U.S. Food & Drug Administration Approved the use of REYATAZ(R) ...

Tag : Health Food
U.S. Food & Drug Administration Approved the use of REYATAZ(R)(atazanavir sulfate) Boosted with Ritonavir, in CombinationTherapy, for Previously Untreated HIV-1 Infected Adult Patients

10.01.08, 6:06 PM ET

PRINCETON, N.J., October 01, 2008. Bristol-Myers Squibb Companyannounced today that the U.S. Food & Drug Administration (FDA)approved the use of REYATAZ(R) (atazanavir sulfate) 300 mgonce-daily boosted with ritonavir 100 mg as part of combinationtherapy in previously untreated (treatment-naive) HIV-1 infectedpatients. REYATAZ boosted with ritonavir (REYATAZ/r) taken oncedaily with food is recognized by the U.S. Department of Health andHuman Services (DHHS) as a preferred component of combination HIVtherapy for treatment-naive patients(1).

For treatment-naive patients who are unable to tolerate ritonavir,REYATAZ 400 mg (without ritonavir), taken once daily with food, isrecommended.

This use of once-daily REYATAZ/r in HIV-1 infected treatment-naiveadult patients is based on 48-week results from the CASTLE study,which demonstrated similar antiviral efficacy of REYATAZ/r totwice-daily lopinavir/ritonavir (lopinavir/r), each as part of HIVcombination therapy, in treatment-naive HIV-1 infected adultpatients.

Within the CASTLE study, the REYATAZ/r arm was associated with lowincreases from baseline in total cholesterol (13 percent), LDLcholesterol (14 percent), HDL cholesterol (29 percent), andtriglycerides (15 percent). The lopinavir/r arm was associated with25 percent increase in total cholesterol, 19 percent increase inLDL cholesterol, 37 percent increase in HDL cholesterol, and 52percent increase in triglycerides. Two percent of patients in theREYATAZ(R) (atazanavir sulfate)/r arm and eight percent of patientsin the lopinavir/r arm required lipid-lowering therapy in thestudy, compared to 1 percent in each arm at baseline.

Safety events in this study were consistent with prior experience.Grade 2-4 treatment-related adverse events that occurred in twopercent or greater of patients in the CASTLE study includedjaundice (4 percent and zero percent), nausea (4 percent and 8percent), diarrhea (2 percent and 11 percent) and rash (3 percentand 2 percent) in the REYATAZ/r and lopinavir/r arms, respectively.Grade 3-4 increases in total bilirubin were seen in 34 percent ofpatients in the REYATAZ/r arm and in less than 1 percent ofpatients in the lopinavir/r arm.

"Bristol-Myers Squibb is committed to developing medicines thatenhance the care of people living with HIV and AIDS," said ElliottSigal, M.D., Ph.D., Executive Vice President, Chief ScientificOfficer and President, Research and Development, Bristol-MyersSquibb. "Boosted REYATAZ provides health care professionals a newlyapproved, once-daily dosing option as part of combination therapyfor patients naive to HIV therapy."

About the CASTLE Study

The CASTLE study is the first large-scale (n=883), open-label,randomized study designed to demonstrate the non-inferiority ofREYATAZ/r to lopinavir/r in treatment-naive HIV-1 infected adultpatients. Forty-eight week data from the study were presentedearlier this year at the 15th Conference on Retroviruses andOpportunistic Infections (CROI) in Boston, Mass., and previouslyannounced in a press release on February 6, 2008. Data from theCASTLE study were also published in the August 23 issue of TheLancet.

Important Information About REYATAZ(R) (atazanavir sulfate) 200 mg,300 mg Capsules

REYATAZ is a prescription medicine used in combination with othermedicines to treat people who are infected with the humanimmunodeficiency virus (HIV). REYATAZ has been studied in 48-weektrials in both patients who have taken or have never taken anti-HIVmedicines.

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

REYATAZ should not be taken by patients allergic to REYATAZ or toany of its ingredients.

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

Patients taking REYATAZ should speak with their healthcare providerbefore taking the following medicines : hormonal contraceptives such as birth control pills orcontraceptive patch, 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) or Flovent(R) (fluticasone propionate), or Sustiva(R)(efavirenz).

The above lists of medicines are not complete. The use of allprescription and non-prescription medicines, vitamins, herbalsupplements, or other health preparations should be discussed witha healthcare provider .

Any side effects, symptoms, or conditions, including the following,should be reported to a healthcare provider right away:

-- Mild rash (redness and itching) without other symptoms sometimes occurs inpatients taking REYATAZ(R) (atazanavir sulfate), most often in thefirst few weeks after the medicine is started, and usually goesaway within two weeks with no change in treatment.

-- Severe rash has occurred in a small number of patients taking REYATAZ. Thistype of rash is associated with other symptoms which could beserious and potentially cause death. If rash develops with any of the following symptoms, the patient should stop using REYATAZ and call a healthcareprovider 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 inbilirubin levels in the blood (bilirubin is made by the liver).
-- A change in the way the heart beats may occur and could be asymptom of a heart problem.
-- Diabetes and high blood sugar may occur in patients takingprotease inhibitor medicines like REYATAZ(R) (atazanavir sulfate).
-- In patients with liver disease, including hepatitis B or C, theliver disease may get worse when taking anti-HIV medicines likeREYATAZ.
-- Kidney stones have been reported in patients taking REYATAZ.Signs or symptoms of kidney stones include pain in the side, bloodin the urine, and pain when urinating.
-- End stage kidney disease managed with hemodialysis.
-- Some patients with hemophilia have increased bleeding problemswith protease inhibitor medicines like REYATAZ.
-- Changes in body fat have been seen in some patients takinganti-HIV medicines. The cause and long-term effects are not knownat this time.

Other side effects of REYATAZ(R) (atazanavir sulfate) taken withother 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 should be taken once daily with food (a meal or snack).REYATAZ and other anti-HIV medicines should be taken exactly asinstructed by healthcare providers.

Please see accompanying Full Prescribing Information, or visithttp://www.reyataz.com or http://www.BMS.com.

REYATAZ is a registered trademark of Bristol-Myers Squibb Company.SUSTIVA is a registered trademark of Bristol-Myers Squibb PharmaCompany. All other trademarks are the property of their respectiveowners and not of Bristol-Myers Squibb.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whosemission is to extend and enhance human life. For more informationvisit www.bms.com.

(1) Panel on Antiretroviral Guidelines for Adults and Adolescents.Guidelines for the use of antiretroviral agents in HIV-1-infectedadults and adolescents. Department of Health and Human Services.January 29, 2008; 1-128. Available athttp://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf.Accessed September 25, 2008.