Safety and Efficacy of Enfuvirtide (Fuzeon) in Children with HIV

Enfuvirtide (Fuzeon, T-20) is the only fusion inhibitor approved for the treatment of HIV infection. The drug is FDA-approved for use in adults, and dosage recommendations exist for children aged 6 years or older.

T20-310 was a multicenter, open-label, non-randomized, non-comparative study to assess the safety and efficacy enfuvirtide in children. A total of 52 treatment-experienced pediatric HIV patients (3-16 years old) received 2.0 mg/kg (maximum 90 mg) twice-daily subcutaneous enfuvirtide for 48 weeks, along with optimized background therapy.

Results

• Enfuvirtide was generally well tolerated, and no new patterns of adverse events compared with those seen in adults were observed.

• Mild-to-moderate injection-site reactions were the most common adverse event.

• Among those participants on treatment for 48 weeks, the median HIV RNA decrease from baseline was 1.17 log10 copies/mL (n = 32).

• The median CD4 cell increase from baseline was 106 cells/mm3 and the median CD4 percentage increase was 4.7 (n = 25).

• 17 children (32.7%) achieved a viral load decrease of at least 1 log10 copies/mL and 11 children (21.2%) achieved an HIV RNA level below 400 copies/mL.

• Virological and immunological treatment responses were substantially better for children (< 11 years) than adolescents.

• Steady-state mean enfuvirtide C-trough levels were stable over 24 weeks with no differences between children and adolescents.

Conclusion

The study authors concluded that enfuvirtide is an effective treatment for children and adolescents with HIV infection receiving optimized background therapy and has a favorable safety profile.

The authors noted that, "Efficacy in adolescents was inferior; probably related to unique adherence challenges." Nevertheless, they concluded, "The long-term safety and efficacy of enfuvirtide in pediatric patients is comparable to that observed in adults."

Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, NY; Children's Hospital Los Angeles, Los Angeles, CA; USF/All Children's Hospital, St. Petersburg, FL; Alfred I. DuPont Hospital for Children, Wilmington, DE; Roche, Welwyn, UK; Roche, Nutley, NJ.

09/11/07

Reference
A Wiznia, A Church, P Emmanuel, and others (T20-310 Study Group). Safety and Efficacy of Enfuvirtide for 48 Weeks as Part of an Optimized Antiretroviral Regimen in Pediatric Human Immunodeficiency Virus 1-Infected Patients. Pediatric Infectious Disease Journal 26(9): 799-805. September 2007.