DUBLIN, Ireland, Nov. 18 /PRNewswire-FirstCall/ -- In a 48-week study presented today at the Tenth European AIDS Conference (EACS), 7% of HIV-1- infected patients who switched from a stable, protease inhibitor-based (PI) anti-HIV regimen to a regimen containing the Bristol-Myers Squibb Company once-daily PI REYATAZ(R) (atazanavir sulfate) experienced viral rebound, compared to 16% of patients who continued on their current PI regimen.
“Data such as these expand our understanding of the role REYATAZ may play in anti-HIV regimens,” said Jose Gatell, M.D., Ph.D., of the Hospital Clinic Provincial, Barcelona, Spain, and lead investigator of the SWAN Study.
The SWAN Study (BMS AI424-097) was an open-label, European trial designed to compare the efficacy and safety of switching to a REYATAZ-based regimen versus continuing on an existing, boosted or unboosted stable PI-containing regimen. The study evaluated 419 HIV-1-infected patients who were virologically suppressed (HIV-RNA level of less than 50 copies per milliliter at screening) on stable, PI-based regimens. Existing PI-containing regimens included any of the commercially available PIs, not including REYATAZ.
Patients were randomized in a two-to-one ratio either to change PI(s) to a REYATAZ-based regimen or to continue their current therapy. The primary endpoint of the study was to compare the proportion of patients experiencing viral rebound (defined as two sequential HIV-RNA levels greater than or equal to 50 copies per milliliter) at or prior to 48 weeks. The secondary endpoints examined time to virologic rebound, magnitude of change from baseline CD4+ count through Week 48, frequency and severity of adverse events, discontinuations, and changes from baseline in lipids through Week 48.
To enroll in the study, patients were required to be receiving a PI with or without ritonavir with an HIV viral load of less than 50 copies per milliliter, and to have not experienced previous virologic failure while taking a PI-containing regimen. Patients had an average of 3.4 years of prior PI therapy.
SWAN STUDY KEY SAFETY RESULTS
Rates of discontinuation from the study due to adverse events were 6% in the REYATAZ arm and 6% in the comparator PI arm. Treatment-emergent gastrointestinal adverse events of any grade (diarrhea, nausea, vomiting or abdominal pain) were reported in 13% of patients in the comparator PI arm and 8% of patients in the REYATAZ arm.
Grade 3-4 elevations in total bilirubin were reported in 43% of patients on REYATAZ and in 3% of patients on comparator PIs. The most common adverse events of any grade experienced by patients receiving REYATAZ were scleral icterus (7%) and jaundice (5%). Grade 3-4 jaundice or scleral icterus occurred in 5 cases (2%) of patients receiving REYATAZ. One percent of patients in the REYATAZ arm discontinued due to jaundice or scleral icterus. No cases of jaundice or scleral icterus were reported in the comparator PI group.
The rate of Grade 3-4 ALT elevation was 6% for the comparator PI arm versus 4% for the REYATAZ arm. The rate of Grade 3-4 AST elevation was 3% in both arms of the study.
In addition to the primary endpoint findings, changes from baseline in lipid parameters at Week 48 for patients who switched to a regimen containing REYATAZ vs. the comparator PI regimen were as follows: total cholesterol (-15% vs. -3%), fasting LDL cholesterol (-12% vs. -5%), HDL cholesterol (-1% vs. -3%), and fasting triglycerides (-33% vs. +9%). The clinical impact of these changes in lipids has not been demonstrated. These changes in lipids are likely due to the discontinuation versus the continuation of the patients’ previous PI regimen.
Important Information about REYATAZ(R) (atazanavir sulfate)
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 http://www.REYATAZ.com.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb on the World Wide Web at 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.
Full prescribing information for REYATAZ is available at http://www.bms.com.
Bristol-Myers Squibb Company
CONTACT: Eric Miller of Bristol-Myers Squibb Company, +1-609-252-7981, oreric.miller@bms.com
