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Safety and efficacy of enfuvirtide for 48 weeks as part of an optimized antiretroviral regimen in pediatric human immunodeficiency virus 1-infected patients.

AbstractBACKGROUND:
Enfuvirtide is the only entry inhibitor approved for the treatment of human immunodeficiency virus (HIV)-1 infection. It is approved for use in adults and dosage recommendations exist for children aged 6 years or older.
METHODS:
T20-310 was a multicenter, open-label, nonrandomized, noncomparative study of the safety and efficacy of 2.0 mg/kg (maximum 90 mg) twice-daily subcutaneous enfuvirtide for 48 weeks in 52 treatment-experienced, HIV-1-infected pediatric patients (3-16 years) receiving optimized background therapy.
RESULTS:
Enfuvirtide was generally well tolerated, and no new patterns of adverse events compared with adults were observed. Mild-to-moderate injection-site reactions were the most common adverse event. Of those participants on treatment for 48 weeks, the median change from baseline in HIV-1 RNA was -1.17 log10 copies/mL (n = 32), and there was a median CD4 change of +106 (n = 25) cells/mm3 and +4.7 CD4%. Seventeen (32.7%) patients achieved a viral load decrease of > or =1 log10 copies/mL and 11 (21.2%) achieved HIV-1 RNA <400 copies/mL. Virologic and immunologic treatment responses were substantially better for children (<11 years) than adolescents. Steady-state mean enfuvirtide C(trough) levels were stable during 24 weeks with no differences between children and adolescents.
CONCLUSIONS:
Enfuvirtide is an effective treatment for HIV-1 infection in children and adolescents receiving optimized background therapy and has a favorable safety profile. Efficacy in adolescents was inferior; probably related to unique adherence challenges. The long-term safety and efficacy of enfuvirtide in pediatric patients is comparable to that observed in adults.
AuthorsAndrew Wiznia, Joseph Church, Patricia Emmanuel, Stephen Eppes, Lucy Rowell, Claire Evans, Anne Bertasso, T20-310 Study Group
JournalThe Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 26 Issue 9 Pg. 799-805 (Sep 2007) ISSN: 0891-3668 [Print] United States
PMID17721374 (Publication Type: Journal Article)
Chemical References
  • Anti-Retroviral Agents
  • HIV Antibodies
  • HIV Envelope Protein gp41
  • HIV Fusion Inhibitors
  • Peptide Fragments
  • Enfuvirtide
Topics
  • Adolescent
  • Anti-Retroviral Agents (administration & dosage, adverse effects, pharmacokinetics)
  • Child
  • Child, Preschool
  • Enfuvirtide
  • Female
  • HIV Antibodies (blood)
  • HIV Envelope Protein gp41 (administration & dosage, adverse effects, pharmacokinetics)
  • HIV Fusion Inhibitors (administration & dosage, adverse effects, pharmacokinetics)
  • HIV Infections (drug therapy, immunology)
  • Humans
  • Male
  • Multicenter Studies as Topic
  • Peptide Fragments (administration & dosage, adverse effects, pharmacokinetics)
  • Treatment Outcome

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