Fidler, Sarah, Porter, Kholoud, Ewings, Fiona, Frater, John, Ramjee, Gita, Cooper, David, Rees, Helen, Fisher, Martin and et al., (2013) Short-course antiretroviral therapy in primary HIV infection. New England Journal of Medicine, 368 (3). pp. 207-217. ISSN 0028-4793

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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 followup
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 log10 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 Controlled-Trials.com number,
ISRCTN76742797, and EudraCT number, 2004-000446-20.)

Item Type:	Article
Schools and Departments:	Brighton and Sussex Medical School > Brighton and Sussex Medical School
Subjects:	R Medicine > RC Internal medicine > RC0109 Infectious and parasitic diseases
Related URLs:	http://www.nejm.org/doi/pdf/10.1056/NEJM...
Depositing User:	Ellen Thomas
Date Deposited:	08 Jul 2013 10:50
Last Modified:	09 Jul 2019 13:45
URI:	http://sro.sussex.ac.uk/id/eprint/45594

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