Richard M. Rutstein, MD, Kelly A. Gebo, MD, MPH, Patricia M. Flynn, MD, John A. Fleishman, PhD, Victoria L. Sharp, MD, George K. Siberry, MD, MPH, and Stephen A. Spector, MD

Med Care 2005;43: III-15–III-22

Background
The goal of highly active antiretroviral therapy (HAART) has been to stabilize and reconstitute immune function and suppress viral replication to the greatest degree possible. Suppression of HIV viral replication has been associated with improved long-term and short-term prognosis. Limited data are available on the level of virologic suppression and immune function of pediatric patients followed in clinical settings in the HAART era.

Objective
The objective of this study was to assess the level of virologic suppression and immune function in a cohort of children with perinatally acquired HIV infection followed at dedicated HIV specialty care sites. Research Design: This study comprised a cohort study of HIVinfected children and adolescents.

Subjects
Study subjects consisted of 263 HIV-positive children (_17 years old), on HAART, with at least one outpatient visit and CD4 test recorded in 2001 seen at 4 U.S. HIV primary pediatrics and specialty care sites (2 eastern, 1 southern, and 1 western). Measures: Measures consisted of all plasma HIV-1 RNA levels _400 during calendar year 2001.

Results
Two hundred sixty-three patients received HIV-related treatment during 2001, with a mean age of 8.5 years. Sixty-eight percent were black, 54% were females, and the majority (85%) was insured by Medicaid. A total of 28.6% had a class C AIDS diagnosis. A total of 23.5% and 34% of patients maintained viral suppression at _50 copies per milliliter (cpm), or _400 cpm, respectively, for the calendar year; 32.5% and 38.8%, respectively, fulfilled the criteria if one “blip” to _5000 cpm was allowed. Forty-eight percent maintained all viral loads _5000 cpm, and 74.9% overall had HIV-1 RNAs _15,000 cpm. Eighty-seven percent of patients had CD4% _25; only 4.2% had CD4 _15%. Overall, 12.5% of patients had either CD4% _15 or severely decreased absolute CD4 counts (adjusted for age). A total of 4.6% of patients had HIV-1 RNAs _100,000 cpm and severe immunosuppression. Patients who were less likely to achieve virologic suppression to _400 cpm included those with CD4 count _200 cells/mm3 (odds ratio _OR_, 0.06; 95% confidence interval _CI_, 0.007– 0.46), those with AIDS (OR, 0.5; 95% CI, 0.28–0.94), and those with moderate (OR, 0.42; 95% CI, 0.22– 0.79), or severe immunologic suppression (OR, 0.14; 95% CI, 0.046–0.43) based on CD4%.

Conclusion 
In this multisite, pediatric cohort, the rate of nearcomplete virologic suppression (_50 or _400 cpm) was low. However, the majority of patients have near-normal CD4 counts and viral loads _15,000 cpm. Follow up will be critical to assess the implications of ongoing low-level viral replication with near-normal CD4 values.

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