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Gilead Presents Results From Study Of Patients Switched To Bictegravir-regimen

Gilead Sciences, Inc. (GILD) on Wednesday announced detailed 48-week results from a Phase 3 study, or Study 1878, that evaluates the efficacy and safety of switching virologically suppressed HIV-1 infected adult patients from a multi-tablet regimen containing a boosted protease inhibitor or bPI to a fixed-dose combination of bictegravir (50 mg), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF), a dual-NRTI backbone.

In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. Gilead is presenting the data at DWeek 2017 in San Diego.

"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," said Eric Daar, Chief of the Division of HIV Medicine at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and lead author of Study 1878.

In Study 1878, a total of 577 virologically suppressed adults with HIV taking regimens of boosted atazanavir or ATV, or darunavir or DRV + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF) were randomized 1:1 to continue their bPI regimen or to switch to open-label coformulated BIC/FTC/TAF once daily.

At the primary endpoint of Week 48, switching to BIC/FTC/TAF was non-inferior to continuing on a bPI regimen with 1.7 percent of patients in each group having HIV-1 RNA =50 c/mL. The proportion of patients with HIV-1 RNA <50 c/mL was 92.1 percent in the BIC/FTC/TAF arm and 88.9 percent in the bPI arm, according to FDA snapshot algorithm.

Gilead filed a New Drug Application for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and the U.S. Food and Drug Administration or FDA set a target action date of February 12, 2018, under the Prescription Drug User Fee Act.

A marketing application for BIC/FTC/TAF is also under review in the European Union and was validated by the European Medicines Agency or EMA on July 13.

Bictegravir in combination with FTC/TAF as a single-tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.

by RTT Staff Writer

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