Indirect treatment comparison of efficacy, safety and resistance of EVG/COBI/FTC/TDF (Quad) vs. RAL+FTC/TDF in treatment‐na?ve HIV patients

摘要

Purpose To compare the efficacy, tolerability and resistance profile at week 48 of elvitegravir 150 mg/ cobicistat 150 mg/ emtricitabine 200 mg/ tenofovir DF 300 mg qd (QUAD) relative to raltegravir 400 mg bid + emtricitabine 200 mg/ tenofovir DF 300 mg qd (RAL+FTC/TDF) in treatment‐na?ve, HIV‐1‐infected adults based on an indirect treatment comparison. Methods Using the phase 3 studies GS‐US‐236‐0102 (102) and STARTMRK, outcomes examined were viral suppression (HIV RNA Results The odds ratio (OR) of viral suppression with QUAD relative to RAL+FTC/TDF was 0.98 (CI: 0.52; 1.86). Discontinuations due to any reason or AE were comparable. The OR of resistance with QUAD relative to RAL+FTC/TDF was 0.63 (CI: 0.09; 4.21). The estimated probability of viral suppression was 88.8% (CI: 85.3%; 91.9%) for QUAD; 88.8% (CI: 82.7%; 93.4%) for RAL+FTC/TDF. Mean CD4+ cell count change from baseline was estimated at 239.0 cells/μL (CI: 220.9; 257.1) for QUAD and 232.0 cells/μL (CI: 204.9; 259.2) for RAL+FTC/TDF. The estimated probability of discontinuation due to any reason is 10.6% (CI: 7.6%; 14.1%) for QUAD and 9.2% (CI: 4.9%; 15.4%) for RAL+FTC/TDF and due to AE 3.7% (CI: 2.0%; 6.0%) for QUAD and 2.9% (CI: 1.0%; 6.4%) for RAL+FTC/TDF. Integrase resistance is estimated at 2.0% (CI: 1.0%; 4.0%) for QUAD and 4.3% (CI: 1.0%; 16.0%) for RAL+FTC/TDF. Conclusion Comparable results were found between QUAD and RAL+FTC/TDF for the studied outcomes analyzed at week 48, in treatment‐na?ve, HIV‐1‐infected patients.