Capetti Amedeo Ferdinando, Cossu Maria Vittoria, Sterrantino Gaetana, Barbarini Giorgio, Di Giambenedetto Simona, De Socio Giuseppe Vittorio, Orofino GianCarlo, Di Biagio Antonio, Celesia Benedetto M, Rusconi Stefano, Argenteri Barbara, Rizzardini Giuliano
1 ASST Fatebenefratelli-Sacco, Milano, Italy.
2 Careggi' Hospital, Firenze, Italy.
Ann Pharmacother. 2018 Aug;52(8):740-746. doi: 10.1177/1060028018761600. Epub 2018 Feb 26.
Data from clinical studies confirm the efficacy of switching to dolutegravir (DTG) plus rilpivirine (RPV) in selected patients.
The primary objective is to report the 96-week virological suppression in our cohort, assessing the durability of this strategy in complicated situations. The secondary objective is to describe the safety and metabolic profile.
All patients who had switched to DTG plus RPV between October 1, 2014, and September 30, 2015, were analyzed using a retrospective-prospective design, approved by ethics committees. Routine metabolic, immunological, and virological data were regularly sent to the coordinating center. Viral control was classified as HIV-1 RNA ≥50 copies/mL, 1 to 49 copies/mL, or undetectable (no virus detected [NVD]).
We followed 145 patients for a median of 101 weeks. The median age was 52 years; 31.7% were women, and 9.6% non-Caucasian; 50.3% had failed at least 1 antiretroviral regimen; and 15% had ≥50 copies/mL at baseline. The reasons for switching were as follows: simplification (51.7%), toxicity (36.5%), drug-drug interactions (6.9%), persistent low-level viremia (3.0%), nonadherence (2.1%), and viral failure (1.4%). By week 96, seven patients dropped out. At week 96, none had ≥50 HIV-1 RNA copies/mL, 138 (95.2%) had <50 copies/mL, and 123 (84.8%) had NVD. The low- to high-density lipoprotein cholesterol (LDL-C/HDL-C) ratio decreased significantly ( P = 0.04). Of the 287 baseline altered laboratory parameters, 32.7% normalized by week 96. Serum glucose and total- and LDL-cholesterol normalization were statistically significant.
Switching to DTG plus RPV improved viral suppression and LDL-C/HDL-C ratio.
临床研究数据证实，在部分患者中换用多替拉韦（DTG）联合rilpivirine（RPV）具有疗效。
主要目的是报告我们队列中96周的病毒学抑制情况，评估该策略在复杂情况下的持久性。次要目的是描述安全性和代谢特征。
采用回顾性-前瞻性设计对2014年10月1日至2015年9月30日期间换用DTG联合RPV的所有患者进行分析，该设计已获伦理委员会批准。常规代谢、免疫学和病毒学数据定期发送至协调中心。病毒控制情况分为HIV-1 RNA≥50拷贝/mL、1至49拷贝/mL或检测不到（未检测到病毒[NVD]）。
我们对145例患者进行了中位时间为101周的随访。中位年龄为52岁；31.7%为女性，9.6%为非白种人；50.3%至少有1种抗逆转录病毒治疗方案失败；15%在基线时HIV-1 RNA≥50拷贝/mL。换药原因如下：简化治疗方案（51.7%）、毒性反应（36.5%）、药物相互作用（6.9%）、持续性低水平病毒血症（3.0%）、依从性差（2.1%）和病毒学失败（1.4%）。到96周时，7例患者退出研究。在96周时，无患者HIV-1 RNA≥50拷贝/mL，138例（95.2%）<50拷贝/mL，123例（84.8%）检测不到病毒。低密度脂蛋白胆固醇与高密度脂蛋白胆固醇（LDL-C/HDL-C）比值显著降低（P = 0.04）。在287项基线时异常的实验室参数中，32.7%在96周时恢复正常。血清葡萄糖、总胆固醇和低密度脂蛋白胆固醇恢复正常具有统计学意义。
换用DTG联合RPV可改善病毒抑制及LDL-C/HDL-C比值。
