Descovy Bottle with Tablet
Fixed-Dose Combination HIV Treatment Backbone Can Be Paired with Range of Third Agents
- Patrick O’Brien, Investors - (650) 522-1936
- Ryan McKeel, Media - (650) 377-3548
Foster City, Calif., April 4, 2016 – Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
Descovy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B. See below for important safety information.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.
“As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care. As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “With today’s approval, Gilead is now able to offer patients and providers in the United States a range of options from our TAF based-portfolio, which is designed to help address the diverse needs of HIV patients worldwide.”
The approval of Descovy is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the F/TAF-based regimen (administered as Genvoya®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) met its primary objective of non-inferiority compared to an F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, E/C/F/TDF) among treatment naïve adult patients. Tests of certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen.
The approval also is supported by a Phase 3 study (Study 109) evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adult patients who switched from F/TDF-based regimens. In the study, the F/TAF-based regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens. Additionally, the approval is supported by data from Phase 3 studies evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adults with mild-to-moderate renal impairment and among treatment naïve adolescents. Finally, bioequivalence studies demonstrated that Descovy achieved the same drug levels of TAF and emtricitabine in the blood as Genvoya.
Descovy does not cure HIV infection or AIDS.
Patient Assistance Programs
Gilead’s U.S. Advancing Access® program provides assistance to appropriate patients in the United States who are uninsured, underinsured or who need financial assistance to pay for their medications, including Descovy.
The program offers information and assistance for patients, including:
Additionally, Gilead is working closely with the ADAP Crisis Task Force, as the company has done for each of its other HIV medications, to provide discounts to state AIDS Drug Assistance Programs (ADAPs) that will help ensure access to Descovy for patients who receive medications through these programs.
Information about how to apply for any of these forms of assistance can be found at www.GileadAdvancingAccess.com or by calling 1-800-226-2056 between 9:00 a.m. and 8:00 p.m. EST.
Important U.S. Safety Information for Descovy
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Renal monitoring: In all patients, monitor CrCl, urine glucose, and urine protein prior to initiating and during therapy. In patients with chronic kidney disease, additionally monitor serum phosphorus.
Dosage and administration
Pregnancy and lactation
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, California.
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 risk that physicians may not see the benefits of prescribing Descovy. 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-K for the year ended December 31, 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.
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U.S. Full Prescribing Information, including BOXED WARNING, for Descovy, Genvoya, Stribild, Truvada and Viread are available at www.gilead.com.
Descovy, Genvoya, Stribild, Truvada, Viread and Advancing Access are registered trademarks of Gilead Sciences, Inc., or its related companies.
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.