Landmark Five-Year Data on Gilead's Anti-HIV Drug Viread(R) Presented at 8th International Workshop on Adverse Drug Reactions and Lipodystrophy



    Gilead Sciences, Inc. (Nasdaq: GILD) today announced two
    presentations of long-term efficacy and safety data from Study 903E on
    the company's leading once-daily anti-HIV medication, Viread(R)
    (tenofovir disoproxil fumarate). This clinical trial is an ongoing
    open-label extension of Gilead's Study 903, a three-year
    double-blinded randomized clinical trial that compared once-daily
    Viread to twice-daily stavudine (d4T), both in combination with
    lamivudine and efavirenz in treatment-naive patients. A subset of
    patients who completed Study 903 were enrolled in Study 903E and
    received two additional years of treatment with Viread, lamivudine and
    efavirenz. Long-term data were presented for patients who remained on
    a Viread-containing regimen for a total of five years and for those
    who switched from twice-daily stavudine to once-daily Viread upon
    enrollment in Study 903E. Data from both analyses of Study 903E were
    presented this week at the 8th International Workshop on Adverse Drug
    Reactions and Lipodystrophy in HIV, held September 24-26 in San
    Francisco (Posters #82 and #29).

    "With the rapid progress in HIV therapy and the availability of
    potent, safe and well-tolerated regimens, long-term safety and
    efficacy data are increasingly important," said Norbert Bischofberger,
    PhD, Executive Vice President, Research and Development, Gilead
    Sciences. "Our decision to extend Study 903 four additional years to a
    total of seven years in duration underscores our commitment to helping
    physicians and patients properly assess the long-term impact of
    treatment on side effects such as lipodystrophy and changes in
    cholesterol."

    Viread is a component of two once-daily fixed-dose combination
    tablets, Truvada(R) (emtricitabine and tenofovir disoproxil fumarate),
    and ATRIPLA(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir
    disoproxil fumarate 300 mg). ATRIPLA is the first and only once-daily
    single tablet regimen for the treatment of HIV-1 infection in adults
    as stand-alone therapy or in combination with other agents.

    Study 903E

    Study 903E is an ongoing four-year open-label extension for a
    subset of patients who successfully completed three years of treatment
    in Study 903. In Study 903, 600 patients were randomized and received
    treatment for three years with once-daily Viread (n=299) or
    twice-daily stavudine (n=301), both in combination with lamivudine and
    efavirenz. Patients who completed three years of treatment in Study
    903 at sites in Argentina, Brazil and the Dominican Republic were
    rolled over into the open-label Study 903E extension.

    Eighty-six patients randomized to receive three years of treatment
    in the once-daily Viread arm of Study 903 were rolled over into Study
    903E and continued on the same regimen for two additional years. (Of
    these patients, nine discontinued prior to year five; four either
    withdrew consent, were non-compliant or lost to follow-up, two
    discontinued due to pregnancy, two experienced virologic failure and
    one discontinued due to an adverse event.) Eighty-five patients
    randomized to receive three years of treatment in the twice-daily
    stavudine arm of Study 903 were switched and received two additional
    years of open label therapy with a once-daily regimen of Viread,
    lamivudine and efavirenz in Study 903E. (Of these patients, two
    withdrew consent and discontinued prior to year five.)

    Of the 86 patients from the Viread arm of Study 903 who entered
    903E at year three, 83 percent experienced viral load suppression to
    less than 50 copies/mL following two additional years of treatment in
    Study 903E. These patients experienced a mean increase from baseline
    in CD4 count of 273 cells/mm(3) at year three in Study 903. An
    additional mean increase in CD4 cell count of 148 cells/mm(3) was
    observed from years three to five in Study 903E. No patient developed
    the K65R mutation during the open-label extension of the study.

    Limb fat measurement was initiated in Study 903 at year two. Among
    Study 903E patients from the Viread arm of Study 903, mean total limb
    fat remained stable from years two to five (8.0 to 8.2 kilograms).
    There was no evidence of lipoatrophy among Viread-treated patients.
    Loss of limb fat, or peripheral lipoatrophy, is a hallmark of
    lipodystrophy, which has been associated with long-term administration
    of some anti-HIV medications and with HIV disease.

    The overall adverse event profile observed during the open-label
    extension was similar to that seen in the first three years of the
    study. There were no discontinuations due to renal adverse events and
    no patient reported Fanconi syndrome. Additionally, there was no
    evidence of clinically relevant effects on bone mineral density
    related to Viread. One patient experienced bone fracture during the
    open-label extension phase which was trauma related and not associated
    with study drug.

    In a second presentation, data were presented for patients
    randomized to the twice-daily stavudine arm of Study 903 who were
    switched and received two additional years of open-label therapy with
    once-daily Viread, lamivudine and efavirenz in Study 903E. Of the 85
    patients from the stavudine arm of Study 903 who entered Study 903E at
    year three, 91 percent experienced viral load suppression to less than
    50 copies/mL at two years in Study 903E. These patients experienced a
    mean increase from baseline in CD4 count of 343 cells/mm(3) at year
    three in Study 903. An additional mean increase in CD4 cell count of
    103 cells/mm(3) was observed from years three to five in Study 903E.
    No patients discontinued treatment due to adverse events.

    Study 903E patients in the twice-daily stavudine arm of Study 903
    experienced a decrease in mean total limb fat from 5.0 kilograms at
    year two to 4.6 kilograms upon entering Study 903E. Following a switch
    to the once-daily Viread-containing regimen, an increase in mean total
    limb fat was observed (4.6 to 5.5 kilograms; p less than 0.001) at two
    years in Study 903E.

    Study 903E patients in the twice-daily stavudine arm of Study 903
    experienced a mean increase in fasting triglycerides of 102 mg/dL and
    mean increase in fasting total cholesterol of 59 mg/dL at year three
    in Study 903. Following a switch to the once-daily Viread-containing
    regimen, a mean decrease in fasting triglycerides of 75 mg/dL (p less
    than 0.001) and a mean decrease in fasting total cholesterol of 23
    mg/dL (p less than 0.001) was observed at two years in Study 903E.

    Among patients who switched from stavudine to Viread upon entry in
    Study 903E, no significant changes in bone mineral density (BMD) were
    observed at the spine and a mean decrease of 2.3 percent was observed
    at the hip (p less than 0.001) from years three to five in Study 903E.
    One patient experienced a fracture which was trauma related and not
    associated with study drug.

    About Viread

    In the United States, Viread is indicated in combination with
    other antiretroviral agents for the treatment of HIV-1 infection.
    Viread should not be used in combination with Truvada.

    Drug interactions have been observed when didanosine, atazanavir
    or lopinavir/ritonavir is coadministered with Viread and dose
    adjustments may be necessary. Data are not available to recommend a
    dose adjustment of didanosine for patients weighing less than 60 kg.
    Patients on atazanavir and lopinavir/ritonavir plus Viread should be
    monitored for Viread-associated adverse events, which may require
    discontinuation. When co-administered with Viread, it is recommended
    that atazanavir 300 mg be given with ritonavir 100 mg. Atazanavir
    without ritonavir should not be co-administered with Viread.

    Renal impairment, including cases of acute renal failure and
    Fanconi syndrome (renal tubular injury with severe hypophosphatemia),
    has been reported among patients taking Viread. Renal impairment
    occurred most often in patients with underlying systemic or renal
    disease or in patients taking concomitant nephrotoxic agents, though
    some cases have appeared in patients without identified risk factors.
    Decreases in bone mineral density (BMD) at the lumbar spine and hip
    have been seen with the use of Viread. The effects of
    Viread-associated changes in BMD and biochemical markers on long-term
    bone health and future fracture risk are unknown. Redistribution
    and/or accumulation of body fat have been observed in patients
    receiving antiretroviral therapy. Immune reconstitution syndrome has
    been reported in patients treated with combination antiretroviral
    therapy including Viread.

    The most common adverse events among patients receiving Viread
    with other antiretroviral agents in clinical trials 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 and
    anxiety (Study 903). Less than 1 percent of patients discontinued
    participation because of gastrointestinal events (Study 907).

    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. Visit Gilead on the World Wide Web at
    www.gilead.com.

    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 that 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 the Gilead Annual Report on Form 10-K for the year ended
    December 31, 2005, 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 prescribing information for Viread is available at
    www.viread.com.

    Viread and Truvada are registered trademarks of Gilead Sciences,
    Inc.

    ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences,
    LLC.