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Dennis Sifris, MD and James Myhre

Is U.S. Edging Closer Toward HIV Treatment "On Diagnosis?"

By May 7, 2013

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We have gotten a number of queries on our recently updated Understanding HIV Therapy, regarding the adult treatment initiation guidelines issued by the U.S. Department of Health and Human Services (DHHS) at the end of March, which state:

"The Panel has updated its recommendations on initiation of ART in treatment-naïve patients...The strength and evidence for this recommendation vary by pretreatment CD4 cell count: CD4 count <350 cells/mm3; CD4 count 350 cells/mm3 to 500 cells/mm3; CD4 count >500 cells/mm3."

Simply put, the Panel recommends that antiretroviral therapy (ART) be initiated in previously untreated ("treatment-naïve") patients when their CD4 count is either

  • under 350 cells/mm3;
  • between 350-500 cells/mm3, or;
  • over 500 cells/mm3.

But wait a second... doesn't that just mean to start treatment whenever you want? And if so, why not say as much?

Despite the apparent ambiguity of it all, the DHHS guidelines reflect the shifting consensus among U.S. treaters, many of whom are calling for the initiation of ART at the time of diagnosis, irrespective of CD4 count. While the Panel doesn't actually go as far that, their recommendations clearly pave the way for such an approach.

Breaking Down the DHHS Recommendations

In the end, the DHHS extended their reach as far as they  could, basing their recommendations on the available science, while acknowledging that some of the evidence is not entirely conclusive. Their rationale is as follows:

  • Strongly recommend initiation at CD4 under 350 cells/mm3 based on randomized control trials that "provide strong evidence that ART improves survival and delays disease progression."
  • Strongly recommend initiation at CD4 between 350-500 cells/mm3 based on observational studies and secondary analyses, which demonstrate that initiation at this level can "reduce HIV-related disease progression" while "demonstrating the public health benefit of earlier intervention."
  • Moderately recommend initiation at CD4 over 500 cells/mm3 based on collaborative cohort studies and the evaluation of public clinics with a universal ART approach, which suggest that the "reduction in community viral load can potentially reduce new HIV infections" while "untreated HIV infection increases the risk of many non-AIDS-defining diseases."

City of San Francisco as Case Model

The San Francisco Department of Public Health adopted the universal ART approach back in 2010, which was considered controversial at the time. In a study presented at the 2012 Conference on Retroviruses and Opportunistic Infections (CROI), researchers from the University of California San Francisco reported that, a result of the policy change, the proportion of people initiating ART with a CD4 count of over 350 increased from 48% in 2004 to 92% in 2010.

Meanwhile, for those who entered the program with a CD4 count of over 500, 50% were able to rapidly suppress their viral load. Previous to universal ART, only one in ten were able to achieve this.

At the time of the CROI presentation, it was reported that half of the DHHS Panel had recommended HIV treatment at the time of diagnosis. No word yet on whether that number has shifted with the release of the new guidelines.

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