-- Vemlidy is a Once-Daily Treatment that
Demonstrated Similar Efficacy with Improved Renal and Bone
Laboratory Safety Parameters Compared to Viread --
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
U.S. Food and Drug Administration (FDA) has approved Vemlidy®
(tenofovir alafenamide, TAF) 25mg, a once-daily treatment for
adults with chronic hepatitis B virus (HBV) infection with
compensated liver disease.
Vemlidy has a boxed warning in its product label regarding the
risks of lactic acidosis/severe hepatomegaly with steatosis and
post-treatment severe acute exacerbation of hepatitis B. See below
for important safety information.
Vemlidy is a novel, targeted prodrug of tenofovir that has
demonstrated antiviral efficacy similar to and at a dose less than
one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate,
TDF) 300mg. Data show that because Vemlidy has greater plasma
stability and more efficiently delivers tenofovir to hepatocytes
compared to Viread, it can be given at a lower dose, resulting in
less tenofovir in the bloodstream. As a result, Vemlidy improved
renal and bone laboratory safety parameters compared to Viread.
“Chronic hepatitis B is a life-threatening illness that affects
up to 2.2 million people in the U.S.,” said Calvin Pan, MD,
Clinical Professor of Medicine, NYU Langone Medical Center, and
investigator in the Vemlidy clinical trials. “Clinical trials
demonstrated Vemlidy is efficacious with improved renal and bone
safety parameters compared to Viread, representing an important
development for people living with this chronic disease.”
Photos and multimedia gallery available
at www.GileadHBVMedia.com.
Vemlidy’s approval is supported by 48-week data from two
international Phase 3 studies (Studies 108 and 110) among 1,298
treatment-naïve and treatment-experienced adult patients with
chronic HBV infection. Study 108 randomized and treated 425
HBeAg-negative patients with either Vemlidy or Viread, and Study
110 randomized and treated 873 HBeAg-positive patients with either
Vemlidy or Viread. Both studies met their primary endpoint of
non-inferiority to Viread based on the percentage of patients with
chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48
weeks of therapy.
In an integrated analysis of both studies, patients receiving
Vemlidy demonstrated improvements in certain bone and renal
laboratory parameters compared to those treated with Viread.
Patients in the Vemlidy arm also experienced numerically higher
rates of normalization of blood serum alanine aminotransferase
(ALT) levels.
Vemlidy and Viread were generally well-tolerated by patients in
both studies and discontinuations due to adverse events were 1% and
1.2%, respectively. The most commonly reported adverse events in
both studies included headache, abdominal pain, fatigue, cough,
nausea and back pain and occurred at similar rates in patients
receiving either Vemlidy or Viread.
“Since the mid-1990s, Gilead has been working to improve and
simplify care for people living with chronic hepatitis B,” said
John Milligan, Ph.D., President and Chief Executive Officer of
Gilead Sciences. “Vemlidy is the first medication approved to treat
this disease in nearly a decade, and we are excited to offer a new,
effective option to help advance long-term care for patients.”
Additional data on TAF will be presented at The Liver Meeting®
2016 in Boston.
U.S. Patient Support
Program
Gilead’s U.S. Advancing Access® patient support program provides
information regarding access and reimbursement coverage options to
patients in the United States who need assistance with coverage for
their medications, including Vemlidy.
Advancing Access conducts Vemlidy benefits investigations and
provides patients with information regarding their insurance
options. Further, the Vemlidy Co-pay Coupon Program offers co-pay
assistance for eligible patients with private insurance who need
assistance paying for out-of-pocket medication costs.
Information about how to enroll can be found at
https://AdvancingAccessConsent.iassist.com/ or by calling
1-800-226-2056 between 9:00 a.m. and 8:00
p.m. (Eastern).
Global Availability
Gilead is committed to helping enable access to Vemlidy for all
people in need, regardless of where they live or what resources
they have. Since 2003, the company has operated a dedicated
business unit focused on expanding access to medicines in
lower-income countries. Gilead works with regional business
partners on local country regulatory submissions to provide branded
HBV drugs at reduced prices in 125 low- and middle-income
countries. Gilead has also established licensing agreements with 19
generic drug manufacturers in India, South Africa and China, as
well as the Medicines Patent Pool, granting them rights to produce
and sell high-quality, low-cost generic versions of Gilead HBV
medicines in 112 developing countries. Vemlidy is already an
integrated component of the company’s generic licensing agreements,
and with FDA approval, manufacturing partners may begin production
and distribution of a generic version of this medicine.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH
STEATOSIS and POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS
B
- Lactic acidosis and severe
hepatomegaly with steatosis, including fatal cases, have been
reported with the use of nucleoside analogs.
- Discontinuation of anti-hepatitis B
therapy, including VEMLIDY, may result in severe acute
exacerbations of hepatitis B. Hepatic function should be monitored
closely with both clinical and laboratory follow-up for at least
several months in patients who discontinue anti-hepatitis B
therapy, including VEMLIDY. If appropriate, resumption of
anti-hepatitis B therapy may be warranted.
Warnings and Precautions
- Risk of Development of HIV-1
Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk,
VEMLIDY alone is not recommended for the treatment of HIV-1
infection. Safety and efficacy of VEMLIDY have not been established
in HBV/HIV-1 coinfected patients. HIV antibody testing should be
offered to all HBV-infected patients before initiating therapy with
VEMLIDY, and, if positive, an appropriate antiretroviral
combination regimen that is recommended for HBV/HIV-1 coinfected
patients should be used.
- 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 VEMLIDY, there have been no cases of Fanconi syndrome or
proximal renal tubulopathy (PRT). Patients with impaired renal
function and/or taking nephrotoxic agents (including NSAIDs) are at
increased risk of renal-related adverse reactions. Discontinue
VEMLIDY in patients who develop clinically significant decreases in
renal function or evidence of Fanconi syndrome.Renal monitoring:
Assess serum creatinine, serum phosphorus, CrCl, urine glucose, and
urine protein prior to initiating and during therapy in all
patients as clinically appropriate.
Adverse Reactions
Most common adverse reactions (incidence ≥5%; all grades) were
headache, abdominal pain, fatigue, cough, nausea and back pain.
Drug Interactions
- Coadministration of VEMLIDY with drugs
that reduce renal function or compete for active tubular secretion
may increase concentrations of tenofovir and the risk of adverse
reactions.
- Coadministration of VEMLIDY is not
recommended with the following: oxcarbazepine, phenobarbital,
phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort.
Such coadministration is expected to decrease the concentration of
tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY.
Drugs that strongly affect P-gp and BCRP activity may lead to
changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more
information on potentially significant drug interactions, including
clinical comments.
Dosage and Administration
- Dosage: Adults; 1 tablet taken
once daily with food.
- Renal Impairment: Not
recommended in patients with CrCl <15 mL/min.
- Hepatic Impairment: Not
recommended in patients with decompensated (Child-Pugh B or C)
hepatic impairment.
- Testing prior to initiation: HIV
infection.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases worldwide. Gilead
has operations in more than 30 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 physicians may not see the benefits of
prescribing Vemlidy for the treatment of chronic HBV. In addition,
Gilead may be unable to obtain regulatory approval for Vemlidy for
the treatment of chronic HBV from other regulatory authorities.
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 September 30, 2016, 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
statement.
U.S. full prescribing information for Vemlidy,
including BOXED WARNING, is available at www.gilead.com.
VEMLIDY, VIREAD, and ADVANCING ACCESS 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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