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Experts debate when to initiate ART in asymptomatic HIV
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GLASGOW — The pros and cons of when to initiate ART in asymptomatic patients with HIV were debated here at the HIV11 Congress.
Although there is a divide over whether to initiate ART immediately or to wait until CD4 count levels are approximately 350 cells/mcL, there are also opposing views on whether comorbidities in HIV patients are associated with treatment regimens or whether current treatment options are less toxic than years past, and waiting to treat these patients increases their risk for comorbidities.
Treat as soon as possible
According to Michael S. Saag, MD, Jim Straley Endowed Chair in AIDS Research, and director of the Center for AIDS Research at the University of Alabama at Birmingham, there are several factors supporting the initiation of therapy as soon as possible.
For example, the biology of viral replication backs early initiation; there is an association between inflammation and earlier onset of multiple comorbidities; and the safety and efficacy of current treatment regimens have improved from years past.
Saag said data have demonstrated a clear benefit of ART at any CD4 count level — although data from randmonized trials are lacking for the highest CD4 count strata.
“In addition to the demonstrated and inferred benefits to the individual patient, we now have a public health benefit of earlier intervention — treatment is prevention,” Saag said. “From a practical perspective, we are talking about life-long therapy.
“All the evidence is screaming at us that early intervention makes sense. My concern is the damage that will be done if we wait to treat the patient — we will start to see earlier heart attacks, cancer, neurocognitive impairment, and strokes. The risk for adverse events from HIV doesn’t simply go away because we wait to treat the patient,” he said.
Wait to treat
Jens Lundgren, MD, professor at Copenhagen University Hospital/Rigshospitalet and at the University of Copenhagen, Denmark, said it is best to wait to initiate treatment until the patient has CD4 count levels of approximately 350 cells/mcL.
Jens Lundgren
“It remains controversial whether the extent to which ART results in net benefit if used by patients with HIV with a high CD4 count, particularly those with early HIV infection,” he said. “This controversy is primarily reflecting lack of solid evidence from randomized controlled trials.”
No trial has demonstrated net benefit from use of ART above currently accepted CD4 count thresholds (350 cells/mcL), and the completed observation studies do not support the claim of benefit either, according to Lundgren, who added that there are also no data to support early ART in resource-limited settings.
“The new START trial may show net harm from early use of ART, and such a result would severely undermine use of ART as prevention in early HIV infection,” he said. “The risk of early ART initiation to the HIV infected vs. the benefit of prevention to society is important to accurately determine. Current guidelines of generally initiating ART once the patient develops HIV-related symptoms or the CD4 count drops to levels around 350 cells/mcL should be adhered to until further evidence has emerged.”
For more information:
Lundgren J. #113.
Saag M. #112. Both presented at: HIV11 Congress; Nov. 11-15, 2012; Glasgow.
Disclosure: Saag reports financial relationships with BI, BMS, Gilead, Merck, Janssen and ViiV. Lundgren reports no relevant financial disclosures.