Llibre Josep M, de Lazzari Elisa, Molina Jean-Michel, Gallien Sébastien, Gonzalez-García Juan, Imaz Arkaitz, Podzamczer Daniel, Clotet Bonaventura, Domingo Pere, Gatell Josep M
Infectious Diseases Department and "Lluita contra la SIDA" Foundation, University Hospital Germans Trias i Pujol, Badalona, Spain; Universitat Autònoma de Barcelona, Spain.
Fundació Clinic per a la Recerca Biomèdica, Hospital Clinic/IDIBAPS, Barcelona, Spain.
Enferm Infecc Microbiol Clin (Engl Ed). 2018 Jan;36(1):16-20. doi: 10.1016/j.eimc.2016.07.006. Epub 2016 Aug 29.
To evaluate the efficiency of single-tablet regimens (STR) and multiple-tablet regimens (MTR) with exactly the same or different components.
A study was conducted on HIV-1-infected antiretroviral-naïve patients from 6 Spanish or French centers, who were started on treatment with STR-Atripla, or the same components separately (MTR-SC), or a different MTR (MTR-Other). Effectiveness was measured as percentage of HIV-RNA <50copies/mL at 48 weeks (ITT). Efficiency was the ratio between costs (direct cost of antiretrovirals plus outpatient visits, hospital admissions, and resistance tests) and effectiveness.
The study included a total of 2773 patients (759 STR-Atripla, 483 MTR-SC, and 1531 MTR-Other). Median age was 37 years, 15% were HCV co-infected, 27% had a CD4+ count <200cells/μL, and 30% had viral load ≥100.000copies/mL. The duration of the assigned treatment was longer for STR-Atripla (P<.0001). Response rates (adjusted for CD4+ count, viral load, and clustered on hospitals) at 48 weeks were 76%, 74%, and 62%, respectively (P<.0001). Virological failure was more common in MTR patients (P=.0025), and interruptions due to intolerance with MTR-Other (P<.0001). Cost per responder at 48 weeks (efficiency) was €12,406 with STR-Atripla, €11,034 with MTR-SC (0.89 [0.82, 0.99] times lower), and €18,353 (1.48 [1.38, 1.61] times higher) with MTR-Other.
STR-Atripla and MTR-SC regimens showed similar effectiveness, but virological failure rate was lower with STR-Atripla. MTR-SC, considered less convenient, had a marginally better efficiency, mainly due to lower direct costs. MTR-Other regimens had both a worse effectiveness and efficiency. Similar efficiency analyses adjusting for baseline characteristics should be recommended for new STRs.
评估成分完全相同或不同的单片复方制剂（STR）和多片复方制剂（MTR）的疗效。
对来自6个西班牙或法国中心的初治HIV-1感染患者进行研究，这些患者开始接受STR-Atripla治疗，或接受相同成分的单独用药（MTR-SC），或接受不同的MTR（MTR-其他）治疗。疗效以48周时HIV-RNA<50拷贝/毫升的患者百分比（意向性分析）来衡量。疗效是成本（抗逆转录病毒药物的直接成本加上门诊就诊、住院和耐药性检测费用）与疗效之间的比值。
该研究共纳入2773例患者（759例接受STR-Atripla治疗，483例接受MTR-SC治疗，1531例接受MTR-其他治疗）。中位年龄为37岁，15%的患者合并丙型肝炎病毒感染，27%的患者CD4+细胞计数<200个/微升，30%的患者病毒载量≥100,000拷贝/毫升。STR-Atripla的指定治疗持续时间更长（P<0.0001）。48周时的应答率（根据CD4+细胞计数、病毒载量和医院分组进行调整）分别为76%、74%和62%（P<0.0001）。病毒学失败在MTR患者中更常见（P=0.0025），MTR-其他组因不耐受导致的治疗中断更常见（P<0.0001）。48周时每位应答者的成本（疗效），STR-Atripla为12,406欧元，MTR-SC为11,034欧元（低0.89[0.82,0.99]倍），MTR-其他组为18,353欧元（高1.48[1.38,1.61]倍）。
STR-Atripla和MTR-SC方案显示出相似的疗效，但STR-Atripla的病毒学失败率更低。MTR-SC虽然不太方便，但疗效略好，主要是因为直接成本较低。MTR-其他方案的疗效和效率都较差。对于新的STRs，建议进行类似的根据基线特征调整的疗效分析。
