Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Initiation of Antiretroviral Therapy for HIV

A look at the benefits and risk

The initiation of antiretroviral therapy in 4,685 HIV-positive adult study participants with a CD4+ count of more than 500 cells per cubic millimeter provided net benefits over beginning the same therapy in patients after the CD4+ count had declined to 350 cells per cubic millimeter.

The patients were followed for a mean of 3 years and at study entry the median HIV viral load was 12,759 copies per milliliter, with the median CD4+ count of 651 cells per cubic millimeter. Primary composite end point was any serious AIDS-related events, serious non-AIDS-related events, or death from any cause. Among the finds that resulted in recommendation that patients in the deferred-initiation group be offered antiretroviral therapy were:

• Primary end point occurred in 42 patients in the immediate-initiation group compared with 96 patients in the deferred-initiation group (HR 0.43).

• Hazard ratios for serious AIDS-related and serious non-AIDS-related events were 0.28, respectively.

• 68% of the primary end points occurred in patients with a CD4+ count of more than 500 cells per cubic millimeter.

Citation: Lundgren JD, Babiker AG, Gordin F, et al. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. [Published online ahead of print July 20, 2015]. doi: 10.1056/NEJMoa1506816.

Commentary: Standard therapy recommendations have suggested waiting until the CD4+ count has decreased below a defined threshold, with the threshold being different in different guideline recommendations and having changed over time. This study provides strong evidence that initiation of therapy in HIV-positive adults with a CD4+ count of greater than 500 leads to improved outcomes compared to waiting until a CD4+ count of less than 350. Early initiation of therapy led to a decreased rate of serious AIDS and non-AIDS related events. This information, along with evidence that treatment decreases transmission of disease, suggests important benefit to early initiation of therapy. —Neil Skolnik, MD

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