Revuelta-Herrero José Luis, Chamorro-de-Vega Esther, Rodríguez-González Carmen Guadalupe, Alonso Roberto, Herranz-Alonso Ana, Sanjurjo-Sáez María
1 Pharmacy Department. Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Hospital Gregorio Marañón (IiSGM), Madrid, Spain.
2 Microbiology and Infectious Diseases Department. Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Hospital Gregorio Marañón (IiSGM), Madrid, Spain.
Ann Pharmacother. 2018 Jan;52(1):11-18. doi: 10.1177/1060028017728294. Epub 2017 Aug 24.
Evidence about the use of dolutegravir (DTG) and rilpivirine (RPV) as an antiretroviral therapy (ART) in treatment-experienced patients is scarce.
To explore the effectiveness, safety, and costs of switching to a DTG plus RPV regimen in this population.
This observational, prospective study included all treatment-experienced patients who switched to DTG plus RPV between November 2014 and July 2016. Patients were excluded if resistance mutations to integrase inhibitors or RPV were found. The effectiveness endpoint was the proportion of patients who achieved virological suppression (viral load [VL] <50 copies/mL) at week 48 (W48). Safety (incidence of adverse events leading to discontinuation and laboratory abnormalities), adherence, and costs were analyzed.
A total of 35 patients were included, and 91.4% were virologically suppressed at baseline. Patients were treated with ART for a median of 14 years (interquartile range = 7-20). At W48, 91.4% of patients were virologically suppressed (95% CI = 77.0-98.2). Two of the 3 patients not suppressed at baseline achieved undetectable VL at W48, and 2 patients discontinued DTG plus RPV (intolerance and a drug-drug interaction). None of the virologically suppressed patients at baseline showed virological rebound through W48. There were no significant changes in lipid, liver, and renal profiles. The proportion of patients with an ART adherence >90% increased from 65.6% to 93.8% ( P = 0.004). The annual per-patient ART costs dropped by €665 ( P = 0.265).
Switching to DTG plus RPV seems to be an effective and safe strategy. Significant improvements in patients' adherence and costs were achieved.
关于度鲁特韦（DTG）和利匹韦林（RPV）作为抗逆转录病毒疗法（ART）用于经治患者的证据稀缺。
探讨在该人群中换用DTG加RPV方案的有效性、安全性和成本。
这项观察性前瞻性研究纳入了2014年11月至2016年7月间换用DTG加RPV的所有经治患者。若发现对整合酶抑制剂或RPV的耐药突变，则将患者排除。有效性终点是在第48周（W48）实现病毒学抑制（病毒载量[VL]<50拷贝/毫升）的患者比例。分析了安全性（导致停药的不良事件发生率和实验室异常）、依从性和成本。
共纳入35例患者，91.4%在基线时实现了病毒学抑制。患者接受ART治疗的中位时间为14年（四分位间距=7 - 20）。在W48时，91.4%的患者实现了病毒学抑制（95%CI = 77.0 - 98.2）。3例基线时未实现抑制患者中的2例在W48时病毒载量不可测，2例患者停用DTG加RPV（不耐受和药物相互作用）。基线时病毒学抑制的患者在W48时均未出现病毒学反弹。脂质、肝脏和肾脏指标无显著变化。ART依从性>90%的患者比例从6
