长效卡博特韦/利匹韦林对比标准口服抗逆转录病毒疗法的安全性和有效性：一项系统评价与荟萃分析

Safety and efficacy of long-acting cabotegravir/rilpivirine versus standard oral antiretroviral therapy: a systematic review and meta-analysis.

作者信息

Manalu Samuel Bungaran Partahi Saud, Perez Navarro Andrea, Fairhead Cassandra, Hill Andrew

机构信息

School of Public Health, Imperial College London, London, UK.

School of Medicine, Imperial College London, London, UK.

出版信息

J Antimicrob Chemother. 2025 Mar 3;80(3):624-632. doi: 10.1093/jac/dkae480.

BACKGROUND

In 2023, there were 39.9 million people living with HIV (PLWH) worldwide and 630 000 deaths related to HIV. New strategies are needed, and long-acting antiretrovirals (LAAs) are now widely considered to have great potential to help end the HIV epidemic. This systematic review and meta-analysis compare the safety and efficacy of LAA versus standard oral treatment (SOT) for HIV.

METHODS

PubMed and Embase databases, supplemented by ClinicalTrials.gov and grey literature, were searched. Randomized controlled trials (RCTs) reporting efficacy and/or safety of LAA versus SOT for PLWH until June 2024 were included. Efficacy (HIV RNA < 50 copies/mL) and HIV RNA ≥ 50 copies/mL, adverse events (AEs), treatment discontinuation, CD4 count, metabolic parameters and drug resistance were assessed. Prespecified subgroup analyses were conducted. The risk of bias was assessed with Cochrane RoB 2.0. Certainty of evidence was assessed using GRADE.

RESULTS

Six RCTs were eligible for inclusion, involving 2829 participants. LAA was non-inferior to SOT in suppressing HIV RNA < 50 copies/mL [Risk Difference (RD), -0.00; 95% CI, -0.03-0.02; P = 0.83; I2 = 51%; high quality of evidence (QoE)]. LAA was associated with higher drug resistance (percentage pooled estimate, 57%; 95% CI, 33%-78% versus 9%; 95% CI, 2%-30%; moderate QoE) and risk of grade 1-4 AEs than SOT [Risk Ratio (RR), 1.22; 95% CI, 1.12-1.33; P < 0.001; I2 = 62%; moderate QoE].

CONCLUSIONS

LAA has non-inferior efficacy compared to SOT. However, participants receiving LAA were at a higher risk of developing drug resistance, cross-resistance and AEs.

背景

2023年，全球有3990万人感染艾滋病毒（HIV感染者），63万人死于与艾滋病毒相关的疾病。需要新的策略，长效抗逆转录病毒药物（LAA）目前被广泛认为在帮助终结艾滋病毒流行方面具有巨大潜力。本系统评价和荟萃分析比较了LAA与标准口服治疗（SOT）对艾滋病毒的安全性和疗效。

方法

检索了PubMed和Embase数据库，并辅以ClinicalTrials.gov和灰色文献。纳入了截至2024年6月报告LAA与SOT对HIV感染者疗效和/或安全性的随机对照试验（RCT）。评估了疗效（HIV RNA＜50拷贝/mL）和HIV RNA≥50拷贝/mL、不良事件（AE）、治疗中断、CD4细胞计数、代谢参数和耐药性。进行了预先设定的亚组分析。使用Cochrane RoB 2.0评估偏倚风险。使用GRADE评估证据的确定性。

结果

六项RCT符合纳入标准，涉及2829名参与者。在抑制HIV RNA＜50拷贝/mL方面，LAA不劣于SOT[风险差异（RD），-0.00；95%置信区间，-0.03-0.02；P = 0.83；I² = 51%；高质量证据（QoE）]。与SOT相比，LAA与更高的耐药性（合并估计百分比，57%；95%置信区间，33%-78%对9%；95%置信区间，2%-30%；中度QoE）和1-4级AE风险相关[风险比（RR），1.22；95%置信区间，1.12-1.33；P＜0.001；I² = 62%；中度QoE]。