Adherence challenges with drugs for pre-exposure prophylaxis to prevent HIV infection.

Adherence challenges with drugs for pre-exposure prophylaxis to prevent HIV infection.
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DOI:
10.1007/s11096-013-9861-1
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发表时间:
2014-02
影响因子:
2.4
通讯作者:
Mansoor, Leila E.
Mansoor, Leila E.
中科院分区:
医学4区
文献类型:
--
作者:
Gengiah, Tanuja N.;Moosa, Atika;Naidoo, Anushka;Mansoor, Leila E.

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全世界有3400万艾滋病毒感染者,而且这个数字每年都在增加。在发现疫苗之前,预防新的艾滋病毒感染仍然是一个紧迫的优先事项。已经完成了几项研究使用口服和局部药物预防艾滋病毒感染的试验。事实证明,坚持是实现产品功效的主要挑战。为临床药剂师提供对口服暴露前预防(PrEP)和局部杀微生物剂产品管道的了解,同时强调坚持使用这些药物以避免HIV感染的至关重要性。使用适当的关键词检索PubMed/Medline和基于网络的临床试验注册中心(ClinTrials.gov)。在1992年至2013年期间-所有II期和III期安全性和有效性研究-用于预防HIV感染的检测药物均纳入审查范围。提取疗效估计值、依从性估计值和报告的依从性挑战。在审查期间发现了24项II期和III期临床试验。其中20项试验已经完成,6项试验显示在预防艾滋病毒感染方面有效。大多数成功的试验是口服PrEP,迄今为止,只有一种阴道抗逆转录病毒杀微生物剂凝胶的杀微生物剂试验显示出有效性。对研究产品的依从性在试验结局中发挥了重要作用,不依从的原因有几个。这些因素包括高试验妊娠率、低试验保留率、低受试者风险感知、受试者特征(如年龄<25岁、单身状态、迁移性伴侣和试验疲劳)。研究产品的特征,如剂型、给药间隔以及相关不良事件也可能影响依从性。中度至高度依从性对于证明预防艾滋病毒药物的有效性至关重要。对于外用药物,与性交相关的间歇使用比每日使用更有效,特别是如果性生活不频繁或伴侣迁移。对于口服药物,每日使用是有效的,但使用药物的动机和高风险认知是重要的。在血清不一致的夫妇,早期开始HAART在感染的合作伙伴提供了几乎完全保护阴性的合作伙伴。药物需要适合风险人群,提供多种药物选择也很重要。
There are 34 million people living with HIV worldwide and each year this number increases. Until a vaccine is discovered, the prevention of new HIV infections remains an urgent priority. Several trials studying the use of oral and topical agents for the prevention of HIV infection have already been completed. Adherence has proved to be a major challenge in achieving product efficacy. To provide the clinical pharmacist with an understanding of the oral pre-exposure prophylaxis (PrEP) and topical microbicide product pipeline whilst emphasizing the critical importance of adherence to these drugs to avert HIV infection. PubMed/Medline and the web-based clinical trials registry (ClinTrials.gov) were searched using appropriate key words. For the time period 1992 to 2013 - all phase II and phase III safety and effectiveness studies - testing agents for prevention of HIV infection were included in the review., Efficacy estimates, adherence estimates and reported challenges with adherence were extracted. Twenty four phase II and III clinical trials were found during review. Of these, 20 trials have been completed, and six trials show effectiveness in preventing HIV infection. The majority of the successful trials were to oral PrEP and to date only one microbicide trial of a vaginal antiretroviral microbicide gel has showed effectiveness. Adherence to study product played a major role in trial outcomes and there are several reasons for non-adherence. These include high on-trial pregnancy rates, low trial retention rates, low participant perception of risk, participant characteristics such as age<25 years, single status, migratory partners and trial fatigue. Study product characteristics such as dosage form, dosing interval, as well as associated adverse events may also influence adherence. Moderate to high adherence is critical to demonstrate efficacy of drugs for HIV prevention. For topical agents, intermittent use associated with coitus is more effective than daily use, particularly if sex is infrequent or partners migrant. For oral agents, daily use is effective but the motivation to use the drug and high risk perception is important. In serodiscordant couples, early initiation of HAART in the infected partner affords almost complete protection to the negative partner. Drugs need to be tailored to the population at risk and availability of multiple drug options are important.
DOI: 10.1371/journal.pone.0055013
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发表时间: 2010-09-03
期刊: Science (New York, N.Y.)
影响因子: --
作者:
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期刊: The New England journal of medicine
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Baeten JM;Donnell D;Ndase P;Mugo NR;Campbell JD;Wangisi J;Tappero JW;Bukusi EA;Cohen CR;Katabira E;Ronald A;Tumwesigye E;Were E;Fife KH;Kiarie J;Farquhar C;John-Stewart G;Kakia A;Odoyo J;Mucunguzi A;Nakku-Joloba E;Twesigye R;Ngure K;Apaka C;Tamooh H;Gabona F;Mujugira A;Panteleeff D;Thomas KK;Kidoguchi L;Krows M;Revall J;Morrison S;Haugen H;Emmanuel-Ogier M;Ondrejcek L;Coombs RW;Frenkel L;Hendrix C;Bumpus NN;Bangsberg D;Haberer JE;Stevens WS;Lingappa JR;Celum C;Partners PrEP Study Team
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发表时间: 2008
期刊: PloS one
影响因子: 3.7
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