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1 Indications And Usage Complera ® Is Indicated As A Complete Regimen For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients Weighing At Least 35 Kg: As Initial Therapy In Those With No Antiretroviral Treatment History With Hiv-1 Rna Less Than Or Equal To 100,000 Copies/ml At The Start Of Therapy Or To Replace A Stable Antiretroviral Regimen In Those Who Are Virologically Suppressed (Hiv-1 Rna Less Than 50 Copies/ml) On A Stable Antiretroviral Regimen For At Least 6 Months With No Treatment Failure And No Known Substitutions Associated With Resistance To The Individual Components Of Complera [See Microbiology (12.4) And Clinical Studies (14) ] . Complera, A Combination Of Two Nucleoside Analog Hiv-1 Reverse Transcriptase Inhibitors (Emtricitabine And Tenofovir Disoproxil Fumarate) And One Non-Nucleoside Reverse Transcriptase Inhibitor (Rilpivirine), Is Indicated For Use As A Complete Regimen For The Treatment Of Hiv-1 Infection In Patients Weighing At Least 35 Kg (1) As Initial Therapy In Those With No Antiretroviral Treatment History And With Hiv-1 Rna Less Than Or Equal To 100,000 Copies/ml At The Start Of Therapy, Or (2) Or To Replace A Stable Antiretroviral Regiment In Those Who Are Virologically Suppressed (Hiv-1 Rna <50 Copies/ml) On A Stable Antiretroviral Regimen For At Least 6 Months With No Treatment Failure And No Known Substitutions Associated With Resistance To The Individual Components Of Complera. ( 1 , 14 ) Limitations Of Use: More Rilpivirine-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 Rilpivirine-Treated Subjects With Hiv-1 Rna Less Than Or Equal To 100,000 Copies/ml. ( 1 , 14 ) Limitations Of Use : More Rilpivirine-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 Rilpivirine-Treated Subjects With Hiv-1 Rna Less Than Or Equal To 100,000 Copies/ml [See Clinical Studies (14) ] .
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