Bryant J, Baxter L, Hird S
Southampton Health Technology Assessments Centre, Wessex Institute for Health Research and Development, University of Southampton, Southampton, UK.
Health Technol Assess. 2009 Feb;13(14):iii, ix-x, 1-60. doi: 10.3310/hta13140.
To review the evidence on the clinical effectiveness and cost-effectiveness of non-occupational postexposure prophylaxis (PEP) for HIV.
Eleven electronic databases were searched from inception to December 2007.
Selected studies were assessed, subjected to data extraction using a standard template and quality assessment using published criteria. Studies were synthesised using a narrative approach with full tabulation of results from all included studies.
One clinical effectiveness study meeting the inclusion criteria was identified, a cohort study of PEP in a high-risk HIV-negative homosexual male cohort in Brazil. The quality of the study was generally weak. Seroincidence in the cohort as a whole (2.9 per 100 person-years) was very similar to that expected in this population (3.1 per 100 person-years, p > 0.97), despite the seroconversion to HIV being 1/68 in the PEP group and 10/132 in the group not receiving PEP. High-risk sexual activities declined over time for both PEP and non-PEP users. Four economic evaluations met the inclusion criteria of the review. The methodological quality of the studies was mixed. The studies are constrained by a lack of published data on the clinical effectiveness of PEP after non-occupational exposure, with effectiveness data derived from one study of occupational PEP. Their generalisability to the UK is not clear. Results suggest that PEP following non-occupational exposure to HIV was cost saving for men who have unprotected receptive anal intercourse with men, whether the source partner is known to be HIV positive or not; heterosexuals after unprotected receptive anal intercourse; and intravenous drug users sharing needles with a known HIV-positive person. PEP following non-occupational exposure to HIV was cost-effective for all male-male intercourse (unprotected receptive and insertive anal intercourse, unprotected receptive oral sex, and 'other') and was possibly cost-effective for intravenous drug users and high-risk women. Four additional studies were identified giving further information about adverse events associated with PEP after non-occupational exposure to HIV. The majority of participants experienced adverse events with the most common being nausea and fatigue. Rates were generally higher in participants receiving triple therapy than in participants receiving dual therapy. Completion of PEP therapy was variable, ranging from 24% to 78% of participants depending on type of therapy. Toxicity was the main reason for discontinuation of treatment.
It is not possible to draw conclusions on the clinical effectiveness of non-occupational PEP for HIV because of the limited evidence available. The review of cost-effectiveness suggests that non-occupational PEP may be cost-effective, especially in certain population subgroups; however, the assumptions made and data sources used in the cost-effectiveness studies mean that their results should be used with caution.
综述关于非职业性暴露后预防(PEP)治疗HIV的临床有效性和成本效益的证据。
检索了11个电子数据库,检索时间从建库至2007年12月。
对所选研究进行评估,使用标准模板进行数据提取,并根据已发表的标准进行质量评估。采用叙述性方法对研究进行综合分析,并完整列出所有纳入研究的结果。
确定了一项符合纳入标准的临床有效性研究,是对巴西一个高危HIV阴性同性恋男性队列进行的PEP队列研究。该研究质量总体较弱。尽管PEP组的HIV血清转化率为1/68,未接受PEP组为10/132,但整个队列的血清发病率(每100人年2.9例)与该人群预期发病率(每100人年3.1例,p>0.97)非常相似。随着时间推移,PEP使用者和未使用PEP者的高危性行为均有所减少。四项经济评估符合本综述的纳入标准。这些研究的方法学质量参差不齐。这些研究受到非职业性暴露后PEP临床有效性缺乏已发表数据的限制,有效性数据来自一项职业性PEP研究。其对英国的普遍性尚不清楚。结果表明,对于与男性进行无保护肛交的男性,无论源伴侣是否已知为HIV阳性;异性恋者在无保护肛交后;以及与已知HIV阳性者共用针头的静脉吸毒者,非职业性暴露后PEP可节省成本。非职业性暴露后PEP对所有男男性行为(无保护肛交、插入式肛交、无保护口交和“其他”)具有成本效益,对静脉吸毒者和高危女性可能具有成本效益。另外确定了四项研究,提供了关于非职业性暴露后PEP相关不良事件的更多信息。大多数参与者经历了不良事件,最常见的是恶心和疲劳。接受三联疗法的参与者的发生率通常高于接受双联疗法的参与者。PEP治疗的完成率各不相同,取决于治疗类型,参与者的完成率在24%至78%之间。毒性是停止治疗的主要原因。
由于现有证据有限,无法就非职业性PEP治疗HIV的临床有效性得出结论。成本效益综述表明,非职业性PEP可能具有成本效益,尤其是在某些人群亚组中;然而,成本效益研究中所做的假设和使用的数据来源意味着应谨慎使用其结果。