CD4 Cell Count-guided Treatment Interruption: Be Smart and Wait for More Evidence

A review and commentary by Dr. Roberto Arduino (University of Texas) on structured treatment interruptions in patients with chronic HIV infection appear in the current issue of Clinical Infectious Diseases (March 1, 2005). The following excerpt from his editorial is concerned with CD4 cell count-guided treatment interruption and with the results of the study by Nuesch and others that appears in the same issue of the journal.

“Recent data from observational cohorts identified the CD4 cell count as a strong predictor of progression to AIDS or death in individuals receiving HAART. The risk of disease progression markedly increases as CD4 cell count drops to <200 cells/mm3. These data suggest that a strategy of discontinuation of HAART until the CD4 cell count drops to 250 cells/mm3 may have merit.

“Although the study by Nuesch and colleagues suggests that a CD4 cell count-guided STI strategy may be safe among patients previously treated with dual-NRTI therapy, the benefits and risks of strategic treatment interruptions for chronically HIV-infected individuals like those studied and others who initiate HAART can best be determined by a large, long-term, randomized, clinical end point trial that is adequately powered not only to evaluate risk of resistance for CD4 cell count–guided STI and continuous treatment strategies but also to compare clinical outcomes, including AIDS, major toxicities, and survival.

“The SMART study (a large trial comparing 2 strategies for management of antiretroviral therapy) plans to randomize 6,000 HIV-infected subjects with a CD4 cell count >350 cell/mm3 to receive 1 of 2 different strategies: (1) "drug conservation," aimed at minimizing patients' exposure to antiretroviral drugs by use of episodic antiretroviral treatment to maintain a CD4 cell count between 250 and 350 cell/mm3; or (2) "viral suppression," aimed at maintaining the viral burden as low a level as possible by use of continuous antiretroviral treatment.”

In conclusion Dr. Arduino writes, “Given the established benefits of continuous HAART, we need much more definitive data on CD4 cell count- guided strategies before they should be recommended in clinical practice.”

Division of Infectious Diseases, University of Texas Health Science Center at Houston, Houston, TX.

02/14/05

Reference
R Arduino. CD4 Cell Count–Guided Treatment Interruption: Be Smart and Wait for More Evidence (editorial). Clinical Infectious Diseases 40(5): 735-737. March 1, 2005.

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