Phanuphak Nittaya, Lo Ying-Ru, Shao Yiming, Solomon Sunil Suhas, O'Connell Robert J, Tovanabutra Sodsai, Chang David, Kim Jerome H, Excler Jean Louis
1 SEARCH, The Thai Red Cross AIDS Research Centre , Bangkok, Thailand .
2 HIV, Hepatitis, and STI Unit, WHO Regional Office for the Western Pacific , Manila, Philippines .
AIDS Res Hum Retroviruses. 2015 Nov;31(11):1060-76. doi: 10.1089/aid.2015.0049. Epub 2015 Jun 24.
An overall decrease of HIV prevalence is now observed in several key Asian countries due to effective prevention programs. The decrease in HIV prevalence and incidence may further improve with the scale-up of combination prevention interventions. The implementation of future prevention trials then faces important challenges. The opportunity to identify heterosexual populations at high risk such as female sex workers may rapidly wane. With unabating HIV epidemics among men who have sex with men (MSM) and transgender (TG) populations, an effective vaccine would likely be the only option to turn the epidemic. It is more likely that efficacy trials will occur among MSM and TG because their higher HIV incidence permits smaller and less costly trials. The constantly evolving patterns of HIV-1 diversity in the region suggest close monitoring of the molecular HIV epidemic in potential target populations for HIV vaccine efficacy trials. CRF01_AE remains predominant in southeast Asian countries and MSM populations in China. This relatively steady pattern is conducive to regional efficacy trials, and as efficacy warrants, to regional licensure. While vaccines inducing nonneutralizing antibodies have promise against HIV acquisition, vaccines designed to induce broadly neutralizing antibodies and cell-mediated immune responses of greater breadth and depth in the mucosal compartments should be considered for testing in MSM and TG. The rationale and design of efficacy trials of combination prevention modalities such as HIV vaccine and preexposure prophylaxis (PrEP) remain hypothetical, require high adherence to PrEP, are more costly, and present new regulatory challenges. The prioritization of prevention interventions should be driven by the HIV epidemic and decided by the country-specific health and regulatory authorities. Modeling the impact and cost-benefit may help this decision process.
由于有效的预防项目，目前在几个亚洲关键国家观察到艾滋病毒流行率总体下降。随着联合预防干预措施的扩大，艾滋病毒流行率和发病率的下降可能会进一步改善。未来预防试验的实施面临着重大挑战。识别高危异性恋人群（如女性性工作者）的机会可能会迅速减少。鉴于男男性行为者（MSM）和变性者（TG）人群中艾滋病毒疫情持续，有效的疫苗可能是扭转疫情的唯一选择。在男男性行为者和变性者中进行疗效试验的可能性更大，因为他们较高的艾滋病毒发病率允许进行规模较小、成本较低的试验。该地区不断演变的HIV-1多样性模式表明，需要密切监测艾滋病毒疫苗疗效试验潜在目标人群中的分子艾滋病毒疫情。CRF01_AE在东南亚国家和中国的男男性行为者人群中仍然占主导地位。这种相对稳定的模式有利于进行区域疗效试验，并在疗效得到证实后进行区域许可。虽然诱导非中和抗体的疫苗有望预防艾滋病毒感染，但应考虑在男男性行为者和变性者中测试旨在诱导更广泛、更深入的黏膜区室中广泛中和抗体和细胞介导免疫反应的疫苗。艾滋病毒疫苗和暴露前预防（PrEP）等联合预防模式的疗效试验的基本原理和设计仍然是假设性的，需要高度坚持PrEP，成本更高，并且带来了新的监管挑战。预防干预措施的优先排序应由艾滋病毒疫情驱动，并由各国特定的卫生和监管当局决定。对影响和成本效益进行建模可能有助于这一决策过程。
