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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

o ask their HCP about how to recognize symptoms of skin and liver problems. VIRAMUNE should be discontinued and not restarted in patients who have any of these reactions.

Any patient can experience liver problems with VIRAMUNE, but women and patients who have higher CD4+ counts when they begin VIRAMUNE treatment have a greater risk. A woman with CD4+ >250 cells/mm3, or a man with CD4+ >400 cells/mm3 should not begin taking VIRAMUNE unless they and their HCP have decided that the benefit of doing so outweighs the risk. Women, including pregnant women, with CD4+ cell counts >250 cells/mm3 are at the greatest risk.

Do not take VIRAMUNE if you have severe liver problems.

The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days, followed by one 200-mg tablet twice daily. VIRAMUNE is always taken with other anti-HIV medications. The 14-day lead-in period is important because it can help reduce your chances of getting a potentially serious skin rash. Patients who have a skin rash during the first 14 days should immediately contact their HCP and not increase their VIRAMUNE dose to twice a day. The total duration of the once-daily lead-in dosing period should not exceed 28 days, at which point an alternative regimen may need to be started.

Other side effects that patients have experienced include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Changes in body fat may occur in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.

Please see full Prescribing Information, including boxed WARNING, for VIRAMUNE at www.VIRAMUNE.com.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingel
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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