Jaeckle M, Khaykin P, Haberl A, De Leuw P, Schüttfort G, Stephan C, Wolf T
HIV Center, Department of Infectious Diseases, University Hospital, Frankfurt, Germany
MainFachArzt, Specialist Practice for Infectious Diseases and Primary Care, Frankfurt, Germany.
Int J STD AIDS. 2016 Nov;27(13):1170-1179. doi: 10.1177/0956462415610678. Epub 2015 Oct 1.
Raltegravir is one of the standard antiretroviral therapy (ART) options in treatment-experienced and -naïve patients. However, efficacy data from clinical practice are scarce. Therefore, the efficacy of raltegravir-containing ART in clinical practice was investigated retrospectively. In all, 295 treatment-naïve and -experienced patients were analysed using two different cut-offs for virological failure (200 or 50 copies/ml). The response at week 24 and onwards was evaluated as a 'time to loss of virological response' analysis and estimated as a survival function. Additionally, dual therapy regimens (raltegravir plus boosted protease inhibitor) were compared to standard combinations in experienced patients performing a snapshot analysis at weeks 24 and 48, as well as a time to loss of virological response analysis. A total of 86.2% of the 64 treatment-naïve patients maintained virological suppression using a cut-off of 200 copies/ml (c/ml), while 67.7% maintained virological suppression with a 50 copies/ml cut-off from week 24 until the end of observation. Among the 231 treatment-experienced patients, 84.8% maintained virological suppression from week 24 onwards using a cut-off of 200 copies/ml; and 71.0% using 50 copies/ml, respectively. In the subgroup snapshot analysis at week 24, 98.3% (86.7% using a cut-off of 50 copies/ml) and at week 48, 93.3% (80.0%) of patients responded to dual therapy. Patients who were receiving a standard background therapy responded in 88.3% (81.3%) at week 24 and in 86.0% (80.7%) at week 48. Differences were not significant. This study shows again the overall long-term efficacy of raltegravir-based ART and furthermore gives reference for a comparable efficacy of dual and standard nucleos(t)ide reverse transcriptase inhibitor-backbone regimens in experienced patients on raltegravir over a period of 48 weeks in a real-life cohort where patients with severe comorbidities were included.
拉替拉韦是治疗经验丰富和初治患者标准抗逆转录病毒疗法(ART)的选择之一。然而,临床实践中的疗效数据稀缺。因此,对临床实践中含拉替拉韦的ART疗效进行了回顾性研究。总共对295例初治和经治患者进行了分析,采用了两种不同的病毒学失败临界值(200或50拷贝/毫升)。将第24周及之后的反应评估为“病毒学反应丧失时间”分析,并估计为生存函数。此外,在24周和48周进行了快照分析以及病毒学反应丧失时间分析,将双药治疗方案(拉替拉韦加增效蛋白酶抑制剂)与经治患者的标准联合方案进行了比较。64例初治患者中,总共86.2%的患者使用200拷贝/毫升(c/ml)的临界值维持病毒学抑制,而从第24周直至观察结束,67.7%的患者使用50拷贝/毫升的临界值维持病毒学抑制。在231例经治患者中,从第24周起,分别有84.8%和71.0%的患者使用200拷贝/毫升和50拷贝/毫升的临界值维持病毒学抑制。在第24周的亚组快照分析中,双药治疗的患者反应率为98.3%(使用50拷贝/毫升临界值时为86.7%),在第48周为93.3%(80.0%)。接受标准背景治疗的患者在第24周的反应率为88.3%(81.3%),在第48周为86.0%(80.7%)。差异不显著。这项研究再次显示了基于拉替拉韦的ART的总体长期疗效,此外还为在一个纳入了严重合并症患者的真实队列中,经治患者使用拉替拉韦治疗48周期间双药和标准核苷(酸)逆转录酶抑制剂主干方案的可比疗效提供了参考。