加拿大不列颠哥伦比亚省艾滋病治疗和暴露前预防客户中因抗逆病毒药物非专利替代品引起的药物不良反应。

IF 1.3 4区 医学 Q4 INFECTIOUS DISEASES
Katherine J Lepik, Olivia L Hunt, Nic Bacani, Lu Wang, Marianne Harris, Junine Toy, Taylor McLinden, Paul Sereda, Linda J Akagi, Erin Ready, Julio Sg Montaner, Rolando Barrios
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引用次数: 0

摘要

背景:在不列颠哥伦比亚省,用于艾滋病毒治疗(HIV-Tx)和暴露前预防(PrEP)的抗逆转录病毒药物(ARVs)通过公共资助的药物治疗计划(DTPs)免费提供。如果有价格较低的非专利药,则用其替代品牌抗逆转录病毒药物。我们描述了由非专利抗逆转录病毒药物引起的产品替代问题(PSI)药物不良反应(ADR)的发生率和类型:队列包括接受非专利ARV治疗HIV-Tx(阿巴卡韦-拉米夫定、恩曲他滨-替诺福韦DF、依非韦伦-恩曲他滨-替诺福韦DF、阿扎那韦或达鲁那韦,2017年6月1日至2022年6月30日)或PrEP(恩曲他滨-替诺福韦DF,2018年4月1日至2022年6月30日)的≥19岁的DTP患者。从 DTP 数据库中提取了人口统计学、ARV 和 ADR 数据,并通过描述性统计进行了总结。在品牌向非专利药过渡和非专利药向普通药过渡(推出后第一年)后的一年中,计算每种产品的 PSI 发生率,并使用广义估计方程比较不同非专利药之间的发生率。为便于理解,在相同的 1 年时间内,还计算了与任何抗逆转录病毒药物相关的 ADR 发生率:结果:在推广后的第一年期间,5339 名 HIV-Tx 客户(83% 为男性,中位年龄为 52 岁)和 8095 名 PrEP 客户(99% 为男性,中位年龄为 33 岁)接受了非专利抗逆转录病毒药物治疗,并分别报告了 78 例和 23 例非专利 PSI。由于神经精神不良反应较多,PSI 发生率为 p = .004。任何 ADR 的发生率在各测量期间均保持稳定,非专利 PSI 占所有产品相关 ADR 的比例不到三分之一:结论:HIV-Tx 和 PrEP 抗逆转录病毒药物的非专利替代品耐受性良好,轻度-中度 PSI ADR 发生率低于 2%。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adverse drug reactions attributed to generic substitution of antiretroviral medications among HIV treatment and pre-exposure prophylaxis clients in British Columbia, Canada.

Background: In British Columbia, antiretrovirals (ARVs) for HIV treatment (HIV-Tx) and pre-exposure prophylaxis (PrEP) are free-of-charge through publicly-funded Drug Treatment Programs (DTPs). When available, less costly generics are substituted for brand-name ARVs. We describe the incidence and type of product substitution issue (PSI) adverse drug reactions (ADRs) attributed to generic ARVs.

Methods: Cohorts included DTP clients ≥19 years who received generic ARVs for HIV-Tx (abacavir-lamivudine, emtricitabine-tenofovir DF, efavirenz-emtricitabine-tenofovir DF, atazanavir or darunavir between 01 Jun 2017 and 30 Jun 2022) or PrEP (emtricitabine-tenofovir DF, 01 Apr 2018 to 30 Jun 2022). Demographic, ARV and ADR data were extracted from DTP databases and summarized by descriptive statistics. PSI incidence was calculated for each product during the year following brand-to-generic and generic-to-generic transitions (first-year-post-rollout), and compared between generic versions using generalized estimating equations. For context, incidence of any ARV product-related ADR was calculated in the same 1-year periods.

Results: During first-year-post-rollout periods, 5339 HIV-Tx (83% male, median age 52 years) and 8095 PrEP (99% male, median 33 years) clients received generic ARVs, and reported 78 and 23 generic PSIs, respectively. PSI incidence was <1% for most generic ARVs, with mild-moderate symptoms including gastrointestinal upset, headache, dizziness, fatigue/malaise and skin rash. In HIV-Tx clients, the efavirenz-containing product had higher PSI incidence than other ARVs (2.2%, p = .004), due to more neuropsychiatric adverse reactions. Any ADR incidence was stable across measurement periods, and generic PSIs represented less than one third of all product-related ADRs.

Conclusions: Generic substitution of antiretrovirals for HIV-Tx and PrEP was well tolerated, with ≤2% incidence of mild-moderate PSI ADRs.

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来源期刊
Antiviral Therapy
Antiviral Therapy 医学-病毒学
CiteScore
2.60
自引率
8.30%
发文量
35
审稿时长
4-8 weeks
期刊介绍: Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases. The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.
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