New Single Tablet Regimen For HIV Approved by FDA

genvoyabottleongraywithgsipillOn November 5th the FDA granted approval to Gilead Sciences new single tablet regimen elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF . The brand name for this new product is Genvoya.

TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s tenofovir disoproxil fumarate, TDF. TDF is found in the following products: Viread, Truvada, Atripla, Complera, Stribild.

Genvoya is the first product to replace TDF with TAF and the only one approved by the FDA at this time.

Genvoya was studied in clinical trials in more than 3500 patients across 21 countries including treatment naïve, virologically suppressed, renally impaired and adolescent patients. The studies were the following:

  • Study 104 & 111
  • Study 109

Studies showed that E/C/F/TAF is non-inferior to Stribild and improvements in tests of renal and bone paramaters favored Genvoya over Stribild

Two other TAF-based regimens are bring reviewed by the FDA:

  1. A fixed dose combination of emtricitabine 200mg + tenofovir alafenamine 25mg or 10mg
  2. Once daily single tablet regimen that combines emtricitabine 200mg + alafenamide 25mg + rilpivirine 25mg (R/F/TAF)

The Advancing Access program provides assistance to patients in the United Sates who are uninsured, underinsured or who need financial assistance to pay for their meds. Genvoya is now part of the program. The copay assistance program for eligible patients pays up to $6000 per year with no monthly minimum.

For more info ask your physician or HIV Pharmacist. See the full package insert Here #KnowYourPharmacistKnowYourPharmacy