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1 Indications And Usage Edurant ® , In Combination With Other Antiretroviral Agents, Is Indicated For The Treatment Of Human Immunodeficiency Virus Type 1 (Hiv-1) Infection In Antiretroviral Treatment-Naïve Patients 12 Years Of Age And Older And Weighing At Least 35 Kg With Plasma Hiv-1 Rna Less Than Or Equal To 100,000 Copies/ml At The Start Of Therapy. Edurant Is A Human Immunodeficiency Virus Type 1 (Hiv-1) Specific, Non-Nucleoside Reverse Transcriptase Inhibitor (Nnrti) Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Treatment-Naïve Patients 12 Years Of Age And Older And Weighing At Least 35 Kg With Hiv-1 Rna Less Than Or Equal To 100,000 Copies/ml ( 1 ). Limitations Of Use: More Edurant Treated Subjects With Hiv-1 Rna Greater Than 100,000 Copies/ml At The Start Of Therapy Experienced Virologic Failure (Hiv-1 Rna ≥ 50 Copies/ml) Compared To Edurant Treated Subjects With Hiv-1 Rna Less Than Or Equal To 100,000 Copies/ml. ( 1 , 14 ) Limitations Of Use: More Edurant Treated Subjects With Hiv-1 Rna Greater Than 100,000 Copies/ml At The Start Of Therapy Experienced Virologic Failure (Hiv-1 Rna ≥ 50 Copies/ml) Compared To Edurant Treated Subjects With Hiv-1 Rna Less Than Or Equal To 100,000 Copies/ml [See Clinical Studies (14.1) ] .
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