CORRECTING and REPLACING CASTLE Data Showed Boosted REYATAZ(R) (atazanavir sulfate)...

Tue Aug 5, 2008 9:23pm EDT
 
[-] Text [+]
CORRECTING and REPLACING CASTLE Data Showed Boosted REYATAZ(R) (atazanavir sulfate) and Lopinavir/r Achieved Similar Results for Undetectable Viral Load in Treatment-Naive HIV-1 Infected Patients, Regardless of Gender

    CASTLE gender subanalysis provides largest scale information to
date about boosted protease inhibitor-based combination HIV therapy in
                         treatment-naive women
MEXICO CITY--(Business Wire)--
Please replace the release with the following corrected version
due to multiple revisions.

   The corrected version reads:

   CASTLE DATA SHOWED BOOSTED REYATAZ(R) (ATAZANAVIR SULFATE) AND
LOPINAVIR/R ACHIEVED SIMILAR RESULTS FOR UNDETECTABLE VIRAL LOAD IN
TREATMENT-NAIVE HIV-1 INFECTED PATIENTS, REGARDLESS OF GENDER

   CASTLE gender subanalysis provides largest scale information to
date about boosted protease inhibitor-based combination HIV therapy in
treatment-naive women

   Bristol-Myers Squibb Company (NYSE: BMY) today announced results
from a pre-specified subanalysis of the CASTLE study, in which
once-daily boosted REYATAZ(R) (atazanavir sulfate) (REYATAZ 300 mg
taken with 100 mg of ritonavir, or REYATAZ/r) and twice-daily
co-formulated lopinavir 400 mg and ritonavir 100 mg (lopinavir/r),
each as part of HIV combination therapy, showed similar results for
undetectable viral load at 48 weeks regardless of gender in
treatment-naive HIV-1 infected adults. Women comprise half of all
people living with HIV around the world, and in 2006, more than 25
percent of new HIV-1 infections in the U.S. were in women.(i)
Moreover, women have been shown to have differences in HIV viral load,
drug-related side effects and drug pharmacokinetics compared to men,
but there are few data to guide decision-making about choice of
therapy and dosing by gender.(ii)

   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. The
CASTLE gender subanalysis was conducted to determine the effect of
both study regimens on women and men. The CASTLE study enrolled 277
women and 606 men from 29 countries. Results from this gender
subanalysis were presented for the first time at the 17th
International AIDS Conference (IAC) today in Mexico City.

   "It is very important for women to be involved in clinical
research so we can better understand efficacy and tolerability of
antiretroviral therapy in women," said Dawn Averitt Bridge, Founder
and Chair of the Board, The Well Project. "This subanalysis of the
CASTLE study has made a significant contribution to that
understanding."

   Overall in the CASTLE study, 78 percent of the 440 patients in the
REYATAZ(R) (atazanavir sulfate)/r arm and 76 percent of the 443
patients in the lopinavir/r arm met the non-inferiority primary
endpoint of achieving undetectable viral load (defined as HIV-1 RNA
less than 50 copies/mL) at 48 weeks.

   The gender subanalysis data showed that 76 percent of the 138
female patients in the REYATAZ/r arm and 73 percent of the 139 female
patients in the lopinavir/r arm achieved undetectable viral load at 48
weeks. In male patients, 79 percent of the 302 patients in the
REYATAZ/r arm and 78 percent of the 304 patients in the lopinavir/r
arm achieved undetectable viral load. In female patients, the mean
increase in CD4+ cell count from baseline at 48 weeks was 199
cells/mm3 in the REYATAZ/r arm and 221 cells/mm3 in the lopinavir/r
arm. In male patients, the mean increase in CD4+ cell count from
baseline at 48 weeks was 205 cells/mm3 in the REYATAZ/r arm and 219
cells/mm3 in the lopinavir/r arm.

   In female patients, Grade 2-4 treatment-related adverse events
were reported by 30 percent in the REYATAZ/r arm and 32 percent in the
lopinavir/r arm. In male patients, Grade 2-4 treatment-related adverse
events were reported by 24 percent in the REYATAZ/r arm and 28 percent
in the lopinavir/r arm.

   About the CASTLE Study

   The international, multi-center, open-label, non-inferiority,
96-week CASTLE study randomized 883 treatment-naive patients infected
with HIV-1, of which 31 percent (n=277) were women and 69 percent
(n=606) were men. 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 co-formulated 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. Patients were required to have a baseline viral load
(HIV-1 RNA) 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 who achieved undetectable
viral load (HIV-1 RNA of less than 50 copies/mL) at 48 weeks.

   Important Information About REYATAZ(R) (atazanavir sulfate)
Capsules

   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 administered
once-daily in all patient populations.

   REYATAZ is a prescription medicine used in combination with other
medicines to treat people who are infected with the human
immunodeficiency virus (HIV). REYATAZ has been studied in 48-week
trials in both patients who have taken or have never taken anti-HIV
medicines.

   REYATAZ does not cure HIV or help prevent passing HIV to others.

   REYATAZ should not be taken with the following medicines: ergot
medicines, Versed(R) (midazolam), Halcion(R) (triazolam), Orap(R)
(pimozide), Propulsid(R) (cisapride), Camptosar(R) (irinotecan),
Crixivan(R) (indinavir), Mevacor(R) (lovastatin), Zocor(R)
(simvastatin), rifampin, or St. John's wort (Hypericum perforatum).

   People taking REYATAZ should speak with their healthcare provider
before taking the following medicines: Viagra(R) (sildenafil),
Levitra(R) (vardenafil), Cialis(R) (tadalafil), Vfend(R)
(voriconazole), AcipHex(R) (rabeprazole), Nexium(R) (esomeprazole),
Prevacid(R) (lansoprazole), Prilosec(R) (omeprazole), Protonix(R)
(pantoprazole), Axid(R) (nizatidine), Pepcid AC(R) (famotidine),
Tagamet(R) (cimetidine), or Zantac(R) (ranitidine), Advair(R)
(fluticasone propionate and salmeterol inhalation powder), Flonase(R)
(fluticasone propionate), or Flovent(R) (fluticasone propionate). The
above lists of medicines are not complete. The use of all
prescriptions and non-prescription medicines, vitamins, herbal
supplements, or other health preparations should be discussed with a
healthcare provider.

   The following side effects or conditions should be reported to a
healthcare provider right away:

-0-
*T
-- A change in the way the heart beats may occur and could be a
 symptom of a heart problem.

-- Mild rash (redness and itching) without other symptoms sometimes
 occurs in patients taking REYATAZ, most often in the first few weeks
 after the medicine is started, and usually goes away within two weeks
 with no change in treatment.

-- Severe rash has occurred in a small number of patients taking
 REYATAZ. This type of rash is associated with other symptoms which
 could be serious and potentially cause death. If rash develops with
 any of the following symptoms, the patient should stop using REYATAZ
 and call a healthcare provider right away:

   - Shortness of breath

   - General ill-feeling or 'flu-like' symptoms

   - Fever

   - Muscle or joint aches

   - Conjunctivitis (red or inflamed eyes, like "pink-eye")

   - Blisters

   - Mouth sores

   - Swelling of the face

-- Yellowing of the skin and/or eyes may occur due to increases in
 bilirubin levels in the blood (bilirubin is made by the liver).

-- In patients with liver disease, including hepatitis B or C, the
 liver disease may get worse when taking anti-HIV medicines like
 REYATAZ.

-- Kidney stones have been reported in patients taking REYATAZ. Signs
 or symptoms of kidney stones include pain in the side, blood in the
 urine, and pain when urinating.

-- Diabetes and high blood sugar may occur in patients taking protease
 inhibitor medicines like REYATAZ(R) (atazanavir sulfate).

-- Some patients with hemophilia have increased bleeding problems with
 protease inhibitor medicines like REYATAZ.

-- Changes in body fat have been seen in some patients taking anti-HIV
 medicines. The cause and long-term effects are not known at this
 time.

*T

   Other side effects of REYATAZ taken with other anti-HIV medicines
include: nausea, headache, stomach pain, vomiting, diarrhea,
depression, fever, dizziness, trouble sleeping, numbness, and tingling
or burning of hands or feet.

   REYATAZ and other anti-HIV medicines should be taken exactly as
instructed by healthcare providers. Please see accompanying Full
Prescribing Information, or visit http://www.reyataz.com or
http://www.BMS.com.

   REYATAZ(R) is a registered trademark of Bristol-Myers Squibb
Company. The other brands listed are registered trademarks of their
respective owners and are not trademarks of Bristol-Myers Squibb
Company.

   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.

   (i) Centers for Disease Control and Prevention. "Sex of adults and
adolescents with HIV/AIDS diagnosed during 2006." Factsheet: HIV/AIDS
in the United States. March 2008. Available at:
http://www.cdc.gov/hiv/resources/factsheets/us.htm. Accessed 17 July
2008.

   (ii) JAMA, August 16, 2006-Vol 296, No. 7, pg. 839.

Bristol-Myers Squibb Company
Media:
Sonia Choi
cell: 609-213-6015
office: 609-252-5132
sonia.choi@bms.com
or
Investors:
Suketu Desai, 609-252-5796
suketu.desai@bms.com

Copyright Business Wire 2008

 

Editor's Choice

A selection of our best photos from the past 24 hours.  Slideshow 

Most Popular on Reuters

  • Articles
  • Video
Join the Reuters Consumer Insight Panel and help us get to know you better

Join the Reuters Consumer Insight Panel and help us get to know you better