Navigation Links
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
Date:2/6/2008

Data also showed differences in gastrointestinal and lipid effects between

REYATAZ/ritonavir and lopinavir/ritonavir among study population

PRINCETON, N.J., Feb. 6 /PRNewswire-FirstCall/ -- 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 (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, 78 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 CASTLE study provides important additional data to inform the use of a once-daily regimen including REYATAZ and ritonavir in antiretroviral-naive HIV-infected patients," said Jean-Michel Molina, M.D., Hopital Saint Louis, Paris, France. "When choosing a treatment in previously untreated patients it is important to ensure antiviral activity as well as tolerability to optimize the management of HIV infection over the long term."

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) (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) 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 (p<0.0001). 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 event.

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.

Additional Study Results

A number of secondary endpoints were also measured with regard to efficacy, lipid effects, safety and tolerability. Additional study results include:

Achievement of Undetectable Viral Load in Patients with High Baseline Viral Load
* In the study, 74 percent 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 48 weeks, vs. 72 percent of the 225 patients with high baseline

viral load in the twice-daily lopinavir/r arm.

Immunologic Response

* The mean increase in CD4+ count from baseline at 48 weeks was

203 cells/mm3 in patients in the REYATAZ/r arm and 219 cells/mm3 in

patients in the lopinavir/r arm.

Lipid Effects

* Seven percent of patients in the REYATAZ/r arm vs. eighteen percent of

patients in the lopinavir/r arm had total cholesterol greater than or

equal to 240 mg/dL.

* Less than one percent of patients in the REYATAZ/r arm vs. four percent

of patients in the lopinavir/r arm had triglyceride levels greater than

or equal to 751 mg/dL.

Safety and Tolerability

* 26% of patients in the REYATAZ/r arm and 30% 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

two percent in the REYATAZ/r arm and three percent in the lopinavir/r

arm.

* Renal adverse events of any grade were experienced in two percent of

patients in both treatment arms.

* 34% 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.

-- Grade 3-4 ALT elevations: 2% in the once-daily REYATAZ(R)

(atazanavir sulfate)/r arm vs. 1% in the twice-daily lopinavir/r arm

-- Grade 3-4 AST elevations: 2% in the REYATAZ/r arm vs. less than 1%

in the lopinavir/r arm

A prespecified descriptive analysis of virologic response rates (HIV-1 RNA less than 50 copies/mL) by baseline CD4+ categories (greater than 200 cells/mm3, between 100 and 200 cells/mm3, between 50 and 100 cells/mm3, and less than 50 cells/mm3) indicated that response rates were consistent across all baseline CD4+ categories in the REYATAZ/r arm. This descriptive analysis indicated that response rates were reduced for subjects with lower CD4+ counts in the lopinavir/r arm. A post hoc analysis showed no association between virologic response rates and CD4+ category within the REYATAZ/r arm (p = 0.51) and a statistically significant association between virologic response rates and CD4+ category within the lopinavir/r arm (p = 0.0085).

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 administered once-daily in all patient populations.

Indication and Important Safety Information About REYATAZ(R) (atazanavir sulfate) Capsules

REYATAZ(R) (atazanavir sulfate) 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(R) (atazanavir sulfate) 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:

* A change in the way the heart beats may occur and could be a symptom of

a heart problem.

* Diabetes and high blood sugar may occur in patients taking protease

inhibitor medicines like REYATAZ.

* Yellowing of the skin and/or eyes may occur due to increases in

bilirubin levels in the blood (bilirubin is made by the liver).

* Rash (redness and itching) 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.

* 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(R)

(atazanavir sulfate). Signs or symptoms of kidney stones include pain

in the side, blood in the urine, and pain when urinating.

* 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.

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. United States Full Prescribing Information for REYATAZ is available at http://www.reyataz.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 and related health care products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb at http://www.bms.com.


'/>"/>
SOURCE Bristol-Myers Squibb Company
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Joslin Study Identifies Key Factor That Links Metabolic Syndrome; Finding May Help Millions at High Risk of Cardiovascular Disease
2. Ceremeds OSTENE(R) Stops Bone Bleeding Without Added Risk of Surgical Infection, New Study Finds
3. IDM Pharma Announces Phase 3 Mifamurtide (L-MTP-PE) Study Demonstrating Improved Survival Published in the Journal of Clinical Oncology
4. Tigris Pharmaceuticals Initiates Phase I Study of AFP-464 in Patients with Solid Tumors
5. Inverseon Announces Positive Phase IIa Asthma Study
6. Takeda Doses First Patient in a U.S. Phase 1 Study of Hematide(TM) to Treat Chemotherapy Induced Anemia
7. Study Says Allergy Shots Help Children, Reduce Health Care Costs
8. EntreMed Commences Phase 2 Study With MKC-1 in Ovarian/Endometrial Cancers
9. Mayo Clinic Study Finds Further Association Between Diabetes and Pancreatic Cancer
10. Divine Corporations Personal Lubricants Shown to Block Cancer-causing Viruses in a Study by the National Cancer Institute
11. Protalix BioTherapeutics Extends Research Agreement With Yissum Based on Promising Acetylcholinesterase Program Results in Animal Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... NORTH CHESTERFIELD, Va. , May 25, 2016 ... commercially-available next-generation sequencing test for wounds and infections. ... fungi, ALL parasites, and select viruses. The test ... infected area. David G. ... advanced molecular testing to facilitate wound healing: "We ...
(Date:5/25/2016)... PUNE, India , May 25, 2016 /PRNewswire/ ... Pipeline Review, H1 2016"market research report that provides ... complete with comparative analysis at various stages, therapeutics ... route of administration (RoA) and molecule type, along ... releases. It also reviews key players involved in ...
(Date:5/24/2016)...   , Study met ... bowel cleansing and superiority in , ... of the ascending colon   ... Norgine B.V. today announced new positive data from the phase ... preparation) versus standard 2 litre PEG with ascorbate. The study met ...
Breaking Medicine Technology:
(Date:5/28/2016)... ... May 28, 2016 , ... May 26, 2016- In search of the K. ... theme event of “K Warriors” on June 4, 2016 at Ashbury Hotel and Suites ... is sponsored and hosted by Shaolin Institute and sanctioned by KSF (Kungfu Sanda Federation), ...
(Date:5/27/2016)... Columbia, SC (PRWEB) , ... May 27, 2016 , ... ... launched a line of classic American timber frame barn kits, which can be found ... are inspired by historic American barn plans, and they highlight the craftsmanship of ...
(Date:5/27/2016)... ... 2016 , ... With over 60 percent of acute stroke survivors being left ... to aid in the rehabilitation process has steadily increased. Ekso Bionics had been working ... due to stroke. , Ekso Bionics has now received clearance from the U.S. Food ...
(Date:5/27/2016)... Texas (PRWEB) , ... May 27, 2016 , ... ... satisfying Army body fat composition regulations. This is the first time that Coolsculpting ... normally screened at least every six months to ensure they meet the prescribed body-fat ...
(Date:5/27/2016)... ... May 27, 2016 , ... With a team ... and food industries. Aside from its GMP accreditation, Validation Center is also a ... certified products, services and staff. , Validation Center is ISO17025 accredited and only ...
Breaking Medicine News(10 mins):