Huerta García Gloria, Mata-Marín José Antonio, Domínguez-Hermosillo Juan Carlos, Chavez-García Marcelino, Banda-Lara Marco Issac, Nuñez-Rodríguez Nohemi, Cruz-Herrera Javier Enrique, Sandoval-Ramírez Jorge Luis, Villagómez-Ruiz Alfredo, Manjarrez-Tellez Bulmaro, Gaytan-Martínez Jesús Enrique
National Medical Center "Siglo XXI", IMSS, Distrito Federal, Distrito Federal, Mexico.
J Infect Dev Ctries. 2016 Jun 30;10(6):605-11. doi: 10.3855/jidc.7512.
Treatment options are limited for HIV-1-infected individuals who have received extensive previous antiretroviral therapy. ETV has shown significant clinical benefits in treatment-experienced HIV-1+ patients with antiretroviral resistance. The aim of this study was to evaluate the effectiveness of ETV plus optimized background regimen in real-life conditions in a cohort of highly HIV-1 antiretroviral-experienced patients.
Retrospective cohort of treatment-experienced HIV-1-infected adults with virological failure who started therapy with an ETV-containing regimen. The effectiveness was evaluated using HIV-1 RNA viral load and changes in CD4+ cell count after 48 weeks of treatment.
Forty-two patients ≥ 16 years of age were included; 74% were men, and the median age was 45 years (IQR 41-53). All participants had prior non-nucleoside reverse transcriptase inhibitor use (55% nevirapine, 83%, efavirenz, and 28% both). Baseline median HIV-1 RNA viral load was 15,598 copies/mL (IQR 2651-84,175) and CD4+ cell count was 276 cells/mL (IQR 155-436). After 48 weeks of treatment, 90.5% (95% CI 78-96) of patients had HIV-1 RNA viral load < 200 copies/mL and 76% (95% CI 61-86) had < 50 copies/mL. CD4+ cell counts increased from baseline to 48 weeks of treatment to a median of 407 cells/mL (IQR 242-579); p < 0.001. Virological outcome was associated with virological failure at baseline HIV-1 RNA viral load ≥ 100,000 copies/mL (OR 7.6; 95% CI 1.2-44.80; p = 0.025).
Our study provides clinically important evidence of the effectiveness and safety of ETV in highly antiretroviral-experienced HIV-1-infected patients.
对于先前接受过广泛抗逆转录病毒治疗的HIV-1感染者，治疗选择有限。在有抗逆转录病毒耐药性的经治HIV-1阳性患者中，恩替卡韦（ETV）已显示出显著的临床益处。本研究的目的是评估在一组高度经治的HIV-1抗逆转录病毒治疗患者的实际临床情况下，ETV联合优化背景治疗方案的有效性。
对有病毒学失败的经治HIV-1感染成人进行回顾性队列研究，这些患者开始使用含ETV的治疗方案。在治疗48周后，使用HIV-1 RNA病毒载量和CD4+细胞计数的变化来评估有效性。
纳入了42名年龄≥16岁的患者；74%为男性，中位年龄为45岁（四分位间距41-53）。所有参与者既往均使用过非核苷类逆转录酶抑制剂（55%使用过奈韦拉平，83%使用过依非韦伦，28%两者均使用过）。基线时HIV-1 RNA病毒载量中位数为15,598拷贝/mL（四分位间距2651-84,175），CD4+细胞计数为276个/mL（四分位间距155-436）。治疗48周后，90.5%（95%置信区间78-96）的患者HIV-1 RNA病毒载量<200拷贝/mL，76%（95%置信区间61-86）的患者<50拷贝/mL。CD4+细胞计数从基线增加到治疗48周时的中位数407个/mL（四分位间距242-579）；p<0.001。病毒学结局与基线HIV-1 RNA病毒载量≥100,000拷贝/mL时的病毒学失败相关（比值比7.6；95%置信区间1.2-44.80；p=0.025）。
我们的研究为ETV在高度经治的HIV-1感染患者中的有效性和安全性提供了重要的临床证据。
