Can Pediatric Primary Care Practices Afford Integrated Behavioral Health? A Comparison of 5 Pediatric Practices.

Licensed behavioral health providers (LBHPs) were integrated into 5 pediatric primary care practices in southeast and east Texas from October 2018 through March 2020. LBHPs Licensed behavioral health providers across the sites were 3 licensed clinical social workers (LCSW), 1 psychologist, and 1 nurse practitioner (NP). Practices provided data for 6 to 15 months. Overall, 2769 units of behavioral health services were provided to 746 children over 2243 hours. Across 4 sites, 44.3% of behavioral health patients were diagnosed with trauma disorders, 22.1% with anxiety, 19.3% with attention-deficit hyperactivity disorder, 15.1% with depression, and 10.9% with disruptive behavior disorders. Overall, the model was financially successful at 2 sites (LCSWs) and unsuccessful at 1 site (NP). The other 2 sites demonstrated potential for financial sustainability with increased behavioral health patient volume. Overall, this model is a financially viable option for pediatric primary care practices with adequate patient volumes to provide integrated behavioral health services.

Combination therapy with saquinavir soft gelatin capsules in children with human immunodeficiency virus infection.

OBJECTIVES: To evaluate the pharmacokinetics, tolerance, safety and antiviral activity of the HIV protease inhibitor, saquinavir, formulated as soft gelatin capsules (SQV-SGC), given in combination with nucleoside antiretroviral agents (NRTIs) with or without nelfinavir in HIV-infected children. METHODS: This was an open label study of HIV-infected children ages 3 to 16 years, conducted in two parts. In Part 1 of the study 14 children were treated orally with SQV-SGC (initially given in three 33-mg/kg doses daily; dosage adjusted to 50 mg/kg three times daily based on initial pharmacokinetics) and two NRTIs. Addition of nelfinavir was permitted for children who did not achieve a predetermined steady state target plasma saquinavir exposure. In Part 2 a new group of 13 children received SQV-SGC (33 mg/kg three times daily) in combination with nelfinavir and one or two NRTIs. Pharmacokinetics were assessed after the first dose and 4 weeks into treatment (steady state). Patients were treated for 72 and 48 weeks in Parts 1 and 2, respectively. RESULTS: Most adverse events were mild; the most commonly reported were diarrhea, abdominal discomfort and headache. Two children were withdrawn from the study because of adverse events (one each of nausea and dysphagia) related to the study treatment. There were no deaths or serious adverse events attributed to the study medication. Steady state saquinavir area under the plasma concentration vs. time curves (AUC24) were 6,210 and 11,010 ng/h/ml for Parts 1 and 2, respectively. Compared with baseline measurements median changes in plasma HIV RNA concentrations were -2.12 log10 copies/ml [5 of 14 (36%) with HIV RNA <50 copies/ml) (Week 72)] and -2.58 log10 copies/ml [8 of 13 (62%) <50 copies/ml) (Week 48)] in Parts 1 and 2, respectively. The median changes in CD4+ lymphocyte count were +292 and +154 cells/microl for Parts 1 and 2, respectively. Genotypic resistance assays revealed a low frequency of saquinavir-associated resistance mutations after 48 weeks of therapy, with only 2 of 27 children having substitutions at positions 48V and/or 90M. CONCLUSIONS: Combination therapy with SQV-SGC was well-tolerated and safe in HIV-infected children, and antiviral activity was observed. Saquinavir plasma concentrations were lower than expected, particularly for Part 1 (SQV-SGC plus NRTIs), but addition of nelfinavir increased saquinavir exposures.

Pilot study of hydroxyurea in human immunodeficiency virus-infected children receiving didanosine and/or stavudine.

OBJECTIVE: To evaluate the safety and antiviral and immunologic effects of hydroxyurea given with didanosine (ddI) and/or stavudine (d4T) to symptomatic HIV-infected children. METHODS: HIV-infected children with a history of long term nucleoside antiretroviral therapy were treated orally with hydroxyurea (initial dose, 10 to 20 mg/kg once daily; final dose, 30 mg/kg once daily), added to existing therapy that included ddI and/or d4T. RESULTS: Sixteen children were enrolled (mean age, 6.7 years; range, 1.8 to 13.4 years). Antiretroviral therapy used with hydroxyurea included d4T/ddI (12), ddI (2), d4T (1) and d4T/lamivudine (1). Children received between 24 and 48 weeks of therapy, which was well-tolerated. Hydroxyurea was held temporarily during the first month of therapy in 4 cases because of neutropenia; all patients resumed hydroxyurea at full dosage without recurrence of neutropenia. No patient discontinued therapy permanently because of intolerance or toxicity. For the 13 children who completed 48 weeks of study treatment, the mean plasma HIV RNA concentration decreased from 4.6 log10 copies/ml at baseline to 4.2 log10 copies/ml at study Week 48 (P = 0.035, paired t test). Eight of these 13 children experienced a 0.5-log10 copies/ml or greater drop in HIV RNA concentration in the 48 weeks of study treatment. Appreciable changes in CD4+ lymphocyte percentage were not noted. CONCLUSIONS: Hydroxyurea, added to existing therapy with ddI and/or d4T, was well-tolerated and safe in HIV-infected children. Evidence of antiviral activity was observed in some cases.