ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

November 18, 2020 Auto Bot Breakthrough, cabotegravir, HIV, receives, regulatory, therapy, Us FDA, ViiV Healthcare 0

Shots:

  • This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020)
  • Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing HIV compared to daily oral FTC/TDF tablets. The HIV incidence rate is 0.41% in the cabotegravir group and 1.22% in the FTC/TDF group
  • A partner HIV prevention study (HPTN 084) in sub-Saharan African women was stopped earlier this month based upon recommendation of the independent DSMB following the superioriority of cabotegravir to oral FTC/TDF tablets. The company plans to use the data from both the HPTN studies for future regulatory submissions

Click here ­to­ read full press release/ article | Ref: ViiV Healthcare | Image: ViiV Healthcare

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