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GlaxoSmithKline and Vertex Pharmaceuticals Announce Preliminary 48-Week Results from Head-to-Head Clinical Study of HIV Protease Inhibitors Lexiva (Telzir) and Kaletra in Treatment-naive Patients with HIV
GlaxoSmithKline and Vertex Pharmaceuticals Announce Preliminary 48-Week Results from Head-to-Head Clinical Study of HIV Protease Inhibitors Lexiva (Telzir) and Kaletra in Treatment-naive Patients with HIV.
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[{"type":"text","content":"\n\n\n\n\nRESEARCH TRIANGLE PARK, N.C., May 16 /CNW/ -- CAMBRIDGE,\nMass. -- GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated\n(Nasdaq: VRTX) today announced preliminary 48-week results from a head-to-head\nclinical study that indicated that Lexiva (Telzir; fosamprenavir calcium) 700\nmg plus ritonavir 100 mg given twice daily was comparable (non-inferior) to\nKaletra (lopinavir/ritonavir fixed-dose combination) given twice daily in\ntreatment-naive HIV patients. All patients in the study also received a\nonce-daily fixed-dose combination of abacavir 600 mg and lamivudine 300 mg as\nthe backbone of antiretroviral therapy.\nIn the study, which enrolled 887 patients, 73 percent of patients\nreceiving Lexiva/ritonavir maintained suppression of viral replication (less\nthan 400 copies/mL plasma HIV RNA) after 48 weeks of dosing, compared with 71\npercent of patients receiving Kaletra (Intent-to-Treat Analysis). The results\nwill be submitted to the FDA and other health regulatory authorities when the\nfinal analysis is concluded.\nLexiva/ritonavir was compared to Kaletra in this study due to Kaletra's\nposition as the preferred HIV protease inhibitor in HIV treatment guidelines\ndeveloped by the United States Department of Health and Human Services (DHHS)\nand the International AIDS Society (IAS). Based on these results from this\nstudy, researchers have concluded that Lexiva appears to be comparable to\nKaletra and has met the primary endpoints of this non-inferiority trial.\nGSK will present results from the study at a medical conference in 2006.\nLexiva was co-discovered by Vertex and GlaxoSmithKline.\n\nEAN Study Design and Results\nThe results announced today are from the KLEAN study, a randomized,\nopen-label study of the safety and efficacy of Lexiva, dosed as 700 mg twice\ndaily, in combination with 100 mg ritonavir twice daily, versus Kaletra, dosed\nas 400 mg in a fixed-dose combination with 100 mg ritonavir twice-daily, in\n887 treatment-naive HIV infected adults for 48 weeks. All patients in the\nstudy received concomitant treatment with a once-daily fixed-dose combination\nof 600 mg abacavir and 300 mg lamivudine.\nPreliminary results indicated that 73 percent of patients receiving Lexiva\nplus ritonavir in combination therapy maintained suppression of viral\nreplication (less than 400 copies/mL plasma HIV ...