Department of Medical Statistics, School of Public Health, Sun Yat-Sen University, Guangzhou, China.
Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.
Medicine (Baltimore). 2024 Jun 7;103(23):e38497. doi: 10.1097/MD.0000000000038497.
Integrase strand transfer inhibitors (INSTIs) in anti-retroviral therapy (ART) have been recommended by the World Health Organization for their higher efficacy, favorable safety and tolerability. However, the clinical evidence supporting switching to INSTI-containing regimens in low-and-middle-income countries (LMICs) is limited, as few patients have access to these regimens. We aimed to assess the effectiveness of INSTI-containing regimens in real-world settings in China compared to government-provided free ART. We compared the short-term (first 4 mo following ART initiation) and long-term (1 year after ART initiation) effectiveness between INSTI-containing regimens and free ART drugs provided by the Chinese government in 4 dimensions: viral suppression status, immune response, liver and kidney function, and AIDS-related diseases. We obtained data from electronic medical records in the National Infectious Disease Surveillance System. To control baseline confounders, we used propensity score matching (PSM), calculated using logistic regression including socio-demographic and baseline factors. Among 12,836 patients from 2012 to 2019, 673 (5.2%) used INSTI-containing regimens. Patients with INSTI-containing regimens were matched to those with free drugs (644 vs 644). For short-term effectiveness, patients initiating INSTI-containing regimens were more likely to achieve viral suppression (81.4% vs 52.0%; P < .001). The differences in immune response, liver and kidney function and AIDS-related diseases were not significant between the 2 groups. For long-term effectiveness, viral suppression rates were similar (87.96% vs 84.59%; P = .135), with no significant differences in immune response, liver and kidney function, or AIDS-related diseases. Our study suggests that patients initiating ART with INSTI-containing regimens have worse physical status at baseline than patients starting with free ART drugs. Furthermore, we found better virological performances of INSTI-containing regimens in the short-term but not in the long-term due to a high rate of drug changes. Our findings have clinical implications and provide new evidence regarding the effectiveness of INSTI-containing regimens in LMICs.
整合酶链转移抑制剂(INSTIs)在抗逆转录病毒治疗(ART)中因其更高的疗效、良好的安全性和耐受性而被世界卫生组织推荐。然而,在中低收入国家(LMICs),支持转换为包含 INSTI 的方案的临床证据有限,因为很少有患者能够获得这些方案。我们旨在评估与中国政府提供的免费 ART 相比,包含 INSTI 的方案在真实环境中的疗效。我们比较了包含 INSTI 的方案和中国政府提供的免费 ART 药物在四个方面的短期(ART 开始后 4 个月)和长期(ART 开始后 1 年)疗效:病毒抑制状态、免疫反应、肝肾功能和艾滋病相关疾病。我们从国家传染病监测系统的电子病历中获取数据。为了控制基线混杂因素,我们使用了倾向评分匹配(PSM),使用包括社会人口统计学和基线因素的逻辑回归进行计算。在 2012 年至 2019 年期间,从 12836 名患者中,有 673 名(5.2%)使用了包含 INSTI 的方案。包含 INSTI 的方案组的患者与使用免费药物的患者相匹配(644 例与 644 例)。在短期疗效方面,开始使用包含 INSTI 的方案的患者更有可能实现病毒抑制(81.4% vs 52.0%;P<.001)。两组之间在免疫反应、肝肾功能和艾滋病相关疾病方面的差异没有统计学意义。在长期疗效方面,病毒抑制率相似(87.96% vs 84.59%;P=.135),免疫反应、肝肾功能或艾滋病相关疾病方面无显著差异。我们的研究表明,开始 ART 时使用包含 INSTI 的方案的患者在基线时的身体状况比开始使用免费 ART 药物的患者差。此外,我们发现包含 INSTI 的方案在短期内具有更好的病毒学表现,但在长期内没有,这是由于药物更换率较高。我们的研究结果具有临床意义,并为包含 INSTI 的方案在 LMICs 中的疗效提供了新的证据。