在初治HIV感染者中，比克替拉韦与多替拉韦、拉替拉韦及基于依非韦伦的抗逆转录病毒疗法的疗效比较。

Comparative effectiveness of bictegravir versus dolutegravir, raltegravir, and efavirenz-based antiretroviral therapy among treatment-naïve individuals with HIV.

作者信息

Núñez Isaac, Caro-Vega Yanink, MacDonald Conor, Mosqueda Juan Luis, Piñeirúa-Menéndez Alicia, Matthews Anthony A

机构信息

Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Ave, Boston, MA 02115, United States; Department of Medical Education, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Division of Postgraduate Studies, Faculty of Medicine, Universidad Nacional Autónoma de México, Mexico City, Mexico; Unit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.

Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.

出版信息

Eur J Intern Med. 2025 Mar;133:86-92. doi: 10.1016/j.ejim.2025.01.013. Epub 2025 Jan 21.

DOI:10.1016/j.ejim.2025.01.013

PMID:39843330

Abstract

OBJECTIVE

Bictegravir or dolutegravir based antiretroviral therapy are first-line HIV treatments. However, no trial has recruited enough participants to estimate the most effective treatment, and there is little evidence on the comparative effectiveness of bictegravir and other available antiretrovirals, like efavirenz and raltegravir.

METHODS

We emulated a four-arm target trial using country-wide data from Mexico. The eligibility criteria of the target trial were people with HIV, treatment naïve with viral load >500 copies/mL, without tuberculosis, not pregnant, and started either bictegravir, dolutegravir, efavirenz or raltegravir-based treatment between July 2019 and September 2021. The main outcome was the probability of viral suppression (HIV-RNA <50 copies/mL) at three months estimated using an adjusted logistic regression model, with assignment assumed to be random within levels of adjusted covariates. Probabilities were compared via differences and non-parametric bootstrapping was used to calculate 95 % confidence intervals.

RESULTS

20,285 individuals were included, of whom 84.3 % started bictegravir, 7.2 % dolutegravir, 6.6 % efavirenz, and 1.8 % raltegravir. The adjusted probability of viral suppression at 3 months was 79.4 % (79.4 %, 80.2 %) with bictegravir, 78.5 % (76.2 %, 81.1 %) with dolutegravir, 63.9 % (60.6 %, 67.7 %) with efavirenz, and 69.8 % (63.8 %, 76.1 %) with raltegravir. When compared with bictegravir, this resulted in differences of -0.8 % (-3.5 %, 1.9 %) for dolutegravir, -15.5 % (-19 %, -11.7 %) for efavirenz, and -9.6 % (-15.9 %, -3.3 %) for raltegravir. Differences shrank at twelve months and with a higher viral threshold (200 copies/mL).

CONCLUSIONS

Bictegravir was similar to dolutegravir and slightly more effective than efavirenz or raltegravir at three months, but differences became negligible at twelve months.

摘要

目的

基于比克替拉韦或多替拉韦的抗逆转录病毒疗法是治疗HIV的一线疗法。然而，尚无试验招募足够的参与者来评估最有效的治疗方法，而且关于比克替拉韦与其他可用抗逆转录病毒药物（如依非韦伦和拉替拉韦）的比较疗效的证据很少。

方法

我们使用来自墨西哥的全国性数据模拟了一项四臂目标试验。目标试验的纳入标准为HIV感染者，初治，病毒载量>500拷贝/mL，无结核病，未怀孕，且在2019年7月至2021年9月期间开始接受基于比克替拉韦、多替拉韦、依非韦伦或拉替拉韦的治疗。主要结局是使用调整后的逻辑回归模型估计的三个月时病毒抑制（HIV-RNA<50拷贝/mL）的概率，假设在调整协变量水平内分配是随机的。通过差异比较概率，并使用非参数自助法计算95%置信区间。

结果

纳入20285人，其中84.3%开始使用比克替拉韦，7.2%开始使用多替拉韦，6.6%开始使用依非韦伦，1.8%开始使用拉替拉韦。比克替拉韦组三个月时调整后的病毒抑制概率为79.4%（79.4%，80.2%），多替拉韦组为78.5%（76.2%，81.1%），依非韦伦组为63.9%（60.6%，67.7%），拉替拉韦组为69.8%（63.8%，76.1%）。与比克替拉韦相比，多替拉韦的差异为-0.8%（-3.5%，1.9%），依非韦伦为-15.5%（-19%，-11.7%），拉替拉韦为-9.6%（-15.9%，-3.3%）。在十二个月时以及病毒阈值较高（200拷贝/mL）时差异缩小。