integrase inhibitors, emtricitabine or tenofovir.
  • When a treatment strategy with an integrase inhibitor is planned, it is a second-line therapeutic option given:

-            the important potential risk of renal toxicity and on calcium and phosphorus metabolism (related to tenofovir alafenamide), the low genetic barrier to resistance of elvitegravir, the absence of demonstration of superior efficacy compared with other available integrase inhibitors (INIs) (dolutegravir, raltegravir) and the need for it to be combined with a pharmacokinetic enhancer, cobicistat,

-            the high potential for drug interactions due to cobicistat,

-            the existence of treatment alternatives in this therapeutic class of INIs, such as dolutegravir and raltegravir, which have a better safety profile and fewer drug interactions.

  • It must be used alongside monitoring of renal function and of calcium and phosphorus metabolism. Good compliance with treatment is, moreover, recommended, given the low genetic barrier of elvitegravir.




Clinical Benefit

Substantial

-


Clinical Added Value

no clinical added value

-


Therapeutic use

-

-

 

Contact Us

Évaluation des médicaments