China National Medical Products Administration (NMPA) Approves Gilead’s Vemlidy® (Tenofovir Alafenamide) for Chronic Hepatitis B Virus (HBV) Infection

– First New Oral Treatment Approved for HBV in Ten Years Offers
Improved Renal and Bone Laboratory Safety Parameters Compared to
Tenofovir Disoproxil Fumarate (TDF) –

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China
National Medical Products Administration (NMPA) has approved Vemlidy®
(tenofovir alafenamide, TAF) 25 mg, a once-daily treatment for chronic
hepatitis B in adults and adolescents (aged 12 years and older with body
weight at least 35 kg).

Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated
antiviral efficacy similar to Gilead’s Viread® (tenofovir
disoproxil fumarate, TDF) 300 mg but at one-tenth of the dose. 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. In
clinical trials, Vemlidy demonstrated improved renal and bone laboratory
safety parameters compared to Viread.

With the approval of Vemlidy, physicians can now offer their patients a
treatment that retains the efficacy of TDF while improving renal and
bone safety parameters in clinical trials,” said Prof. Jinlin Hou,
Nanfang Hospital of Southern Medical University.

HBV is highly prevalent in China with an estimated 20 million people
meeting current guidelines for therapy – accounting for almost one-third
of all patients currently requiring therapy worldwide. Each year,
approximately 300,000 people in China die from cirrhosis of the liver
related to HBV.

Chronic hepatitis B remains an urgent public health issue in China, and
many people still need well tolerated and effective treatment options
with a high barrier to resistance, especially as therapy can be
life-long,” said Gregg Alton, Gilead Chief Patient Officer. “Gilead is
committed to working with health officials and affected communities to
help address the ongoing hepatitis B challenge in China.”

Vemlidy’s approval is supported by data from two international Phase 3
studies (Studies 108 and 110) among 1,632 treatment-naive and
treatment-experienced adult patients with HBeAg-negative and
HBeAg-positive HBV disease (including 334 treated in China). 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. In addition, no
patient developed resistance to tenofovir during the studies through 96
weeks of therapy.

The most commonly reported adverse events through 96 weeks 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.

The U.S. Prescribing Information for Vemlidy has a Boxed Warning for the
risk of post-treatment severe acute exacerbation of hepatitis B. See
below for U.S. Important Safety Information and Indication. In the U.S.,
Vemlidy is only indicated for adult patients with compensated liver

Vemlidy received marketing approval from the U.S. Food and Drug
Administration (FDA) and the Japanese Ministry of Health, Labour and
Welfare in 2016, and from the European Commission in 2017.



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
    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. Monitor renal function in all patients – See Dosage and
  • Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal
    cases have been reported with the use of nucleoside analogs, including
    TDF. Discontinue VEMLIDY if clinical or laboratory findings suggestive
    of lactic acidosis or pronounced hepatotoxicity develop, including
    hepatomegaly and steatosis in the absence of marked transaminase

Adverse Reactions

  • Most common adverse reactions (incidence ≥5%; all grades) were
    headache, abdominal pain, cough, back pain, fatigue, nausea,
    arthralgia, diarrhea, and dyspepsia.

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, Screening, and Monitoring: VEMLIDY is not
    recommended in patients with CrCl <15 mL/min. In all patients, assess
    serum creatinine, estimated creatinine clearance, urine glucose, and
    urine protein prior to initiating and during treatment, on a
    clinically appropriate schedule. In patients with chronic kidney
    disease, also assess serum phosphorus.
  • Hepatic Impairment: Not recommended in patients with
    decompensated (Child-Pugh B or C) hepatic impairment.
  • Testing prior to initiation: HIV infection.


VEMLIDY is indicated for the treatment of chronic hepatitis B virus
(HBV) infection in adults with compensated liver disease.

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 physicians may not see the benefits of prescribing Vemlidy. 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, 2018,
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 Vemlidy and Viread including BOXED
is available at

VEMLIDY and VIREAD are registered trademarks of Gilead Sciences,
Inc., or its related companies.

For more information on Gilead Sciences, please visit the company’s
website at 
follow Gilead on Twitter (
or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.


Sung Lee, Investors
Sonia Choi, Media


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