|
1 Indications And Usage Odefsey Is Indicated As A Complete Regimen For The Treatment Of Hiv-1 Infection In Adult 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 Per Ml Or To Replace A Stable Antiretroviral Regimen In Those Who Are Virologically-Suppressed (Hiv-1 Rna Less Than 50 Copies Per Ml) For At Least 6 Months With No History Of Treatment Failure And No Known Substitutions Associated With Resistance To The Individual Components Of Odefsey [See Microbiology (12.4) And Clinical Studies (14) ]. Odefsey Is A Three-Drug Combination Of Emtricitabine (Ftc) And Tenofovir Alafenamide (Taf), Both Hiv Nucleoside Analog Reverse Transcriptase Inhibitors (Nrtis), And Rilpivirine (Rpv), A Non-Nucleoside Reverse Transcriptase Inhibitor (Nnrti), And Is Indicated As A Complete Regimen For The Treatment Of Hiv-1 Infection In Patients Weighing At Least 35kg As Initial Therapy In Those With No Antiretroviral Treatment History With Hiv-1 Rna Less Than Or Equal To 100,000 Copies Per Ml; Or To Replace A Stable Antiretroviral Regimen In Those Who Are Virologically-Suppressed (Hiv-1 Rna Less Than 50 Copies Per Ml) For At Least 6 Months With No History Of Treatment Failure And No Known Substitutions Associated With Resistance To The Individual Components Of Odefsey. ( 1 ) 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. ( 14.2 , 14.3 ) Limitations Of Use : More Rilpivirine-Treated Subjects With No Antiretroviral Treatment History 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 (14.2 , 14.3) ].
|