Shafran Stephen D, Hughes Christine A
Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Alberta, Canada.
HIV Med. 2023 Mar;24(3):361-365. doi: 10.1111/hiv.13376. Epub 2022 Aug 16.
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is approved for treatment of HIV without known resistance to its components. Several studies have demonstrated efficacy of B/F/TAF in patients with nucleoside reverse transcriptase inhibitor (NRTI) resistance-associated mutations (RAMs), mainly identified by proviral DNA testing, but data on the efficacy of B/F/TAF in patients with NRTI RAMs identified in viraemic plasma are limited.
We used a retrospective analysis of patients receiving B/F/TAF identified by searching electronic health records with eligibility confirmed by review of individual patient records. Patients included were ≥ 18 years, had 2019 International Antiviral Socitey-USA (IAS-USA) major RAMs affecting NRTIs detected in viraemic plasma prior to starting B/F/TAF and one or more HIV viral load (VL) after starting B/F/TAF.
In all, 50 patients met the study criteria: mean age of 54 years, mean proximal CD4 count of 609 cells/μL, 64% male. A total of 46 were virologically suppressed (< 200 copies/mL) when B/F/TAF was initiated, two were treatment-naïve, one stopped prior antiretroviral therapy (ART) and one had a VL of 961 HIV-1 RNA copies/mL on ART. Twenty-nine had one NRTI RAM (24 were M184V/I), nine had two NRTI RAMs, three had three NRTI RAMs, four had four NRTI RAMs, two had five NRTI RAMs, one had six NRTI RAMs, one had seven RAMs and one had eight NRTI RAMs. At the last VL on B/F/TAF, a mean of 18.6 months after starting B/F/TAF, 49 out of 50 had VL < 100 copies/mL and one had a VL of 208 copies/mL at 11 months but only filled 5 months of B/F/TAF.
B/F/TAF was effective in maintaining HIV VL suppression in patients with previously documented NRTI RAMs without integrase resistance.
比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（B/F/TAF）已被批准用于治疗对其成分无已知耐药性的HIV患者。多项研究已证明B/F/TAF在伴有核苷类逆转录酶抑制剂（NRTI）耐药相关突变（RAMs）的患者中具有疗效，这些突变主要通过原病毒DNA检测确定，但关于B/F/TAF在病毒血症血浆中检测到的NRTI RAMs患者中的疗效数据有限。
我们对通过搜索电子健康记录确定接受B/F/TAF治疗的患者进行回顾性分析，并通过查阅个体患者记录确认其符合纳入标准。纳入的患者年龄≥18岁，在开始B/F/TAF治疗前，病毒血症血浆中检测到影响NRTI的2019年美国国际抗病毒学会（IAS-USA）主要RAMs，且在开始B/F/TAF治疗后有一次或多次HIV病毒载量（VL）检测结果。
共有50名患者符合研究标准：平均年龄54岁，CD4细胞计数近端平均值为609个/μL，男性占64%。开始使用B/F/TAF时，共有46例患者病毒学抑制（<200拷贝/mL），2例为初治患者，1例停止了先前的抗逆转录病毒治疗（ART），1例在接受ART时病毒载量为961 HIV-1 RNA拷贝/mL。29例患者有一个NRTI RAM（24例为M184V/I），9例有两个NRTI RAM，3例有三个NRTI RAM，4例有四个NRTI RAM，2例有五个NRTI RAM，1例有六个NRTI RAM，1例有七个RAM，1例有八个NRTI RAM。在B/F/TAF治疗的最后一次病毒载量检测时，即开始B/F/TAF治疗后平均18.6个月，50例患者中有49例病毒载量<100拷贝/mL，1例在11个月时病毒载量为208拷贝/mL，但仅服用了五个月的B/F/TAF。
B/F/TAF在维持先前记录有NRTI RAMs且无整合酶耐药的患者的HIV病毒载量抑制方面有效。
