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| |  Data From Cohort Study Showed Better Virologic Response in Regimens Containing SUSTIVA(R) Compared to Viramune(R)-Containing Regimens in HIV Treatment-Naive Patients PRINCETON, N.J. -- August 12, 2002 --Data from a large observational cohort study published in the July/August issue of HIV Clinical Trials showed that anti-HIV combination treatment regimens containing SUSTIVA® (efavirenz) had a better virologic response than regimens containing Viramune® (nevirapine) in HIV treatment-naive patients. The results are consistent with findings from two other large cohort analyses comparing regimens including SUSTIVA or Viramune (EuroSIDA, Phillips, 8th CROI, 2001; Matthews, BHIVA, 2001). "A cohort comparison of treatment-naive patients who were treated with a regimen containing either SUSTIVA or Viramune showed that patients treated with SUSTIVA had a longer time to treatment failure, had a more pronounced decrease in plasma HIV-1 RNA, and were more likely to have HIV-1 RNA below the levels of detection," said Philip Keiser, M.D., Associate Professor of Medicine, University of Texas Southwestern Medical Center, and Medical Director, Parkland HIV Services Department. "These results, coupled with other cohort analyses looking at this same comparison, provide support to physicians and patients to consider using a combination regimen with SUSTIVA." The results were from a 1,078 patient cohort analysis (555 patients on combination therapy including SUSTIVA; 523 patients on nevirapine combination therapy). The data showed that for the primary analysis of time to treatment failure, patients in the nevirapine arm failed more rapidly (303 days) compared to patients in the arm containing SUSTIVA (589 days). This difference was statistically significant (p-value less than 0.001). There was also a greater log decrease in plasma HIV-1 RNA in the patients receiving a regimen containing SUSTIVA (-1.32 log) compared to patients receiving nevirapine-containing regimens (-0.51 log). This difference was also statistically significant (p-value less than 0.001) and was maintained over the two-year observation period. Additionally, 51 percent of patients on combination therapy containing SUSTIVA maintained a viral load of less than 400 copies/mL following one year of therapy versus 45 percent of patients on nevirapine-containing therapy. Data was taken from three large HIV treatment centers -- Parkland Health and Hospital System HIV/AIDS Department (Dallas, Texas), Harris County Hospital District HIV Clinic (Houston, Texas), and the Center for AIDS Research, Education and Services (CARES; Sacramento, Calif.). The combined database represents over 10,000 individuals. Each center has an electronic database where data are prospectively collected and stored. Data elements include demographics, HIV risk, start and stop dates of antiretroviral therapy, prescription records, CD4 cell counts and viral load measurements. Criteria for inclusion in the cohort were all HIV-1 infected individuals treated with two nucleoside reverse transcriptase inhibitors (NRTIs) and either SUSTIVA or nevirapine from 1996 through 2000. Additionally, each participant must have had a follow-up HIV-1 RNA and CD4 counts performed at least every three months. Because patients were not randomized to either SUSTIVA or Viramune, the potential for treatment bias cannot be ruled out. The study's primary endpoint was time to treatment failure as determined by two consecutive HIV-1 plasma RNA levels greater than 400 copies/mL in participants who previously had undetectable plasma HIV-1 RNA or the failure to achieve plasma HIV-1 RNA less than 400 copies/mL. Other endpoints included change in plasma HIV-1 RNA from baseline and percent of patients with a viral load less than 400 copies/mL over time. Change in CD4 cell count from baseline was also determined. SUSTIVA is a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination therapy for the treatment of HIV. In February, the FDA approved a new formulation of SUSTIVA -- a 600 mg tablet once-daily, an option to three 200 mg capsules once-daily (as SUSTIVA has been used since it was approved in September 1998). In February 2002, the U.S. Department of Health and Human Services (DHHS) continued, for the third year in a row, to list SUSTIVA as the only non- nucleoside reverse transcriptase inhibitor "strongly recommended" for use in first-line combination with NRTIs for the treatment of HIV-infected individuals. It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime. Many patients have dizziness, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams when taking SUSTIVA. These feelings tend to go away after taking SUSTIVA for a few weeks. A small number of patients taking SUSTIVA have reported severe depression, strange thoughts, or angry behavior. There have been occasional reports of suicide but SUSTIVA has not been established as the cause. One of the most common side effects is rash which is usually mild and goes away in a few weeks. SUSTIVA should not be taken with Hismanal® (astemizole), Propulsid® (cisapride), Versed® (midazolam), Halcion® (triazolam) or ergot derivatives. Tell your doctor about any medication or herbal products (particularly St. John's wort) that you are taking. Women should not become pregnant or breastfeed while taking SUSTIVA. SUSTIVA does not cure HIV or prevent passing HIV to others. Bristol-Myers Squibb Company (NYSE: BMY - News) is a $19 billion pharmaceutical and related health care products company whose mission is to extend and enhance human life. For full SUSTIVA prescribing information, please visit the company's website at www.BMSVirology.com or call 1-800-426-7644. SUSTIVA® is a registered trademark of Bristol-Myers Squibb Pharma Company. The other brands listed are the registered trademarks of their respective owners and are not the trademarks of Bristol-Myers Squibb Company. For more information, contact: David M. Rosen of Bristol-Myers Squibb Company, 609-897-4763, pager, 800-759-8888, PIN 1144801#, david.m.rosen@bms.com ; or Carrie Sessine of Golin/Harris International, 312-729-4152, csessine@golinharris.com .
SOURCE: Bristol-Myers Squibb Company
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