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1 Indications And Usage Hiv-1 Treatment ( 1.1 ): Descovy Is A Two-Drug Combination Of Emtricitabine (ftc) And Tenofovir Alafenamide (taf), Both Hiv Nucleoside Analog Reverse Transcriptase Inhibitors (nrtis), And Is Indicated: In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients Weighing At Least 35 Kg. In Combination With Other Antiretroviral Agents Other Than Protease Inhibitors That Require A Cyp3a Inhibitor For The Treatment Of Hiv-1 Infection In Pediatric Patients Weighing At Least 25 Kg And Less Than 35 Kg. Hiv-1 Prep ( 1.2 ): Descovy Is Indicated In At-Risk Adults And Adolescents Weighing At Least 35 Kg For Pre-Exposure Prophylaxis (prep) To Reduce The Risk Of Hiv-1 Infection From Sexual Acquisition, Excluding Individuals At Risk From Receptive Vaginal Sex. Individuals Must Have A Negative Hiv-1 Test Immediately Prior To Initiating Descovy For Hiv-1 Prep. Limitations Of Use ( 1.2 ): The Indication Does Not Include Use Of Descovy In Individuals At Risk Of Hiv-1 From Receptive Vaginal Sex Because Effectiveness In This Population Has Not Been Evaluated. 1.1 Treatment Of Hiv-1 Infection Descovy Is Indicated, In Combination With Other Antiretroviral Agents, For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients Weighing At Least 35 Kg. Descovy Is Indicated, In Combination With Other Antiretroviral Agents Other Than Protease Inhibitors That Require A Cyp3a Inhibitor, For The Treatment Of Hiv-1 Infection In Pediatric Patients Weighing At Least 25 Kg And Less Than 35 Kg. 1.2 Hiv-1 Pre-Exposure Prophylaxis (prep) Descovy Is Indicated In At-Risk Adults And Adolescents Weighing At Least 35 Kg For Pre-Exposure Prophylaxis (prep) To Reduce The Risk Of Hiv-1 Infection From Sexual Acquisition, Excluding Individuals At Risk From Receptive Vaginal Sex. Individuals Must Have A Negative Hiv-1 Test Immediately Prior To Initiating Descovy For Hiv-1 Prep [see Dosage And Administration (2.2) And Warnings And Precautions (5.2) ]. Limitations Of Use: The Indication Does Not Include Use Of Descovy In Individuals At Risk Of Hiv-1 From Receptive Vaginal Sex Because Effectiveness In This Population Has Not Been Evaluated [see Clinical Studies (14.3) ].
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