Unit of Infectious Diseases, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
Infectious and Tropical Diseases Unit, Padua University Hospital, Padua, Italy.
J Acquir Immune Defic Syndr. 2023 Nov 1;94(3):235-243. doi: 10.1097/QAI.0000000000003248.
Few data are available about the efficacy, durability, and tolerability of doravirine (DOR) + integrase strand inhibitors (INI) as a switching strategy among antiretroviral therapy (ART)-experienced people living with HIV (PLWH).
Retrospective, multicenter cohort study investigating the durability, efficacy, and tolerability of 2 off-label drug associations of DOR + INI among ART-experienced PLWH.
The study included PLWH who switched to DOR combined with either raltegravir (RAL) or dolutegravir (DTG) between June 1, 2020, and December 31, 2021, with at least 1 follow-up (FU) visit. Virologic, biometric, and metabolic parameters were evaluated at baseline (T0) and at 1-3 (T1), 6 (T2), and 12 (T3) months. Univariate and multivariate survival analyses assessed the 28-week probability of persistence on the regimens. Patient satisfaction was measured using the HIV Treatment Satisfaction Questionnaire.
Ninety-five PLWH were included, 52 in DOR + RAL and 43 in DOR + DTG. Six treatment discontinuations were reported during a mean of 37 (±17) weeks of FU (incidence of 2.7 × 1000 person-weeks FU). Only 2 were the result of virological failure without resistance mutations. DOR + DTG demonstrated significantly higher 28-week persistence than DOR + RAL (HR 1.90, 95% CI: 1.24-2.90, log-rank: P = 0.003). Weight, waist circumference, and fasting lipids reduced considerably at T3 vs T0. Overall, high satisfaction with the new treatment was reported, particularly in the DOR + RAL (68 (64-72)/72), compared with the DOR + DTG group (58 (50-65)/72, P < 0.001).
Our experience revealed few treatment discontinuations, improved metabolic parameters, and high patient satisfaction among ART-experienced PLWH switching to DOR combined with INI, irrespective of the specific INI used.
关于达芦那韦（DOR）+整合酶抑制剂（INI）作为艾滋病毒（HIV）感染者接受抗逆转录病毒治疗（ART）经验者的转换策略的疗效、持久性和耐受性的数据很少。
回顾性、多中心队列研究，调查 2 种 DOR+INI 非标签药物联合在 ART 经验丰富的 HIV 感染者中的持久性、疗效和耐受性。
该研究纳入了 2020 年 6 月 1 日至 2021 年 12 月 31 日期间转换为 DOR 联合拉替拉韦（RAL）或多替拉韦（DTG）的至少有 1 次随访（FU）的 ART 经验丰富的 PLWH。在基线（T0）和 1-3 个月（T1）、6 个月（T2）和 12 个月（T3）时评估病毒学、生物计量和代谢参数。单变量和多变量生存分析评估了方案 28 周的持续率。使用 HIV 治疗满意度问卷测量患者满意度。
共纳入 95 例 PLWH，其中 52 例在 DOR+RAL 组，43 例在 DOR+DTG 组。在平均 37（±17）周的 FU 期间报告了 6 例治疗中断（FU 发生率为 2.7×1000人周）。只有 2 例是由于没有耐药突变的病毒学失败导致的。DOR+DTG 与 DOR+RAL 相比，28 周的持续率显著更高（HR 1.90，95%CI：1.24-2.90，对数秩：P=0.003）。与 T0 相比，T3 时体重、腰围和空腹血脂显著降低。总体而言，新治疗的满意度很高，特别是在 DOR+RAL 组（68（64-72）/72），与 DOR+DTG 组（58（50-65）/72，P<0.001）。
我们的经验表明，ART 经验丰富的 PLWH 转换为 DOR 联合 INI 治疗，无论使用何种特定的 INI，治疗中断率较低，代谢参数改善，患者满意度高。
