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
Ref: Gilead | Image:Gilead
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