New Results From ARTEN Study of Nevirapine Plus Tenofovir and Emtricitabine (TDF/FTC) Versus Boosted Protease Inhibitor Regimen of Atazanavir/Ritonavir Plus TDF/FT... (s who received once-daily nevirapine (40...)

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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

s 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

Safety/Tolerability Data

In the nevirapine group, the most common adverse event was rash/eruptions/exanthema (16.0 percent). Of the nevirapine-associated rashes that resulted in discontinuation, 76.2 percent (16 of 21) were identified during the two-week lead-in phase. The rate of hepatitis as reported by investigators was 1.6 percent in patients who received once-daily nevirapine, 2.1 percent in patients who received twice-daily nevirapine and 0.0 percent in patients who received ATV/r. Rates of liver enzyme elevations were 5.9 percent in patients who received once-daily nevirapine, 7.4 percent in patients who received twice-daily nevirapine and 1.6 percent in patients who received ATV/r. The rate of serious adverse events seen at 48 weeks in patients was 9.6 percent in the nevirapine group and 8.8 percent in the ATV/r group. Discontinuation due to adverse events was 13.6 percent in the nevirapine arms (51 of 376 patients), and 3.6 percent in the ATV/r arm (7 of 193 patients).(4) 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.

VIRAMUNE Important Safety Information

VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection.

VIRAMUNE does not cure HIV or AIDS, and has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination.

VIRAMUNE can cause severe liver disease and skin reactions that can cause death. These reactions occur most often during the first 18 weeks of treatment, but can occur later. Patients need t
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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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/FT...(s who received once-daily nevirapine (40...),Health