- Important New Treatment Option for Millions in United States
Affected by Life-Threatening Liver Disease -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 11, 2008--Gilead
Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and
Drug Administration (FDA) has granted marketing approval for Viread(R)
(tenofovir disoproxil fumarate) for the treatment of chronic hepatitis
B, a serious liver disease caused by the hepatitis B virus (HBV).
Chronic hepatitis B is the leading cause of liver cancer worldwide and
affects an estimated two million individuals in the United States.
Viread is now also indicated for the treatment of chronic
hepatitis B in adults. The drug is administered as a once-daily
tablet, and works by blocking HBV DNA polymerase, the enzyme that is
necessary for the virus to replicate in liver cells. Viread has been
available in the United States as a treatment for HIV infection in
adults since 2001.
"Viread will be an important new treatment option and its approval
represents a significant step forward in the fight against chronic
hepatitis B," said Ira Jacobson, M.D., Chief, Division of
Gastroenterology and Hepatology, Weill Cornell Medical College.
Pivotal Clinical Trials
Today's approval is based on data from two ongoing, randomized and
double-blind Phase III clinical trials, Studies 102 and 103, which
compared Viread to Gilead's Hepsera(R) (adefovir dipivoxil) over 48
weeks of treatment. Results from both studies show that a
significantly greater percentage of patients with chronic hepatitis B
who received Viread achieved a complete response to treatment compared
to those who received Hepsera. A complete response was defined as
serum HBV DNA levels below 400 copies/mL and histologic improvement
characterized by at least a two point reduction in the Knodell
necroinflammatory score (a measure of necro-inflammation - an
inflammatory process in the liver including or leading to death of
liver cells) with no concurrent worsening of fibrosis (scarring of
liver tissue). Trial participants included both patients new to HBV
therapy (n=375) and patients (n=51) who had received prior nucleoside
treatment. To date, more than 400 chronic hepatitis B patients have
been treated with Viread in these studies.
"The approval of Viread for hepatitis B represents more than a
decade of work in both the fields of HIV and hepatitis B to develop a
medication that offers significant viral suppression, once-daily
dosing and a well-established safety profile," said Kevin Young,
Executive Vice President, Commercial Operations, Gilead Sciences. "We
extend our thanks to the investigators and patients who participated
in the clinical trials that support today's approval, and we look
forward to partnering with community members to increase disease
awareness and expand access to treatment for those patients in need."
Because chronic HBV infection can persist for years without
causing any noticeable symptoms, many people are unaware they are
infected and do not seek treatment. The disease disproportionately
affects Asian Americans: One in 10 foreign-born Asian Americans is
estimated to be living with chronic HBV infection, a rate 100 times
greater than that of the non-Asian U.S. population, which reflects the
high prevalence of HBV in many Asian countries.
"Although we've made great strides in reducing the overall
incidence of chronic hepatitis B in the United States, the disease
still takes a devastating toll in Asian-American communities," said
Danny Chu, M.D., Community Physician, New York. "Greater public
awareness and effective new treatment options are urgently needed to
help reduce this significant health disparity."
The approval of Viread expands Gilead's hepatic health franchise.
The company's first treatment for chronic hepatitis B, Hepsera, is
currently the most widely prescribed oral agent for the disease in the
United States. The company is also developing small-molecule compounds
for the treatment of hepatitis C and a hepatoprotectant for multiple
forms of hepatitis-related liver fibrosis, including nonalcoholic
steatohepatitis (also known as NASH).
Viread was approved for the treatment of chronic hepatitis B in
the European Union, Turkey, Australia and New Zealand earlier this
year, and a marketing application is currently pending in Canada.
Important Information About Viread for Chronic Hepatitis B
Viread (tenofovir disoproxil fumarate) is indicated for the
treatment of chronic hepatitis B in adults.
The following points should be considered when initiating therapy
with Viread for the treatment of HBV infection:
-- This indication is based on data from one year of treatment in
primarily nucleoside-treatment-naive adult patients with
HBeAg-positive and HBeAg-negative chronic hepatitis B with
compensated liver disease.
-- The numbers of patients in clinical trials who were
nucleoside-experienced or who had lamivudine-associated
mutations at baseline was too small to reach conclusions of
efficacy.
-- Viread has not been evaluated in patients with decompensated
liver disease.
The recommended dose for the treatment of chronic hepatitis B is
300 mg once daily taken orally without regard to food. Dose interval
adjustment is recommended in renal impairment.
LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS AND POST
TREATMENT EXACERBATION OF HEPATITIS
Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogs
alone or in combination with other antiretrovirals.
Severe acute exacerbations of hepatitis have been reported in
HBV-infected patients who have discontinued anti-hepatitis B therapy,
including Viread. 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 Viread.
If appropriate, resumption of anti-hepatitis B therapy may be
warranted.
New onset or worsening of renal impairment including cases of
acute renal failure and Fanconi syndrome have been reported with the
use of Viread. It is recommended to assess creatinine clearance (CrCl)
before initiating treatment with Viread and monitor CrCl and serum
phosphorus in patients at risk. Administering Viread with concurrent
or recent use of nephrotoxic drugs, including Hepsera should be
avoided.
HIV antibody testing should be offered to all HBV-infected
patients before initiating therapy with Viread. Viread should only be
used as part of an appropriate antiretroviral combination regimen in
HIV-infected patients with or without HBV coinfection.
Decreases in bone mineral density (BMD) have been observed in
HIV-infected patients. It is recommended that BMD monitoring be
considered for patients with a history of pathologic fracture or who
are at risk for osteopenia. The bone effects of Viread have not been
studies in patients with chronic HBV infection.
In controlled clinical trials in patients with chronic hepatitis
B, the most common adverse reaction (all grades) is nausea. Other
treatment-emergent adverse reactions reported in greater than 5
percent of patients treated with Viread included: abdominal pain,
diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain and
skin rash.
About Chronic Hepatitis B
The hepatitis B virus (HBV) is up to 100 times more easily
transmitted than HIV. While most new cases of HBV infection in
previously healthy adults are cleared by the immune system within a
few months, many people - especially those infected as newborns and
young children - will develop chronic, lifelong infections. In these
cases, chronic hepatitis B can slowly destroy the liver, causing
scarring (cirrhosis), liver disease, or liver cancer over many years
or decades. Because it is believed to be the cause of 80 percent of
all liver cancer cases worldwide, HBV is second only to tobacco among
known human carcinogens.
The hepatitis B virus can be transmitted by any activity that
involves exposure to blood and other body fluids, including sexual
contact and use of contaminated needles during injection drug use. It
can also be transmitted from mother to child at birth, which is the
primary transmission route among Asian Americans. Asian Americans are
one of the fastest-growing minority groups in the United States,
numbering approximately 15 million people in 2007. A recent study
showed that up to two-thirds of Asian Americans with chronic hepatitis
B did not know they were infected.
Although there is no simple cure for chronic hepatitis B,
antiviral treatment can slow viral replication and therefore reduce
liver inflammation and liver injury.
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. Headquartered in
Foster City, California, Gilead has operations in North America,
Europe and Australia.
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
risks that physicians may not prescribe the product over existing HBV
medications and regulatory agencies and payers may be reluctant to
approve or provide reimbursement for the product. 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
Annual Report on Form 10-K for the year ended December 31, 2007 and
its Quarterly Report on Form 10-Q for the second quarter of 2008, 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.
Full U.S. prescribing information for Viread is available at
www.Viread.com
Full U.S. prescribing information for Hepsera is available at
www.Hepsera.com
Viread and Hepsera are registered trademarks of Gilead Sciences,
Inc.
For more information on Gilead, please call the Gilead Public
Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit
www.gilead.com.
CONTACT: Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Cara Miller, 650-522-1616 (Media)
SOURCE: Gilead Sciences, Inc.
