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Antiretroviral Therapy in Children
Monday, 1:30 - 3:30 pm
Background: T20-310 is an ongoing phase 1/2 pharmacokinetic, safety, and efficacy study of enfuvirtide (ENF) in combination with an optimized background in HIV-infected children and adolescents.
Methods: ENF was administered subcutaneously at a dose of 2 mg/kg twice daily (maximum 90 mg/dose) to heavily pretreated HIV-1-infected adolescents aged 12 through 16 years with HIV-1 RNA >5000 copies/mL. Assessments for clinical and laboratory safety parameters, including evaluations of injection site reactions, adherence, HIV-1 RNA, and CD4 counts were performed monthly through week 24 and bimonthly thereafter. Planned 24-week safety and exploratory efficacy results in adolescents are presented.
Results: We enrolled 28 adolescents with a mean baseline HIV-1 RNA and CD4 count of 5.2 log10 copies/mL and 131 cells/µL, respectively, of whom 86% had an HIV classification of moderate or severe. HIV-1 virus from 21 (75%) patients was sensitive to 3 or fewer antiretrovirals at baseline based on genotype testing; 7 (25%) patients were either resistant to all available therapies or were sensitive to only 1 ARV. By week 24, 1 patient discontinued for safety reasons (increased creatinine and BUN) and 7 patients reported serious adverse effects. The only serious adverse effect considered by the investigator to be related to ENF was cellulitis. Injection site reactions were reported by most patients (79%) and were predominantly mild or moderate. The most frequent injection site reactions signs and symptoms were induration (68%), erythema (61%), and nodules and cysts (46%). Other events commonly reported were upper respiratory infection (n = 8, 29%), nausea (n = 7, 25%), otitis media, sinusitis, diarrhea and vomiting (each in 5 patients, 18%). 57% of patients had a mean adherence to ENF of >80%. Overall, average changes from baseline HIV-1 RNA and CD4 cell count were -0.98 log10 copies/mL and 148 cells/µL, respectively.
Conclusions: ENF appears to have a favorable safety profile in heavily pretreated HIV-1-infected adolescents. Although adherence was not optimal, an impressive immunological response together with a good antiviral activity was demonstrated in this difficult to treat HIV-infected adolescent population.
Keywords: enfuvirtide; pediatric; T20-310