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

 
• By Joseph Haas

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?

Gilead Sciences Inc. revealed success demonstrating non-inferiority in four Phase III trials testing its investigational integrase inhibitor bictegravir head-to-head against other HIV therapy regimens, but it remains unclear whether these findings will give the virology specialist an edge against ViiV Healthcare's Tivicay (dolutegravir).

The Foster City, Calif

More Data To Come

In the two studies testing BIC/F/TAF against Triumeq and against Tivicay/F/TAF in treatment-naïve patients, the primary endpoint was proportion of patients achieving virologic control at 48 weeks. The data, however, are blinded out to 144 weeks so that Gilead can obtain a fuller sense of efficacy duration.

In the studies of treatment-experienced patients, one randomized patients either to stay with Triumeq or switch to BIC/F/TAF, while the other compared BIC/F/TAF with regimens containing Janssen Pharmaceuticals Inc.'s Prezista (darunavir) or Bristol-Myers Squibb Co

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