Abstract：
We assessed the virologic efficacy of switching to co-formulated elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate (E/C/F/TDF) in patients with controlled HIV infection.
We conducted a retrospective multicenter observational cohort study including adult patients with controlled HIV-1 infection on any stable antiretroviral (ART) regimen, who switched to E/C/F/TDF. Success was measured by the proportion of patients with plasma viral load < 50 copies/ml at W48 using the FDA snapshot algorithm. We also assessed risk factors associated with virological failure (VF).
382 patients with HIV RNA < 50 copies/mL who switched to E/C/F/TDF were included in the study. Most patients (69.9%) were male, with median age 44 years (IQR 38-51), who had been on ART for a median of 7 years (IQR 4-13). Median CD4 count was 614/mm3 and 24.6% of the patients had a history of previous virological failure. The reasons for switching were simplification (67.0%) and tolerance issues (22.0%). At week 48, 314 (82.0% [95% CI 78.4-86.0]) patients had HIV RNA < 50 copies/mL, 13 (3.5% [95% CI 3.64-8.41]) experienced virological failure. Genotype at failure was available in 6/13 patients with detection of resistance-associated mutations to integrase inhibitors and NRTIs in 5/6 (83.3%) patients. We found no predictive factor associated with virological failure except for a borderline significance with the duration of viral suppression before the switch. Tolerability of E/C/F/TDF was good with 23/382 (6.0%) patients experiencing mild adverse reactions.
In our cohort, switching well-suppressed patients to E/C/F/TDF resulted in few virologic failures and was well tolerated. However, resistance to integrase inhibitors emerged in patients with virological failure.
We conducted a retrospective multicenter observational cohort study including adult patients with controlled HIV-1 infection on any stable antiretroviral (ART) regimen, who switched to E/C/F/TDF. Success was measured by the proportion of patients with plasma viral load < 50 copies/ml at W48 using the FDA snapshot algorithm. We also assessed risk factors associated with virological failure (VF).
382 patients with HIV RNA < 50 copies/mL who switched to E/C/F/TDF were included in the study. Most patients (69.9%) were male, with median age 44 years (IQR 38-51), who had been on ART for a median of 7 years (IQR 4-13). Median CD4 count was 614/mm3 and 24.6% of the patients had a history of previous virological failure. The reasons for switching were simplification (67.0%) and tolerance issues (22.0%). At week 48, 314 (82.0% [95% CI 78.4-86.0]) patients had HIV RNA < 50 copies/mL, 13 (3.5% [95% CI 3.64-8.41]) experienced virological failure. Genotype at failure was available in 6/13 patients with detection of resistance-associated mutations to integrase inhibitors and NRTIs in 5/6 (83.3%) patients. We found no predictive factor associated with virological failure except for a borderline significance with the duration of viral suppression before the switch. Tolerability of E/C/F/TDF was good with 23/382 (6.0%) patients experiencing mild adverse reactions.
In our cohort, switching well-suppressed patients to E/C/F/TDF resulted in few virologic failures and was well tolerated. However, resistance to integrase inhibitors emerged in patients with virological failure.
摘要：
目的：我们评估了转换为共同配制的elvitegravir的病毒学疗效，cobicistat,恩曲他滨,替诺福韦酯富马酸酯（E/C/F/TDF）在控制HIV感染的患者中。
方法：我们进行了一项回顾性多中心观察性队列研究，包括在任何稳定的抗逆转录病毒（ART）治疗方案下控制HIV-1感染的成年患者，谁切换到E/C/F/TDF。使用FDA快照算法通过在W48处血浆病毒载量<50拷贝/ml的患者的比例来测量成功。我们还评估了与病毒学失败（VF）相关的危险因素。
结果：382例HIVRNA<50拷贝/mL且转换为E/C/F/TDF的患者被纳入研究。大多数患者（69.9％）为男性，中位年龄44岁（IQR38-51），中位接受ART治疗7年（IQR4-13）。中位CD4计数为614/mm3，24.6%的患者有既往病毒学失败史。切换的原因是简化（67.0%）和公差问题（22.0%）。在第48周，314（82.0%[95%CI78.4-86.0]）患者的HIVRNA<50拷贝/mL，13例（3.5%[95%CI3.64-8.41]）经历了病毒学失败。在6/13患者中可获得失败时的基因型,在5/6(83.3%)患者中检测到整合酶抑制剂和NRTIs的抗性相关突变。我们没有发现与病毒学失败相关的预测因素，除了与转换前的病毒抑制持续时间有边界线意义。E/C/F/TDF耐受性良好，有23/382（6.0％）患者出现轻度不良反应。
结论：在我们的队列中，将抑制良好的患者转换为E/C/F/TDF导致很少的病毒学失败，并且耐受性良好。然而,病毒学失败患者出现整合酶抑制剂耐药.
方法：我们进行了一项回顾性多中心观察性队列研究，包括在任何稳定的抗逆转录病毒（ART）治疗方案下控制HIV-1感染的成年患者，谁切换到E/C/F/TDF。使用FDA快照算法通过在W48处血浆病毒载量<50拷贝/ml的患者的比例来测量成功。我们还评估了与病毒学失败（VF）相关的危险因素。
结果：382例HIVRNA<50拷贝/mL且转换为E/C/F/TDF的患者被纳入研究。大多数患者（69.9％）为男性，中位年龄44岁（IQR38-51），中位接受ART治疗7年（IQR4-13）。中位CD4计数为614/mm3，24.6%的患者有既往病毒学失败史。切换的原因是简化（67.0%）和公差问题（22.0%）。在第48周，314（82.0%[95%CI78.4-86.0]）患者的HIVRNA<50拷贝/mL，13例（3.5%[95%CI3.64-8.41]）经历了病毒学失败。在6/13患者中可获得失败时的基因型,在5/6(83.3%)患者中检测到整合酶抑制剂和NRTIs的抗性相关突变。我们没有发现与病毒学失败相关的预测因素，除了与转换前的病毒抑制持续时间有边界线意义。E/C/F/TDF耐受性良好，有23/382（6.0％）患者出现轻度不良反应。
结论：在我们的队列中，将抑制良好的患者转换为E/C/F/TDF导致很少的病毒学失败，并且耐受性良好。然而,病毒学失败患者出现整合酶抑制剂耐药.
