In early HIV infection, immediate vs deferred antiretroviral therapy reduced serious illnesses at 3 years.

Question: In adults with HIV infection and CD4+ count > 500 cells/mm[sup 3], does immediate antiretroviral therapy (ART) reduce serious AIDS-related or non–AIDS-related illnesses compared with deferred ART? Methods Design: Randomized controlled trial (Strategic Timing of Antiretroviral Therapy [START] study). ClinicalTrials.gov NCT00867048. Allocation: Concealed.* Blinding: Blinded* (outcome adjudicators). Follow-up period: Mean 3 years. Setting: 215 centers in 35 countries. Patients: 4685 generally healthy patients ≥ 18 years of age (median age 36 y, 73% men, median CD4+ count 651 cells/mm[sup 3]) who were HIV positive, had 2 CD4+ counts > 500 cells/mm[sup 3]≥ 2 weeks apart ≤ 60 days before enrollment, and had not started ART. Exclusion criteria included pregnancy, breastfeeding, or history of AIDS. Intervention: ART started immediately (n = 2326) or deferred until CD4+ count reached ≤ 350 cells/mm[sup 3] or an AIDS-related event or other condition requiring ART occurred (n = 2359). Outcomes: Primary outcome was a composite of serious AIDS-related events (death due to AIDS or any AIDS-defining event other than nonfatal herpes simples virus infection or esophageal candidiasis) or serious non–AIDS-related events (death not related to AIDS, cardiovascular disease, end-stage renal disease, decompensated liver disease, or non–AIDS-defining cancer other than basal cell or squamous cell skin cancer). Other outcomes included components of the composite outcome, all-cause mortality, grade 4 events (symptomatic, non–AIDS-related, potentially life-threatening events requiring medical intervention), and unscheduled non–AIDS-related hospitalization. Patient follow-up: 95% (intention-to-treat analysis). Main results: Immediate ART reduced serious AIDS-related and non–AIDS-related events compared with deferred ART; groups did not differ for all-cause mortality, grade 4 events, or unscheduled non–AIDS-related hospitalizations (Table). Conclusion: In adults with HIV infection and CD4+ count > 500 cells/mm[sup 3], immediate antiretroviral therapy reduced serious illnesses compared with deferred therapy. [ABSTRACT FROM AUTHOR]