Mounzer Karam, Osterman Michael D, Brunet Laurence, Hsu Ricky K, Pierone Gerald, Fusco Jennifer S, Prata Menezes Neia, Gruber Joshua, Lim Travis, Dunbar Megan, Fusco Gregory P
Philadelphia FIGHT Community Health Centers, Philadelphia, PA, USA.
Epividian, Inc., Raleigh, NC, 27601, USA.
AIDS Res Ther. 2025 Jul 21;22(1):71. doi: 10.1186/s12981-025-00769-x.
Despite advancements in antiretroviral therapy (ART) for people with HIV, barriers to adherence remain, potentially leading to long-term gaps in adherence known as treatment interruptions. These treatment interruptions are associated with viral rebound and can impact the effectiveness of the subsequent regimen and the long-term health of the individual. We aimed to characterize unplanned ART treatment interruptions in the OPERA cohort and investigate virologic outcomes among individuals who resumed treatment with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).
We identified adults with HIV-1 who were active in care and on an oral ART regimen with ≥ 2 antiretrovirals, including ≥ 1 anchor agent, between 30JUN2021 and 31AUG2023. Individuals with ≥ 1 period of ≥ 45 days without any ART, based on supply from last prescription, were considered to have experienced a treatment interruption. Individuals who resumed treatment by 31AUG2023 were defined as having experienced a treatment interruption with resumption. Each interruption observed during the study period was described, allowing for multiple interruptions per person. Treatment interruptions, pre-interruption regimens, and post-interruption regimens were described. Among individuals who resumed treatment with B/F/TAF, virologic outcomes were investigated through 29FEB2024 using Kaplan-Meier methods. All analyses were repeated with treatment interruption definitions of ≥ 60 and ≥ 90 days.
Of 76,883 people for whom a treatment interruption could be observed, 8,550 (11%) experienced ≥ 1 period of ≥ 45 days without any ART. By 31AUG2023, 4,163 (49%) individuals resumed treatment (mean: 1.25 per person) and were included in the study population. The median age was 44 years, 81% were male, 52% Black, 41% White, and 18% Hispanic. Median time since HIV diagnosis was 118 months. B/F/TAF was the most common pre- and post-interruption regimen (49% and 51%, respectively). The cumulative probability of achieving virologic suppression on B/F/TAF was 68% (95% CI: 57, 78) when the viral load measurement was ≥ 200 copies/mL at resumption.
Treatment interruptions occurred in 11% of ART users in routine clinical care during the 26-month study period. Despite treatment interruption increasing the risk for viral rebound, most individuals who resumed treatment with B/F/TAF were able to achieve virologic suppression or avoid virologic failure.
尽管针对艾滋病毒感染者的抗逆转录病毒疗法（ART）取得了进展，但坚持治疗仍存在障碍，这可能导致长期的治疗中断，即依从性出现差距。这些治疗中断与病毒反弹相关，并可能影响后续治疗方案的有效性以及个体的长期健康。我们旨在描述OPERA队列中计划外的ART治疗中断情况，并调查重新使用比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（B/F/TAF）进行治疗的个体的病毒学结局。
我们确定了在2021年6月30日至2023年8月31日期间接受治疗且正在服用包含≥2种抗逆转录病毒药物（包括≥1种核心药物）的口服ART方案的HIV-1成人感染者。根据最后一次处方的用药情况，连续≥45天未服用任何ART的个体被视为经历了一次治疗中断。在2023年8月31日前重新开始治疗的个体被定义为经历了治疗中断并已恢复治疗。描述了研究期间观察到的每一次中断情况，允许每人有多次中断。描述了治疗中断情况、中断前的治疗方案和中断后的治疗方案。在重新使用B/F/TAF进行治疗的个体中，使用Kaplan-Meier方法调查至2024年2月29日的病毒学结局。所有分析均采用≥≥60天和≥90天的治疗中断定义重复进行。
在76,883名可观察到治疗中断情况的个体中，8,550名（11%）经历了至少1次连续≥45天未服用任何ART的情况。截至2023年8月31日，4,163名（49%）个体重新开始治疗（平均每人1.25次）并被纳入研究人群。中位年龄为44岁，81%为男性，52%为黑人，41%为白人，18%为西班牙裔。自HIV诊断以来的中位时间为118个月。B/F/TAF是中断前和中断后最常用的治疗方案（分别为49%和51%）。重新开始治疗时病毒载量测量值≥200拷贝/mL的个体中，使用B/F/TAF实现病毒学抑制的累积概率为68%（95%CI：57, 78）。
在为期26个月的研究期间，常规临床护理中11%的ART使用者出现了治疗中断。尽管治疗中断增加了病毒反弹的风险，但大多数重新使用B/F/TAF进行治疗的个体能够实现病毒学抑制或避免病毒学失败。
