Abstract | BACKGROUND:
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.
|
Authors | Andrew Wiznia, Joseph Church, Patricia Emmanuel, Stephen Eppes, Lucy Rowell, Claire Evans, Anne Bertasso, T20-310 Study Group |
Journal | The Pediatric infectious disease journal
(Pediatr Infect Dis J)
Vol. 26
Issue 9
Pg. 799-805
(Sep 2007)
ISSN: 0891-3668 [Print] United States |
PMID | 17721374
(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
|