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.'s Reyataz (atazanavir) plus a backbone of either F/TAF or lamivudine and abacavir. The primary endpoint measured continued virologic suppression, requiring a margin of no more than 4% between existing therapy and the switch regimen.

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

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