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CD4 noninferior to viral load monitoring in HIV
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There was no difference in the 3-year rates of clinical failure or loss of treatment options in patients with HIV monitored by CD4 counts instead of viral load, researchers with the Programs for HIV Prevention and Treatment study team in Thailand have found.
“Monitoring of viral load is central to [the HIV] therapeutic approach and to national guidelines in most resource-rich settings,” the researchers wrote in PLOS Medicine. “However, in low- and middle-income countries, with limited resources and restricted access to more costly second- and third-line drugs, the utility of this approach is debated. Moreover, a viral load monitoring strategy may lead to more frequent treatment changes, limiting future drug options.”
The study was a randomized, noninferiority trial that was conducted in 21 public hospitals in Thailand. From May 2005 to April 2007, 716 participants with HIV were enrolled into the trial, and they were randomly assigned to viral load monitoring or CD4 count monitoring. All patients had a confirmed CD4 count of 50 cells/mm3 to 250 cells/mm3 and have not previously received ART. The patients initiated ART when upon enrollment. Patients were monitored for 3 years.
Fifty-eight patients reached the clinical failure primary endpoint: three had CD4 counts decrease below 50 cells/mm3, 33 developed an AIDS-defining event and 22 died. The risk of clinical failure at 3 years was not different between the two arms: 8% in the viral load monitoring arm vs. 7.4% in the CD4 monitoring arm. At 3 years, the cumulative risk for death was also similar: 4.3% in the viral load monitoring arm and 3.4% in the CD4 monitoring arm.
Fifty patients were switched to second-line regimens, but there was no significant difference between the two arms. The median time from enrollment to the switch was shorter in the viral load monitoring arm: 11.7 months vs. 24.7 months (P=.001).
“These findings confirm that access to life-saving ART should continue to be expanded even in settings without virological monitoring, and provide reassurance to treatment programs currently based on CD4 monitoring alone, as viral load measurement becomes more affordable and feasible in resource-limited settings,” the researchers wrote.
Disclosure: The researchers report no relevant financial disclosures.
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