在中国广东,治疗前的耐药性可能会影响初治hiv -1感染患者96周抗逆转录病毒治疗的疗效

P. Guo, Y. Lan, Quanmin Li, X. Ling, Junbin Li, Xiaoping Tang, F. Hu, W. Cai, Linghua Li
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The rate of HIV-1 virologic failure (VF) and CD4+ T-cell counts of the 2 arms were compared at the 96th week after ART to evaluate the impact of PDR on the efficacy of ART. Results Pretreatment drug resistance was detected in 125 cases (6.46%) from the 1936 enrolled participants, most of which were resistant to non-nucleoside reverse transcriptase inhibitors (64.00%, 80/125). One hundred and eight of 125 completed the follow-up of 96 weeks (PDR arm). In this cohort, 52 patients whose ART regimen containing the resistant drug were grouped as con-PDR arm, and the remaining 56 patients whose ART regimen did not contain the resistant drug were grouped as non- con-PDR arm. A total of 125 patients without PDR were randomly selected as the control group (non-PDR arm), 112 of whom had completed the 96-week follow-up. At the 96th week after ART initiation, 7 patients (6.5%, 7/108) in the PDR arm and 1 patient (0.9%, 1/112) in the non-PDR arm developed VF, exhibiting a significant difference (χ2 = 4.901, P = 0.029). Meanwhile, 3 patients (5.8%, 3/52) in the con-PDR arm developed VF; the rate was also higher than that in the non-PDR arm, but without a significant difference (χ2 = 3.549, P = 0.095). The CD4+ T-cell count in the non-PDR arm increased more than the PDR arm (386.6 vs. 319.1 cells/μL, t = 2.448, P = 0.015) or the con-PDR arm (386.6 vs. 325.1 cells/μL, t = 1.821, P = 0.070) at 12 weeks after ART. However, no significant differences were observed in the CD4+ T-cell count from the 24th week after ART onward. 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引用次数: 0

摘要

摘要背景治疗前耐药(pre- drug resistant, PDR)的高发及对病毒学抑制的潜在影响,使得PDR的检测显得尤为必要。本研究旨在确定PDR在中国广东的流行情况及其对初次接受治疗的HIV患者抗逆转录病毒治疗(ART)的影响。方法采用回顾性队列研究。对2018年8月至2019年12月在广州第八人民医院感染科门诊接受治疗的1936例hiv -1感染患者在开始抗逆转录病毒治疗前进行了PDR突变检测。筛选PDR突变患者(PDR组)并与无耐药突变患者(非PDR组)进行比较。在ART治疗后第96周比较两组患者HIV-1病毒学失败率(VF)和CD4+ t细胞计数,以评价PDR对ART疗效的影响。结果1936例受试者中有125例(6.46%)检测到预处理耐药,其中大部分对非核苷类逆转录酶抑制剂耐药(64.00%,80/125)。125例中有108例完成了96周的随访(PDR组)。在该队列中,52例ART方案中含有耐药的患者被分为con-PDR组,其余56例ART方案中不含有耐药的患者被分为non- con-PDR组。随机选择125例无PDR的患者作为对照组(非PDR组),其中112例完成了96周的随访。开始ART治疗后第96周,PDR组7例(6.5%,7/108)、非PDR组1例(0.9%,1/112)发生VF,差异有统计学意义(χ2 = 4.901, P = 0.029)。非pdr组3例(5.8%,3/52)发生VF;P = 0.095,差异无统计学意义(χ2 = 3.549)。在ART治疗后12周,非PDR组CD4+ t细胞计数高于PDR组(386.6 vs. 319.1 cells/μL, t = 2.448, P = 0.015)或con-PDR组(386.6 vs. 325.1 cells/μL, t = 1.821, P = 0.070)。然而,从抗逆转录病毒治疗后第24周开始,CD4+ t细胞计数没有明显差异。结论在96周的观察期内,广东地区预处理耐药普遍存在,并可能影响抗逆转录病毒治疗的疗效,提示在开始抗逆转录病毒治疗前应密切监测PDR。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pre-treatment Drug Resistance Could Impact the 96-Week Antiretroviral Efficacy in Treatment-Naive HIV-1–Infected Patients in Guangdong, China
Abstract Background With the high prevalence of pre-treatment drug resistance (PDR) and the potential impact to the virological inhibition, the detection of PDR was particularly necessary. This study aimed to determine the prevalence of PDR in Guangdong, China, and its impact on antiretroviral therapy (ART) in treatment-naive HIV patients. Methods A retrospective cohort study was conducted. A total of 1936 HIV-1–infected treatment-naive patients in the clinic of the infectious department, Guangzhou Eighth People’s Hospital, between August 2018 and December 2019 were assayed for PDR mutations before initiating ART. Patients with PDR mutations (PDR arm) were screened and compared with those without drug-resistant mutations (non-PDR arm). The rate of HIV-1 virologic failure (VF) and CD4+ T-cell counts of the 2 arms were compared at the 96th week after ART to evaluate the impact of PDR on the efficacy of ART. Results Pretreatment drug resistance was detected in 125 cases (6.46%) from the 1936 enrolled participants, most of which were resistant to non-nucleoside reverse transcriptase inhibitors (64.00%, 80/125). One hundred and eight of 125 completed the follow-up of 96 weeks (PDR arm). In this cohort, 52 patients whose ART regimen containing the resistant drug were grouped as con-PDR arm, and the remaining 56 patients whose ART regimen did not contain the resistant drug were grouped as non- con-PDR arm. A total of 125 patients without PDR were randomly selected as the control group (non-PDR arm), 112 of whom had completed the 96-week follow-up. At the 96th week after ART initiation, 7 patients (6.5%, 7/108) in the PDR arm and 1 patient (0.9%, 1/112) in the non-PDR arm developed VF, exhibiting a significant difference (χ2 = 4.901, P = 0.029). Meanwhile, 3 patients (5.8%, 3/52) in the con-PDR arm developed VF; the rate was also higher than that in the non-PDR arm, but without a significant difference (χ2 = 3.549, P = 0.095). The CD4+ T-cell count in the non-PDR arm increased more than the PDR arm (386.6 vs. 319.1 cells/μL, t = 2.448, P = 0.015) or the con-PDR arm (386.6 vs. 325.1 cells/μL, t = 1.821, P = 0.070) at 12 weeks after ART. However, no significant differences were observed in the CD4+ T-cell count from the 24th week after ART onward. Conclusions Pretreatment drug resistance was moderately prevalent in Guangdong, China, and could affect the antiretroviral efficacy during a 96-week observation period, indicating the need to closely monitor PDR before ART initiation.
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