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– Gilead’s First TAF-based Regimen Demonstrates High Efficacy with
Improved Renal and Bone Parameters Compared to TDF-based Regimens –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 5, 2015--
Gilead Sciences, Inc. (NASDAQ:GILD) announced today that the U.S. Food
and Drug Administration (FDA) has approved Genvoya®
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir
alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection.
Genvoya is the first TAF-based regimen to receive FDA approval.
Genvoya is indicated as a complete regimen for the treatment of HIV-1
infection in adults and pediatric patients 12 years of age and older who
have no antiretroviral treatment history or to replace the current
antiretroviral regimen in those who are virologically-suppressed (HIV-1
RNA levels less than 50 copies per mL) on a stable antiretroviral
regimen for at least six months with no history of treatment failure and
no known substitutions associated with resistance to the individual
components of Genvoya. No dosage adjustment of Genvoya is required in
patients with estimated creatinine clearance greater than or equal to 30
mL per minute.
Genvoya 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. Further important safety
information, adverse drug reactions and drug interactions are listed
Photos and multimedia gallery available at www.GileadHIVMedia.com.
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), as
well as 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 lower dose and there is 91 percent less tenofovir in the
“As the HIV patient population ages there is an increased risk for
development of age- and treatment-related comorbidities, including low
bone mineral density and renal impairment. This is due to the
combination of HIV infection, antiretroviral treatments and the natural
aging process,” said David Wohl, MD, Associate Professor of Medicine,
Division of Infectious Diseases, University of North Carolina at Chapel
Hill and lead author of the Genvoya efficacy analysis. “Given its
demonstrated efficacy and safety profile, Genvoya represents an
important new treatment option for a range of patients who are either
new to therapy or who choose to switch treatments.”
Genvoya was studied in a Phase 3 HIV clinical program in more than 3,500
patients across 21 countries, including treatment-naïve, virologically
suppressed, renally impaired and adolescent patients. The approval is
supported by 48-week data from two Phase 3 double-blind studies (Studies
104 and 111) among 1,733 treatment-naïve patients in which the regimen
met its primary objective of non-inferiority compared to Stribild® (elvitegravir
150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil
fumarate 300 mg or E/C/F/TDF). In the combined analysis of the studies,
92.4 percent of Genvoya patients and 90.4 percent of Stribild patients
had HIV-1 RNA levels less than 50 copies/mL at Week 48. Tests of certain
renal and bone laboratory parameters also favored Genvoya over Stribild.
Additionally, the approval is supported by a Phase 3 study (Study 109)
evaluating Genvoya among virologically suppressed patients who switched
from TDF-based regimens. The study enrolled 1,436 subjects and 1,196 had
reached the 48-week time point at the time of filing. Among those
patients, Genvoya was found to be statistically non-inferior to the
TDF-based regimens based on the percentages of patients with HIV-1 RNA
levels less than 50 copies/mL at Week 48. Patients receiving Genvoya
also demonstrated improvements in certain bone and renal laboratory
parameters compared to those treated with the TDF-based regimens.
Finally, data from Phase 3 studies evaluating Genvoya among adolescents
and patients with mild-to-moderate renal impairment supported the
“While exceptional progress has been made in the field of HIV, there is
still a need for new treatment options that may help improve the health
of people as they grow older with the disease,” said John C. Martin,
PhD, Chairman and Chief Executive Officer, Gilead Sciences. “For more
than 25 years, Gilead has been committed to changing the trajectory of
HIV management and we are now pleased to introduce Genvoya, the first in
a portfolio of TAF-based products that have the potential to advance the
long-term treatment of HIV.”
Two other TAF-based regimens are currently under evaluation by the FDA.
The first is an investigational, fixed-dose combination of emtricitabine
200 mg and tenofovir alafenamide 25 or 10 mg (F/TAF) for use in
combination with other antiretroviral agents. The second is an
investigational, once-daily single tablet regimen that combines
emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg
(R/F/TAF). Emtricitabine and tenofovir alafenamide are from Gilead and
rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen
Pharmaceutical Companies of Johnson & Johnson.
F/TAF and R/F/TAF are investigational products and have not been
determined to be safe or efficacious.
Genvoya does not cure HIV infection or AIDS.
Patient Assistance Programs
Gilead’s U.S. Advancing Access® program provides assistance
to patients in the United States who are uninsured, underinsured or who
need financial assistance to pay for their medications, including
The program offers support services for patients and providers,
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 Genvoya 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. (Eastern).
Important U.S. Safety Information for Genvoya
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Dosage and administration
Pregnancy and breastfeeding
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 Genvoya. In
addition, marketing authorizations for F/TAF and R/F/TAF may not be
approved by the FDA or other regulatory authorities, and any marketing
approvals, if granted, may have significant limitations on their use.
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 September 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
U.S. Full Prescribing Information, including BOXED WARNING,
for Genvoya is available at www.gilead.com.
U.S. Full Prescribing Information, including BOXED WARNING,
for Stribild, Truvada and Viread are available at www.gilead.com.
Genvoya, Stribild, Truvada and Viread 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
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Investors:Patrick O’Brien, 650-522-1936orMedia:Ryan