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Dual Prevention Pill (DPP) / TELE

The proposed product is a fixed-dose combination (FDC) tablet of TDF / FTC / LNG / EE indicated for both the prevention of HIV and pregnancy.  The product will be supplied as a 28-count blister compliance pack containing 21 tablets of the fixed-dose combination of TDF, FTC, LNG, and EE (a 3-week supply) plus 7 tablets of FTC and TDF (a 1-week supply).

Development Stage:

Clinical – Bioequivalence Study

Hormonal/Non-Hormonal:

Hormonal

Delivery Route & Method:

Systemic - Pill/Tablet- Oral

Mechanism of Action:

Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate; Emtricitabine is a nucleoside analogue of cytidine. Progestogen-oestrogen combination acts by inhibiting ovulation.

Developer:

  • Viatris

Funding:

  • The Bill & Melinda Gates Foundation
  • Children’s Investment Fund Foundation (CIFF)

Active Ingredient(s):

  • Emtricitabine (FTC)
  • Ethinyl Estradiol (EE)
  • Levonorgestrel
  • Tenofovir Disoproxil Fumarate (TDF)

Product Indication(s):

  • HIV
  • Pregnancy

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