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|Gilead’s Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for the Treatment of HIV-1 Meets Primary Endpoint in Four Phase 3 Studies|
– U.S. NDA Submission Planned for Q2 2017; EU MAA Filing Planned for Q3 2017 –
"Since the approval of Viread 16 years ago, Gilead has continually
worked to develop and improve treatments for people living with HIV.
This investigational single tablet regimen brings together the potency
of an integrase inhibitor, bictegravir, with the demonstrated efficacy
and safety profile of the FTC/TAF backbone,” said
Studies 1489 and 1490 are double-blind studies in which treatment-naïve
patients (n=600 in each study) were randomized 1:1 to receive
BIC/FTC/TAF and abacavir/dolutegravir/lamivudine (600/50/300mg)
In study 1844, patients (n=520) who were virologically suppressed (HIV-1
RNA levels <50 copies/mL) on a regimen of
BIC/FTC/TAF met the definition of non-inferiority in all four studies, with comparable proportions of patients having HIV-1 RNA <50 copies/mL (Studies 1489 and 1490) and HIV-1 RNA ≥50 copies/mL (Studies 1844 and 1878). In all studies BIC/FTC/TAF was well tolerated and no patients discontinued study medication due to renal events. No patients randomized to the bictegravir or dolutegravir arms developed treatment-emergent resistance. One patient randomized to the protease inhibitor arm in Study 1878 developed an abacavir resistance mutation (L74V).
Gilead plans to submit data from these Phase 3 studies for presentations at scientific conferences in 2017.
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.
Further information about the clinical studies can be found at www.clinicaltrials.gov.
For nearly 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including risks
related to its ability to submit regulatory applications for BIC/FTC/TAF
For more information on
Gilead Sciences, Inc.
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