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Long-Term Effectiveness of Rilpivirine-Based Single-Tablet Regimens in a Seven-Year, Two-Center Observational Cohort of People Living with HIV
AIDS Research and Human Retroviruses ( IF 1.5 ) Pub Date : 2022-06-06 , DOI: 10.1089/aid.2021.0161
Lucia Taramasso 1 , Sergio Lo Caputo 2 , Laura Magnasco 1 , Federica Briano 3 , Mariacristina Poliseno 2 , Serena Rita Bruno 2 , Sergio Ferrara 2 , Rachele Pincino 3 , Giovanni Sarteschi 3 , Sabrina Beltramini 4 , Elisabetta Sasso 4 , Sara Mora 5 , Mauro Giacomini 5 , Matteo Bassetti 3 , Antonio Di Biagio 3
Affiliation  

Data on the long-term durability of rilpivirine (RPV) are still scarce. A two-center retrospective study was performed, including all people living with HIV (PLWH) treated with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)/RPV or tenofovir alafenamide (TAF)/FTC/RPV in the period January 2013–December 2019. Aims of the study were to assess the rate of discontinuation of the RPV single-tablet regimen (STR) and identify factors associated with the risk of discontinuation according to Cox's regression analysis. A total of 684 PLWH were enrolled. Mean duration of RPV-STR treatment was 192.5 (±99.5) weeks for 123 antiretroviral therapy (ART)-naïve participants (18%) and 173.3 (± 85.6) weeks for 561 ART-experienced study participants (82%). During the study period, the incidence of discontinuation was 7.7 per 100 person-years. The estimated proportions of discontinuation after 48 and 96 weeks were 5.6% and 13.4%, respectively. Causes of discontinuation were loss to follow-up (30%), side effects (15%), ART optimization (14%), virological failure (VF) (12%), death or transfer to another center (9%), low adherence (7%), drug interactions (6%), simplification to dual therapy (3%), and unknown (3%). No differences were observed in cumulative probability of discontinuation between ART-naïve and -experienced PLWH. Heterosexual (hazard ratio [HR] 3.0, 95% confidence interval [CI] 1.4–6.8) and mother-to-child (HR 5.3, 95% CI 1.8–15.3) transmission of HIV infection and history of previous VF (HR 1.7, 95% CI 1.2–2.5) were associated with higher risk of discontinuation. High RPV-STR effectiveness and durability were confirmed in our real-life population of PLWH. Given these data, RPV has the potential to be a drug for life in patients selected according to current guidelines.

中文翻译:

以利匹韦林为基础的单片方案在艾滋病病毒感染者的七年、两中心观察队列中的长期有效性

关于利匹韦林(RPV)长期持久性的数据仍然很少。进行了一项双中心回顾性研究,包括在 2013 年 1 月至 2019 年 12 月期间接受富马酸替诺福韦酯/恩曲他滨 (TDF/FTC)/RPV 或丙酚替诺福韦 (TAF)/FTC/RPV 治疗的所有 HIV 感染者 (PLWH) . 研究的目的是评估 RPV 单片方案 (STR) 的停药率,并根据 Cox 的回归分析确定与停药风险相关的因素。共有 684 名 PLWH 入组。123 名未接受抗逆转录病毒治疗 (ART) 的参与者 (18%) 的 RPV-STR 治疗平均持续时间为 192.5 (±99.5) 周,而 561 名接受过 ART 的研究参与者 (82%) 的平均持续时间为 173.3 (± 85.6) 周。在研究期间,停药的发生率为每 100 人年 7.7 人。48 周和 96 周后停药的估计比例分别为 5.6% 和 13.4%。停药的原因是失访 (30%)、副作用 (15%)、ART 优化 (14%)、病毒学失败 (VF) (12%)、死亡或转移到另一个中心 (9%)、低依从性 (7%)、药物相互作用 (6%)、简化为双重治疗 (3%) 和未知 (3%)。在未接受过抗逆转录病毒治疗和经历过 PLWH 之间的累积终止概率方面没有观察到差异。异性恋(风险比 [HR] 3.0,95% 置信区间 [CI] 1.4-6.8)和母婴(HR 5.3,95% CI 1.8-15.3)传播 HIV 感染和既往 VF(HR 1.7, 95% CI 1.2-2.5)与较高的停药风险相关。在我们现实生活中的 PLWH 人群中证实了高 RPV-STR 有效性和持久性。鉴于这些数据,
更新日期:2022-06-08
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