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| |  ECCATH: Atazanavir Demonstrates Antiviral Efficacy, Favorable Lipid Profile ATHENS, GREECE -- October 29, 2001 -- Data shows that a regimen containing the novel and potent investigational protease inhibitor, atazanavir, given once daily as part of a highly active antiretroviral therapy (HAART) regimen is associated with significantly lower concentrations in total cholesterol, fasting low-density lipoprotein (LDL) cholesterol and fasting triglycerides than a comparator regimen containing nelfinavir. This benefit was maintained in patients who were followed for 48 weeks. The study was presented here today at the 8th European Conference on Clinical Aspects and Treatment of HIV Infection (ECCATH). "Generally, in regimens that include a protease inhibitor, we see a rapid, marked, and sustained increase in lipid levels. This does not happen with atazanavir, even at 48 weeks," said Prof. Giuseppe Pantaleo, Department of Medicine, Hospital de Beaumont, Lausanne, Switzerland. "We know from our experience in non-HIV populations, that controlling lipid levels can have an important cardiovascular benefit." Analysis of 48-week data from a randomized study, (BMS AI424-008) including 467 patients, compared the efficacy of atazanavir versus nelfinavir in combination with stavudine (Zerit®, d4T) and lamivudine (3TC) in the treatment of antiretroviral-naive HIV-infected patients. Patients were randomized to receive blinded 400 mg or 600 mg of atazanavir once daily (n = 181 and n=195, respectively) or open-label nelfinavir at 1,250 mg twice daily (n = 91) in combination with stavudine and lamivudine. At 48 weeks, the atazanavir regimen was safe and well tolerated in both treatment arms. Atazanavir taken once daily displayed antiviral efficacy similar to nelfinavir given twice daily. In patients who completed the treatment through 48 weeks, the proportion of responders with HIV RNA < 400 c/mL was 74 percent for atazanavir 400 mg versus 60 percent for nelfinavir, which demonstrated the superiority of atazanavir 400 mg relative to nelfinavir. The HIV virus was suppressed rapidly and durably (~2.5 log10 HIV-1 RNA copies/mL). Immune reconstitution as measured by the CD4 cell counts showed an increase of ~240 cells/mm3. In addition, patients treated with atazanavir had superior lipid profiles as assessed by the mean percent changes in total cholesterol, fasting LDL cholesterol and fasting triglycerides from baseline at 48 weeks. Clinically insignificant changes in total cholesterol were observed in atazanavir (5 percent in the 400 mg arm, 6 percent in the 600 mg arm) compared to the nelfinavir arm (25 percent). Fasting LDL cholesterol changes from baseline were minimal in atazanavir (5 percent in the 400 mg atazanavir arm and 7 percent in the 600 mg atazanavir arm) versus 23 percent in the nelfinavir arm. Marked differences were also seen in fasting triglyceride changes from baseline for nelfinavir-treated subjects (50 percent) versus those for atazanavir (7 percent in the 400 mg arm, 8 percent rise in the 600 mg arm). Increases in total cholesterol, LDL cholesterol and triglycerides over baseline were significantly higher in the nelfinavir arm compared to the atazanavir arms. "With increasing frequency, physicians who treat people with HIV are confronted with patients with significant lipid disorders," said Prof. Pantaleo. "Atazanavir may offer an important new treatment option for people with HIV by helping to prevent cardiovascular related complications in treatment-naive patients. In addition, once daily atazanavir could be a benefit in patient adherence and may prove a versatile option for future simplified regimens." Adverse events seen most frequently included infection and headache, with similar number of incidences in the atazanavir and nelfinavir arms. The nelfinavir arm had a higher incidence of diarrhea (56 percent) compared to the atazanavir 400 mg (20 percent) and 600 mg arms (15 percent). Hyperbilirubinemia was reported as a serious adverse event in <1 percent of patients treated with atazanavir. SOURCE: Bristol-Myers Squibb Company Related Link: Bristol-Myers Squibb Company.
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