We systematically reviewed studies on DRM in pre-exposure prophylaxis according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020 guidelines. PubMed, Cochrane, and SAGE databases were searched for English-language primary studies published between January 2001 and December 2023. The initial search was conducted on 9 August 2021 and was updated through 31 December 2023 to ensure the inclusion of the most recent findings. The registration number for this protocol review was CRD42022356061.
A total of 26,367 participants and 562 seroconversion cases across 12 studies were included in this review. The pooled prevalence estimate for all mutations was 6.47% (95% Confidence Interval-CI 3.65-9.93), while Tenofovir Disoproxil Fumarate/Emtricitabine-associated drug resistance mutation prevalence was 1.52% (95% CI 0.23-3.60) in the pre-exposure prophylaxis arm after enrolment. A subgroup analysis, based on the study population, showed the prevalence in the heterosexual and men who have sex with men (MSM) groups was 5.53% (95% CI 2.55-9.40) and 7.47% (95% CI 3.80-12.11), respectively. Notably, there was no significant difference in the incidence of DRM between the pre-exposure prophylaxis and placebo groups (log-OR = 0.99, 95% CI -0.20 to 2.18, I2 = 0%; p = 0.10).
Given the constrained prevalence of DRM, the World Health Organization (WHO) advocates the extensive adoption of pre-exposure prophylaxis. Our study demonstrated no increased risk of DRM with pre-exposure prophylaxis (p > 0.05), which is consistent with these settings. These findings align with the previous meta-analysis, which reported a 3.14-fold higher risk in the pre-exposure prophylaxis group than the placebo group, although the observed difference did not reach statistical significance (p = 0.21).
Despite the low prevalence of DRM, pre-exposure prophylaxis did not significantly increase the risk of DRM compared to placebo. However, long-term observation is required to determine further disadvantages of extensive pre-exposure prophylaxis use. PROSPERO Number: CRD42022356061.
方法:我们根据2020年系统评价和荟萃分析指南的首选报告项目,系统地回顾了DRM在暴露前预防中的研究。PubMed,科克伦,我们在SAGE数据库中搜索了2001年1月至2023年12月期间发表的英语主要研究.初步搜索于2021年8月9日进行,并在2023年12月31日之前进行了更新,以确保包含最新的调查结果。该方案审查的注册号为CRD42022356061。
结果:在12项研究中,共有26,367名参与者和562例血清转换病例被纳入本综述。所有突变的合并患病率估计值为6.47%(95%置信区间-CI3.65-9.93),而富马酸替诺福韦酯/恩曲他滨相关耐药突变患病率在纳入后的暴露前预防组中为1.52%(95%CI0.23-3.60).亚组分析,根据研究人群,显示异性恋和男男性行为者(MSM)组中的患病率为5.53%(95%CI2.55-9.40)和7.47%(95%CI3.80-12.11),分别。值得注意的是,暴露前预防组和安慰剂组的DRM发生率无显著差异(log-OR=0.99,95%CI-0.20~2.18,I2=0%;p=0.10).
结论:鉴于DRM的受限流行,世界卫生组织(WHO)提倡广泛采用暴露前预防。我们的研究表明,暴露前预防不会增加DRM的风险(p>0.05),这与这些设置是一致的。这些发现与之前的荟萃分析一致,据报道,暴露前预防组的风险比安慰剂组高3.14倍,尽管观察到的差异没有达到统计学意义(p=0.21)。
结论:尽管DRM的患病率较低,与安慰剂相比,暴露前预防并未显著增加DRM的风险.然而,需要长期观察以确定广泛的暴露前预防使用的其他缺点.PROSPERO编号:CRD42022356061。