新加坡（SEALS）研究中，对病毒学抑制的 HIV-1 个体切换使用阿巴卡韦/拉米夫定联合利匹韦林进行维持治疗的安全性和有效性。

Safety and effectiveness of switching to Abacavir/Lamivudine plus rilpivirine for maintenance therapy in virologically suppressed HIV-1 individuals in Singapore (SEALS).

机构信息

Department of Pharmacy, Ng Teng Fong General Hospital, Singapore, Singapore.

Department of Pharmacy, National Centre of Infectious Diseases, Singapore, Singapore.

出版信息

AIDS Res Ther. 2021 Nov 1;18(1):80. doi: 10.1186/s12981-021-00402-7.

DOI:10.1186/s12981-021-00402-7

PMID:34724931

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8561921/

Abstract

BACKGROUND

The efficacy and tolerability of an antiretroviral regimen are important considerations for selection of HIV-1 infection maintenance therapy. Abacavir/lamivudine plus rilpivirine (ABC/3TC + RPV) has been shown in international studies to be effective and well-tolerated in virologically suppressed individuals. This study evaluated the effectiveness and safety of switching to ABC/3TC + RPV as maintenance therapy in virologically suppressed HIV-1 infected individuals in Singapore.

METHODS

In this retrospective, single-centre study, we included individuals who were prescribed ABC/3TC + RPV, had HIV-1 viral load (VL) < 50 copies/ml immediately pre-switch, and had no documented history of resistance mutations or virologic failure to any of the components. The follow-up period was 48 ± 12 weeks. The primary outcome was the proportion of individuals who maintained virologic suppression of HIV-1 VL < 50 copies/ml at the end of follow-up period based on on-treatment analysis. The secondary outcomes were the resistance profiles associated with virologic failure, changes in immunologic and metabolic parameters, and the safety profile of ABC/3TC + RPV.

RESULTS

A total of 222 individuals were included in the study. The primary outcome was achieved in 197 individuals [88.8%, 95% confidence interval: 83.7-92.4%]. There were 21 individuals (9.5%) who discontinued treatment for non-virologic reasons. The remaining 4 individuals experienced virologic failure, of whom, 3 of these individuals had developed emergent antiretroviral resistance and had HIV-1 VL > 500 copies/ml at the end of the 48 ± 12 weeks follow-up period. The remaining individual experienced sustained low level viremia and subsequently achieved viral suppression without undergoing resistance testing. A total of 49 adverse events were observed in 31 out of 222 individuals (14.0%), which led to 13 individuals discontinuing therapy. Neuropsychiatric adverse events were most commonly observed (53.1%). A statistically significant increase in CD4 was observed (p < 0.01), with a median absolute change of 31 cells/uL (interquartile range: - 31.50 to 140.75). No significant changes in lipid profiles were detected.

CONCLUSION

ABC/3TC + RPV is a safe and effective switch option for maintenance therapy in virologically suppressed HIV-1 individuals with in Singapore.

摘要

背景

抗逆转录病毒疗法的疗效和耐受性是选择 HIV-1 感染维持治疗的重要考虑因素。在国际研究中，已证明阿巴卡韦/拉米夫定加利匹韦林（ABC/3TC+RPV）在病毒学抑制的个体中有效且耐受良好。本研究评估了在新加坡病毒学抑制的 HIV-1 感染者中转换为 ABC/3TC+RPV 作为维持治疗的有效性和安全性。

方法

在这项回顾性、单中心研究中，我们纳入了接受 ABC/3TC+RPV 治疗、转换前 HIV-1 病毒载量（VL）<50 拷贝/ml 且无耐药突变或任何成分病毒学失败记录的个体。随访期为 48±12 周。主要结局是根据治疗期间分析，在随访期末维持 HIV-1 VL<50 拷贝/ml 的个体比例。次要结局是与病毒学失败相关的耐药谱、免疫和代谢参数的变化以及 ABC/3TC+RPV 的安全性。

结果

共有 222 名个体纳入研究。197 名个体（88.8%，95%置信区间：83.7-92.4%）达到主要结局。21 名个体（9.5%）因非病毒学原因停止治疗。其余 4 名个体发生病毒学失败，其中 3 名个体出现新的抗逆转录病毒耐药，在 48±12 周随访期末 HIV-1 VL>500 拷贝/ml。其余 1 名个体出现持续低水平病毒血症，随后在未进行耐药检测的情况下实现病毒抑制。222 名个体中观察到 49 例不良事件（14.0%），导致 13 名个体停药。最常见的是神经精神不良事件（53.1%）。观察到 CD4 计数显著增加（p<0.01），中位数绝对变化为 31 个细胞/μL（四分位距：-31.50 至 140.75）。未检测到脂质谱的显著变化。