An open-label safety study of enfuvirtide injection with a needle-free injection device or needle/syringe: the Biojector 2000 Open-label Safety Study (BOSS).

Academic Article

Abstract

  • Enfuvirtide (ENF) administration by needle/syringe is commonly associated with injection site reactions (ISRs). This study assessed ISRs and participant preference between a needle-free injection device (NFID) and a 27-gauge 1/2-inch needle/syringe (NS). A total of 349 participants with human immunodeficiency virus infection, who had difficulty tolerating long-term administration of ENF by NS, underwent randomization (2:1) to ENF administered twice daily by NFID for 8 weeks, or by NS for 4 weeks followed by NFID for 4 weeks. The objectives of the study were to compare ISRs associated with ENF injection using NFID or NS based on a composite endpoint, ISR incidence/severity, overall ISR scores, and discontinuations. In the NFID group, ISRs improved as the percentage of participants meeting the composite endpoint decreased from baseline (40.1%) to week 4 (25.4%) and remained stable at week 8 (21.2%). In the NS --> NFID group, the percentage meeting the composite endpoint worsened from baseline (36.5%) to week 4 (45.1%), but improved at week 8 (26.1%) after switching. Between-participant comparison showed a statistically significant greater improvement from baseline to week 4 in overall ISR score in the NFID group compared to the NS group. Within-participant comparison of the NS --> NFID group showed a significantly greater decrease in overall ISR score from baseline to week 8. In responses to a questionnaire, 87.2% of the participants surveyed preferred the NFID delivery system over NS. NFID is an alternative injection method that may reduce the incidence and severity of treatment-limiting ISRs associated with ENF administration.
  • Published In

    Keywords

  • Adult, Enfuvirtide, Equipment Safety, Female, HIV Envelope Protein gp41, HIV Fusion Inhibitors, HIV Infections, HIV-1, Humans, Injections, Intradermal, Injections, Jet, Male, Middle Aged, Patient Compliance, Patient Satisfaction, Patient Selection, Peptide Fragments, Single-Blind Method, Surveys and Questionnaires
  • Digital Object Identifier (doi)

    Author List

  • Lalezari JP; Saag M; Walworth C; Larson P
  • Start Page

  • 805
  • End Page

  • 813
  • Volume

  • 24
  • Issue

  • 6