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Comparison of RTV vs Cobi

Comparison of RTV vs Cobi. GS-US-216-0114. Study GS-US-216-0114: ATV + ritonavir + FTC/TDF QD vs ATV + cobicistat + FTC/TDF. Design. Randomisation* 1 : 1 Double-blind. W48. W192. > 18 years ARV-naïve HIV RNA > 5,000 c/mL Any CD4 cell count eGFR > 70 mL/min Sensitivity to ATV, FTC

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Comparison of RTV vs Cobi

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  1. Comparison of RTV vs Cobi • GS-US-216-0114

  2. Study GS-US-216-0114: ATV + ritonavir + FTC/TDF QD vs ATV + cobicistat + FTC/TDF • Design Randomisation* 1 : 1 Double-blind W48 W192 > 18 years ARV-naïve HIV RNA > 5,000 c/mL Any CD4 cell count eGFR > 70 mL/min Sensitivity to ATV, FTC And TDF on genotype N = 344 N = 348 * Randomisation was stratified by HIV RNA (< or > 100,000 c/mL) at screening • Objective • Non inferiority of COBI compared with RTV at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis (lower limit for the 95% CI for the difference = -12%, 95% power) Gallant JE. JID 2013;208:32-9 GS-US-216-0114

  3. Study GS-US-216-0114: ATV + ritonavir + FTC/TDF QD vs ATV + cobicistat + FTC/TDF Baseline characteristics and patient disposition Gallant JE. JID 2013;208:32-9 GS-US-216-0114

  4. Study GS-US-216-0114: ATV + ritonavir + FTC/TDF QD vs ATV + cobicistat + FTC/TDF Response to treatment at week 48 HIV RNA < 50 c/mL COBI + ATV + FTC/TDF % RTV + ATV + FTC/TDF Primary analysis 98.0 98.0 100 87.4 85.2 Viral suppression was high in both treatment arms, for various subgroups, including patients with HIV RNA > 100,000 c/mL at baseline 75 50 25 Mean CD4/mm3 increase at W48 : + 213 COBI vs + 219 RTV 0 ITT, snapshot Per protocol Adjusted difference (95% CI)= -2.2%( - 7.4 ; 3.0) Adjusted difference (95% CI)= -0.1 % ( - 2.5 ; 2.3) Gallant JE. JID 2013;208:32-9 GS-US-216-0114

  5. Study GS-US-216-0114: ATV + ritonavir + FTC/TDF QD vs ATV + cobicistat + FTC/TDF • Criteria for resistance testing : confirmed HIV-1 RNA load rebound of ≥ 400 c/mL or not obtaining HIV RNA < 400 c/mL by or after week 8 • Laboratory abnormalities Gallant JE. JID 2013;208:32-9 GS-US-216-0114

  6. Adverse events occurring in > 10% of patients in either group (W48) Study GS-US-216-0114: ATV + ritonavir + FTC/TDF QD vs ATV + cobicistat + FTC/TDF • Adverse events leading to discontinuation of study drug by W48 Gallant JE. JID 2013;208:32-9 GS-US-216-0114

  7. Summary of week 48 results COBI was non inferior to RTV in combination with ATV plus FTC/TDF at week 48 Both regimens achieved high rates of virologic success Safety and tolerability profiles of the 2 regimens were comparable Once-daily COBI is a safe and effective pharmaco-enhancer of the protease inhibitor ATV Renal safety was comparable between treatment arms Discontinuation due to renal events was 1.7% in the COBI group and 1.4% in the RTV group Proximal tubulopathy occurred in 5 vs 2 patients A small, but significantly higher with COBI, increase in creatinine was seen in both groups, as early as week 2, with peak at week 8, and stabilization through 48 weeks Study GS-US-216-0114: ATV + ritonavir + FTC/TDF QD vs ATV + cobicistat + FTC/TDF Gallant JE. JID 2013;208:32-9 GS-US-216-0114

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