Antiretroviral Drug Holidays May Be Safe in Some HIV Patients  

By Will Boggs, MD

It may be safe to discontinue antiretroviral therapy in a subset of HIV-infected patients who started treatment at CD4 cell counts higher than currently recommended, according to a report in the November 1st Journal of Acquired Immune Deficiency Syndromes.

"By looking at outcomes in patients who stop HAART (highly active antiretroviral therapy) as we did, we may be able to learn about the feasibility of a strategy of drug holidays, e.g., for which patients is it a reasonable strategy," Dr. Daniel J. Skiest, at the University of Texas Southwestern Medical Center in Dallas, told Reuters Health.

Dr. Skiest and colleagues examined the clinical, virologic, and immunologic outcomes of 107 HIV-infected patients who stopped antiretroviral therapy for at least 5 consecutive weeks.

They had started therapy at a mean CD4 count of 463 cells/microliter, and 89% of the group was above 250 at that point.

The mean CD4 count was 739 when HAART was stopped, and all but two of the patients had CD4 cell counts of at least 350 cells/microliter.

During the first 60 days off therapy, CD4 cell counts fell by 65 cells/month, the authors report, but the decline leveled off at about 8 cells/month through the 13-months of follow-up.

The median CD4 cell count at the end of follow-up remained above that of the pre-antiretroviral therapy CD4 cell count, the report indicates.

The change in HIV viral load was basically a mirror image of the CD4 pattern.

Those who began HAART at CD4 counts below 250 were most likely to reach a drug holiday CD4 cell count below 250 cells/microliter, or restart antiretroviral therapy, the results indicate. Older age and the cumulative number of antiretroviral medications prior to the drug holiday also independently predicted these endpoints.

Restarting therapy was associated with rapid increases in CD4 cell counts and declines in HIV levels, the investigators report.

"There is a select subset of individuals who started HAART when recommendations were to start at CD4 cell counts > 350, in whom it is safe to stop HAART," Dr. Skiest said. "Obviously these patients require close follow-up," he added.

"Prospective studies are needed to more accurately predict the immunologic, virologic, and clinical course following discontinuation of antiretroviral therapy," the authors conclude.

"We have an ongoing study in the AIDS Clinical Trial Group which is following patients for two years after stopping HAART," Dr. Skiest commented.

12/13/04

J Acquir Immune Defic Syndr 2004;37:1351-1357.

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