Making the Case for Earlier ART in HIV

The benefits of antiretroviral therapy (ART) during acute and early HIV infection remain unproven, despite several years of investigations into the topic. Studies have yielded conflicting results, with many having too few participants involved to make concrete, universal conclusions. It can also be challenging to identify patients who have been infected within the previous 6 months, making it difficult to conduct randomized trials in this population. As such, national guidelines currently recom­mend that ART be considered optional for acute and early HIV infection. Testing Early ART in Recently Infected Patients In the January 2012 Journal of Infectious Disease, researchers from the AIDS Clinical Trials Group Setpoint Study randomized patients with recent but not acute HIV infection to 36 weeks of ART followed by treatment discontinuation or to no treat­ment until pre-specified criteria for therapy initiation were met. “We aimed to deter­mine whether early treatment was associ­ated with a durable clinical benefit,” explains Christine M. Hogan, MD, lead author of the study. “To do that, we set out to demon­strate whether treatment during early infec­tion would lower the virologic set point (plasma HIV-1 RNA level)—an indepen­dent predictor of clinical outcome—after treatment was discontinued at 72 weeks.” The primary endpoint in the analysis was a composite of required treatment or retreat­ment and plasma HIV-1 RNA level at Week 72 for both groups and at Week 36 for the delayed-treatment group. The secondary end­point was the time to meeting guideline cri­teria—including CD4 count below 350 cells/mm3, clinical progression, or certain virologic criteria—for starting ART in the delayed-treatment arm or restarting ART after 36 weeks in the immediate-treatment arm. Unexpected Results from Delayed...