Department of Systems Medicine, Infectious Disease Clinic, University of Rome Tor Vergata, Roma, Lazio, Italy.
Microbiology and Diagnostic Immunology, Bambino Gesu Paediatric Hospital, Roma, Italy.
Sex Transm Infect. 2024 Oct 17;100(7):442-449. doi: 10.1136/sextrans-2024-056199.
While antiretroviral therapy (ART) is highly effective, detection of low levels of HIV-1 RNA in plasma is common in treated individuals. Given the uncertainties on the topic, we convened a panel of experts to consider different clinical scenarios, producing a Delphi consensus to help guide clinical practice.
A panel of 17 experts in infectious diseases, virology and immunology rated 32 statements related to four distinct scenarios: (1) low-level viremia during stable (≥6 months) first-line ART (≥2 consecutive HIV-1 RNA measurements 50-500 copies/mL); (2) a viral blip during otherwise suppressive ART (a HIV-1 RNA measurement 50-1000 copies/mL with adjacent measurements <50 copies/mL); (3) low-level viral rebound during previously suppressive ART (≥2 consecutive HIV-1 RNA measurements 50-500 copies/mL); (4) residual viremia during suppressive ART (persistent HIV-1 RNA quantification below 50 copies/mL). A systematic review, conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement, informed the 32 statements. The Delphi procedure was modified to include two voting rounds separated by a moderated group discussion. Grading of Recommendations, Assessment, Development, and Evaluations-based recommendations were developed.
Overall, 18/32 statements (56.2%) achieved a strong consensus, 3/32 (9.4%) achieved a moderate consensus and 11/32 (34.4%) did not achieve a consensus. Across the four scenarios, the panel unanimously emphasised the importance of implementing specific interventions prior to considering therapy changes, including assessing adherence, testing for genotypic drug resistance and scheduling more frequent follow-up visits. Strategies indicated in selected circumstances included therapeutic drug monitoring, quantifying total HIV-1 DNA and evaluating concomitant chronic infections.
While acknowledging the many uncertainties about source, significance and optimal management of low-level viremia during ART, the findings provide insights to help harmonise clinical practice. There is a need for well-designed randomised studies assessing different interventions to manage low-level viremia and future research regarding its definition.
虽然抗逆转录病毒疗法（ART）非常有效，但在接受治疗的个体中，常检测到血浆中 HIV-1 RNA 水平低。鉴于该主题存在不确定性，我们召集了一组专家来考虑不同的临床情况，产生了德尔菲共识，以帮助指导临床实践。
一组 17 名传染病、病毒学和免疫学专家对与四个不同场景相关的 32 个陈述进行了评分：（1）稳定期（≥6 个月）一线 ART 时低水平病毒血症（≥2 次连续 HIV-1 RNA 测量值为 50-500 拷贝/ml）；（2）抑制性 ART 期间出现病毒短暂升高（HIV-1 RNA 测量值为 50-1000 拷贝/ml，相邻测量值<50 拷贝/ml）；（3）先前抑制性 ART 期间的低水平病毒反弹（≥2 次连续 HIV-1 RNA 测量值为 50-500 拷贝/ml）；（4）抑制性 ART 期间的残留病毒血症（持续低于 50 拷贝/ml 的 HIV-1 RNA 定量）。根据系统评价和荟萃分析的首选报告项目，对 32 个陈述进行了系统回顾，为其提供了信息。修改了德尔菲程序，包括两轮投票，中间穿插一次小组讨论。基于推荐评估、发展和评估的分级推荐被制定出来。
总体而言，18/32 项陈述（56.2%）达成了强烈共识，3/32 项陈述（9.4%）达成了中度共识，11/32 项陈述（34.4%）未达成共识。在这四个场景中，专家组一致强调在考虑治疗改变之前，实施特定干预措施的重要性，包括评估依从性、检测基因型药物耐药性和安排更频繁的随访。在选定情况下，指示的策略包括治疗药物监测、定量测定总 HIV-1 DNA 和评估伴随的慢性感染。
尽管在 ART 期间低水平病毒血症的来源、意义和最佳管理存在许多不确定性，但研究结果提供了有助于协调临床实践的见解。需要设计良好的随机研究来评估不同的干预措施，以管理低水平病毒血症，并开展关于其定义的未来研究。
