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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...

Antiretroviral Therapy in HIV Infection: A Guideline Update

Successful antiretroviral therapy (ART) has been linked to dramatic decreases in HIV- and AIDS-defining conditions and their associated mortality. In 2008, the International AIDS Society–USA released guidelines on the timing of therapy, optimal regimen choices, and monitoring in patients with HIV. Since that time, treatment options have expanded, and knowledge on the initiation and long-term management of ART in adults with HIV infection has evolved. “Recent research has shed light on the role of ART in reducing the rates of serious non-AIDS events associated with uncontrolled HIV replication,” explains Melanie A. Thompson, MD. “Clinicians have also gained a better understanding of the efficacy, toxicity, and potential uses of newer drugs. As such, an expert panel was convened to update the International AIDS Society–USA guidelines for the use of ART in adults with HIV infection.” The updated guidelines were presented at the AIDS 2010: XVIII International AIDS Conference and published in the July 21, 2010 JAMA. The Need for Early Initiation of ART Clinical studies have shown that progressive damage occurs during asymptomatic HIV infection. “This underscores the potential benefit of ART, even when the risk of traditional AIDS-defining diseases is relatively low,” says Dr. Thompson, who chaired the International AIDS Society–USA antiretroviral therapy guidelines consensus panel. Dr. Thompson notes that non-AIDS events are now a major contributor to morbidity and mortality in persons with HIV infection. “Uncontrolled HIV replication is associated with immune activation and inflammation, and these are associated with non-AIDS illnesses,” she says. “This suggests that viral suppression with ART might improve survival and quality of life for patients. Multiple studies have now shown this to be...
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