Clinical Trial Comparison of Immediate vs Deferred Antiretroviral Therapy in HIV-Infected Individuals

This study compared immediate initiation of antiretroviral therapy (ART) with deferred treatment in HIV-infected individuals with CD4+ count >500 cells/mm3. Results showed a significant reduction in primary composite endpoint events in the immediate ART group compared to the deferred ART group. Serious AIDS events and serious non-AIDS events were also significantly lower in the immediate ART group. Subgroup analysis based on CD4+ count further highlighted the benefits of immediate ART initiation. Overall, early initiation of ART in this population demonstrated better clinical outcomes and reduced disease progression.

• Clinical Trial
• Antiretroviral Therapy
• HIV Infection
• CD4 Count
• Disease Progression

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1. START Design HIV-infected individuals who are ART-na ve with CD4+ count > 500 cells/mm3 (N=4,685) Immediate ART Group Deferred ART Group Initiate ART immediately following randomization Defer ART until the CD4+ count declines to < 350 cells/mm3or AIDS develops N=2,326 N=2,359 Primary composite endpoint, target = 213 Serious AIDS or death from AIDS Serious Non-AIDS Events and death not attributable to AIDS o CVD, ESRD, decompensated liver disease, & non-AIDS defining cancers Lundgren IAS 2015, NEJM

2. START Primary Endpoint - 1 Immediate ART Deferred ART No. with Event (%) 42 (1.8%) 96 (4.1%) Rate/100PY 0.60 1.38 HR (Imm/Def) 0.43 (95% CI: 0.30 to 0.62, p <0.001) Serious AIDS: 0.28 (95% CI: 0.15 to 0.50, p <0.001) Serious Non-AIDS: 0.61 (95% CI: 0.38 to 0.97, p=0.04) 5.3 2.5 2 Lundgren IAS 2015, NEJM

3. Primary Endpoint Counts and Rates in Participants with Latest CD4+ Count >500 or <350 cells/mm3 Latest CD4+ count >500 cells/mm3: Imm. ART Defer. ART % of primary events 88% (37/42) 59% (57/96) Rate (/100 PY) 0.6 1.1 Lundgren IAS 2015, NEJM

4. Primary End Point for Subgroups 1 4 Lundgren IAS 2015, NEJM