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Single pill regimens have the potential to increase medication adherence by making it easier for patients to take their drugs. In this panel moderated by Prof. Pedro Cahn, Drs. Jean-Pierre Routy and Calvin Cohen discuss the release of the first Phase III data from the new once-a-day Quad therapy pill containing elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. The Quad pill was found to be non-inferior to both Atripla®, another single pill regimen, and a combined regimen of atazanavir/ritonavir plus emtricitabine/tenofovir.
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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
• DisconPnuaPon 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 #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
• DisconPnuaPon 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 Pharmacokinehcs . CROI 2012 Paper #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 #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 Pharmacokinehcs . CROI 2012 Paper #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 = 0.006)
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
