�Bristol-Myers Squibb Company (NYSE: BMY) announced results from a pre-specified subanalysis of the CASTLE study, in which once-daily boosted REYATAZ� (atazanavir sulfate) (REYATAZ three hundred mg taken with C 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 encumbrance at 48 weeks careless of sex 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 per centum 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 at that place are few data to guide deciding about choice of therapy and dosing by grammatical gender.ii
CASTLE is the first large-scale, open-label, randomised study designed to show the non-inferiority of REYATAZ/r to lopinavir/r in previously untreated HIV-1 infected adult patients. The CASTLE sexuality subanalysis was conducted to determine the effect of both cogitation regimens on women and men. The CASTLE written report enrolled 277 women and 606 work force 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 identical important for women to be involved in clinical research so we tin better translate 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 work, 78 percent of the 440 patients in the REYATAZ� (atazanavir sulfate)/r arm and 76 percent of the 443 patients in the lopinavir/r weapon system met the non-inferiority chief endpoint of achieving insensible 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 weapon system and 73 percent of the 139 female patients in the lopinavir/r sleeve achieved undetectable viral lode at 48 weeks. In male patients, 79 per centum 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+ cellular telephone 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 person 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 twenty-four treatment-related inauspicious events were reported by 30 per centum in the REYATAZ/r subdivision and 32 percent in the lopinavir/r arm. In male patients, Grade 24 treatment-related adverse events were reported by 24 percentage 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 one C and 40 patients were randomized to receive REYATAZ 300 mg and ritonavir 100 mg once day-after-day and 443 patients were randomized to receive co-formulated lopinavir cd mg and ritonavir hundred mg twice daily, each in compounding with a once-daily, fixed-dose combination of emtricitabine cc mg/tenofovir disoproxil fumarate ccc mg. Patients were required to give a baseline viral load (HIV-1 RNA) of greater than or equal to 5,000 copies/mL; there was no CD4+ cell count limitation for written report entry. The primary end point for the study was the symmetry of patients who achieved undetectable viral load (HIV-1 RNA of less than 50 copies/mL) at 48 weeks.
Important Information About REYATAZ� (atazanavir sulfate) Capsules
REYATAZ� (atazanavir sulphate) 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 secondhand 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 world Health Organization have interpreted or take never taken anti-HIV medicines.
REYATAZ does not cure HIV or help keep passing HIV to others.
REYATAZ should non be taken with the following medicines ergot medicines, Versed (midazolam), Halcion(triazolam), Orap(pimozide), Propulsid(cisapride), Camptosar(irinotecan), Crixivan(indinavir), Mevacor(lovastatin), Zocor(simvastatin), rifampin, or St. John?s wort (Hypericum perforatum).
People taking REYATAZ should address with their healthcare provider before taking the following medicines: Viagra(sildenafil), Levitra(vardenafil), Cialis(tadalafil), Vfend(voriconazole), AcipHex(rabeprazole), Nexium(esomeprazole), Prevacid(lansoprazole), Prilosec(omeprazole), Protonix(pantoprazole), Axid(nizatidine), Pepcid AC(famotidine), Tagamet(cimetidine), or Zantac(ranitidine), Advair(fluticasone propionate and salmeterol inhalation pulverisation), Flonase(fluticasone propionate), or Flovent(fluticasone propionate). The above lists of medicines are non complete. The use of all prescriptions and nonprescription medicines, vitamins, herbal supplements, or other health preparations should be discussed with a health care provider.
The following side effects or conditions should be reported to a healthcare supplier right off:
-- A change in the way the essence 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 ofttimes in the first few weeks later the medicine is started, and commonly goes away within deuce weeks with no change in handling.
-- Severe rash has occurred in a small number of patients taking REYATAZ. This type of roseola is associated with other symptoms which could be serious and potentially suit death. If rash develops with whatsoever of the following symptoms, the patient should stop using REYATAZ and call a health care provider correct away:
- Shortness of breath
- General ill-feeling or �flu-like? symptoms
- Fever
- Muscle or joint aches
- Conjunctivitis (red or inflamed eyes, like "pinkeye")
- Blisters
- Mouth sores
- Swelling of the face
-- Yellowing of the pelt and/or eyes english hawthorn occur ascribable 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 commence worse when taking anti-HIV medicines like REYATAZ.
-- Kidney stones hold 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 proteolytic enzyme inhibitor medicines like REYATAZ� (atazanavir sulphate).
-- Some patients with hemophilia have increased bleeding problems with peptidase inhibitor medicines like REYATAZ.
-- Changes in body fat have been seen in some patients taking anti-HIV medicines. The cause and long-term personal effects are not known at this time.
Other side effects of REYATAZ taken with other anti-HIV medicines include: nausea, vexation, stomach pain in the neck, vomiting, diarrhea, depression, febricity, dizziness, fuss sleeping, numbness, and ingling or burning of hands or feet.
REYATAZ and other anti-HIV medicines should be taken just as instructed by healthcare providers. Please see resultant Full Prescribing Information, or visit hypertext transfer protocol://www.reyataz.com or http://www.BMS.com.
REYATAZ� is a registered hallmark of Bristol-Myers Squibb Company. The other brands listed are registered trademarks of their respective owners and are non trademarks of Bristol-Myers Squibb Company.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to hold out and enhance human life. For more information visit http://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.
