鍵接愛滋病毒預防可及性上的鴻溝

資料來源：www.thelancet.com/hiv Vol 10 August 2023

    根據聯合國愛滋病規劃署2023年全球最新情況，2022年全球新增愛滋病毒感染人數下降幅度不大，預計新增感染人數為130萬，與2021年相比僅減少20萬，遠低於2025年37萬的目標。採取廣泛有效的預防方案對於減少新發感染至關重要。儘管口服暴露前預防 (PrEP) 有助於減少新感染，但認識和需求主要集中在男男性行為者身上。新的 PrEP 產品，如長效注射劑和達匹韋林陰道環（long-acting injectables and dapivirine rings），提供了更多的選擇，但需要解決阻礙其實施的障礙，包括監管審批、負擔能力、可及性和社會接受度，以發揮其潛力。

    儘管南非批准了長效注射用卡博特韋和達匹韋林陰道環等預防方案，但原定於 2023 年初啟動的試點實施延遲，削弱了愛滋病毒界的熱情。由於製造商包裝不符合該國的監管要求，長效注射劑卡博特韋的推出已被推遲，阻礙了旨在為使用者在現實環境中提供不同 PrEP 產品選擇的實施研究。即使克服了這一障礙，其最終定價仍存在不確定性，而且由於仿製藥製造商數量較少，卡博特韋注射液的全球供應有限。對於達匹韋林陰道環，由於進口後測試問題導致延誤，儘管試點現在可以開始。

    在本期中，帕特爾及其同事提出了令人信服的案例，說明了在考慮個人偏好和需求的同時提供愛滋病毒預防方案之選擇和實施有效實施方法的重要性。信息和選擇對於女性尤其重要，在美國等國家，女性佔新 HIV 診斷的 18%，但僅佔 PrEP 使用者的 8%。聯合國愛滋病規劃署估計，到2022 年，約有21 萬名少女和年輕女性（15-24 歲）感染愛滋病毒。與口服PrEP 相比，達匹韋林陰道環和長效注射劑卡博特拉韋可以為處境脆弱的女性提供更謹慎的選擇，幫助克服圍繞女性控制的預防方法的區域恥辱。長效注射劑的持續作用時間還可以提高注射藥癮者的便利性和可及性，對他們來說，不穩定的生活環境或物質使用模式可能會阻礙他們堅持於每日口服的 PrEP。

    從歷史上看，愛滋病毒預防產品的實施給醫療保健系統帶來了重大挑戰。繼世界衛生組織於2015 年建議對愛滋病毒高危人群進行口服PrEP 後，很快就發現不同地區、國家和社區在採用口服PrEP 時面臨著各種挑戰，部分原因是受到社會文化規範、信仰和實踐的影響。沒有一個國家能夠擺脫這些障礙。例如，上個月，美國於2012 年成為第一個批准口服PrEP 的國家，它重新引入了《PrEP 獲取和覆蓋法案》，該法案旨在透過為公共和私人保險付款人提供零成本之覆蓋並建立全國性的針對未參保者的補助金計畫。然而，該法案已經因德克薩斯州一名聯邦法官的裁決而受到破壞，該裁決認為為 LGBTQ+ 人群提供愛滋病毒預防資金侵犯了私營公司的宗教自由。該裁決給美國人預防愛滋病毒的機會蒙上了嚴重的陰影。

    儘管相對於其人口規模，重點人群仍然承受著不成比例的愛滋病毒負擔，但針對這些人群採取的針對性措施已取得了顯著成果，導致愛滋病毒傳播率大幅下降。這一進展的一個例子是英國新發愛滋病毒感染情況的變化，其中異性戀者所報告的新發愛滋病毒診斷數量已經超過了男男性行為者。衛生保健系統迫切需要透過向所有可能受益的潛在使用者展示 PrEP 的包容性，來擴大認識並產生需求。擺脫道德判斷並創造一個讓個人能夠輕鬆表達自己的需求、並能夠獲得易於理解的信息的環境，是影響整個社會的關鍵。

    對 PrEP 的認識和需求必須包括在所有面臨愛滋病毒風險的人。透過以人們之多面向、多樣性為中心的教育和獲取計畫，衛生保健系統所應尋求的不僅只是獲得功能性愛滋病毒預防產品，並應努力公平地提供即將推出的一系列 PrEP 方案。■刺胳針愛滋病毒

Bridging accessibility gaps in HIV prevention

www.thelancet.com/hiv Vol 10 August 2023

    According to the UNAIDS global update for 2023, the global decline in new HIV infections was modest in 2022, with an estimated 1·3 million new infections, down just 200000 compared with 2021, and far short of the 2025 target of 370000. Equitable access to a wide array of effective prevention options is crucial to achieving reductions in new infections. Although oral pre-exposure prophylaxis (PrEP) has contributed to declines in new infections, awareness and demand are concentrated in men who have sex with men. New PrEP products, such as long-acting injectables and dapivirine rings, offer expanded choice, but barriers blocking their implementation, including regulatory approvals, affordability, accessibility, and societal acceptance, need to be addressed to realise their potential.

    Despite the approval of preventive options such as long-acting injectable cabotegravir and dapivirine vaginal rings in South Africa, delays in implementation pilots due to start in early 2023 have tempered enthusiasm within the HIV community. Roll-out of long-acting injectable cabotegravir has been delayed because manufacturer packaging does not meet the country’s regulatory requirements, hindering implementation studies aimed at offering users a choice between different PrEP products in a real-life environment. Even when this roadblock is passed, there is still the uncertainty surrounding its final pricing and the limited global supply of cabotegravir injections due to the small number of generic manufacturers. For the dapivirine vaginal ring, delays were caused by issues in post-importation testing, although the pilots can now begin.

    In this issue, Patel and colleagues make a compelling case for the importance of providing a choice of HIV prevention options and implementing effective delivery approaches while considering individual preferences and needs. Information and choice are particularly important for women, who in a country such as the USA comprise 18% of new HIV diagnoses but represent only 8% of PrEP users. UNAIDS estimates that about 210000 adolescent girls and young women (aged 15–24 years) acquired HIV in 2022. Compared with oral PrEP, the dapivirine vaginal ring and long-acting injectable cabotegravir could offer more discreet options for women in vulnerable situations, helping to overcome regional stigmas surrounding female-controlled prevention methods. The sustained duration of long-acting injectables can also enhance convenience and accessibility for people who inject drugs, for whom unstable living situations or substance use patterns can hinder adherence to daily oral PrEP.

    Historically, the implementation of HIV prevention products has posed significant challenges for healthcare systems. Following WHO’s recommendation for oral PrEP in 2015 for populations at high risk of HIV, it quickly became evident that different regions, countries, and communities face a variety of challenges in adopting it, partly influenced by sociocultural norms, beliefs, and practices. No country is free from these roadblocks. For example last month the USA, which in 2012 was the first country to approve oral PrEP, reintroduced the PrEP Access and Coverage Act, which aims to bridge access gaps by providing zero-cost coverage for both public and private insurance payers and establishing a national grant programme for the uninsured. However, the act is already undermined by the ruling of a federal judge in Texas that funding HIV prevention for LGBTQ+ people violates religious freedom of private companies. The ruling casts a grave shadow over Americans’ access to HIV prevention.

    Although key populations continue to bear a disproportionately heavy burden of HIV relative to their population size, targeted approaches for these groups have yielded remarkable results, leading to a substantial reduction in HIV transmission rates. An example of this progress is the shift in the landscape of new HIV infections in the UK, where, the number of reported new HIV diagnoses among heterosexual individuals has surpassed that among men who have sex with men. Health-care systems face the impending need to scale awareness and generate demand by showcasing the inclusive nature of PrEP to all potential users who might benefit. Moving away from moral judgment and creating an environment where individuals feel comfortable expressing their needs and are able to access easily understandable information are key to reaching all of society.

    Awareness and demand for PrEP must include all those at risk of HIV. Through educational and access programmes that place people’s multifaceted diversity at their centre, health-care systems should seek to obtain more than just functional HIV prevention products, and strive to enable equitable delivery of the incoming array of PrEP options. ■ The Lancet HIV