Early Zidovudine plus Lamivudine Therapy of HIV Infected Asymptomatic Infants† 847

Although treatment with a combination of antiretroviral agents is the recommended therapy for HIV infected symptomatic children, little data are available on the effects of early combined antiretroviral therapy in asymptomatic infants. We report viral load and lymphocyte subset data obtained before and during 180 days of treatment with zidovudine and lamivudine for 6 infants. Standard clinical laboratory procedures were used to obtain viral and immunologic data.

At initiation of therapy patients (ages 26, 60, 67, 70, 97 and 202 days of life) HIV RNA levels grouped to 2 clusters; 4 had high and 2 lower concentrations of virus (63,000-645,000 versus ≈5,000 RNA copies/ml, respectively). At approximately 30 days into therapy 5 (83%) patients had significant reductions in HIV RNA levels (log₁₀ mean decline as compared to pretherapy value -1.74); viral load in the remaining patient was unchanged. For patients with reduced viral loads, mean CD4 lymphocytes (both as absolute number (2,979) and as percent (46%)) met the CDC standard for normal for this age; the patient with unchanged viral load presented with an abnormally low CD4 (1,003, 22%). At approximately 180 days of therapy 4 (67%) patients had significant reductions in HIV RNA levels (log₁₀ mean decline -1.50); plasma virus in the remaining patients increased an average+1.48 log₁₀. CD4 lymphocytes were normal except for the patient previously identified as immunosuppressed. Of the 6 patients studied, 3 had rapid decreases in viral load following initiation of therapy and maintained this reduction throughout the period of observation. One maintained high viral loads until after day 90 of therapy at which time a marked reduction was found. The remaining 2 patients who had the lowest viral load at initiation of therapy had an initial significant reduction in viral load followed by increases to above pretherapy levels. The tested therapy regimen was associated with a marked reduction in HIV RNA for all patients and an at least 180 day sustained reduction in HIV RNA levels in 50% of patients.