Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives MHLW’s Approval for HIV-1 Infection in Japan

Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives MHLW’s Approval for HIV-1 Infection in Japan

Shots:

  • The approval is based on four P-III 1489 and 1490 & 1844 and 1878 studies result assessing Biktarvy vs PBO in 2,415 naive patients with HIV-1 infected & virologically suppressed adults respectively
  • The P-III 1489 and 1490 & 1844 and 1878 studies results: @48wks. met its 1EPs; no treatment emergent virologic resistance; no discontinuation; no cases of proximal renal tubulopathy/Fanconi syndrome; high barrier to resistance
  • Biktarvy (qd) is an INSTI-based triple-therapy STR combining bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg (BIC/FTC/TAF) and has a boxed warning for its discontinuation of post treatment acute exacerbation of Hepatitis B

Click here to read full press release/ article | Ref: Gilead | Image: Twitter