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Abstract：
BACKGROUND: Low-level viremia (LLV) has been identified as a potential precursor to virologic failure (VF), yet its clinical implications, particularly within the context of Integrase Strand Transfer Inhibitors (INSTIs)-based regimens, remain insufficiently explored. The study aimed to investigate the relationship between LLV and VF within ART-naïve patients on INSTIs-based regimens in China.
METHODS: A longitudinal cohort study was conducted with ART-naïve patients aged ≥ 18 years at Beijing Ditan Hospital, under the Chinese National Free Antiretroviral Treatment Program (NFATP). The LLV was defined as a viral load (VL) ranging from 50 to 199 copies/mL after six months of ART initiation, and VF as a VL ≥ 200 copies/mL. Sensitive analyses were also performed, defining LLV as 50-999 copies/mL and VF as exceeding 1000 copies/mL. Multivariate logistic regression, Kaplan-Meier (KM) curve, and Generalized Estimating Equation (GEE) models were used to evaluate the risk factors associated with LLV and VF events.
RESULTS: The study involved 830 ART-naïve patients, comprising 600 in the INSTIs group and 230 in the protease inhibitors (PIs) group. LLV events were observed in 10.4% of patients on PIs-based regimens and and 3.2% on INSTIs-based regimens (P < 0.001). INSTIs-based regimens demonstrated a protective effect against LLV events (aHR = 0.27, 95% CI 0.137-0.532). VF events occurred in 10.9% of patients on PIs-based regimens and 2.0% on INSTIs-based regimens, respectively (P < 0.001). The occurrence of LLV events significantly increased the risk of VF by 123.5% (95% CI 7.5%-364.4%), while the integrase inhibitors were associated with a 76.9% (95% CI 59.1%-86.9%) reduction in VF risk.
CONCLUSIONS: Our findings indicate that INSTIs-based regimens are critical protective factors against LLV and subsequent VF. These results underscore the importance of HIV viral load monitoring to ensuring effective treatment outcomes, highlighting the necessity for prompt and precise monitoring to refine HIV treatment methodologies.
METHODS: A longitudinal cohort study was conducted with ART-naïve patients aged ≥ 18 years at Beijing Ditan Hospital, under the Chinese National Free Antiretroviral Treatment Program (NFATP). The LLV was defined as a viral load (VL) ranging from 50 to 199 copies/mL after six months of ART initiation, and VF as a VL ≥ 200 copies/mL. Sensitive analyses were also performed, defining LLV as 50-999 copies/mL and VF as exceeding 1000 copies/mL. Multivariate logistic regression, Kaplan-Meier (KM) curve, and Generalized Estimating Equation (GEE) models were used to evaluate the risk factors associated with LLV and VF events.
RESULTS: The study involved 830 ART-naïve patients, comprising 600 in the INSTIs group and 230 in the protease inhibitors (PIs) group. LLV events were observed in 10.4% of patients on PIs-based regimens and and 3.2% on INSTIs-based regimens (P < 0.001). INSTIs-based regimens demonstrated a protective effect against LLV events (aHR = 0.27, 95% CI 0.137-0.532). VF events occurred in 10.9% of patients on PIs-based regimens and 2.0% on INSTIs-based regimens, respectively (P < 0.001). The occurrence of LLV events significantly increased the risk of VF by 123.5% (95% CI 7.5%-364.4%), while the integrase inhibitors were associated with a 76.9% (95% CI 59.1%-86.9%) reduction in VF risk.
CONCLUSIONS: Our findings indicate that INSTIs-based regimens are critical protective factors against LLV and subsequent VF. These results underscore the importance of HIV viral load monitoring to ensuring effective treatment outcomes, highlighting the necessity for prompt and precise monitoring to refine HIV treatment methodologies.
摘要：
背景：低水平病毒血症（LLV）已被确定为病毒学失败（VF）的潜在前兆，然而它的临床意义，特别是在基于整合酶链转移抑制剂（INSTIs）的方案中，仍然没有充分的探索。该研究旨在调查中国基于INSTIs的方案的ART初治患者中LLV和VF之间的关系。
方法：对北京地坛医院年龄≥18岁的ART初治患者进行纵向队列研究，根据中国国家免费抗逆转录病毒治疗计划（NFATP）。LLV定义为ART开始六个月后50至199拷贝/mL的病毒载量（VL）。VF为VL≥200拷贝/mL。还进行了敏感性分析，将LLV定义为50-999个拷贝/mL，将VF定义为超过1000个拷贝/mL。多元逻辑回归，Kaplan-Meier(KM)曲线,和广义估计方程（GEE）模型用于评估与LLV和VF事件相关的危险因素。
结果：该研究涉及830名未接受ART治疗的患者，在INSTIs组中包含600个，在蛋白酶抑制剂（PI）组中包含230个。在基于PIs的方案和基于INSTIs的方案中，有10.4％的患者观察到LLV事件（P<0.001）。基于INSTIs的方案对LLV事件具有保护作用（aHR=0.27，95％CI0.137-0.532）。在基于PI的方案和基于INSTIs的方案中，有10.9%的患者发生VF事件，有2.0%的患者发生VF事件。分别(P<0.001)。LLV事件的发生显着增加了VF的风险123.5％（95％CI7.5％-364.4％），而整合酶抑制剂与VF风险降低76.9%(95%CI59.1%-86.9%)相关.
结论：我们的研究结果表明，基于INSTIs的方案是对抗LLV和随后VF的关键保护因素。这些结果强调了HIV病毒载量监测对确保有效治疗结果的重要性。强调需要进行及时和精确的监测，以完善艾滋病毒治疗方法。
方法：对北京地坛医院年龄≥18岁的ART初治患者进行纵向队列研究，根据中国国家免费抗逆转录病毒治疗计划（NFATP）。LLV定义为ART开始六个月后50至199拷贝/mL的病毒载量（VL）。VF为VL≥200拷贝/mL。还进行了敏感性分析，将LLV定义为50-999个拷贝/mL，将VF定义为超过1000个拷贝/mL。多元逻辑回归，Kaplan-Meier(KM)曲线,和广义估计方程（GEE）模型用于评估与LLV和VF事件相关的危险因素。
结果：该研究涉及830名未接受ART治疗的患者，在INSTIs组中包含600个，在蛋白酶抑制剂（PI）组中包含230个。在基于PIs的方案和基于INSTIs的方案中，有10.4％的患者观察到LLV事件（P<0.001）。基于INSTIs的方案对LLV事件具有保护作用（aHR=0.27，95％CI0.137-0.532）。在基于PI的方案和基于INSTIs的方案中，有10.9%的患者发生VF事件，有2.0%的患者发生VF事件。分别(P<0.001)。LLV事件的发生显着增加了VF的风险123.5％（95％CI7.5％-364.4％），而整合酶抑制剂与VF风险降低76.9%(95%CI59.1%-86.9%)相关.
结论：我们的研究结果表明，基于INSTIs的方案是对抗LLV和随后VF的关键保护因素。这些结果强调了HIV病毒载量监测对确保有效治疗结果的重要性。强调需要进行及时和精确的监测，以完善艾滋病毒治疗方法。
