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Datum nieuwsfeit: 26-10-2008
( BW)(NJ-BRISTOL-MYERS-SQUIBB)(BMY) 96-Week Data From CASTLE Study
Continue to Show Similar Efficacy Between Once-Daily REYATAZ(R)
(atazanavir sulfate)/Ritonavir and Twice-Daily Lopinavir/Ritonavir In
Previously Untreated HIV-1 Infected Adult Patients
Data continues to show differences in gastrointestinal and lipid
effects among study population
Business Editors/Health/Medical Writers
PRINCETON, N.J.--(BUSINESS WIRE)--Oct. 26, 2008--Bristol-Myers
Squibb Company (NYSE: BMY) today announced 96-week data from the
CASTLE study, in which 74 percent of the 440 patients in the REYATAZ/r
arm achieved an undetectable viral load, defined as HIV-1 RNA less
than 50 copies/mL, compared with 68 percent of the 443 patients in the
lopinavir/r arm. The difference between treatment arms may have been
related to the 16 percent discontinuation rate in the REYATAZ/r arm
and the 21 percent discontinuation rate in the lopinavir/r arm. These
data from the CASTLE study were presented today at the joint 48th
Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC)/Infectious Diseases Society of America (IDSA) 46th annual
conference in Washington, D.C.
"The 96-week analysis of the CASTLE study is consistent with the
findings seen at 48 weeks, specifically the non-inferiority of
once-daily REYATAZ/r compared to twice-daily lopinavir/r in
treatment-naive patients," said Jean-Michel Molina, M.D., Hopital
Saint Louis, Paris, France and from The University of Paris Diderot.
"When initiating patients on antiretroviral combination therapy, it is
important to include medicines with sustained activity against the
virus, along with tolerability, to assist in the long-term treatment
of patients with HIV-1."
The most common grade 2-4 adverse events occurring in greater than
or equal to three percent of patients in the once-daily REYATAZ/r arm
or the twice-daily lopinavir/r arm were diarrhea (2 percent and 12
percent, respectively), nausea (4 percent and 8 percent,
respectively), jaundice (4 percent and 0 percent, respectively).
The REYATAZ(R) (atazanavir sulfate)/r arm was associated with
significantly lower increases from baseline compared to the
lopinavir/r arm in total cholesterol, non-HDL cholesterol, and
triglycerides at 96 weeks (p less than 0.0001). Two percent of
patients in the REYATAZ/r arm and nine percent of patients in the
lopinavir/r arm required initiation of lipid-lowering therapy while on
study.
Safety events in this study were consistent with prior experience.
No new or unexpected safety events were identified. Six deaths were
reported in the REYATAZ/r arm (equal to one percent of total patients
on REYATAZ/r arm) and five deaths were reported in the lopinavir/r arm
(equal to one percent of total patients on lopinavir/r arm) at 96
weeks. Fourteen percent of patients in the REYATAZ/r arm and eleven
percent of patients in the lopinavir/r arm experienced a serious
adverse event.
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 (REYATAZ/r) once daily and 443 patients were
randomized to receive lopinavir 400 mg and ritonavir 100 mg
(lopinavir/r) 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 less than 50 copies/mL at
48 weeks. The CASTLE results demonstrated the non-inferiority of
REYATAZ/r once daily versus lopinavir/r twice daily, each as part of
HIV combination therapy in previously untreated HIV-1 infected adult
patients.
Additional Study Results
A number of secondary endpoints were also measured with regard to
efficacy, resistance, safety, tolerability, and lipid effects.
Additional study results include:
-0-
*T
Achievement of Undetectable Viral Load in Patients with High Baseline
Viral Load
In the study, 74% of the 223 patients with high baseline viral
load (greater than or equal to 100,000 copies/mL) in the once-
daily REYATAZ(R) (atazanavir sulfate)/r arm achieved undetectable
viral load at 96 weeks vs. 66% of the 225 patients with high
baseline viral load in the twice-daily lopinavir/r arm.
Resistance
Analysis of emergent resistance was conducted in patients with
virologic failure (HIV-1 RNA greater than or equal to 400
copies/mL) and without baseline phenotypic protease-inhibitor
resistance to the on-treatment protease inhibitor. One subject in
each arm developed emergent major or minor PI substitutions with
phenotypic resistance to REYATAZ/r and lopinavir/r, respectively,
at Week 96.
*T
Immunologic Response
-- The mean increase in CD4+ cell count from baseline at 96 weeks
was similar between treatment arms with 268 cells/mm3 in
patients in the REYATAZ/r arm and 290 cells/mm3 in patients in
the lopinavir/r arm.
Safety and Tolerability
-- 30% of patients in the REYATAZ/r arm and 32% of patients in
the lopinavir/r arm experienced any grade 2-4
treatment-related adverse event.
-- The incidence of treatment discontinuation due to adverse
events was 3% in the REYATAZ/r arm and 5% in the lopinavir/r
arm. The overall treatment discontinuation rates were 16% and
21% for REYATAZ/r and lopinavir/r arms, respectively.
-- Renal adverse events of any grade were experienced in 4% of
patients in each treatment arm.
-- 44% of patients in the once-daily REYATAZ/r arm and less than
1% of patients in the twice-daily lopinavir/r arm experienced
elevations in total bilirubin greater than 2.5 times the upper
limit of normal.
-- The rates of grade 3-4 liver enzyme elevations (greater than 5
times the upper limit of normal) were similar between
treatment arms.
-0-
*T
-- Grade 3-4 ALT elevations: 3% in the once-daily REYATAZ(R)
(atazanavir sulfate)/r arm vs. 2% in the twice-daily
lopinavir/r arm
-- Grade 3-4 AST elevations: 3% in the REYATAZ/r arm vs. 1%
in the lopinavir/r arm
*T
Lipid Effects
-- In the study, 11% of patients in the REYATAZ/r arm vs. 25% of
patients in the lopinavir/r arm had total cholesterol greater
than or equal to 240 mg/dL.
-- In the study, less than 1% of patients in the REYATAZ/r arm
vs. 4% of patients in the lopinavir/r arm had triglyceride
levels greater than or equal to 751 mg/dL.
About REYATAZ(R) (atazanavir sulfate)
REYATAZ is a protease inhibitor that has been studied extensively
in both treatment-naive and treatment-experienced HIV-infected
patients and is administered once-daily in all patient populations.
REYATAZ is a registered trademark of Bristol-Myers Squibb Company.
SUSTIVA is a registered trademark of Bristol-Myers Squibb Pharma
Company. All other trademarks are the property of their respective
owners and not of Bristol-Myers Squibb.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to extend and enhance human life. For more information
visit www.bms.com.
For full prescribing information for Reyataz, please consult the
Summary of Product Characteristics, or contact Annie Simond at
Bristol-Myers Squibb at +33 1 58 83 65 66.
--30--MD/ny*
CONTACT: Bristol-Myers Squibb Company
Media:
Annie Simond, +33 608 956762
annie.simond@bms.com
or
Investors:
John Elicker, 212-546-3775
john.elicker@bms.com
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