– 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.
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