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Clinical and immunologic outcomes after immediate or deferred antiretroviral therapy initiation during primary HIV infection: The Sabes randomized clinical study

Clinical Infectious Diseases Mar 08, 2020

Lama JR, Ignacio RAB, Alfaro R, et al. - In addition to confirmed public health benefits on decreasing transmission, there remains uncertainty concerning how early antiretroviral therapy (ART) should be initiated following HIV acquisition to maximize individual benefits. Researchers here randomized adult MSM and transgender women with acute (HIV-antibody negative/HIV-1 RNA positive) or recent (confirmed negative HIV-antibody or RNA test within three months) HIV infection to start ART immediately vs defer by 24 weeks in this open-label randomized clinical study in Lima, Peru. Among 216 participants, 105 were randomized to immediate arm and 111 to deferred arm (median age 26.8 years, 37% with acute HIV). Non-ART-related adverse events were less frequent in immediate vs deferred arm, fewer infections in those treated immediately dominated the difference. After 24 weeks of ART, lessening of between-group differences in CD4/CD8 cell ratio was observed, but there remained differences between those initiating ART ≤ 30 days from estimated date of detectible infection (EDDI), and those initiating > 90 days. In principal components analysis of 20 immune biomarkers, they noted distinct patterns between those starting ART > 90 days from EDDI vs those starting within 30 or 90 days. This work is supposed to be the only evaluation of randomized ART initiation during primary HIV and presented evidence to explicitly acknowledge acute HIV in WHO recommendations for universal ART.
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