Simmons R, Kall M, Collins S, Cairns G, Taylor S, Nelson M, Fidler S, Porter K, Fox J
MRC, Clinical Trials Unit University College, London, UK.
Public Health England, London, UK.
HIV Med. 2017 Feb;18(2):73-79. doi: 10.1111/hiv.12391. Epub 2016 May 11.
Involvement of people living with HIV (PLHIV) in the design of HIV cure studies is important, given the potential risks to participants. We present results of an international survey of PLHIV to define these issues and inform cure research.
PLHIV were recruited in June-November 2014 through HIV websites, advocacy forums, social media and 12 UK HIV clinics. The survey included questions concerning demographics, HIV disease history, the desirability of types of cure and the patient's willingness to accept potential toxicity and treatment interruption (TI). We examined factors associated with TI and willingness to accept substantial risks.
A total of 982 PLHIV completed the survey; 87% were male, 79% white and 81% men who have sex with men (MSM). Fifty-one per cent were aged 25-44 years and 69% were UK residents. The median time since diagnosis was 7 years [interquartile range (IQR) 2-17 years]. Eighty-eight per cent were receiving antiretrovirals (91% reported undetectable viral load). Health/wellbeing improvements (96%) and an inability to transmit HIV (90%) were more desirable cure characteristics than testing HIV-negative (69%). Ninety-five per cent were interested in participating in cure studies, and 59% were willing to accept substantial risks. PLHIV with a low CD4 count [201-350 cells/μL vs. ≥ 350 cells/μL; odds ratio (OR) 2.11; 95% confidence interval (CI) 1.11-4.00] were more likely to accept risks, whereas those with limited knowledge of HIV treatments vs. excellent/good knowledge and those aged ≥ 65 years vs. 45-64 years were less likely to accept risks [OR 0.58 (95% CI 0.37-0.90) and OR 0.18 (95% CI 0.07-0.45), respectively]. TI was acceptable for 62% of participants, with the main concerns being becoming unwell (82%), becoming infectious (76%) and HIV spreading through the body (76%).
Cure research was highly acceptable to the PLHIV surveyed. Most individuals would accept risks, including TI, even in the absence of personal benefit. An optimal cure would improve health and minimize onward transmission risk.
鉴于对参与者存在潜在风险，让艾滋病病毒感染者（PLHIV）参与艾滋病治愈研究的设计非常重要。我们展示了一项针对PLHIV的国际调查结果，以明确这些问题并为治愈研究提供信息。
2014年6月至11月，通过艾滋病病毒网站、宣传论坛、社交媒体以及英国的12家艾滋病诊所招募PLHIV。该调查包括有关人口统计学、艾滋病病史、治愈类型的可取性以及患者接受潜在毒性和治疗中断（TI）的意愿等问题。我们研究了与TI以及接受重大风险意愿相关的因素。
共有982名PLHIV完成了调查；87%为男性，79%为白人，81%为男男性行为者（MSM）。51%的年龄在25至44岁之间，69%为英国居民。自诊断以来的中位时间为7年[四分位间距（IQR）2 - 17年]。88%的人正在接受抗逆转录病毒治疗（91%报告病毒载量检测不到）。与检测呈艾滋病病毒阴性（69%）相比，改善健康/福祉（96%）和无法传播艾滋病病毒（90%）是更可取的治愈特征。95%的人有兴趣参与治愈研究，59%的人愿意接受重大风险。CD4细胞计数低的PLHIV[201 - 350个细胞/微升与≥350个细胞/微升相比；优势比（OR）2.11；95%置信区间（CI）1.11 - 4.00]更有可能接受风险，而对艾滋病治疗知识了解有限的人与知识优秀/良好的人相比，以及年龄≥65岁的人与45 - 64岁的人相比，接受风险的可能性较小[分别为OR 0.58（95% CI 0.37 - 0.90）和OR 0.18（95% CI 0.07 - 0.45）]。62%的参与者可接受TI，主要担忧是身体不适（82%）、具有传染性（76%）以及艾滋病病毒在体内扩散（76%）。
接受调查的PLHIV对治愈研究高度认可。即使没有个人益处，大多数人也愿意接受包括TI在内的风险。理想的治愈方法应改善健康并将传播风险降至最低。
