European CHMP Issues Positive Opinion for Viread(R) for the Treatment of Chronic Hepatitis B



    Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
    Committee for Medicinal Products for Human Use (CHMP) of the European
    Medicines Agency (EMEA) has issued a positive opinion on the company´s
    application to extend the indication for Viread(R) (tenofovir
    disoproxil fumarate) to include the treatment of chronic hepatitis B
    in adults. The application, known as a Type II variation, was
    submitted to European regulatory authorities in October 2007.

    The CHMP´s positive opinion will be forwarded to the European
    Commission, which will amend the Marketing Authorisation for Viread in
    the 27 countries of the European Union to reflect the Type II
    variation. The European Commission generally issues an updated
    Marketing Authorisation within a few months following a positive CHMP
    recommendation. Viread represents Gilead´s second once-daily antiviral
    developed for the potential treatment of chronic hepatitis B. The
    active ingredient in Viread, tenofovir disoproxil fumarate, is the
    most widely prescribed molecule for the treatment of HIV infection in
    the United States and several countries of the EU.

    "The complications associated with chronic hepatitis B make it a
    leading cause of death worldwide," said Patrick Marcellin, MD, Hopital
    Beaujon, Clichy, France. "In Europe, the incidence of chronic
    hepatitis B is significant and growing, which underscores the
    importance of increased screening and immunization for eligible
    patients, and the need for safe and effective treatment options that
    can slow or potentially even halt the progression of liver damage for
    patients living with chronic hepatitis B."

    The application is based primarily on data from two ongoing Phase
    III clinical trials, Studies 102 and 103, in patients chronically
    infected with the hepatitis B virus (HBV). These studies evaluate the
    efficacy, safety and tolerability of Viread compared to adefovir
    dipivoxil. Positive data from both studies were described in
    late-breaker presentations at the annual meeting of the American
    Association for the Study of Liver Diseases in November 2007.
    Additional 72-week data from these studies will be presented at the
    annual meeting of the European Association for the Study of the Liver
    (EASL), taking place in Milan, Italy, April 23-27.

    Gilead has also submitted applications for marketing approval of
    Viread for hepatitis B in the United States, Australia, Canada, New
    Zealand and Turkey.

    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 so 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 chronic hepatitis B virus (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.

    Full prescribing information for Viread in the United States is
    available at www.Viread.com. For full prescribing information outside
    of the United States physicians should consult their local product
    labeling.

    The parent compound of Viread was discovered through 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.

    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 risks
    that regulatory authorities may not approve Viread for the treatment
    of chronic hepatitis B in the United States or European Union, and
    marketing approval, if granted, may have significant limitations on
    its use. 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, 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.

    Viread is a registered trademark 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