The children are currently being followed to assess the long-term benefit of this treatment. Due to limitations in reporting, we believe that the CDC numbers are low. We are pleased with the results of this study. The combination was generally well-tolerated by most children. The results are comparable or superior to other combinations and we think that the once-daily dosing with Sustiva may provide an advantage to children and their families.
Compliance is a critical issue in pediatric treatment.
Until the introduction of Sustiva, preferred first line therapy for HIV-infected patients was considered to be a combination of one or more protease inhibitors plus two nucleoside analogues. More patients in the indinavir-containing arm discontinued prior to 48 weeks. The difference in discontinuations as a result of adverse events makes it difficult to assess the relative efficacy of the treatment. Significant CD4 cell count increases were noted with all combinations. Data on the 1266 patients ultimately randomized to this study were recently presented at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy.