De La Mata Nicole L, Cooper David A, Russell Darren, Smith Don, Woolley Ian, Sullivan Maree O, Wright Stephen, Law Matthew
Sex Health. 2016 Apr 21. doi: 10.1071/SH15210.
Integrase inhibitors (INSTI) are a newer class of antiretroviral (ARV) drugs that offer additional treatment options for experienced patients. Our aim is to describe treatment durability and virological outcomes in treatment-experienced HIV-positive patients using INSTI-based regimens. All patients in the Australian HIV Observational Database who had received an INSTI-based regimen ≥ 14 days as well as previous therapy were included in the study. We defined two groups of treatment-experienced patients: (1) those starting a second-line regimen with INSTI; and (2) highly experienced patients, defined as having prior exposure to all three main ARV classes, nucleoside reverse transcriptase inhibitor, nonnucleoside reverse transcriptase inhibitors and protease inhibitors, before commencing INSTI. Survival methods were used to determine time to viral suppression and treatment switch, stratified by patient treatment experience. Covariates of interest included age, gender, hepatitis B and C co-infection, previous antiretroviral treatment time, patient treatment experience and baseline viral load. Time to viral suppression and regimen switching from INSTI initiation was similar for second-line and highly experienced patients. The probability of achieving viral suppression at 6 months was 77.7% for second-line patients and 68.4% for highly experienced patients. There were 60 occurrences of regimen switching away from INSTI observed over 1274.0 person-years, a crude rate of 4.71 (95% CI: 3.66-6.07) per 100 person-years. Patient treatment experience was not a significant factor for regimen switch according to multivariate analysis, adjusting for relevant covariates. We found that INSTI-based regimens were potent and durable in experienced HIV-positive patients receiving treatment outside clinical trials. These results confirm that INSTI-based regimens are a robust treatment option.
整合酶抑制剂(INSTI)是一类新型抗逆转录病毒(ARV)药物,为有治疗经验的患者提供了更多治疗选择。我们的目的是描述使用基于INSTI的方案治疗有治疗经验的HIV阳性患者的治疗持久性和病毒学结果。澳大利亚HIV观察数据库中所有接受基于INSTI的方案≥14天以及先前治疗的患者均纳入研究。我们将有治疗经验的患者分为两组:(1)开始使用INSTI进行二线治疗的患者;(2)高度有治疗经验的患者,定义为在开始使用INSTI之前曾接触过所有三种主要抗逆转录病毒药物类别,即核苷类逆转录酶抑制剂、非核苷类逆转录酶抑制剂和蛋白酶抑制剂。采用生存方法确定病毒抑制时间和治疗转换时间,并按患者治疗经验分层。感兴趣的协变量包括年龄、性别、乙肝和丙肝合并感染、先前抗逆转录病毒治疗时间、患者治疗经验和基线病毒载量。二线治疗患者和高度有治疗经验的患者从开始使用INSTI到病毒抑制和方案转换的时间相似。二线治疗患者在6个月时实现病毒抑制的概率为77.7%,高度有治疗经验的患者为68.4%。在1274.0人年中观察到有60次从INSTI方案转换,粗发生率为每100人年4.71次(95%CI:3.66-6.07)。根据多变量分析,在调整相关协变量后,患者治疗经验不是方案转换的显著因素。我们发现,在临床试验之外接受治疗的有治疗经验的HIV阳性患者中,基于INSTI的方案有效且持久。这些结果证实基于INSTI的方案是一种可靠的治疗选择。