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Session 127 Poster Abstracts
Antiretroviral Therapy in Children
Monday, 1:30 - 3:30 pm
Poster Hall


929    
24-week Safety and Efficacy of Enfuvirtide as Part of an Optimized Antiretroviral Regimen in Adolescents
A Wiznia*1, J Church2, J Stavola3, P Emmanuel4, S Bakshi5, I Febo6, C Cunningham7, R Lawrence8, H Gay9, R Fisher10, P Delora11, L Rowell11, A Bertasso11, and and the T20-310 Study Group
1Jacobi Med. Ctr., Bronx, NY, USA; 2Childrens Hosp. Los Angeles, CA, USA; 3Cornell Univ., New York, NY, USA; 4All Children's Hosp., St. Petersburg, FL, USA; 5Bronx Lebanon Hosp. Ctr., Bronx, NY, USA; 6Univ. of Puerto Rico, San Juan, USA; 7State Univ. of New York Upstate, Med. Univ., Syracuse, USA; 8Univ. of Florida, Hlth. Sci. Ctr., Gainesville, USA; 9Univ. of Mississippi Med. Ctr., Jackson, USA; 10Children's Hosp. of the King's Daughters, Norfolk, VA, USA; and 11Roche, Nutley, NJ, USA

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