Diagnostics

Head-to-head Trial Demonstrates Viramune®`s Similar Efficacy And Superior Effect On Lipid Profile Compared To Atazanavir/ritonavir

Results from the ARTEN trial presented at the 5th International AIDS Society (IAS) conference in Cape Town, South Africa demonstrated non-inferiority regarding efficacy between Viramune® (nevirapine) and ritonavir boosted atazanavir (atazanavir/r) both combined with tenofovir and emtricitabine (Truvada ®). This head-to-head study also showed Viramune®Вґs more favourable effect on the lipid profile and now clearly confirms the combination"s place as an important first line therapy for patients with HIV. "ARTEN puts to rest the concerns over a potential lack of efficacy of Viramune® in combination with Truvada®," lead investigator of the ARTEN study, Prof. Vicente Soriano, Assistant Director of the Department of Infectious Diseases, Hospital Carlos III, Madrid said. "The results confirm that the combination of Viramune® and Truvada® is a highly efficacious combination that offers significant benefit even more so to patients with cardiovascular risk." ARTEN is the first large-scale prospective study to compare two frequently prescribed lipid friendly, antiretrovirals(ARVs): atazanavir and Viramune®.1,2 Compared to values at baseline. Viramune® increased absolute HDL-c (the so called good cholesterol) to more than twofold the value achieved with atazanavir/r (9.7 mg/dL vs 3.9 mg/dL (PAbout ARTEN ARTEN is an international, open label, randomized, non-inferiority (12% margin) study comparing ATZ/r 300mg/100mg QD vs. NVP 200mg BID or 400mg QD, each combined with fixed-dose TDF 300mg/FTC 200mg QD. Treatment-naГЇve men and women with CD4 counts 100,000 copies/mL); mean CD4 count was 183 cells/mm3. About Viramune® Viramune® is a product of original research done at Boehringer Ingelheim. Viramune® was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. Viramune® is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and several smaller supportive studies. Studies have also shown that patients switching to Viramune® from a PI-based regimen demonstrate an improved lipid profile while maintaining viral suppression. The most clinically important adverse events associated with Viramune® are rash and hepatic events, which have included fatal cases. Any patient can experience hepatic events; however, female gender and higher CD4+ cell counts at initiation of therapy place patients at greater risk. Women with CD4+ cell counts >250 cells/mm3 are at the greatest risk. Viramune® should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk. The greatest risk of severe rash and hepatic events occurs in the first six weeks of therapy. It is essential that patients be monitored for these reactions at all times, and intensively during the first few months of therapy. Viramune® should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions. About Boehringer Ingelheim The Boehringer Ingelheim group is one of the world"s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. Atazanavir/Ritonavir on a background of Tenofovir and Emtricitabine (Truvada® a trademark of Gilead Sciences, Inc.) versus Nevirapine About Viramune® Viramune® is a product of original research done at Boehringer Ingelheim. Viramune® was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. Viramune® is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and several smaller supportive studies. Studies have also shown that patients switching to Viramune® from a PI-based regimen demonstrate an improved lipid profile while maintaining viral suppression. The most clinically important adverse events associated with Viramune® are rash and hepatic events, which have included fatal cases. Any patient can experience hepatic events; however, female gender and higher CD4+ cell counts at initiation of therapy place patients at greater risk. Women with CD4+ cell counts >250 cells/mm3 are at the greatest risk. Viramune® should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk. The greatest risk of severe rash and hepatic events occurs in the first six weeks of therapy. It is essential that patients be monitored for these reactions at all times, and intensively during the first few months of therapy. Viramune® should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions. About Boehringer Ingelheim The Boehringer Ingelheim group is one of the world"s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. Atazanavir/Ritonavir on a background of Tenofovir and Emtricitabine (Truvada® a trademark of Gilead Sciences, Inc.) versus Nevirapine References: 1 Martinez, E., et al., Substitution of nevirapine, efavirenz, or abacavir for protease inhibitors in patients with human immunodeficiency virus infection. N Engl J Med, 2003. 349(11): p. 1036-46. 2 Friis-Moller, N., et al., Cardiovascular disease risk factors in HIV patients association with antiretroviral therapy. Results from the DAD study. Aids, 2003. 17(8): p. 1179-93. 3 Soriano, V et al., Prospective comparison of Nevirapine and Atazanavir/ritonavir both combined with Tenofovir DF/Emtricitabine in treatment-naГЇve HIV-1 infected patients: ARTEN Study week 48 results 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009), July 19 -22, 2009, Poster LBPEB07 4 UNAIDS 2008 Report 5 Worldwide HIV & AIDS Statistics Commentary 6 Lohse N, Hansen AB, Pedersen G, Kronborg G, Gerstoft J, SГсrensen HT, Vaeth M, Obel N. Survival of persons with and without HIV infection in Denmark, 1995 - 2005. Ann Intern Med. 2007;146:87 - 95. 7 DAD Study Group, Friis-MГсller N, Reiss P, et al., Class of antiretroviral drugs and the risk of myocardial infarction, N Engl J Med, 2007;356(17):1723 - 35. Boehringer Ingelheim

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