-- Truvada is the First HIV PrEP Medicine
Approved in China --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
China National Medical Products Administration (NMPA) has approved
a pre-exposure prophylaxis indication for Truvada (emtricitabine
200 mg/tenofovir disoproxil fumarate 300 mg,FTC/TDF). In China,
Truvada for PrEP® is indicated in combination with safer sex
practices for pre-exposure prophylaxis (PrEP) to reduce the risk of
sexually acquired HIV-1 in at-risk adults and adolescents weighing
at least 35 kg. Truvada for PrEP should be taken once daily and
used together with safer sex practices. Individuals must have a
negative HIV-1 test immediately prior to initiating Truvada for
PrEP.
Truvada is the first medicine approved for HIV prevention in
China. Previously, Truvada was approved in combination with other
antiretroviral medicines as a treatment for HIV-1 infection in
adults and pediatric patients 12 years of age and older.
According to data published by the China National Health
Commission (NHC) in November 2019, 131,000 new HIV infections were
reported between January and October 2019 in China. Among the newly
reported cases, sexual transmission was the main mode of
transmission. In addition to safer sex practices and using condoms
correctly, the World Health Organization (WHO) recommends offering
PrEP to all groups at substantial risk of HIV infection as part of
a comprehensive HIV prevention plan.
“The approval of Truvada for PrEP addresses an area of
significant unmet need in the field of HIV prevention medicine in
China. It provides a new prevention option with a demonstrated
safety and efficacy profile,” said Professor Zhang Fujie, Director
of Clinical and Research Center of Infectious Diseases, Beijing
Ditan Hospital, Capital Medical University. “Truvada for PrEP could
play an important role in our response to the HIV epidemic and may
help reduce the number of new HIV infections in China.”
The approval of Truvada for PrEP was supported by data from two
randomized, double-blind, placebo-controlled trials known as the
Pre-Exposure Prophylaxis Initiative (iPrEx) and Partners PrEP. The
iPrEx trial included 2,499 HIV-seronegative men and transgender
women who have sex with men and the Partners PrEP trial included
4,758 HIV-1 serodiscordant heterosexual couples. In total, 2,834
HIV-1 uninfected adults received Truvada. The number of new HIV-1
seroconversions was significantly lower among those who received
Truvada compared to those in the placebo group.
The efficacy of Truvada for PrEP was strongly associated with
adherence. The most commonly reported adverse events among the
individuals taking Truvada were headache, abdominal pain and weight
decrease.
“Gilead is committed to delivering innovative therapeutics to
help address unmet medical needs in China. Since launching our
operations in China in 2017, we have introduced a number of HIV
treatments for people living with HIV. With the inclusion of our
HIV medicines in the 2019 National Reimbursement Drug List (NRDL),
we are hopeful that access to treatments among people in need will
be increased significantly,” said Rogers Luo, Vice President &
China General Manager, Gilead Sciences. “With the approval of
Truvada for PrEP, Gilead is now able offer options for PrEP and
treatment – as we strive to help people living with and at risk of
acquiring HIV and to partner with the government and healthcare
community to improve public health in China.”
In the United States, Truvada for PrEP is indicated to reduce
the risk of sexually acquired HIV-1 in adults and adolescents (≥35
kg) who are at risk for HIV. HIV-negative status must be confirmed
immediately prior to initiation. Truvada has a Boxed Warning in its
U.S. product label regarding the risk of drug resistance when used
for PrEP in undiagnosed early HIV infection, and the risk of
post-treatment acute exacerbation of hepatitis B. Please see below
for U.S. Indication and Important Safety Information.
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.
Gilead is committed to supporting the global health community to
quickly and effectively respond to serious and life-threatening
viral outbreaks worldwide. To that end, we are contributing our
antiviral expertise and resources to help investigate potential
treatments for patients with COVID-19.
About PrEP
PrEP is an HIV prevention strategy in which medicine is taken
daily before an HIV-negative person may be exposed to the virus
through sex to help reduce the risk of infection. PrEP is highly
effective at reducing the risk of HIV infection in at-risk
populations.
Prevention methods, including PrEP, and safer sex practices are
essential tools in the effort to end the HIV epidemic. PrEP use
received an “A” rating from the U.S. Preventive Services Task Force
(USPSTF), signifying that PrEP has a high certainty of substantial
preventive benefits for reducing the risk of HIV. In addition, PrEP
is recommended by the U.S. Centers for Disease Control and
Prevention, the WHO and other national healthcare organizations as
part of a comprehensive prevention strategy for individuals at risk
for HIV.
U.S. Important Safety Information 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 be prescribed only to patients
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 virus (HBV) have
been reported in patients who have HBV infection and 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.
Contraindication
- Truvada for PrEP is contraindicated in patients with unknown or
positive HIV status.
Warnings and precautions
- Comprehensive management to reduce risks:
- Use Truvada for PrEP to reduce the risk of HIV-1 infection as
part of a comprehensive strategy that includes adherence to daily
dosing and safer sex practices, including condoms, to reduce the
risk of sexually transmitted infections (STIs).
- HIV-1 risk factors: Behavioral, biological, or
epidemiologic HIV-1 risk factors may include, but are not limited
to condomless sex, past or current STIs, self-identified HIV risk,
having sexual partners of unknown HIV-1 viremic status, or sexual
activity in a high-prevalence area or network.
- Reduce STI risk:Counsel on the use of STI prevention
measures (e.g., consistent and correct condom use, knowledge of
partner’s HIV-1 status, including viremic status, regular testing
for STIs).
- Reduce potential for drug resistance: Only prescribe
Truvada for PrEP to patients 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 patients with undetected HIV-1
infection who are taking only Truvada because Truvada alone is not
a complete regimen for treating HIV-1.
- Some HIV tests may not detect acute HIV infection. Prior to
initiating Truvada for PrEP, ask patients about potential recent
exposure events. If recent (<1 month) exposures are reported or
suspected, or symptoms of acute HIV infection (e.g., fever,
fatigue, myalgia, skin rash) are present, confirm HIV-negative
status with a test approved by the FDA for use in the diagnosis of
acute HIV infection.
- If HIV-1 infection is suspected or if symptoms of acute
infection are present while taking Truvada for PrEP, convert the
Truvada for PrEP regimen to a complete HIV treatment regimen until
HIV-negative status is confirmed by a test approved by the FDA for
use in the diagnosis of acute HIV infection.
- Counsel on adherence: Counsel patients to strictly
adhere to daily dosing, as efficacy is strongly correlated with
adherence. Some patients, 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 TDF. Truvada is not recommended in patients 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 section).
- 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 significant difference in the rate of major birth
defects for Truvada compared with a US reference population.
Consider HIV prevention methods, including Truvada for PrEP in
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
patients with CrCl <60 mL/min. Prior to or when initiating
Truvada, and during use on a clinically appropriate schedule,
assess serum creatinine, CrCl, urine glucose, and urine protein in
all patients. In patients with chronic kidney disease, assess serum
phosphorus.
U.S. Indication for Truvada for
PrEP
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. HIV-negative status
must be confirmed immediately prior to initiation.
Forward-Looking
Statements
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 Truvada for PrEP and the risk that individuals may not
maintain adherence to daily dosing of Truvada for PrEP. There is
also the possibility of unfavorable results from ongoing and
additional clinical trials involving Truvada for PrEP. 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, 2020, 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. Prescribing Information for Truvada,
including BOXED WARNING, is available at www.gilead.com.
Truvada, Truvada for PrEP, Gilead and the
Gilead logo are trademarks of Gilead Sciences, Inc. or its related
companies.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@Gilead Sciences) 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/20200811005498/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Larkin Callaghan, Media (650) 425-5078
Maggie Ma, Media - China +86 21 3893 4556
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