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New Results From ARTEN Study of Nevirapine Plus Tenofovir and Emtricitabine (TDF/FTC) Versus Boosted Protease Inhibitor Regimen of Atazanavir/Ritonavir Plus TDF/FTC Revealed
Date:7/20/2009

at the ARTEN study met its primary endpoint," said Peter Piliero, M.D., executive director of Medical Affairs, Virology for Boehringer Ingelheim Pharmaceuticals, Inc. "The study also provides additional important data on the effect of VIRAMUNE on patient lipid profiles in antiretroviral naive patients."

Efficacy Data

Of the patients who received nevirapine in the study (n=376), 67 percent achieved the study's primary endpoint of viral load of <50 copies/mL versus 65 percent of ATV/r patients (n=193) [95% CI=0.059 to 0.98, p=0.63] at two consecutive visits prior to week 48 and without subsequent rebound or change of antiretroviral therapy prior to or at week 48.(1) In patients who began study treatment with viral loads above 100,000 copies/mL, 60 percent of nevirapine patients (n=230) and 52 percent (n=115) of ATV/r patients attained viral load of <50 copies/mL. In patients who began study treatment with viral loads below 100,000 copies/mL, 77 percent of nevirapine patients (n=146) and 85 percent of ATV/r patients (n=78) attained viral load of <50 copies/mL.(2) These results include patients who received once-daily nevirapine (400 mg). Nevirapine is not indicated for once-daily dosing. The safety and efficacy of once-daily dosing have not been established.

Lipid Profile Data

The mean increase from baseline in HDL levels was 9.7 mg/dL among nevirapine patients and 3.9 mg/dL among ATV/r patients (p<0.0001). The mean total cholesterol/HDL ratio in patients receiving nevirapine decreased from baseline (-0.24) and increased in patients receiving ATV/r (+0.13) (p =0.0001). The mean triglyceride levels decreased from baseline in the nevirapine group 0.2 mg/dL and increased 28.1 mg/dL in the ATV/r group (p <0.0001). Mean increases in LDL cholesterol were 15 mg/dL in the nevirapine group and 10.5 mg/dL in the ATV/r group (p=0.011).(3) These results include patient
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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