Bristol-Myers Squibb Company Release: New 48 Week Clinical Trial Data Reported Comparing REYATAZ(R) (Atazanavir Sulfate), With Or Without Ritonavir, in Treatment-Naive Patients
DENVER, Feb. 9 /PRNewswire/ -- Data presented during the Thirteenth Conference on Retroviruses and Opportunistic Infections (CROI) provided results on the virologic and immunologic response and the safety profile of the once-daily protease inhibitor REYATAZ(R) (atazanavir sulfate), both with or without low-dose ritonavir, as part of combination therapy. The clinical trial studied HIV-infected patients who had not received previous antiretroviral treatment (treatment-naive). Results of an Intent-to-Treat analysis demonstrated that 86% of patients in the REYATAZ/ritonavir arm and 85% of patients in the REYATAZ arm responded to treatment with HIV-RNA levels declining to less than 400 copies per milliliter through 48 weeks, the primary efficacy endpoint. Results from this study are the first comparative data presented by Bristol-Myers Squibb Company regarding the use of REYATAZ with ritonavir in this patient population.
About The Study
Study BMS089 is a 96-week, randomized, prospective, open-label, multicenter study. Ninety-five patients were randomized to the REYATAZ 300 mg/ritonavir 100 mg treatment group, and 105 patients to the REYATAZ 400 mg treatment group (the approved dose for this patient population), each combined with lamivudine (3TC) and the investigational compound stavudine extended release as a once-daily regimen. Study entry criteria included patients who were naive to antiretroviral treatment and had plasma HIV-RNA levels of greater than or equal to 2000 copies per milliliter at the time of screening. There were no CD4+ cell count entry restrictions. Randomization was stratified by HIV-RNA levels greater than or equal to or less than 100,000 copies per milliliter at screening.
The primary efficacy endpoint was the proportion of patients who achieved HIV-RNA levels of less than 400 copies per milliliter through week 48. Secondary efficacy analyses examined the proportion of patients who responded to treatment with HIV-RNA levels of less than 50 copies per milliliter through week 48, CD4+ count changes from baseline through week 48, and safety parameters.
The proportions of patients with HIV-RNA levels of less than 50 copies per milliliter were 75% in the REYATAZ/ritonavir treatment group and 70% in the REYATAZ treatment group. CD4+ cell improvements were observed in both arms (mean changes of +189 and +224 cells per cubic millimeter at week 48 in the REYATAZ/ritonavir and REYATAZ arms, respectively).
Adverse events leading to discontinuations were 8% in the REYATAZ/ritonavir arm and less than 1% in the REYATAZ arm. Serious adverse events occurred in 15% of the patients in the REYATAZ/ritonavir arm and 16% of the patients in the REYATAZ arm. Grade 2-4 treatment-related adverse events were reported in 43% of patients in the REYATAZ/ritonavir arm and 34% of the patients in the REYATAZ arm with the following being reported in greater than or equal to 3% of patients in either of the arms, respectively: hyperbilirubinemia reported as a clinical adverse event (13% vs. 5%), headache (2% vs. 4%), rash (2% vs. 4%), and jaundice (3% vs. less than 1%). Selected Grade 3-4 laboratory abnormalities occurred in the REYATAZ/ritonavir and REYATAZ arms, respectively, as follows: total bilirubin elevation (59% vs. 20%), alanine aminotransaminase elevation (6% vs. 3%), aspartate aminotransferase elevation (3% in both arms), total cholesterol elevation (1% vs. less than 1%), triglyceride elevation (2% vs. less than 1%), and hyperglycemia (1% vs. less than 1%).
At week 48, mean changes in lipid parameters from baseline for patients in the REYATAZ/ritonavir arm versus the REYATAZ arm were as follows, respectively: total cholesterol (15% vs. 6%), fasting LDL cholesterol (23% vs. 16%), HDL cholesterol (30% vs. 29%), and fasting triglycerides (26% vs. -3%).
The primary analysis was based on the data available 48 weeks after the last patient was randomized. A final analysis will be conducted 96 weeks after the last patient is randomized to assess long-term safety and virologic response.
Note to editors/reporters: CROI webcasts oral sessions and makes abstracts and posters available online at www.retroconference.org.
Indication and Important Safety Information about REYATAZ(R) (atazanavir sulfate) Capsules
REYATAZ is a prescription medicine used in combination with other medicines to treat people who are infected with HIV and 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 prevent passing HIV to others.
REYATAZ should not be taken with the following medicines: ergot medicines, Versed(R), Halcion(R), Orap(R), Propulsid(R), Camptosar(R), Crixivan(R), Mevacor(R), Zocor(R), rifampin, St. John's wort, AcipHex(R), Nexium(R), Prevacid(R), Prilosec(R) or Protonix(R), Viagra(R), Levitra(R), Cialis(R), Vfend(R), Advair(R), Flonase(R), or Flovent(R) should not be used while taking REYATAZ without first speaking with a healthcare provider. This list of medicines is not complete. The use of all prescription and non-prescription medicines, vitamin and herbal supplements, or other health preparations should be discussed with a healthcare provider.
The following side effects or conditions should be reported to healthcare providers 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; and 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 should be taken once daily with food (a meal or snack). 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 www.REYATAZ.com.
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