Department of Molecular Medicine, University of Padova, Via Gabelli, 63, 35100 Padova, Italy.
Infectious Diseases Unit, Vicenza Hospital, 36100 Vicenza, Italy.
Viruses. 2023 Aug 12;15(8):1727. doi: 10.3390/v15081727.
Switching to bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) from other antiretroviral regimens is safe and effective for virologically suppressed people living with HIV (PLWH). The term virological suppression includes both low but detectable HIV viremia and undetectable HIV viremia, and the latter is possibly associated with a lower immune activation state. Herein, we describe a 24-month follow-up of experienced PLWH with plasma HIV RNA undetectable or detectable < 50 copies/ml switching to BIC/FTC/TAF. A previous 12-month monitoring was available, and the factors correlated with treatment efficacy. This retrospective multicenter study included PLWH who switched to BIC/FTC/TAF in the period of 2019-2022, and who were HBsAg and HCV RNA negative. The follow-up study times were 6 (T6), 12 (T12), 18 (T18), and 24 (T24) months after the switch (T0). Survival analysis with multiple-failure-per-subject design, Kaplan-Meier survival estimates, multivariate analysis of variance, multilevel linear regression, and a hierarchical ordered logistic model were applied. A total of 329 PLWH had plasma HIV RNA which was either undetectable or detectable at <50 copies/mL at T0, and 197 responded to all inclusion criteria: M/F 140/57; the median CD4+ cell count was 677 cells/mm; and HIV RNA at T0 was undetectable in 108 patients. Most of the 197 patients (122, 61.9%) were on a previous INSTI-based regimen. HIV RNA undetectability was more frequent at each follow-up point in patients with HIV RNA that was undetectable at T0, and it showed a higher frequency throughout the follow-up period in patients with always-undetectable HIV RNA in the 12 months before the switch. A higher nadir CD4 cell count had a predictive role, and HBcAb positivity had no influence. In conclusion, the switch could be programmed and possibly delayed on a case-by-case basis in order to achieve persistent plasma HIV RNA undetectability. Undiagnosed loss of HBcAb has no detrimental consequences on the response to BIC/FTC/TAF.
将其他抗逆转录病毒方案转换为比替拉韦、恩曲他滨和替诺福韦艾拉酚胺（BIC/FTC/TAF）对于病毒学抑制的 HIV 感染者（PLWH）是安全有效的。病毒学抑制包括低但可检测到的 HIV 病毒载量和不可检测到的 HIV 病毒载量，后者可能与较低的免疫激活状态相关。在此，我们描述了一项为期 24 个月的经验丰富的 PLWH 随访研究，这些患者的血浆 HIV RNA 不可检测或可检测到 <50 拷贝/ml，转换为 BIC/FTC/TAF。之前有 12 个月的监测数据，并对与治疗效果相关的因素进行了分析。这项回顾性多中心研究纳入了 2019 年至 2022 年期间转换为 BIC/FTC/TAF 的 PLWH，且 HBsAg 和 HCV RNA 均为阴性。随访研究时间为转换后 6（T6）、12（T12）、18（T18）和 24（T24）个月（T0）。采用多因素失效模型下的生存分析、Kaplan-Meier 生存估计、方差分析、多层次线性回归和层次有序逻辑模型。共有 329 名 PLWH 在 T0 时的血浆 HIV RNA 不可检测或可检测到 <50 拷贝/ml，其中 197 名符合所有纳入标准：M/F 140/57；中位 CD4+细胞计数为 677 个细胞/mm；108 名患者 T0 时 HIV RNA 不可检测。197 名患者中的大多数（122 名，61.9%）之前接受过 INSTI 为基础的治疗方案。在 T0 时 HIV RNA 不可检测的患者中，每个随访点的 HIV RNA 不可检测率更高，在转换前 12 个月内 HIV RNA 始终不可检测的患者中，整个随访期间的 HIV RNA 不可检测率更高。较低的 CD4 细胞计数最低点具有预测作用，HBcAb 阳性无影响。总之，为了实现持续的血浆 HIV RNA 不可检测，可以根据具体情况对方案进行规划和可能的延迟。未诊断的 HBcAb 丢失对 BIC/FTC/TAF 的反应没有不利影响。
