September 02, 2015
Gilead’s Investigational Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide (F/TAF) Meets Primary 48-Week Objective in Phase 3 Study
– F/TAF Currently Under Review for Marketing Approval by U.S. and European Regulatory Agencies –
Compared to the TDF-based regimens, the F/TAF-based regimens demonstrated statistically significant differences in mean bone mineral density (BMD) at the hip and spine (p<0.001) and in the median change in estimated glomerular filtration rate (eGFR) (p<0.001). General safety and discontinuation rates due to adverse events were comparable between the two arms. The most commonly reported adverse events included upper respiratory tract infection, diarrhea, nasopharyngitis, headache and bronchitis. Both regimens were generally well tolerated. Gilead plans to submit these data for presentation at a scientific conference in 2016.
“For more than a decade, Truvada has been a cornerstone of HIV therapy,
and the results of this and other recent trials demonstrate the
potential of F/TAF to become a next-generation backbone,” said
TAF and TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
About the Study
The Phase 3 study is a randomized, double-blind clinical trial among 663 virologically suppressed adults (HIV-1 RNA levels < 50 copies/mL) on a stable regimen containing Truvada for ≥ six consecutive months. Patients were randomized 1:1 to either maintain their Truvada-based regimen (Truvada + placebo + third agent) or switch to an F/TAF-based regimen (F/TAF + placebo + third agent). The study will follow patients for 96 weeks after randomization. The daily dose of F/TAF in the trial was 200/25 mg; if used in combination with a protease inhibitor administered with either ritonavir or cobicistat, the daily dose was 200/10 mg.
The study is ongoing. The primary objective is to evaluate the efficacy
of switching FTC/TDF to F/TAF versus maintaining FTC/TDF in HIV-1
positive subjects who are virologically suppressed on regimens
containing FTC/TDF as determined by the proportion of subjects with
HIV-1 RNA < 50 copies/mL at Week 48 as defined by the
Additional information about the study can be found at www.clinicaltrials.gov.
About Tenofovir Alafenamide
TAF is an investigational novel nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread® (TDF), as well as improved renal and bone laboratory parameters compared to TDF in earlier clinical trials in combination with other antiretroviral agents.
In addition to F/TAF, Gilead has filed NDAs with the
A fourth investigational TAF-based regimen containing Gilead’s TAF, emtricitabine and cobicistat, and Janssen’s darunavir (D/C/F/TAF) is also under development under a separate licensing agreement. Under the agreement, Gilead is transferring to Janssen further development of the regimen and, subject to regulatory approval, the manufacturing, registration, distribution and commercialization of the product worldwide.
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 the FDA and other regulatory authorities may not approve F/TAF, E/C/F/TAF, R/F/TAF, D/C/F/TAF and other F/TAF-based regimens in the currently anticipated timelines or at all, and marketing approvals, if granted, may have significant limitations on their use. As a result, F/TAF, E/C/F/TAF, R/F/TAF, D/C/F/TAF and other F/TAF-based regimens may never be successfully commercialized. In addition, Gilead may be unable to file for regulatory approval for these TAF-based regimens with the FDA and other regulatory authorities in the currently anticipated timelines. 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 Annual Report on Form 10-Q for the quarter ended June 30, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Viread and Truvada are registered trademarks of
For more information on
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Ryan McKeel, 650-377-3548 (Media)