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1 Indications And Usage Aptivus, Co-Administered With Ritonavir, Is Indicated For Combination Antiretroviral Treatment Of Hiv-1 Infected Patients Who Are Treatment-Experienced And Infected With Hiv-1 Strains Resistant To More Than One Protease Inhibitor (Pi). This Indication Is Based On Analyses Of Plasma Hiv-1 Rna Levels In Two Controlled Studies Of Aptivus/ritonavir Of 48 Weeks Duration In Treatment-Experienced Adults And One Open-Label 48-Week Study In Pediatric Patients Age 2 To 18 Years. The Adult Studies Were Conducted In Clinically Advanced, 3-Class Antiretroviral (Nrti, Nnrti, Pi) Treatment-Experienced Adults With Evidence Of Hiv-1 Replication Despite Ongoing Antiretroviral Therapy. The Following Points Should Be Considered When Initiating Therapy With Aptivus/ritonavir: The Use Of Aptivus/ritonavir In Treatment-Naïve Patients Is Not Recommended [ See Warnings And Precautions (5.1) ]. The Use Of Other Active Agents With Aptivus/ritonavir Is Associated With A Greater Likelihood Of Treatment Response [ See Microbiology (12.4) And Clinical Studies (14) ]. Genotypic Or Phenotypic Testing And/or Treatment History Should Guide The Use Of Aptivus/ritonavir [ See Microbiology (12.4) ]. The Number Of Baseline Primary Protease Inhibitor Mutations Affects The Virologic Response To Aptivus/ritonavir [ See Microbiology (12.4) ]. Use Caution When Prescribing Aptivus/ritonavir To Patients With Elevated Transaminases, Hepatitis B Or C Co-Infection Or Patients With Mild Hepatic Impairment [ See Warnings And Precautions (5.1) ]. Liver Function Tests Should Be Performed At Initiation Of Therapy With Aptivus/ritonavir And Monitored Frequently Throughout The Duration Of Treatment [ See Warnings And Precautions (5.1) ]. The Drug-Drug Interaction Potential Of Aptivus/ritonavir When Co-Administered With Other Drugs Must Be Considered Prior To And During Aptivus/ritonavir Use [ See Contraindications (4) And Drug Interactions (7) ]. Use Caution When Prescribing Aptivus/ritonavir In Patients Who May Be At Risk For Increased Bleeding Or Who Are Receiving Medications Known To Increase The Risk Of Bleeding [ See Warnings And Precautions (5.4) ]. The Risk-Benefit Of Aptivus/ritonavir Has Not Been Established In Pediatric Patients <2 Years Of Age. There Are No Study Results Demonstrating The Effect Of Aptivus/ritonavir On Clinical Progression Of Hiv-1. Aptivus, A Protease Inhibitor, Co-Administered With Ritonavir, Is Indicated For Combination Antiretroviral Treatment Of Hiv-1 Infected Patients Who Are Treatment-Experienced And Infected With Hiv-1 Strains Resistant To More Than One Protease Inhibitor ( 1 ) Do Not Use Aptivus/ritonavir In Treatment-Naïve Patients ( 1 )
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