FOSTER CITY, Calif.--(BUSINESS WIRE)--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.
“Chronic hepatitis B is a life-threatening illness that affects up to
2.2 million people in the U.S.”
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
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
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
“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
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).
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
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.
Most common adverse reactions (incidence =5%; all grades) were headache,
abdominal pain, fatigue, cough, nausea and back pain.
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
Dosage and Administration
Dosage: Adults; 1 tablet taken once daily with food.
Renal Impairment: Not recommended in patients with CrCl <15
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,
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,
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at 1-800-GILEAD-5 or 1-650-574-3000