Prinapori Roberta, Di Biagio Antonio
Infectious Diseases, University of Genoa, Genoa, Italy.
Unit of Infectious Diseases, IRCCS AOU San Martino-IST, Genoa, Italy.
Patient Prefer Adherence. 2015 Aug 24;9:1213-8. doi: 10.2147/PPA.S88490. eCollection 2015.
The fixed-dose combination (FDC) elvitegravir/cobicistat/emtricitabine/tenofovir (EVG/c/FTC/TDF) is a once-daily, single-tablet regimen containing an integrase strand transfer inhibitor and a pharmacoenhancer (cobicistat) associated with two nucleos(t)ide reverse transcriptase inhibitors. It is approved as the preferred regimen and as the first-line combined antiretroviral therapy in treatment-naïve patients with HIV infection. Two large trials, 102-Study and 103-Study, demonstrated that EVG/c/FTC/TDF was not inferior to efavirenz/FTC/TDF and ritonavir-boosted atazanavir in association with FTC/TDF, in terms of virological suppression and immunological reconstitution through week 144. Also, simplification arms containing EVG/c/FTC/TDF reached noninferiority in comparison with a nonnucleoside reverse transcriptase inhibitor, or a protease inhibitor, or a raltegravir-based regimen. Furthermore, EVG/c/FTC/TDF exhibited an excellent tolerability profile, with a safer lipid profile, and despite the indication of its use in subjects with an estimated creatinine clearance >70 mL/min, recent data demonstrated that EVG/c/FTC/TDF determined a reduction in estimated glomerular filtration rate (GFR) but not a reduction of actual GFR. Moreover, in a cohort of naïve patients with pretreatment mild-to-moderate renal impairment, GFR decrease was noted as early at week 2, after which it generally stabilized and was nonprogressive through week 48. The FDC's efficacy and good tolerability enable EVG/c/FTC/TDF to meet the patients' needs, improving adherence and quality of life, which are among the most important factors affecting the therapeutic efficacy of an antiretroviral regimen. This paper describes the evidence making EVG/c/FTC/TDF a new therapeutic opportunity for different HIV-infected patients.
固定剂量复方制剂（FDC）埃替拉韦/考比司他/恩曲他滨/替诺福韦（EVG/c/FTC/TDF）是一种每日一次的单片治疗方案，包含一种整合酶链转移抑制剂和一种与两种核苷类逆转录酶抑制剂联用的增效剂（考比司他）。它被批准作为初治HIV感染患者的首选方案和一线联合抗逆转录病毒疗法。两项大型试验，即102研究和103研究，表明在第144周时，就病毒学抑制和免疫重建而言，EVG/c/FTC/TDF不劣于依非韦伦/FTC/TDF以及与FTC/TDF联用的利托那韦增强型阿扎那韦。此外，含EVG/c/FTC/TDF的简化治疗组与非核苷类逆转录酶抑制剂、蛋白酶抑制剂或基于拉替拉韦的治疗方案相比达到了非劣效性。此外，EVG/c/FTC/TDF具有良好的耐受性，血脂谱更安全，尽管其使用指征为估计肌酐清除率>70 mL/min，但近期数据表明，EVG/c/FTC/TDF会导致估计肾小球滤过率（GFR）降低，但实际GFR并未降低。此外，在一组初治时存在轻度至中度肾功能损害的患者中，在第2周时就观察到GFR下降，此后通常稳定下来，并且在第48周时无进展。该固定剂量复方制剂的疗效和良好耐受性使EVG/c/FTC/TDF能够满足患者需求，提高依从性和生活质量，而依从性和生活质量是影响抗逆转录病毒治疗方案疗效的最重要因素。本文阐述了使EVG/c/FTC/TDF成为不同HIV感染患者新治疗选择的证据。
