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Gilead's Descovy (Emtricitabine- Tenofovir Alafenamide) Receives NMPA ‘s (CFDA) Approval for HIV-1 Infection

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Gilead's Descovy (Emtricitabine- Tenofovir Alafenamide) Receives NMPA ‘s (CFDA) Approval for HIV-1 Infection

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  • The approval is based on three P-III study (104-111 & 109) results assessing Genvoya (elvitegravir/ cobicistat /emtricitabine /tenofovir alafenamide /150 / 150/ 200/ 10mg- E/C/F/TAF) vs Stribild (E/C/F/TDF-150 mg/ 150 mg/ 200 mg/tenofovir disoproxil fumarate 300 mg) in adults for 144 wks.
  • The pooled study demonstrated non-inferiority data- meeting 1EPs compared with Stribild and improvement in certain bone and renal parameters
  • Descovy (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg- F/TAF) is a TAF based treatment- approved by EU and the US for HIV-1 infection in adults

Ref: Gilead | Image: Gilead

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