CASTLE study showed similar efficacy between once-daily REYATAZ(R) (atazanavir sulfate)/ritonavir and twice-daily lopinavir/ritonavir at 48 weeks in previously untreated HIV-infected adult patients

    Data also showed differences in gastrointestinal and lipid effects
    between REYATAZ/ritonavir and lopinavir/ritonavir among study population

    MONTREAL, Feb. 7 /CNW/ - Bristol-Myers Squibb Company (NYSE:   BMY) today
announced results from the CASTLE study, in which 300 mg of once-daily
REYATAZ(R) (atazanavir sulfate) taken with 100 mg of ritonavir once daily
(REYATAZ/r) showed similar antiviral efficacy to twice-daily lopinavir 400 mg
and ritonavir 100 mg (lopinavir/r) in previously untreated adult HIV-1
infected patients at 48 weeks, as part of HIV combination therapy. In this
study, patients in both arms were treated with TRUVADA (tenofovir
300mg/emtricitabine 200 mg) once daily. Seventy-eight percent of the
440 patients in the REYATAZ/r arm met the primary endpoint of achieving
undetectable viral load (defined as HIV-1 RNA less than 50 copies/mL) at
48 weeks, compared with 76 percent of the 443 patients in the lopinavir/r arm.
    CASTLE is the first large-scale, open-label, randomized study designed to
demonstrate the non-inferiority of REYATAZ/r to lopinavir/r in previously
untreated HIV-1 infected adult patients. Data from the CASTLE study were
presented for the first time at the 15th Conference on Retroviruses and
Opportunistic Infections (CROI) this week in Boston, Mass.
    "The recent release of the 48 week CASTLE study provides clinicians with
important and extremely relevant data on a once-daily regimen containing
Reyataz with ritonavir boosting in combination with Truvada for
anti-retroviral treatment naive HIV+ individuals," said Dr Roger LeBlanc
MD FRCP (C) Montreal Chest Hospital, Immunodeficiency Unit, Montreal, Quebec,
Canada. "There are now many treatment options available. This trial
demonstrates this regimen to be metabolically safe and better tolerated, which
will figure highly in the selection process for the best treatment option for
our patients."
    The most common grade 2-4 (moderate to severe) adverse events occurring
in greater than or equal to three percent of patients in the once-daily
REYATAZ(R) (atazanavir sulfate)/r arm or the twice-daily lopinavir/r arm were
diarrhea (two percent and eleven percent, respectively), nausea (four percent
and eight percent, respectively) jaundice (four percent and zero percent,
respectively), increased bilirubin (six percent and zero percent,
respectively) and rash (three percent and two percent, respectively).
    The REYATAZ/r arm was associated with significantly lower increases from
baseline compared to the lopinavir/r arm in total cholesterol, triglycerides
and non-HDL cholesterol at 48 weeks. Two percent of patients in the REYATAZ/r
arm and seven percent of patients in the lopinavir/r arm required initiation
of lipid-lowering therapy in the study.
    Safety events in this study were consistent with prior experience. Four
deaths were reported in each treatment arm at 48 weeks; none were attributed
to the study medications. Twelve percent of patients in the REYATAZ/r arm and
ten percent of patients in the lopinavir/r arm experienced a serious adverse
    Nine percent of patients in the REYATAZ/r arm and thirteen percent of
patients in the lopinavir/r arm discontinued the study therapy before week 48.

    About the CASTLE Study

    The international, multi-center, open-label, 96-week CASTLE study
randomized 883 treatment-naive patients infected with HIV-1. Four hundred and
forty patients were randomized to receive REYATAZ 300 mg and ritonavir 100 mg
once daily and 443 patients were randomized to receive lopinavir 400 mg and
ritonavir 100 mg twice daily, each in combination with a once-daily,
fixed-dose combination of emtricitabine 200 mg/tenofovir disoproxil fumarate
300 mg. All patients had a baseline viral load of greater than or equal to
5,000 copies/mL; there was no CD4+ cell count restriction for study entry. The
primary endpoint for the study was the proportion of patients with viral load
of less than 50 copies/mL at 48 weeks.

    About REYATAZ(R) (atazanavir sulfate)

    REYATAZ(R) (atazanavir sulfate) is a protease inhibitor that has been
studied extensively in both treatment-naive and treatment-experienced
HIV-infected patients and is designed to be administered once-daily in all
patient populations. BMS recommends treating patients according to the product
label. Currently, once-daily REYATAZ/r is indicated in Canada as part of
combination HIV therapy in treatment-experienced patients. Unboosted REYATAZ
is indicated to treat naive patients in Canada, also as part of combination
HIV therapy. However, if REYATAZ is combined with tenofovir in treatment-naive
patients-or certain other medications (eg, H2-recpetor antagonist, proton pump
inhibitor, efavirenz), ritonavir must also be used.

    About Bristol-Myers Squibb Canada

    Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of
Bristol-Myers Squibb Company, a global pharmaceutical and related health care
products company whose mission is to extend and enhance human life.
Bristol-Myers Squibb Canada is a leading provider of medicines to fight
cancer, cardiovascular and metabolic disorders, infectious diseases (including
HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers
Squibb Company is listed on the New York Stock Exchange under the BMY symbol.
Bristol-Myers Squibb Canada's operations are headquartered in Montréal,

For further information:

For further information: Marc Osborne, Communications, (514) 333-2463,; Bob Butler, Ampersand Communications, (902) 820-2658,

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