Open AccessIndirect treatment comparison of efficacy, safety and resistance of EVG/COBI/FTC/TDF (Quad) vs. RAL+FTC/TDF in treatment‐naïve HIV patients
Author(s) -
DeJesus E,
Felix J,
Vandewalle B,
Rabiais S,
Silva M,
Ferreira D,
Almeida J,
Piontkowsky D,
Szwarcberg J
Publication year - 2012
Publication title -
journal of the international aids society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.724
H-Index - 62
ISSN - 1758-2652
DOI - 10.7448/ias.15.6.18239
Subject(s) - emtricitabine , elvitegravir , medicine , tolerability , discontinuation , cobicistat , efavirenz , raltegravir , viral load , gastroenterology , adverse effect , human immunodeficiency virus (hiv) , virology , antiretroviral therapy
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‐naïve, 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 <50 cps/mL), mean CD4+ cell count (cells/µL) change from baseline, discontinuation due to any reason and due to adverse events (AE) and resistance to EVG and RAL. Efavirenz/emtricitabine/tenofovir DF was used as the common comparator. A Bayesian generalized linear model framework for indirect treatment comparison was adopted to estimate relative and absolute treatment effects, using QUAD as baseline value. 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‐naïve, HIV‐1‐infected patients.