ART in HIV-Positive Persons With Low Pretreatment Viremia: Results From the START Trial.
ART in HIV-Positive Persons With Low Pretreatment Viremia: Results From the START Trial.
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治疗前病毒血症水平较低的 HIV 阳性人群中的 ART:START 试验的结果。
DOI:
10.1097/qai.0000000000002052
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发表时间:
2019
期刊:
影响因子:
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通讯作者:
INSIGHTSTARTStudyGroup
中科院分区:
文献类型:
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作者:
Sereti,Irini;Gulick,RoyM;Krishnan,Sonya;Migueles,StephenA;Palfreeman,Adrian;Touzeau-Römer,Veronique;Belloso,WaldoH;Emery,Sean;Law,MatthewG;INSIGHTSTARTStudyGroup
Background:The benefit of immediate antiretroviral therapy (ART) at CD4> 500 cells/μL was established in the Strategic Timing of Antiretroviral Treatment (START) study. The benefits and risks of immediate ART in participants with low pretreatment viremia, including virologic suppressors, were further assessed.Setting:Randomized prospective international study.Methods:START participants with enrollment viremia< 3000 c/mL were included. We compared clinical outcomes (grade 4 adverse events, hospitalizations, or death), plasma viremia, CD4 counts, and changes in biomarkers in immediate versus deferred ART groups.Results:Participants (N= 1134 including 93 with viremia≤ 50 c/mL) had a median age of 37 years, 40% were women, and median CD4 was 713 cells/µL. Ninety-seven percent in the immediate and 29% in the deferred arm initiated ART at a median of 6 and 699 days, respectively. Clinical outcomes were experienced in 64 versus 61 patients in immediate and deferred arms (hazard ratio 1.10, 95% confidence interval: 0.77 to 1.56). The CD4 count difference was 125 cells/µL at 12 and 235 cells/µL at 36 months higher in the immediate versus deferred groups. D-dimer and VCAM levels decreased, and C-reactive protein increased, in the immediate arm at month 8. No significant changes in CD4 counts or biomarkers were observed in persons who maintained spontaneous virologic suppression.Conclusions:START participants with low enrollment viremia experienced higher CD4 counts, greater proportion with suppressed viremia, and decreases in D-dimer levels on immediate ART despite the lack of difference in serious clinical outcomes. These data support immediate ART in people with low viremia, although equipoise remains for suppressors.