Department of Pharmacy, Ng Teng Fong General Hospital, Singapore, Singapore.
Department of Pharmacy, National Centre of Infectious Diseases, Singapore, Singapore.
AIDS Res Ther. 2021 Nov 1;18(1):80. doi: 10.1186/s12981-021-00402-7.
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.
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.
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.
ABC/3TC + RPV is a safe and effective switch option for maintenance therapy in virologically suppressed HIV-1 individuals with in Singapore.
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。
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。
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。
在新加坡，对于病毒学抑制的 HIV-1 个体，ABC/3TC+RPV 是一种安全有效的维持治疗转换选择。
