Harris Marianne, Ganase Bruce, Watson Birgit, Hull Mark W, Guillemi Silvia A, Zhang Wendy, Saeedi Ramesh, Harrigan P Richard
a British Columbia Centre for Excellence in HIV/AIDS , Vancouver , Canada.
b Faculty of Medicine, Department of Family Practice , University of British Columbia , Vancouver , Canada.
HIV Clin Trials. 2017 Jan;18(1):39-47. doi: 10.1080/15284336.2016.1271503. Epub 2017 Jan 9.
To assess safety and efficacy of a switch to unboosted atazanavir (ATV) among HIV-infected adults receiving ATV/ritonavir (r) and tenofovir disoproxil fumarate (TDF).
HIV-infected adults with viral load (VL) <40 copies/mL at screening and <150 copies/mL consistently for ≥3 months while receiving a regimen including ATV/r and TDF were randomized to continue ATV/r 300/100 mg daily (control) or change to ATV 400 mg daily (switch), while maintaining their TDF backbone. The primary outcome was proportion of subjects without treatment failure (regimen switch or VL > 200 copies/mL twice consecutively) at 48 weeks.
Fifty participants (46 male, median age 47 years) were randomized, 25 to each arm. At week 48, treatment success occurred in 76% in the control arm and 92% in the switch arm (ITT, p = 0.25). ATV trough levels at week 9 were higher in controls (median 438 ng/mL) than in the switch arm (median 124 ng/mL) (p = 0.003), as was total bilirubin at week 48 (median 38 μmol/L and 28 μmol/L, respectively; p = 0.02). Estimated glomerular filtration rate (eGFR) decreased in the control arm (p = 0.007), but did not change in the switch arm. At week 48, eGFR was higher in the switch arm (median 96 mL/min) than in the control arm (median 85 mL/min) (p = 0.035), but the arms were similar with respect to fasting glucose, C-reactive protein, and lipid parameters.
Switching from ATV/r to unboosted ATV appears to be safe and effective in selected virologically suppressed patients receiving TDF-containing regimens, and may have favorable effects on bilirubin and renal function.
评估在接受阿扎那韦/利托那韦（ATV/r）和替诺福韦酯（TDF）治疗的HIV感染成人中，换用无增效阿扎那韦（ATV）的安全性和有效性。
筛选时病毒载量（VL）<40拷贝/mL且在接受包含ATV/r和TDF的治疗方案期间持续≥3个月病毒载量<150拷贝/mL的HIV感染成人，被随机分为继续每日服用ATV/r 300/100mg（对照组）或换为每日服用ATV 400mg（换药组），同时维持其TDF基础用药。主要结局是48周时无治疗失败（方案更换或病毒载量连续两次>200拷贝/mL）的受试者比例。
50名参与者（46名男性，中位年龄47岁）被随机分组，每组25人。在第48周时，对照组治疗成功率为76%，换药组为92%（意向性分析，p=0.25）。第9周时，对照组的阿扎那韦谷浓度（中位值438ng/mL）高于换药组（中位值124ng/mL）（p=0.003），第48周时总胆红素水平也是如此（分别为中位值38μmol/L和28μmol/L；p=0.02）。对照组的估计肾小球滤过率（eGFR）下降（p=0.007），而换药组未改变。在第48周时，换药组的eGFR（中位值96mL/min）高于对照组（中位值85mL/min）（p=0.035），但两组在空腹血糖、C反应蛋白和血脂参数方面相似。
在接受含TDF方案且病毒学得到抑制的特定患者中，从ATV/r换用无增效ATV似乎是安全有效的，并且可能对胆红素和肾功能有有利影响。
