A Phase 3 clinical trial, Study 1878, evaluating Gilead Sciences' (GILD -1.2%) single-tablet, fixed-dose combination of bictegravir (50 mg) and emtricitabine/tenofovir alafenamide (200 mg/25 mg) (BIC/FTC/TAF) for the treatment of adults with HIV-1 infection who switched from a multi-tablet regimen containing a boosted protease inhibitor (bPI) to BIC/FTC/TAF demonstrated non-inferiority after 48 weeks. The data will be presented at IDWeek in San Diego later this week.
No treatment-emergent resistance was observed over the 48-week period.
Eric Daar, MD, Chief of the Division of HIV Medicine at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and lead author of Study 1878 says, “These data demonstrate the potential of BIC/FTC/TAF to match the efficacy of a boosted protease inhibitor regimen while also offering a high barrier to resistance and fewer interactions with other drugs. The findings, along with data from three other Phase 3 studies in both treatment-experienced and treatment-naïve patients, suggest that the investigational regimen of BIC/FTC/TAF may be appropriate for a broad range of people living with HIV.”
Gilead's marketing applications in the U.S. and Europe are currently under review. The FDA's action date is February 12, 2018.
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