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对抗逆转录病毒仿制药的认知:法国对HIV感染患者及其医生的一日调查。

Perception of antiretroviral generic medicines: one-day survey of HIV-infected patients and their physicians in France.

作者信息

Jacomet Christine, Allavena Clotilde, Peyrol Fleur, Pereira Bruno, Joubert Laurence Morand, Bagheri Haleh, Cotte Laurent, Garaffo Rodolphe, Gerbaud Laurent, Dellamonica Pierre

机构信息

Service des Maladies infectieuses et tropicales, Hôpital Gabriel Montpied, CHU Clermont Ferrand, Clermont-Ferrand, France.

Service des Maladies infectieuses et tropicales, CHU Hôtel-Dieu, Nantes, France.

出版信息

PLoS One. 2015 Feb 6;10(2):e0117214. doi: 10.1371/journal.pone.0117214. eCollection 2015.

Abstract

BACKGROUND

In the interest of cost effectiveness, switching antiretroviral brand name medications to generics is recommended in France since 2013. The study objective was to evaluate the perception of generics per se and antiretroviral generics in HIV-infected patients and their hospital physicians.

METHODS AND FINDINGS

556 out of 703 (79%) adult HIV+ outpatients and 116 physicians in 33 clinics were included in a multicentric cross-sectional survey performed in September 2013. Patients completed a self-questionnaire on their perception and acceptability of generics. Physicians completed a questionnaire on their acceptability of switching antiretroviral to generic. Socio-demographic data, medical history and HIV history were collected. Among the 556 patients with a median HIV duration of 13 years, 77% were France native, 59% in active employment, 100% covered by social insurance, 95% on antiretroviral therapy. Seventy-six percent of the patients accepted generics and 55% trusted them overall. Antiretroviral generics were accepted by 44% of them but only by 17% if the pill burden was going to increase. The factor significantly associated with acceptability of antiretroviral generics was acceptance of generics per se (p<0.001). Among the 116 physicians following a median of 100 HIV-patients/year, 75% would prescribe generics, dropping to 26% if the combo had to be broken. Factors significantly associated with willingness to prescribe antiretroviral generics were the absence of concern regarding the chemical entity (OR = 0.33), being aware that the patient would accept generics for other pathologies (OR = 2.04) and would accept antiretroviral generics (OR = 1.94). No factor related to sociodemographic conditions, HIV status or comorbidities was associated with the acceptability of antiretroviral generics.

CONCLUSIONS

Acceptability of antiretroviral generics in this French population was mostly dictated by the patient's and physician's knowledge and use of generics overall. It should be improved with an efficient information of both patients and physicians.

摘要

背景

为了实现成本效益,自2013年起法国就建议将抗逆转录病毒品牌药物换成仿制药。本研究的目的是评估HIV感染患者及其医院医生对仿制药本身以及抗逆转录病毒仿制药的看法。

方法与结果

2013年9月进行了一项多中心横断面调查,纳入了703名成年HIV阳性门诊患者中的556名(79%)以及33家诊所的116名医生。患者完成了一份关于他们对仿制药的看法和可接受性的自我调查问卷。医生完成了一份关于他们将抗逆转录病毒药物换成仿制药的可接受性的调查问卷。收集了社会人口统计学数据、病史和HIV病史。在556名HIV病程中位数为13年的患者中,77%是法国本地人,59%有工作,100%参加了社会保险,95%正在接受抗逆转录病毒治疗。76%的患者接受仿制药,总体上55%信任仿制药。44%的患者接受抗逆转录病毒仿制药,但如果药片负担增加,接受的比例仅为17%。与抗逆转录病毒仿制药可接受性显著相关的因素是对仿制药本身的接受程度(p<0.001)。在每年中位数随访100名HIV患者的116名医生中,75%会开仿制药,如果组合必须拆分,这一比例降至26%。与开抗逆转录病毒仿制药意愿显著相关的因素是对化学实体不担心(OR = 0.33)、知道患者会接受用于其他病症的仿制药(OR = 2.04)以及会接受抗逆转录病毒仿制药(OR = 1.94)。没有与社会人口统计学状况、HIV状态或合并症相关的因素与抗逆转录病毒仿制药的可接受性有关。

结论

在这个法国人群中,抗逆转录病毒仿制药的可接受性主要取决于患者和医生对仿制药的总体了解和使用情况。应该通过对患者和医生进行有效的信息告知来加以改善。

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