From the 1 Department of Medical and Surgical Sciences, Clinics of Infectious Diseases.
Infect Dis (Lond). 2015 Sep;47(9):625-36. doi: 10.3109/23744235.2015.1034169. Epub 2015 Apr 15.
The objective of the study was to assess plasma concentrations of efavirenz, darunavir/ritonavir and raltegravir in patients with human immunodeficiency virus-hepatitis C virus (HIV-HCV)-coinfection without liver cirrhosis.
In this observational, open-label study, adult HIV-infected outpatients treated with tenofovir/emtricitabine plus efavirenz (600 mg daily), darunavir/ritonavir (800/100 mg daily) or raltegravir (400 mg twice daily) for at least 4 weeks were asked to participate. Subjects with liver cirrhosis were excluded. The trough concentration (C trough) of darunavir/ritonavir and raltegravir and the mid-dose concentration (C12h) of efavirenz were assessed at steady state by a validated high-performance liquid chromatography (HPLC)-tandem mass spectrometry method.
A total of 96 HIV-positive patients were enrolled into the study. Thirty-four patients were treated with efavirenz, 33 with darunavir/ritonavir and 29 with raltegravir. The geometric mean plasma C trough [coefficient of variation (%)] of darunavir was comparable between HIV+/HCV+ and HIV+/HCV- subjects: 2644 ng/ml (155%) and 2491 ng/ml (139%), respectively (geometric mean ratio (GMR) = 0.81; 95% confidence interval (CI) = 0.79-1.56; p = 0.69). These values were comparable for raltegravir: 108 ng/ml (149%) in the HIV+/HCV+ group and 96 ng/ml (161%) in the HIV+/HCV- group (GMR = 0.84; 95% CI = 0.61-1.44; p = 0.72). On the contrary, the geometric mean plasma C12h of efavirenz was significantly higher among the 15 HIV+/HCV+ patients (1915 ng/ml, 159%) than among the 19 HIV+/HCV- patients (1505 ng/ml, 167%; GMR = 1.41; 95% CI = 1.19-1.71; p = 0.009).
The mean plasma concentration of efavirenz was significantly higher in HCV-positive than in HCV-negative patients without liver cirrhosis, while the mean plasma levels of darunavir/ritonavir and raltegravir were comparable in both groups.
本研究旨在评估无肝硬化的人类免疫缺陷病毒-丙型肝炎病毒（HIV-HCV）合并感染患者体内依非韦伦、达芦那韦/利托那韦和拉替拉韦的血浆浓度。
本观察性、开放性研究纳入了接受替诺福韦/恩曲他滨加依非韦伦（每日 600mg）、达芦那韦/利托那韦（每日 800/100mg）或拉替拉韦（每日两次 400mg）治疗至少 4 周的成年 HIV 感染门诊患者。排除肝硬化患者。采用经验证的高效液相色谱（HPLC）-串联质谱法测定达芦那韦/利托那韦和拉替拉韦的谷浓度（C 谷）和依非韦伦的中剂量浓度（C12h）。
共纳入 96 例 HIV 阳性患者。34 例患者接受依非韦伦治疗，33 例患者接受达芦那韦/利托那韦治疗，29 例患者接受拉替拉韦治疗。HIV+/HCV+和 HIV+/HCV-患者的达芦那韦血浆 C 谷几何均数[变异系数（%）]相似：分别为 2644ng/ml（155%）和 2491ng/ml（139%）（几何均数比（GMR）=0.81；95%置信区间（CI）=0.79-1.56；p=0.69）。HIV+/HCV+组和 HIV+/HCV-组的拉替拉韦的 C12h 几何均数也相似：分别为 108ng/ml（149%）和 96ng/ml（161%）（GMR=0.84；95%CI=0.61-1.44；p=0.72）。相反，15 例 HIV+/HCV+患者的依非韦伦 C12h 几何均数（1915ng/ml，159%）显著高于 19 例 HIV+/HCV-患者（1505ng/ml，167%）（GMR=1.41；95%CI=1.19-1.71；p=0.009）。
无肝硬化的 HCV 阳性患者体内依非韦伦的平均血浆浓度明显高于 HCV 阴性患者，而达芦那韦/利托那韦和拉替拉韦的平均血浆水平在两组间无差异。
