|View printer-friendly version|
|Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV|
– Bictegravir-Containing Regimen Found to be Non-Inferior to Dolutegravir-Containing Regimens –
– Investigational Regimen Demonstrated No Treatment-Emergent Resistance through 48 Weeks –
“Physicians continue to look for treatment regimens with simple,
convenient dosing that can sustain virologic suppression with a safety
profile that is appropriate for most HIV patients,” said
“These data reinforce the safety and efficacy profile consistently seen
in other trials evaluating regimens based on the FTC/TAF combination,”
In Study 1489, a total of 629 treatment-naïve adults with HIV were
randomized 1:1 to receive BIC/FTC/TAF or
abacavir/dolutegravir/lamivudine (600/50/300mg) (
A separate analysis investigated the effect of the two regimens on
changes in bone mineral density (BMD) and measures of renal function.
Mean percentage changes in BMD from baseline to Week 48 were -0.83
percent for BIC/FTC/TAF vs. -0.60 percent for
In Study 1490, a total of 645 treatment-naïve adults with HIV were randomized 1:1 to receive BIC/FTC/TAF or DTG+FTC/TAF. At Week 48, 89.4 percent (n=286/320) of patients taking BIC/FTC/TAF and 92.9 percent (n=302/325) of patients taking DTG+FTC/TAF achieved the primary endpoint of HIV-1 RNA levels less than 50 copies/mL (difference: -3.5 percent, 95 percent CI: -7.9 percent to 1.0 percent, p=0.12). No patients in either treatment arm developed resistance to any of the study drugs. Lipid changes were not significantly different between the two arms, and there were no renal discontinuations or cases of proximal renal tubulopathy. Discontinuations due to adverse events were low in both treatment arms (1.6 percent (n=5) for BIC/FTC/TAF vs. <1.0 percent (n=1) for DTG+FTC/TAF). The most commonly reported adverse events (all grades) were headache (13 percent for BIC/FTC/TAF vs. 12 percent for DTG+FTC/TAF) and diarrhea (12 percent vs. 12 percent).
“The Phase 3 findings presented at IAS 2017 demonstrate that a
single-tablet combination of bictegravir with the FTC/TAF backbone may
deliver an important novel triple-therapy HIV treatment,” said
In addition to Studies 1489 and 1490, 48-week data from two other ongoing studies evaluating BIC/FTC/TAF among virologically suppressed adult patients (Studies 1844 and 1878) are also part of the regulatory submissions in the U.S. and EU.
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.
Further information about the clinical trials can be found at www.clinicaltrials.gov.
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City,
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 the
possibility that regulatory authorities may not approve BIC/FTC/TAF in
the currently anticipated timelines, and marketing approvals, if
granted, may have significant limitations on their use. As a result,
BIC/FTC/TAF may never be successfully commercialized. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Minimum 20 minute delay