Protease inhibitor therapy in HIV-infected children

We reviewed the short-term response to and safety of protease inhibitor (PI ) therapy in HIV-infected children by performing a retrospective chart revi ew of open-label PI containing combination therapy at two urban pediatric H IV centers. Seventy HIV-infected children received 101 PI containing antire troviral therapy (ART) combinations. Main outcome measures were follow-up C D4 counts, viral loads, and patient or caregiver reported compliance. Durin g follow-up, treatment with PI ART was associated with a mean maximal incre ase in CD4(+) lymphocyte count of 454 x 10(6)/L and a mean maximal decrease in viral load of 1.76 log units. Of the 32 patients who achieved undetecta ble viral loads, 28 (87.5%) remained undetectable through a mean follow-up of 8.9 months. Patients who reported good compliance achieved a higher rate of response (92.6%) than those who reported poor compliance (61.5%). Of 14 changes made to a second PI because of treatment failure, 11 (78.6%) resul ted in a positive response to the second regimen. Nineteen of 101 courses o f PI therapy resulted in significant side effects, including renal complica tions in 8 of 21 patients treated with indinavir. PI ART was associated wit h substantial short-term improvement in immunological and virological param eters in this heavily pretreated cohort, with 40% of patients maintaining a n undetectable viral load after 9 months of therapy. Patients who failed on e PI regimen usually responded to a second regimen. There was a significant rate of side effects from PI treatment.