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Reference: Fidler, S, Porter, K, Ewings, F et al., (2013). Short-course antiretroviral therapy in primary HIV infection. New England Journal of Medicine, 368 (3), 207-217.Citable link to this page:


Short-course antiretroviral therapy in primary HIV infection.

Abstract: 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 log(10) copies 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 number, ISRCTN76742797, and EudraCT number, 2004-000446-20.).

Peer Review status:Peer reviewedPublication status:PublishedVersion:Publisher's version Funder: Wellcome Trust   Notes:Copyright © 2013 Massachusetts Medical Society. Reprinted with permission.

Bibliographic Details

Publisher: Massachusetts Medical Society

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Journal: New England Journal of Medicinesee more from them

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Issue Date: 2013


Urn: uuid:6f4033e4-5e7b-47b0-aff5-016fa0615376

Source identifier: 374194

Eissn: 1533-4406


Issn: 0028-4793 Item Description

Type: Journal article;

Language: eng

Version: Publisher's versionKeywords: SPARTAC Trial Investigators Humans HIV Infections Disease Progression RNA, Viral Anti-Retroviral Agents Drug Administration Schedule CD4 Lymphocyte Count HIV Adult Middle Aged Young Adult Female Follow-Up Studies Male Tiny URL: pubs:374194


Autor: Fidler, S - - - Porter, K - - - Ewings, F - - - Frater, J - institutionUniversity of Oxford Oxford, MSD, Clinical Medicine, Exper



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