China National Medical Products Administration Approves Biktarvy® (Bictegravir, Emtricitabine & Tenofovir Alafenamide) for T...
August 09 2019 - 8:30AM
Business Wire
-- Biktarvy demonstrated high efficacy and a
high barrier to resistance in clinical trials through 48 weeks
--
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the
China National Medical Products Administration (NMPA) has approved
Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir
alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen
(STR) for the treatment of HIV-1 infection. Biktarvy combines the
novel, unboosted integrase strand transfer inhibitor (INSTI)
bictegravir with the demonstrated safety and efficacy profile of
the Descovy® (emtricitabine 200mg/tenofovir alafenamide 25mg;
FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI)
backbone and is the smallest INSTI-based triple-therapy STR
available. In China, Biktarvy is indicated for the treatment of
HIV-1 infection in adults without present or past evidence of viral
resistance to the integrase inhibitor class, emtricitabine or
tenofovir.
“Biktarvy offers high rates of efficacy, high barriers to
resistance and a demonstrated tolerability profile, underscoring
its role as an important new treatment option for a broad range of
patients in China,” said Professor Taisheng Li, Director of
Infectious Disease Department, Peking Union Medical College
Hospital.
In 2018, there were approximately 150,000 people newly diagnosed
with HIV in China. The number of diagnoses has increased
significantly in recent years, partially due to expanded screening.
At the same time, the number of people living with HIV and
receiving antiretroviral treatment has also increased steadily. The
government of China has provided free antiretroviral treatment to
all persons living with HIV since 2003.
The approval of Biktarvy is supported by data from four ongoing
Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1
infected adults, and Studies 1844 and 1878 in virologically
suppressed adults. The trials are comprised of a diverse population
of 2,414 participants on Biktarvy or an active comparator regimen,
including a wide range of adult age groups and races/ethnicities.
Biktarvy met its primary efficacy objective of non-inferiority at
48 weeks across all four studies. Through 48 weeks, no participants
in any of the four studies developed treatment-emergent virologic
resistance while taking Biktarvy, and no patients discontinued
Biktarvy due to renal, bone or hepatic adverse events. The most
common adverse reactions in patients taking Biktarvy through 48
weeks were diarrhea, nausea and headache.
In the United States, Biktarvy has a Boxed Warning in its
product label regarding the risk of post-treatment acute
exacerbation of hepatitis B. See below for U.S. Important Safety
Information and Indication.
“Gilead is pleased that people living with HIV in China will now
have our newest HIV treatment innovation as a treatment option,”
said Diana Brainard, MD, Senior Vice President, HIV and Emerging
Viruses, Gilead Sciences. “The approval of Biktarvy in China
represents a meaningful new option for HIV treatment and the speed
with which it has been approved is a testament to China’s
commitment to bringing the latest innovations to people with urgent
medical need.”
Biktarvy received marketing approval from the U.S. Food and Drug
Administration (FDA) and the European Commission in 2018.
Biktarvy does not cure HIV infection or AIDS.
IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR
BIKTARVY
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS
B
- 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 Biktarvy. Closely monitor hepatic function with
both clinical and laboratory follow-up for at least several months
in patients who are coinfected with HIV-1 and HBV and discontinue
Biktarvy. If appropriate, anti-hepatitis B therapy may be
warranted.
Contraindications
- Coadministration: Do not use Biktarvy with dofetilide or
rifampin.
Warnings and precautions
- Drug interactions: See Contraindications and Drug
Interactions sections. Consider the potential for drug interactions
prior to and during Biktarvy therapy and monitor for adverse
reactions.
- 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 Biktarvy, there have
been no cases of Fanconi syndrome or proximal renal tubulopathy
(PRT). Do not initiate Biktarvy 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 Biktarvy in patients who develop clinically significant
decreases in renal function or evidence of Fanconi syndrome. Renal
monitoring: Prior to or when initiating Biktarvy and during
therapy, assess serum creatinine, CrCl, urine glucose, and urine
protein in all patients as clinically appropriate. In patients with
chronic kidney disease, also assess 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 Biktarvy 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 reactions (incidence ≥5%; all
grades) in clinical studies through 96 weeks were diarrhea (6%),
nausea (6%), and headache (5%).
Drug interactions
- Prescribing information: Consult the full prescribing
information for Biktarvy for more information on Contraindications,
Warnings, and potentially significant drug interactions, including
clinical comments.
- Enzymes/transporters: Drugs that induce P-gp or induce
both CYP3A and UGT1A1 can substantially decrease the concentration
of components of Biktarvy. Drugs that inhibit P-gp, BCRP, or
inhibit both CYP3A and UGT1A1 may significantly increase the
concentrations of components of Biktarvy. Biktarvy can increase the
concentration of drugs that are substrates of OCT2 or MATE1.
- Drugs affecting renal function: Coadministration of
Biktarvy with drugs that reduce renal function or compete for
active tubular secretion may increase concentrations of FTC and
tenofovir and the risk of adverse reactions.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use
of Biktarvy during pregnancy. Dolutegravir, another integrase
inhibitor, has been associated with neural tube defects. Discuss
the benefits and risks of using Biktarvy during pregnancy and
conception. 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 US
reference population.
- Lactation: Women infected with HIV-1 should be
instructed not to breastfeed, due to the potential for HIV-1
transmission.
Dosage and administration
- Dosage: 1 tablet taken once daily with or without
food.
- Renal impairment: Not recommended in patients with CrCl
<30 mL/min.
- Hepatic impairment: Not recommended in patients with
severe hepatic impairment.
- Prior to or when initiating: Test patients for HBV
infection.
- Prior to or when initiating, and during treatment: As
clinically appropriate, assess serum creatinine, CrCl, urine
glucose, and urine protein in all patients. In patients with
chronic kidney disease, assess serum phosphorus.
U.S. INDICATION
Biktarvy is indicated in the U.S. as a complete regimen for the
treatment of HIV-1 infection in adults and pediatric patients
weighing at least 25 kg who have no antiretroviral (ARV) treatment
history or to replace the current ARV regimen in those who are
virologically suppressed (HIV-1 RNA <50 copies per mL) on a
stable ARV regimen with no history of treatment failure and no
known resistance to any component of Biktarvy.
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 physicians may not see the benefits of
prescribing Biktarvy for the treatment of HIV-1 infection and the
possibility of unfavorable results from additional clinical trials
involving Biktarvy. 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.
U.S. full Prescribing Information for Biktarvy,
including BOXED WARNING, is available at www.gilead.com.
Biktarvy, Descovy, 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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Sung Lee, Investors (650) 524-7792 Ryan McKeel, Media (650)
377-3548
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