Single Pill HIV Regimens – Introducing the Quad Pedro Cahn, MD Jean-Pierre Routy, MD Calvin Cohen, MD

Non Inferiority of Quad vs. Atripla® Percentage with HIV RNA of <50 copies/mL at week 48 –Quad 88%, EFV/FTC/TDF 84%, (difference +3.6%, 95%CI – 1.6% to +8.8%). Quad 84%, EFV/FTC/TDF 82% in individuals with >100,000 copies at baseline Mean CD4 counts increase were similar –Quad 239 cells/μL, EFV/FTC/TDF 206 cells/μL Discontinuation rates for adverse events were similar –Quad 3%, ATV/r+FTC/TDF 5% Sax, P. et al. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir (Quad) Has Non-inferior Efficacy and Favorable Safety Compared to Efavirenz/Emtricitabine/Tenofovir in Treatment-naïve HIV-1+ Subjects. CROI 2012 Paper #101Paper #101

Non Inferiority of Quad vs. ATV/r+FTC/TDF Percentage with HIV RNA of <50 copies/mL at week 48 –Quad 90%, ATV/r+FTC/TDF 87%, (difference +3.0%, 95%CI – 1.9% to +7.8%) Quad 85%, ATV/r+FTC/TDF 82% in individuals with >100,000 copies at baseline Median CD4 increases were similar –Quad 207 cells/μL, ATV/r+FTC/TDF 211 cells/μL Discontinuation rates for adverse events were similar –Quad 4%, ATV/r+FTC/TDF 5% DeJesus E., et al. Week 48 Results of an Ongoing Global Phase 3 Study Comparing Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir (Quad) with Atazanavir/ritonavir plus Emtricitabine/Tenofovir in Treatment-naïve HIV-1+ Subjects Showing Efficacy, Safety, and Pharmacokinetics. CROI 2012 Paper #627Paper #627

Quad Effects on Cholesterol Sax, P. et al. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir (Quad) Has Non-inferior Efficacy and Favorable Safety Compared to Efavirenz/Emtricitabine/Tenofovir in Treatment-naïve HIV-1+ Subjects. CROI 2012 Paper #101Paper #101 DeJesus E., et al. Week 48 Results of an Ongoing Global Phase 3 Study Comparing Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir (Quad) with Atazanavir/ritonavir plus Emtricitabine/Tenofovir in Treatment-naïve HIV-1+ Subjects Showing Efficacy, Safety, and Pharmacokinetics. CROI 2012 Paper #627Paper #627 Quad vs. EFV/FTC/TDF –Total cholesterol, LDL, and HDL increases at week 48 were significantly lower for Quad than EFV/FTC/TDF. –Triglyceride increases were the same Quad vs. ATV/r+FTC/TDF –Median triglyceride increases were 11mg/dL in Quad and 29 mg/dL in ATV/r+FTC/TDF (p = )

Fixed Dose Regimens Currently Available –Atripla® (efavirenz, emtricitabine, tenofovir disoproxil fumarate) –Complera® (emtricitabine, rilpivirine, and tenofovir) Coming Soon –QUAD (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) In Development –Dolutegravir, abacavir, lamivudine –Elvitegravir, cobicistat, emtricitabine, GS-7340 –Darunavir, cobicistat, emtricitabine, GS-7340