在一項新的臨床試驗中，研究人員發(fā)現(xiàn)在HIV感染早期階段進行為期48周的抗逆轉(zhuǎn)錄病毒藥物治療能夠延緩對人免疫系統(tǒng)的損傷,，因而延緩開始進行終生抗逆轉(zhuǎn)錄病毒藥物治療的需求,。不過，相對于這些志愿者參與這項治療所花的時間,，這種延緩時間還不是顯著性的長,。相關(guān)研究結(jié)果于2013年1月17日發(fā)表在New England Journal of Medicine期刊上，論文標(biāo)題為"Short-Course Antiretroviral Therapy in Primary HIV Infection",。
除非經(jīng)常去檢查,，不然大多數(shù)人在他們感染上HIV病毒后最初幾年內(nèi)并不會意識到他們是HIV陽性的,。然而，人們的免疫系統(tǒng)從不會成功地清除掉HIV病毒,，相反,，這種病毒躲藏起來，緩慢地削弱身體的防御機制和破壞CD4 T細(xì)胞,，其中這種T細(xì)胞在免疫反應(yīng)種發(fā)揮著關(guān)鍵性的作用,。
如果沒有接受治療，那么免疫系統(tǒng)遭受越來越多的破壞,，讓個人有日益增加的風(fēng)險患上其他的危及生命的感染,。為了阻止這種情形發(fā)生，當(dāng)體內(nèi)剩下來的CD4 T細(xì)胞數(shù)量達到每立方毫米350個細(xì)胞的水平時,，根據(jù)國際治療指南,，醫(yī)生們就得建議個人進行終生的抗逆轉(zhuǎn)錄病毒藥物治療。這些藥物不僅阻止進一步損傷免疫系統(tǒng),，而且也允許它進行自我修復(fù),。
幾項觀察性研究已提示著在HIV感染發(fā)生的時刻進行治療能夠延緩免疫系統(tǒng)受損的程度和速度，因而也就延緩開始進行終生抗逆轉(zhuǎn)錄病毒藥物治療的需求,。血清HIV陽轉(zhuǎn)期間短期抗逆轉(zhuǎn)錄治療(Short Pulse Anti-Retroviral Therapy at HIV Seroconversion,， SPARTAC)是第一個大型的隨機對照試驗來測試這種猜測。這項試驗已開展5年多,，涉及來自澳大利亞,、巴西、冰島,、意大利,、南非、西班牙,、烏干達和英國的366名成年人,。
在SPARTAC試驗中，所有的試驗志愿者在被HIV感染的6個月內(nèi)經(jīng)測試而被鑒定出,，并接受隨機分為三組：第一組接受為期48周的抗逆轉(zhuǎn)錄病毒藥物治療,，第二組接受為期12周的抗逆轉(zhuǎn)錄病毒藥物治療,，第三組不接受藥物治療,。研究人員然后測量每名志愿者的CD4 T細(xì)胞數(shù)量降到每立方毫米350個細(xì)胞以下和/或他們開始進行終生抗逆轉(zhuǎn)錄病毒藥物治療時所需的時間。
在這項研究中,，研究人員發(fā)現(xiàn)沒有接受藥物治療的試驗志愿者在感染HIV病毒平均157周后就得開始接受終生抗逆轉(zhuǎn)錄病毒藥物治療,。而平均而言，那些接受為期12周的抗逆轉(zhuǎn)錄病毒藥物治療的志愿者在感染HIV病毒平均184周后開始接受終生抗逆轉(zhuǎn)錄病毒藥物治療(延緩27周,，但是研究人員并不認(rèn)為這種影響是顯著性的),。
然而,，那些接受為期48周的抗逆轉(zhuǎn)錄病毒藥物治療的志愿者在感染HIV病毒平均222周后開始接受終生抗逆轉(zhuǎn)錄病毒藥物治療，即延緩65周,。相比于不接受藥物治療或接受為期12周的抗逆轉(zhuǎn)錄病毒藥物治療,，這代表著一種重要的延緩，但是總體而言,，相對于這些志愿者參與這項治療所花的時間,，這種延緩時間還不是顯著性的長。
此外,，在這項研究的整個時間內(nèi),，相比于另外兩組志愿者，接受為期48周的抗逆轉(zhuǎn)錄病毒藥物治療的那組志愿者擁有更高的CD4 T細(xì)胞數(shù)量,，因而潛在地降低遭受諸如肺結(jié)核之類的繼發(fā)性感染的風(fēng)險,。而且相對于其他的志愿者，在停止治療一年多后,，他們的血液中的HIV水平也更低,，因而這就能夠降低將HIV病毒傳染到性伴侶的風(fēng)險。(生物谷Bioon.com)
DOI: 10.1056/NEJMoa1110039
PMC:
PMID:
Short-Course Antiretroviral Therapy in Primary HIV Infection
The SPARTAC Trial Investigators
BACKGROUND Short-course antiretroviral therapy (ART) in primary human immunodeficiency virus (HIV) infection may delay disease progression but has not been adequately evaluated. METHODS We randomly assigned adults with primary HIV infection to ART for 48 weeks, ART for 12 weeks, or no ART (standard of care), with treatment initiated within 6 months after seroconversion. The primary end point was a CD4+ count of less than 350 cells per cubic millimeter or long-term ART initiation. RESULTS A total of 366 participants (60% men) underwent randomization to 48-week ART (123 participants), 12-week ART (120), or standard care (123), with an average follow-up of 4.2 years. The primary end point was reached in 50% of the 48-week ART group, as compared with 61% in each of the 12-week ART and standard-care groups. The average hazard ratio was 0.63 (95% confidence interval [CI], 0.45 to 0.90; P=0.01) for 48-week ART as compared with standard care and was 0.93 (95% CI, 0.67 to 1.29; P=0.67) for 12-week ART as compared with standard care. The proportion of participants who had a CD4+ count of less than 350 cells per cubic millimeter was 28% in the 48-week ART group, 40% in the 12-week group, and 40% in the standard-care group. Corresponding values for long-term ART initiation were 22%, 21%, and 22%. The median time to the primary end point was 65 weeks (95% CI, 17 to 114) longer with 48-week ART than with standard care. Post hoc analysis identified a trend toward a greater interval between ART initiation and the primary end point the closer that ART was initiated to estimated seroconversion (P=0.09), and 48-week ART conferred a reduction in the HIV RNA level of 0.44 log10copies per milliliter (95% CI, 0.25 to 0.64) 36 weeks after the completion of short-course therapy. There were no significant between-group differences in the incidence of the acquired immunodeficiency syndrome, death, or serious adverse events. CONCLUSIONS A 48-week course of ART in patients with primary HIV infection delayed disease progression, although not significantly longer than the duration of the treatment. There was no evidence of adverse effects of ART interruption on the clinical outcome. (Funded by the Wellcome Trust; SPARTAC Controlled-Trials.com number,ISRCTN76742797, and EudraCT number, 2004-000446-20.)
