Gilead Sciences (NASDAQ:GILD)
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– Donation Provides up to 2.4 Million Free Bottles Annually to
Uninsured Americans at Risk for HIV –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it will donate
Truvada for PrEP® (emtricitabine 200 mg and tenofovir
disoproxil fumarate 300 mg tablets) to the U.S. Centers for Disease
Control and Prevention (CDC) in support of national efforts to help
prevent HIV and end the epidemic. This medication donation is among the
largest ever in the United States and is part of Gilead’s broader
ongoing initiatives to help ensure that everyone who can benefit from
PrEP is able to access it. Gilead will provide to CDC up to 2.4 million
bottles of Truvada® annually for uninsured Americans at risk
for HIV. The donation, which extends up to 2030, will transition to
Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25
mg tablets), if it is approved for use as PrEP.
Approximately 200,000 of the estimated 1.1 million Americans who are at
risk for HIV currently receive Truvada for PrEP. Broader usage among
at-risk populations is hampered by significant social and structural
barriers, such as HIV stigma, homophobia, limited awareness of PrEP
among providers and patients, and overall lack of access to healthcare.
Gilead’s donation will support a greatly accelerated effort to reach
these individuals, as well as create an opportunity for state and local
partnerships to develop and implement protocols that are intended to
ensure uninsured people at risk for HIV are given access to PrEP at no
cost.
“We are proud to partner with CDC to dramatically expand access to
medication that can help prevent new HIV infections,” said Gregg Alton,
Chief Patient Officer, Gilead Sciences. “We believe today’s donation,
combined with efforts to address the root causes of the epidemic, such
as racism, violence against women, stigma, homophobia and transphobia,
can play an important role in ending the HIV epidemic in the United
States, particularly in parts of the country with the highest burden of
disease.”
Following five years of declines, the annual number of new HIV diagnoses
has remained stable in the United States since 2013. During 2016 and
2017, half of new diagnoses concentrated in 48 “hotspot” counties as
well as Washington, D.C., and Puerto Rico.
In the U.S., Truvada is indicated in combination with safer sex
practices for HIV PrEP to reduce the risk of sexually acquired HIV in
at-risk individuals who are HIV-negative and weigh ≥35 kg. Descovy is
approved in combination with other antiretroviral agents for the
treatment of HIV infection in patients weighing ≥25 kg and is not
approved for PrEP anywhere globally. The use of Descovy for an HIV PrEP
indication is investigational and has not been determined to be safe or
efficacious.
Gilead submitted a supplemental New Drug Application (sNDA) for Descovy
for PrEP to the U.S. Food and Drug Administration (FDA) on April 5,
2019. A Priority Review voucher was submitted with the filing, leading
to an anticipated review time of six months.
Descovy and Truvada each have a Boxed Warning in their respective
product labels regarding the risk of post-treatment acute exacerbation
of hepatitis B; the Truvada label also carries a Boxed Warning for the
risk of drug resistance with PrEP in undiagnosed early HIV infection.
See below for Important Safety Information and complete Indications.
Beyond the donation, Gilead’s commitment to combating the HIV/AIDS
epidemic includes the COMPASS (COMmitment to Partnership in Addressing
HIV/AIDS in Southern States) Initiative™. COMPASS is a 10-year, $100
million commitment to address the HIV/AIDS epidemic in the South through
capacity building, mental health and trauma-informed care, and awareness
and anti-stigma education.
Gilead has longstanding patient support programs in the U.S. to help
eligible individuals with financial need to access Truvada for PrEP. For
commercially insured, eligible individuals, Gilead provides copay coupon
support, through which patients may pay as little as $0 per bottle for
Truvada for PrEP. Those without insurance may be able to access Truvada
for PrEP free of charge through our longstanding Medication Assistance
Program or, in the near future, through the new CDC-Gilead partnership.
Individuals who would like to learn more about support programs that may
be available to them are encouraged to visit the Gilead Advancing Access®
website at www.gileadadvancingaccess.com.
In addition, many government healthcare programs receive significant
discounts on Gilead medicines. For HIV, for example, state Medicaid
programs receive discounts on the company’s products. Gilead established
a price freeze for all of the company’s HIV medications for state AIDS
Drug Assistance Programs (ADAPs) in 2008, which remains in effect
through 2019. ADAPs also receive supplemental discounts.
Important U.S. Safety Information and
Indication for Truvada for PrEP
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP
IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE
EXACERBATION OF HEPATITIS B
-
Truvada for PrEP must only be prescribed to individuals confirmed
to be HIV-negative immediately prior to initiation and at least every
3 months during use. Drug-resistant HIV-1 variants have been
identified with use of Truvada for PrEP following undetected acute
HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1
infection are present unless HIV-negative status is confirmed.
-
Severe acute exacerbations of hepatitis B have been reported in
HBV-infected patients who discontinued Truvada. Hepatic function
should be monitored closely with both clinical and laboratory
follow-up for at least several months in patients with HBV after
discontinuing Truvada. If appropriate, initiation of anti-hepatitis B
therapy may be warranted.
Contraindications
-
Do not use Truvada for PrEP in individuals with unknown or positive
HIV status.
Warnings and precautions: Comprehensive risk reduction strategies
-
Reduce HIV-1 risk: Truvada for PrEP is not always effective in
preventing HIV-1. Use only as part of a comprehensive prevention
strategy that includes safer sex practices, regular testing for HIV-1
and other STIs, and counseling on reducing sexual risk behaviors.
-
Reduce potential for drug resistance: Truvada for PrEP should
only be used in individuals confirmed to be HIV-negative immediately
prior to initiation, at least every 3 months while taking Truvada, and
upon an STI diagnosis. HIV-1 resistance substitutions may emerge in
individuals with undetected HIV-1 infection who are taking only
Truvada. Truvada alone is not a complete regimen for treating HIV-1.
-
HIV antibody tests may not detect acute HIV infection. If recent
exposures are suspected or symptoms of acute HIV infection are present
(e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1
month) or discontinue use and confirm HIV-negative status with a test
approved by U.S. Food and Drug Administration (FDA) for the diagnosis
of acute HIV infection.
-
If a screening test indicates possible HIV-1 infection, convert the
HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative
status is confirmed.
-
Counsel on adherence: Counsel individuals to strictly adhere to
their dosing schedule, as efficacy is strongly correlated with
adherence. Some individuals, such as adolescents, may benefit from
more frequent visits and counseling.
Warnings and precautions
-
New onset or worsening renal impairment: Cases of acute renal
impairment and Fanconi syndrome have been reported with the use of
tenofovir disoproxil fumarate (TDF). Truvada is not recommended in
individuals with estimated creatinine clearance (CrCl) <60 mL/min.
Avoid concurrent or recent use with a nephrotoxic agent. Acute renal
failure has been reported after initiation of high dose or multiple
NSAIDs in patients at risk for renal dysfunction; consider
alternatives to NSAIDs in these patients. Monitor renal function in
all patients – See Dosage and Administration.
-
Bone effects: Decreases in bone mineral density (BMD) and
mineralization defects, including osteomalacia associated with
proximal renal tubulopathy, have been reported with the use of TDF.
Consider monitoring BMD in patients with a history of pathologic
fracture or risk factors for bone loss.
-
Lactic acidosis and severe hepatomegaly with steatosis: Fatal
cases have been reported with the use of nucleoside analogs, including
Truvada. Discontinue use if clinical or laboratory findings suggestive
of lactic acidosis or pronounced hepatotoxicity develop, including
hepatomegaly and steatosis in the absence of marked transaminase
elevations.
-
Drug interactions: See Drug Interactions section. Consider the
potential for drug interactions prior to and during use of Truvada and
monitor for adverse reactions.
Adverse reactions
-
Common adverse reactions (>2% and more frequently than placebo)
of Truvada for PrEP in clinical trials were headache, abdominal pain,
and weight loss.
Drug interactions
-
Prescribing information: Consult the full Prescribing
Information for Truvada for more information, warnings, and
potentially significant drug interactions, including clinical comments.
-
Hepatitis C antivirals: Coadministration with
ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or
sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor
for adverse reactions.
-
Drugs affecting renal function: Coadministration of Truvada
with drugs that reduce renal function or compete for active tubular
secretion may increase concentrations of emtricitabine and/or
tenofovir.
Pregnancy and lactation
-
Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been
established. Available data from observational studies and the APR
show no increase in the rate of major birth defects for Truvada
compared with a U.S. reference population. Consider HIV prevention
methods, including Truvada for PrEP in at-risk women due to the
potential increased risk of HIV-1 infection during pregnancy and
mother to child transmission during acute HIV-1 infection.
-
Lactation: Emtricitabine and tenofovir have been detected in
human milk. Evaluate the benefits and risks of Truvada for PrEP in
breastfeeding women, including the risk of HIV-1 acquisition due to
nonadherence, and subsequent mother to child transmission. Health
benefits of breastfeeding should be considered along with potential
adverse effects of Truvada on the child, which are unknown.
Dosage and administration
-
Dosage: One tablet once daily with or without food.
-
HIV screening: Test for HIV-1 infection prior to initiating and
at least every 3 months during treatment.
-
HBV screening: Test for HBV infection prior to or when
initiating treatment.
-
Renal impairment and monitoring: Not recommended in individuals
with CrCl <60 mL/min. In all patients, assess serum creatinine,
estimated creatinine clearance, urine glucose, and urine protein on a
clinically appropriate schedule. In patients with chronic kidney
disease, also assess serum phosphorus.
INDICATION
Truvada for PrEP (pre-exposure prophylaxis) is indicated to reduce the
risk of sexually acquired HIV-1 in adults and adolescents (≥35 kg) who
are at risk for HIV, when used in combination with safer sex practices.
HIV-negative status must be confirmed immediately prior to initiation.
-
If clinical symptoms of acute HIV-1 infection are present and recent
exposures (<1 month) are suspected, delay initiation for at least 1
month until HIV-negative status is reconfirmed. Alternatively, confirm
HIV-negative status with a test cleared by FDA to aid in the diagnosis
of acute HIV-1 infection.
Individuals at risk for sexually acquired HIV-1 may include those:
-
With HIV-1 infected partner(s), or
-
Who engage in sexual activity in a high prevalence area or social
network and have additional risk factors, such as: inconsistent or no
condom use, diagnosis of sexually transmitted infections (STIs),
exchange of sex for commodities, use of illicit drugs or alcohol
dependence, incarceration, or sexual partners of unknown HIV status
with any of these risk factors.
Important U.S. Safety Information and
Indication for 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
coadministered 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.
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. 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 March 31, 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.
U.S. full Prescribing Information for Descovy and Truvada, including BOXED
WARNING, is available at www.gilead.com
Truvada, Truvada for PrEP, Descovy, Descovy for PrEP, COMPASS
Initiative, Advancing Access, Gilead and the 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190509005987/en/
Ryan McKeel(650) 377-3548
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