Bagella Paola, De Socio Giuseppe Vl, Ricci Elena, Menzaghi Barbara, Martinelli Canio, Squillace Nicola, Maggi Paolo, Orofino Giancarlo, Calza Leonardo, Carenzi Laura, Celesia Benedetto Maurizio, Penco Giovanni, Di Biagio Antonio, Valsecchi Laura, Vichi Francesca, Colombo Valeria, Parruti Giustino, Dentone Chiara, Falasca Katia, Bonfanti Paolo, Madeddu Giordano
Unit of Infectious Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
Infectious Diseases Unit, Department of Medicine, Azienda Ospedaliero-Universitaria di Perugia, Santa Maria Hospital, Perugia, Italy.
Infect Drug Resist. 2018 Apr 26;11:615-623. doi: 10.2147/IDR.S152090. eCollection 2018.
Rilpivirine is associated with a good efficacy and safety profile. However, data from real-life settings are scarce.
We investigated the durability, safety and efficacy of Rilpivirine-based antiretroviral therapy in a prospective, observational, multicenter study.
We enrolled 499 HIV-infected patients, 360 (72.1%) males, mean age 43.4 ± 10.5 years, mean CD4 600 ± 327 cell/μL, mean HIV-RNA 3.80 ± 1.15 log cp/mL. After a median follow up of 16 months, 81 (16.2%) interruptions were reported, 36 (7.2%) of which for adverse events (16 of grade ≥3), most commonly neurological and gastrointestinal. We observed virological failures in only 8 (1.6%) patients. Naive patients showed a significant reduction in eGFR at week 24, 48 and 72 and in total cholesterol (TC)/HDL ratio at week 48 (=0.007). In patients switching from PI we found a significant decrease at week 24 and 48 in TC and triglycerides at week 24, 48 and 72. eGFR showed a significant decrease at week 48 and 72. TC/HDL ratio showed a statistically significant decrease at week 24 (=0.0008) and 72 (=0.04). A significant increase at week 24 and 48 in AST and ALT values was observed. Patients switching from TDF/FTC/EFV showed a reduction in HDL, total cholesterol and triglycerides at week 24 and 48 and in eGFR at all follow up times. TC/HDL ratio showed a significant decrease at week 48 (=0.01). CDC stage C and antiretroviral-experience (especially Protease Inhibitors) were associated with RPV discontinuation.
In conclusion, our data confirm Rilpivirine efficacy, safety and tolerability with improvement in lipid profile. Although hepatic and renal events rarely caused discontinuation, liver and kidney parameters should be monitored.
利匹韦林具有良好的疗效和安全性。然而，来自实际临床环境的数据较少。
我们在一项前瞻性、观察性、多中心研究中调查了基于利匹韦林的抗逆转录病毒疗法的持久性、安全性和疗效。
我们纳入了499例HIV感染患者，其中360例（72.1%）为男性，平均年龄43.4±10.5岁，平均CD4细胞计数为600±327个/μL，平均HIV-RNA为3.80±1.15 log cp/mL。中位随访16个月后，报告了81例（16.2%）治疗中断，其中36例（7.2%）是由于不良事件（16例为≥3级），最常见的是神经系统和胃肠道不良事件。我们仅观察到8例（1.6%）患者出现病毒学失败。初治患者在第24周、48周和72周时eGFR显著降低，在第48周时总胆固醇（TC）/高密度脂蛋白（HDL）比值显著降低（P=0.007）。在从蛋白酶抑制剂（PI）转换治疗的患者中，我们发现第24周和48周时TC显著降低，第24周、48周和72周时甘油三酯显著降低。第48周和72周时eGFR显著降低。TC/HDL比值在第24周（P=0.0008）和72周（P=0.04）时出现统计学显著降低。在第24周和48周时观察到谷草转氨酶（AST）和谷丙转氨酶（ALT）值显著升高。从替诺福韦酯（TDF）/恩曲他滨（FTC）/依非韦伦（EFV）转换治疗的患者在第24周和48周时HDL、总胆固醇和甘油三酯降低，在所有随访时间eGFR均降低。TC/HDL比值在第48周时显著降低（P=0.01）。美国疾病控制与预防中心（CDC）C期和抗逆转录病毒治疗经验（尤其是蛋白酶抑制剂治疗经验）与利匹韦林停药有关。
总之，我们的数据证实了利匹韦林的疗效、安全性和耐受性，以及其对血脂谱的改善作用。尽管肝脏和肾脏事件很少导致停药，但仍应监测肝脏和肾脏参数。
