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Keeping Track: HIV Filings Include Novel Agent From Gilead, Viiv's Two-Drug Maintenance Regimen

Executive Summary

The latest HIV drug development news and highlights from our FDA Performance Tracker.

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ViiV's Two-Drug HIV Tablet Juluca Is Disruptive, Yet Uptake May Be Slow

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.

ViiV/Janssen Forge Two-Drug Future For HIV With SWORD Filings

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.

Gilead's Bictegravir Demonstrates Broad Non-Inferiority, But Will That Suffice?

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?

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