Mugwanya Kenneth K, Baeten Jared M
a Department of Epidemiology , University of Washington , Seattle , WA , USA.
b Department of Global Health , University of Washington , Seattle , WA , USA.
Expert Opin Drug Saf. 2016;15(2):265-73. doi: 10.1517/14740338.2016.1128412. Epub 2015 Dec 23.
Tenofovir disoproxil fumarate (TDF)-based pre-exposure prophylaxis is a novel HIV prevention strategy for individuals at increased sexual risk for HIV infection. For any biomedical prevention intervention, the bar for tolerating adverse effects in healthy persons is high compared to therapeutic interventions.
We provide a concise summary of the clinical safety of TDF-based pre-exposure prophylaxis with focus on TDF-related effects on tolerability, kidney function, bone density, HIV resistance, sexual and reproductive health. The evidence base for this review is derived from a literature search of both randomized and observational studies evaluating efficacy and safety of TDF-based PrEP, TDF alone or in combination with emtricitabine, identified from PUBMED and EMBASE electronic databases, clinicaltrials.gov and major HIV conferences.
TDF-based pre-exposure prophylaxis is a potent intervention against HIV acquisition when taken which is generally safe and well tolerated. The risk of the small, non-progressive, and reversible decline in glomerular filtration rate and bone mineral density as well as the potential selection for drug resistance associated with PrEP are outweighed, at the population level and broadly for individuals, by PrEP's substantial reduction in the risk of HIV infection.
替诺福韦酯（TDF）暴露前预防是针对有较高HIV感染性风险个体的一种新型HIV预防策略。对于任何生物医学预防干预措施而言，相较于治疗性干预措施，健康人群对不良反应的耐受标准更高。
我们简要总结了基于TDF的暴露前预防的临床安全性，重点关注TDF对耐受性、肾功能、骨密度、HIV耐药性、性健康和生殖健康的相关影响。本综述的证据来源于对随机和观察性研究的文献检索，这些研究评估了基于TDF的暴露前预防、单独使用TDF或与恩曲他滨联合使用的疗效和安全性，这些研究来自PUBMED和EMBASE电子数据库、clinicaltrials.gov以及主要的HIV会议。
基于TDF的暴露前预防在服用时是一种有效的预防HIV感染的干预措施，总体上安全且耐受性良好。在人群层面以及广泛的个体层面，TDF导致的肾小球滤过率和骨矿物质密度出现小幅度、非进行性且可逆性下降的风险，以及与暴露前预防相关的耐药性潜在选择风险，均被暴露前预防在大幅降低HIV感染风险方面的作用所抵消。
