Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive, Rome, Italy.
Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Università Cattolica del Sacro Cuore, Rome, Italy.
HIV Res Clin Pract. 2022 Dec;23(1):28-36.
To evaluate the impact of a treatment switch to dolutegravir plus lamivudine on the soluble inflammatory biomarkers of HIV-infected patients treated in a real-life setting. This was a longitudinal study that enrolled virologically-suppressed patients on stable 3-drug ART who switched at baseline to dolutegravir + lamivudine (2DR-group), based on the clinician's decision, or maintained triple therapy (3DR-group). Subjects in the 3DR-group were matched with those in the 2DR-group for age, gender and type of anchor drug. Plasma levels of interleukin-6 (IL-6), I-FABP, D-dimer and C-reactive protein (CRP) were quantified by a microfluidic ultrasensitive ELISA assay at baseline and at 48 weeks. Overall 208 subjects were enrolled: 101 in the 2DR-group and 107 in the 3DR-group. At baseline, biomarker levels were comparable between groups. The differences in mean log change from baseline to 48 weeks between groups (2DR versus 3DR) were: IL-6 (pg/L) -0.051(95% CI -0.115/0.009) versus 0.004 (95% CI -0.046/0.054) (p = 0.159); I-FABP (pg/mL), -0.088 (95% CI -0.14/-0.041) versus 0.033 (95%CI -0.007/0.072) (p < 0.001); D-dimer (pg/mL), -0.011(95% CI-0.055/0.033) versus -0.021 (95% CI -0.071/0.030) (p = 0.780) and CRP (pg/mL), -0.028 (95%CI -0.118/0.063) versus 0.118 (95% CI 0.024/0.211) (p = 0.028). At 1 year, switching to a dolutegravir plus lamivudine dual regimen in this setting showed a favorable trend for two biomarkers analyzed, i.e., I-FABP and CRP, as compared to continuing a triple therapy. These results add important new data in support of the safety of this approach in terms of its effect on the inflammatory milieu.
评估在真实环境下，将治疗方案转换为多替拉韦加拉米夫定对接受治疗的 HIV 感染患者可溶性炎症生物标志物的影响。这是一项纵向研究，共纳入了 208 名病毒学抑制患者，他们在基线时根据临床医生的决定转换为多替拉韦加拉米夫定（2DR 组），或继续三药治疗（3DR 组）。在 3DR 组中，与 2DR 组匹配了年龄、性别和锚定药物类型相同的患者。在基线和 48 周时，使用微流控超敏 ELISA 检测试剂盒定量检测白细胞介素 6（IL-6）、I-FABP、D-二聚体和 C 反应蛋白（CRP）的血浆水平。总体上，208 名患者入组：2DR 组 101 例，3DR 组 107 例。在基线时，两组之间的生物标志物水平无差异。两组之间从基线到 48 周的平均对数变化差异（2DR 与 3DR）为：IL-6（pg/L）-0.051（95%CI-0.115/0.009）与 0.004（95%CI-0.046/0.054）（p=0.159）；I-FABP（pg/mL）-0.088（95%CI-0.14/-0.041）与 0.033（95%CI-0.007/0.072）（p<0.001）；D-二聚体（pg/mL）-0.011（95%CI-0.055/0.033）与-0.021（95%CI-0.071/0.030）（p=0.780）和 CRP（pg/mL）-0.028（95%CI-0.118/0.063）与 0.118（95%CI 0.024/0.211）（p=0.028）。在 1 年时，与继续三药治疗相比，在此环境下转换为多替拉韦加拉米夫定二联方案显示出两种分析的生物标志物，即 I-FABP 和 CRP 的有利趋势。这些结果提供了重要的新数据，支持了这种方法在炎症环境方面的安全性。
