Keeping Track: HIV Filings Include Novel Agent From Gilead, Viiv's Two-Drug Maintenance Regimen
The latest HIV drug development news and highlights from our FDA Performance Tracker.
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Pricing of $31,000 annually for GSK/J&J's single-tablet, two-drug HIV regimen Juluca (dolutegravir/rilpivirine) is on par with marketed fixed-dose combinations that include integrase inhibitors.
The battle of the HIV giants ViiV Healthcare and Gilead Sciences continues with the first filing for a two-drug regimen for use against HIV infection in the US and EU.
Having lost market share in recent years to HIV regimens containing ViiV's Tivicay, will a showing of non-inferiority across four head-to-head Phase III studies give bictegravir the market edge Gilead seeks?