European Commission Approves Viread(R) for Chronic Hepatitis B
April 25 2008 - 9:22AM
Business Wire
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the
European Commission has granted marketing authorisation for Viread�
(tenofovir disoproxil fumarate) for the treatment of chronic
hepatitis B in all 27 member states of the European Union. A
once-daily tablet, Viread works by blocking hepatitis B virus (HBV)
DNA polymerase, the enzyme that is necessary for the virus to
replicate in liver cells. Viread has been approved in the European
Union for use in adult chronic HBV patients with compensated liver
disease, with evidence of active viral replication, persistently
elevated serum alanine aminotransferase (ALT) levels and
histological evidence of active inflammation and/or fibrosis. The
product was recently approved for the treatment of chronic
hepatitis B in Turkey and New Zealand, and marketing applications
are currently pending regulatory review in the United States,
Canada and Australia. �Hepatitis B is a significant problem in
Europe, where approximately 20,000 people die of complications from
the disease each year,� said Patrick Marcellin, MD, PhD, Professor
of Hepatology at the University of Paris and Head of the Viral
Hepatitis Research Unit (INSERM) at the H�pital Beaujon in Clichy,
France. �As a physician and researcher who has studied this drug
extensively in large-scale clinical trials, I believe Viread is an
important treatment option for patients who are just starting
therapy, as well as for those who may have had�previous experience
with other medications, including lamivudine.� Today�s approval is
based primarily on data from two ongoing Phase III clinical trials,
Studies 102 and 103, in patients (n = 375) chronically infected
with HBV who were new to HBV therapy (treatment-naive). Some
patients (n=51) in the Phase III trials have had previous
experience with lamivudine (treatment-experienced). These studies
evaluate the efficacy, safety and tolerability of Viread compared
to Hepsera� (adefovir dipivoxil). Positive data from these studies
were presented in late-breaker presentations at the annual meeting
of the American Association for the Study of Liver Diseases in
Boston, Massachusetts, November 2007. Additional 72-week data from
these studies were presented at the annual meeting of the European
Association for the Study of the Liver in Milan, Italy, April
23-27. �Data from studies 102 and 103 demonstrate that Viread has
many of the preferred qualities of an antiviral treatment:
rapid�and profound viral suppression, a well-established�safety
profile with more than�one million years of patient experience, and
convenient once-daily administration,� said Kevin Young, Executive
Vice President, Commercial Operations at Gilead Sciences. �Now that
Viread is approved for chronic hepatitis B in Europe, our top
priority is working to ensure that all individuals who need the
medication have access to it as quickly as possible.� Viread
represents Gilead's second once-daily antiviral for the treatment
of chronic hepatitis B; the first, Hepsera, is currently widely
used as a treatment for chronic hepatitis B in Europe. In addition,
the company is also developing small molecule compounds for the
treatment of hepatitis C and a hepatoprotectant for
hepatitis-related liver fibrosis. Viread has been available in
Europe as a part of combination therapy for HIV infection in adults
since 2002. Its active ingredient, tenofovir disoproxil, is the
most widely prescribed molecule for the treatment of HIV infection
in several European Union nations. About Chronic Hepatitis B
Chronic hepatitis B is a common and potentially fatal liver disease
caused by the hepatitis B virus, which is up to 100 times more
easily transmitted than HIV. Chronic hepatitis B can produce no
symptoms in its earlier stages, meaning many individuals are
unaware that they are infected until they have advanced liver
disease. Complications commonly associated with chronic hepatitis B
include scarring of the liver (cirrhosis), liver failure and liver
cancer. More than 400 million people are estimated to be
chronically infected with HBV worldwide and, without treatment, up
to one quarter of those will ultimately die of liver disease. About
Viread (tenofovir disoproxil fumarate) for HIV In the United
States, Viread is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection. Lactic
acidosis and severe hepatomegaly with steatosis, including fatal
cases, have been reported with the use of nucleoside analogues
alone or in combination with other antiretrovirals. Viread is not
approved for the treatment of HBV infection and the safety and
efficacy of Viread have not been established in patients coinfected
with HBV and HIV. Severe acute exacerbations of hepatitis B have
been reported in patients who have discontinued Viread. Hepatic
function should be monitored closely with both clinical and
laboratory follow-up for at least several months in patients who
are co-infected with HIV and HBV and discontinue Viread. If
appropriate, initiation of anti-hepatitis B treatment may be
warranted. It is important for patients to be aware that anti-HIV
medicines including Viread do not cure HIV infection or AIDS, and
do not reduce the risk of transmitting HIV to others. Renal
impairment, including cases of acute renal failure and Fanconi
syndrome (renal tubular injury with severe hypophosphatemia), has
been reported in association with the use of Viread. It is
recommended that creatinine clearance be calculated in all patients
prior to initiating therapy with Viread and as clinically
appropriate during therapy. Routine monitoring of calculated
creatinine clearance and serum phosphorous should be performed in
patients at risk for renal impairment. Dosing interval adjustment
and close monitoring of renal function are recommended in all
patients with creatinine clearance less than 50mL/min. Viread
should be avoided with concurrent or recent use of a nephrotoxic
agent. The U.S. package insert advises that co-administration of
Viread and didanosine should be undertaken with caution. Patients
should be monitored closely for didanosine-associated adverse
events and didanosine should be discontinued if these occur.
Patients on atazanavir and lopinavir/ritonavir plus Viread should
be monitored for Viread-associated adverse events and Viread should
be discontinued if these occur. When co-administered with Viread,
it is recommended that atazanavir be given with ritonavir 100 mg.
Atazanavir without ritonavir should not be co-administered with
Viread. Decreases in bone mineral density (BMD) at the lumbar spine
and hip have been seen with the use of Viread. The effect on
long-term bone health and future fracture risk is unknown. Cases of
osteomalacia (associated with proximal renal tubulopathy) have been
reported in association with the use of Viread. Changes in body fat
have been observed in patients taking anti-HIV medicines. The
mechanism and long-term health effect of these changes are unknown.
Immune Reconstitution Syndrome has been reported in patients
treated with combination therapy, including Viread. The most common
adverse events among patients receiving Viread with other
antiretroviral agents in a pivotal clinical study (Study 903) were
mild to moderate gastrointestinal events and dizziness. Moderate to
severe adverse events occurring in more than 5 percent of patients
receiving Viread included rash (rash, pruritis, maculopapular rash,
urticaria, vesiculobullous rash and pustular rash), headache, pain,
diarrhea, depression, back pain, fever, nausea, abdominal pain,
asthenia (weakness) and anxiety. In another pivotal study (Study
907), less than 1 percent of patients discontinued participation
because of gastrointestinal events. For full prescribing
information outside of the United States physicians should consult
their local product labeling. About Hepsera (adefovir dipivoxil) In
the United States, Hepsera is indicated for the treatment of
chronic hepatitis B in patients 12 years of age and older with
evidence of active viral replication and either evidence of
persistent elevations in serum aminotransferases (ALT or AST) or
histologically active disease. Hepsera is not recommended for use
in children less than 12 years of age. Severe acute exacerbations
of hepatitis have been reported in patients who have discontinued
anti-hepatitis B therapy, including Hepsera. Hepatic function
should be closely monitored in both clinical and laboratory
follow-up for at least several months in patients who discontinue
hepatitis B therapy. If appropriate, resumption of therapy may be
warranted. In patients at risk of having underlying renal
dysfunction, chronic administration of Hepsera may result in
nephrotoxicity. These patients should be monitored closely for
renal function and may require dose adjustment. Dose adjustment is
recommended in patients with serum creatinine less than 50 mL/min.
HIV resistance may emerge in chronic hepatitis B patients with
unrecognized or untreated HIV infection treated with anti-hepatitis
B therapies, such as therapy with Hepsera, that may have activity
against HIV. Lactic acidosis and severe hepatomegaly with
steatosis, including fatal cases, have been reported with the use
of nucleoside analogs alone and in combination with other
antiretrovirals. Adverse reactions identified from
placebo-controlled and open label studies include the following:
asthenia, headache, abdominal pain, diarrhea, nausea, dyspepsia,
flatulence, increased creatinine, and hypophosphatemia. Additional
adverse reactions observed from an open-label study in pre- and
post-transplant patients include abnormal renal function, renal
failure, vomiting, rash and pruritus. For full prescribing
information outside of the United States, physicians should consult
their local product labeling. Viread and Hepsera are the result of
a collaborative research effort between Dr. Antonin Holy, Institute
for Organic Chemistry and Biochemistry, Academy of Sciences of the
Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega
Institute for Medical Research, Katholic University in Leuven,
Belgium. 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. U.S. full prescribing information for Viread
is available at www.Viread.com U.S. full 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.
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Jun 2024 to Jul 2024
Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Jul 2023 to Jul 2024