Short-course antiretroviral therapy ( ART ) in primary human immunodeficiency virus ( HIV ) infection may delay disease progression but has not been adequately evaluated.
Researchers randomly assigned adults with primary HIV infection to antiretroviral therapy 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 antiretroviral therapy initiation.
A total of 366 participants ( 60% men ) underwent randomization to 48-week antiretroviral therapy ( 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 ( P=0.01 ) for 48-week ART as compared with standard care and was 0.93 ( 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 longer with 48-week ART than with standard care.
Post hoc analysis has 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 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.
In conclusion, 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 antiretroviral therapy interruption on the clinical outcome. ( Xagena )
The SPARTAC Trial Investigators, N Engl J Med 2013; 368:207-217