基于多替拉韦方案的抗逆转录病毒治疗依从性与病毒抑制之间的关联：来自乌干达的一项观察性队列研究。
The association between adherence to antiretroviral therapy and viral suppression under dolutegravir-based regimens: an observational cohort study from Uganda.
机构信息
Center for Economic and Social Research, University of Southern California, Los Angeles, California, USA.
Department of Economics, Sociology and Statistics, RAND Corporation, Santa Monica, California, USA.
出版信息
J Int AIDS Soc. 2024 Aug;27(8):e26350. doi: 10.1002/jia2.26350.
INTRODUCTION
Millions of people living with HIV (PLWH) take oral antiretroviral therapy (ART), which requires a lifetime of consistent medication adherence. The relationship between adherence and poor HIV outcomes is well documented. Newer ART regimens that include dolutegravir (DTG) could be more forgiving, but empirical evidence on the relationship between adherence and viral suppression under DTG is only emerging.
METHODS
In this observational cohort study (secondary analysis of data from a randomized trial), we used data from 313 ART clients from a large HIV clinic in Kampala, Uganda. Over the 4-year study period (January 2018-January 2022), 91% switched from non-DTG regimens to DTG regimens. We measured adherence using Medication Event Monitoring Systems-caps and extracted prescription information and viral load measures from electronic health records. We estimated unadjusted linear regressions and adjusted models that included individual and time fixed-effects.
RESULTS
Under non-DTG regimens, 96% of participants were virally suppressed (defined as viral load < 200 copies/ml) when adherence was 90% or higher in the 3 months before viral load measurement. Viral suppression was 32 percentage points lower when adherence was between 0% and 49% (95% CI -0.44, -0.20, p < 0.01), 12 percentage points lower when adherence was between 50% and 79% (95% CI -0.23, -0.02, p < 0.01), and not significantly different when adherence was between 80% and 89% (effect of 0.00, 95% CI -0.06, 0.07, p = 0.81). In contrast, for participants taking DTG, there was no statistically significant difference in viral suppression among any of the four adherence levels; more than 95% were virally suppressed at each adherence level. On average, switching to DTG increased viral suppression by 6 percentage points in our adjusted models (95% CI 0.00, 0.13, p = 0.03).
CONCLUSIONS
There was no significant association between adherence levels and viral suppression among PLWH taking DTG regimens, suggesting a high degree of forgiveness for missed doses. The use of DTG should be prioritized over older regimens, particularly for those with low adherence.
CLINICAL TRIAL NUMBER
NCT03494777.
简介
数以百万计的艾滋病毒感染者（PLWH）服用口服抗逆转录病毒疗法（ART），这需要终生坚持一致的服药。药物依从性与不良 HIV 结局之间的关系已有充分记录。包含多替拉韦（DTG）的新型 ART 方案可能更宽容，但关于 DTG 下药物依从性与病毒抑制之间关系的经验证据才刚刚出现。
方法
在这项观察性队列研究（随机试验数据的二次分析）中，我们使用了乌干达坎帕拉一家大型艾滋病毒诊所 313 名 ART 患者的数据。在 4 年的研究期间（2018 年 1 月至 2022 年 1 月），91%的患者从非 DTG 方案转为 DTG 方案。我们使用药物事件监测系统帽来衡量药物依从性，并从电子健康记录中提取处方信息和病毒载量测量值。我们估计了未调整的线性回归模型和包括个体和时间固定效应的调整模型。
结果
在非 DTG 方案下，当病毒载量测量前 3 个月的依从性为 90%或更高时，96%的参与者病毒得到抑制（定义为病毒载量<200 拷贝/ml）。当依从性为 0%至 49%时，病毒抑制率降低 32 个百分点（95%CI -0.44，-0.20，p<0.01），当依从性为 50%至 79%时，病毒抑制率降低 12 个百分点（95%CI -0.23，-0.02，p<0.01），而当依从性为 80%至 89%时，病毒抑制率没有显著差异（效果为 0.00，95%CI -0.06，0.07，p=0.81）。相比之下，对于服用 DTG 的参与者，在任何四个依从性水平中，病毒抑制率均无统计学显著差异；每个依从性水平的病毒抑制率都超过 95%。平均而言，在调整后的模型中，转换为 DTG 使病毒抑制率提高了 6 个百分点（95%CI 0.00，0.13，p=0.03）。
结论
在服用 DTG 方案的 PLWH 中，依从性水平与病毒抑制之间没有显著关联，这表明错过了剂量也有很高的宽容度。应优先使用 DTG 替代旧方案，特别是对于那些依从性较低的患者。
临床试验注册号
NCT03494777。
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