Gilead Sciences Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™
August 07 2019 - 8:44PM
Business Wire
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the
Antimicrobial Drugs Advisory Committee (AMDAC) of the U.S. Food and
Drug Administration (FDA) recommended approval of Descovy®
(emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets;
F/TAF) for the proposed indication of pre-exposure prophylaxis
(PrEP) in men and transgender women (TGW) who have sex with men by
a vote of 16 to 2.
“We appreciate the advisory committee’s thoughtful review and
discussion of the data during today’s meeting and look forward to
collaborating with FDA to make this potential new prevention option
available to people at risk of HIV in the United States,” said
Diana Brainard, MD, Senior Vice President, HIV and Emerging
Viruses, Gilead Sciences. “Descovy represents a potential new
therapeutic option for people at risk of sexually acquired HIV-1
infection. If approved for a PrEP indication, Descovy could play a
meaningful role in the federal initiative to address the nation’s
HIV epidemic.”
Prevention methods and practices are essential tools in the
fight against HIV. PrEP is a vital tool in the fight against HIV
and should be an available HIV prevention strategy for all
appropriate individuals at risk for HIV infection. In addition,
PrEP is included in clinical guidelines as part of a comprehensive
prevention strategy for individuals at risk for HIV.
The AMDAC reviewed Descovy data from the DISCOVER global Phase 3
clinical study, which evaluated the safety and efficacy of Descovy
compared with Truvada® in men and transgender women who have sex
with men and are at high-risk for sexually acquired HIV infection.
Results from the DISCOVER trial demonstrated that Descovy achieved
non-inferiority to Truvada in study participants who were at
substantial and sustained risk of HIV acquisition. Additionally,
statistically significant improvements in renal and bone laboratory
parameters were observed for participants receiving Descovy versus
those receiving Truvada.
The AMDAC also evaluated pharmacokinetic data on Truvada and
Descovy for HIV treatment and PrEP in support of the potential use
of Descovy for PrEP in cis-gender women, a population that was not
part of the DISCOVER study. The committee voted 10 to 8 that there
were not adequate data regarding the efficacy of Descovy for PrEP
in cis-women.
Gilead recognizes the value that Descovy could bring to HIV
prevention efforts for the broadest possible at-risk population in
the United States and will continue to work with FDA as the agency
completes its review of the application.
The AMDAC is convened upon the request of FDA to review and
evaluate safety and efficacy data of human products, including
those for use in the treatment or prevention of HIV. While FDA is
not bound by the committee’s recommendation, the recommendations
made by advisory committees, including the panel deliberations and
voting, may be considered by the agency in making its final
decision on an application.
Descovy was approved in April 2016 for the treatment of HIV-1
infection in adults and pediatric patients weighing at least 35 kg,
in combination with other antiretroviral agents.
Descovy for the prevention of HIV is an investigational use that
has not been determined to be safe or efficacious and is not
approved anywhere globally.
IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR THE USE
OF DESCOVY FOR HIV TREATMENT BOXED WARNING: POST TREATMENT ACUTE
EXACERBATION OF HEPATITIS B
- Descovy is not approved for the treatment of chronic
hepatitis B virus (HBV) infection and the safety and efficacy of
Descovy have not been established in patients coinfected with HIV-1
and HBV. Severe acute exacerbations of hepatitis B have been
reported in patients who are coinfected with HIV-1 and HBV and have
discontinued products containing emtricitabine (FTC) and/or
tenofovir disoproxil fumarate (TDF), and may occur with
discontinuation of Descovy. Hepatic function should be monitored
closely with both clinical and laboratory follow-up for at least
several months in patients who are coinfected with HIV-1 and HBV
and discontinue Descovy. If appropriate, initiation of
anti-hepatitis B therapy may be warranted.
Warnings and precautions
- Immune reconstitution syndrome, including the occurrence of
autoimmune disorders with variable time to onset, has been
reported.
- New onset or worsening renal impairment: Cases of acute renal
failure and Fanconi syndrome have been reported with the use of
tenofovir prodrugs. In clinical trials of FTC and tenofovir
alafenamide with elvitegravir and cobicistat, there have been no
cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do
not initiate Descovy in patients with estimated creatinine
clearance (CrCl) <30 mL/min. Patients with impaired renal
function and/or taking nephrotoxic agents (including NSAIDs) are at
increased risk of renal-related adverse reactions. Discontinue
Descovy in patients who develop clinically significant decreases in
renal function or evidence of Fanconi syndrome. 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.
- Lactic acidosis and severe hepatomegaly with steatosis: Fatal
cases have been reported with the use of nucleoside analogs,
including FTC and TDF. Discontinue Descovy if clinical or
laboratory findings suggestive of lactic acidosis or pronounced
hepatotoxicity develop, including hepatomegaly and steatosis in the
absence of marked transaminase elevations.
Adverse reactions
- Most common adverse reaction (incidence ≥10%; all grades) in
clinical studies was nausea (10%).
Drug interactions
- Prescribing information: Consult the full prescribing
information for Descovy for more information on potentially
significant drug interactions, including clinical comments.
- Metabolism: Drugs that inhibit P-gp can increase the
concentrations of components of Descovy. Drugs that induce P-gp can
decrease the concentrations of components of Descovy, which may
lead to loss of efficacy and development of resistance.
- Drugs affecting renal function: Coadministration of Descovy
with drugs that reduce renal function or compete for active tubular
secretion may increase concentrations of emtricitabine and
tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Patients who weigh ≥25 kg: 1 tablet taken orally once
daily with or without food.
- Renal impairment: Not recommended in patients with CrCl <30
mL/min.
- Testing prior to initiation: Test patients for HBV infection
and assess CrCl, urine glucose and urine protein.
- Pediatrics: The safety and effectiveness of Descovy
coadminstered with an HIV-1 protease inhibitor that is administered
with either ritonavir or cobicistat have not been established in
pediatric subjects weighing less than 35 kg.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use of
Descovy during pregnancy. An Antiretroviral Pregnancy Registry
(APR) has been established; available data from the APR for FTC
shows no difference in the rates of birth defects compared with a
U.S. reference population.
- Lactation: Women infected with HIV-1 should be instructed not
to breastfeed, due to the potential for HIV-1 transmission.
INDICATION
Descovy is indicated in combination with other antiretroviral
(ARV) agents for the treatment of HIV-1 infection in patients
weighing at least 35 kg.
Descovy is also indicated, in combination with other
antiretroviral agents other than protease inhibitors that require a
CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric
patients weighing at least 25 kg and less than 35 kg.
Limitations of Use:
Descovy is not indicated for use as pre-exposure prophylaxis
(PrEP) to reduce the risk of acquiring HIV-1 infection.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California.
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 12 million people living with HIV globally receive
antiretroviral therapy provided by Gilead or one of the company’s
manufacturing partners.
For more information on Gilead Sciences, please visit the
company’s website at www.gilead.com.
Forward Looking Statement
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 FDA and other regulatory agencies may not
approve Descovy for PrEP in the currently anticipated timelines or
at all, and any marketing approvals, if granted, may have
significant limitations on its use. As a result, Descovy for PrEP
may never be successfully commercialized. There is also the
possibility of unfavorable results from additional studies
involving Descovy for PrEP. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. 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 June 30, 2019, 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.
Gilead and Gilead logo are 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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version on businesswire.com: https://www.businesswire.com/news/home/20190807005917/en/
Ryan McKeel, Media (650) 377-3548
Gilead Sciences (NASDAQ:GILD)
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