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控制愛滋病毒流行:改善檢測和抗病毒藥物治療的可及性

 

控制愛滋病毒流行:改善檢測和抗病毒藥物治療的可及性

資料來源:刺胳針愛滋病毒期刊;財團法人台灣紅絲帶基金會編譯www.thelancet.com/hiv Vol 4 December 2017

廣泛的愛滋病毒檢測和快速連結感染愛滋病毒的人們立即進行抗反轉錄病毒藥物治療(ART)可減緩疾病進展並可防止傳播他人。無論其名稱為何「測試和治療」、「測試並開始」、「普遍測試和治療」,或者是「治療即預防 測試和快速連結到醫療照護的方法其實類似於當針對性傳染病和結核病時所採取之長期的控制和綜合性的預防策略。由Zunyou Wu及其同事於「剌胳針愛滋病毒」期刊所撰寫的研究是一個複雜實作科學的例子,在這個集團隨機試驗的研究中,患者隨機地被分配到12個中國醫院中的介入組或標準治療組;六家醫院(232名)的患者提供由測試到連結醫療照護策略之「一點到位服務」(One4All),收治到其他六家醫院(246名)的病人則提供廣西省當地標準的照護。 One4All包括快速愛滋檢測的到點服務,以及被確診為HIV陽性者其CD4計數和病毒載量之測試;所有HIV感染者都是迅速連結到即時的抗反轉錄病毒藥物治療(ART),且無論他們CD4計數或病毒載量是多少。 One4All之患者流程旨在加速診斷和分期並提供符合條件的患者立即接受抗反轉錄病毒治療,就如同世衛組織以及關鍵臨床指引所推薦的方式。這項研究最主要結果是完全地測試接觸個案30天內的完整性;作者還評估了90天內於醫院之入院次數,以及進入研究後12個月的死亡人數。隨著實作科學研究的進行,這項試驗是嚴謹和適切的,更為改善愛滋治療的結果及降低愛滋病毒感染者的傳染性上提供了一條新的道路。雖然早期測試和連結治療體系等更對顧客友善的服務使得成本上漲了,但整體介入措施仍極具成本效益。

可惜的是,在醫院隨機分配時沒有很理想地去平衡不同的群體。標準照護組其成員受教育之程度較低,有較多的少數民族壯族,且住院病人比One4All介入組多,導致偏離虛無假設(如,冒著可能之風險,即介入組結果中有顯著差異可能真的源於標準照護組之參與者其背景的不同)。在多變量分析中可進行適當的統計調整,但是在臨床試驗中當隨機分配時,若能夠成功地平衡其介入組和標準治療組中所有可能會影響結果的特徵,則它在科學上將會更令人滿意。無法完全平衡個案背景特徵,在集團隨機試驗中比在個體隨機試驗中更為常見,這在實作科學是方法論上的一項挑戰。吳和其同事們發現了以顧客為中心的One4All介入措施的好處非常地令人信服,232名患者中有177名(76%)都在註冊後的30天內完成了所有推薦的測試,相較於標準治療組的246名患者中只有63名(26%)(經醫院集團效應及基準共變數調整後勝算比為19.9, 95%,信賴區間為 3.86-103.04P = 0·0004)。老年患者以及從住院病人中招募的患者完成測試的可能性較小。這些發現有些令人驚訝因為年輕人往往在愛滋病毒檢測中很難被觸及,以及住院病人通常是一個較具有動機的亞群。在追蹤的過程中較低的住院率和明顯減少的死亡人數此一趨勢,也支持One4All有效率的測試和連結照護之介入措施。

在非洲透過精簡效率的到點全面照護之檢驗,整合母親和新生兒照護、任務由護士轉移到社區衛生工作者以及男性的參與,成功地提升了感染愛滋病毒之孕婦的篩檢測試。在中國,擴大了抗反轉錄病毒藥物治療(ART)可能有助於傳播之預防。

非洲一項重要的臨床試驗(愛滋預防試驗網絡[HPTN] 071協議,PopART研究)正不間斷地評估擴大測試和連結照護對預防上的益處。類似的數據預期在未來將由吳和他的同事們所進行的試驗中產出,而重要的是去看看是否One4All介入措施可以足夠強大到去證明,在介入的社區中獲得更早期和更廣泛的抗反轉錄病毒藥物治療(ART)可以真正的達到減少傳播的結果。由吳和其同事們的研究早期所透露之跡象、另一項關於男男間性行為者的北京研究,以及由HPTN 071PopART)研究其過程成果中的發現等等均很有前景。這些作者群們已抓住了現今全球壓倒性共識的精髓,有效率精簡的促成儘早和簡易的篩檢和HIV檢測之確認、CD4細胞之計數和病毒載量量測,當其結合至抗反轉錄病毒藥物治療的連結時,可以改善臨床結果。這亦可能會減少傳播他人,但是否可以達到足夠的涵蓋率以形成改變則還有待觀察。

 

Control of HIV epidemic: improve access to testing and ART

Widespread HIV testing and rapid linkage of people with HIV to immediate antiretroviral therapy (ART) both slows disease progression and prevents transmission to others. Regardless of its moniker—test and treat, test and start, universal testing and treatment, or treatment as prevention—the testing and rapid linkage-to-care approach is analogous to long-standing control and combination prevention strategies for other sexually transmitted infections and for tuberculosis. The study by Zunyou Wu and colleagues in this issue of Lancet HIV is a sophisticated example of implementation science, in this case a cluster randomised trial that assigned patients to intervention or standard of care at 12 randomised Chinese hospitals; patients at six hospitals (n=232) were offered the One4All testing and linkage-to-care strategy and patients at the other six hospitals (n=246) received the local Guangxi Province standard of care. The One4All included rapid, point-of-care HIV testing and, for those who were identifies as HIV-positive, CD4 counts and viral load testing. All patients with HIV infection were linked promptly to immediate ART, regardless of their

CD4 count or viral load. The One4All patient flow was designed to accelerate diagnosis and staging and provide immediate ART for eligible patients, exactly as WHO and key clinical guidelines recommend. The study’s primary outcome was full testing completeness within 30 days of contact. The authors also assessed hospital admissions for 90 days and deaths for 12 months after study enrolment. As implementation science studies go, this trial was rigorous and relevant, providing a new path to improve HIV outcomes and reduce infectiousness of people with HIV infection. Although costs rose with the more user-friendly system of early testing and linkage-tocare, the intervention was highly cost-effective.

Unfortunately, hospital randomisation did not balance the groups optimally. The standard-of-care group was less educated, had more Zhuang minority individuals, and had more inpatients than the One4All

intervention group, introducing biases away from the null hypothesis (ie, risking showing a difference

as a result of the intervention that might really have originated in the backgrounds of the participants in

the standard-of-care group). Appropriate statistical adjustments were made in multivariable analysis, but

it is more scientifically satisfying when randomization in a clinical trial succeeds in balancing the intervention and standard-of-care groups on all characteristics that could potentially influence a given outcome. Failure to balance background characteristics fully is more common in cluster randomised trials than in individually randomised trials, and this is a methodological challenge in implementation science.

Wu and colleagues found that the benefits of the client-centred One4All intervention were quite

compelling, with 177 (76%) of 232 patients completing all recommended testing within 30 days of enrolment versus 63 (26%) of 246 in the standard-of-care group (odds ratio adjusted for hospital clustering effect and baseline covariates 19·9, 95% CI 3·86–103·04, p=0·0004). Older patients were less likely to complete testing, as were patients who were recruited from an inpatient setting. These findings were somewhat surprising because young people can often be difficult to contact for HIV testing and inpatients are often a motivated subpopulation. The trends for lower hospital admissions and significantly fewer deaths at follow-up are also supported the streamlined testing and linkageto-care One4All intervention.

In Africa, testing successes in pregnant women with HIV infection have been enhanced by streamlined point of-care testing, integrated mother and neonatal care, task shifting from nurses to community health workers, and male engagement. In China, expanded ART might have contributed to transmission prevention. An important clinical trial in Africa (HIV Prevention Trials Network [HPTN] 071 protocol, the PopART study) is ongoing to assess prevention benefits of expanded testing and linkage-to-care. Similar data are anticipated from the trial by Wu and colleagues in the future and it will be important to see if the

One4All intervention proves robust enough to have actually reduced transmission as a result of earlier and

more widespread ART availability in the intervention communities. Early indications from the study by Wu

and colleagues, a Beijing study of men who have sex with men, and process outcome findings in the HPTN

071 (PopART) study are promising. The authors have captured the essence of what is now an overwhelming

global consensus, that streamlining to enable early, easy screening and confirmatory HIV testing, CD4 cell counts, and viral loads, when combined with linkage to ART, can improve clinical outcomes. This is likely to reduce transmission to others, but whether sufficient coverage can be reached to make a difference remains to be seen.

www.thelancet.com/hiv Vol 4 December 2017

 

 

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