Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients

David Wright, Allen Rodriguez, Eliot Godofsky, Sharon Walmsley, Emily Labriola-Tompkins, Lucille Donatacci, Anna Shikhman, Ernestine Tucker, Yu Yuan Chiu, Jain Chung, Lucy Rowell, Ralph DeMasi, Neil Graham, Miklos Salgo

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

Purpose: To evaluate the safety and antiviral activity of once-daily (qd) enfuvirtide (ENF) compared with twice daily (bid) ENF. Method: T20-401 was a phase 2, open-label, randomized, 48-week pilot study comparing ENF 180 mg qd versus ENF 90 mg bid, added to an optimized background (OB) regimen. Patients were randomized 1:1 to receive ENF 180 mg qd given as two 90-mg injections (n = 30) or one 90-mg injection bid (n = 31), plus OB. The primary efficacy endpoint was the proportion of patients achieving a HIV-1 RNA viral load <400 copies/mL. Adherence, pharmacokinetics, safety, and tolerability parameters, including injection site reactions (ISRs), were compared between treatment arms. Results: At Week 48, 23.3% of patients on once daily versus 22.6% on twice daily (p = .969) reached <400 copies/mL and 13.3% and 22.6% (p = .323), respectively, reached <50 copies/mL. The proportion reporting ≥1 adverse event or ISRs was comparable between arms, despite an increased incidence of grade 4 erythema (13% vs. 0%), induration (33% vs. 12%), and ecchymosis (7% vs. 0%) on twice daily versus once daily. ENF adherence (≥95% of prescribed doses) was higher on once daily (80.0%) versus twice daily (58.1%). Conclusion: The antiviral efficacy, safety, and tolerability of 180 mg ENF qd appeared comparable with that of 90 mg ENF bid at Week 48, although the study was not powered to demonstrate the noninferiority of once daily versus twice daily.

Original languageEnglish (US)
Pages (from-to)73-82
Number of pages10
JournalHIV Clinical Trials
Volume9
Issue number2
DOIs
StatePublished - Mar 1 2008

Keywords

  • Enfuvirtide
  • Fusion inhibitor
  • Once-daily dosing
  • Qd
  • T20-401

ASJC Scopus subject areas

  • Virology
  • Immunology

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    Wright, D., Rodriguez, A., Godofsky, E., Walmsley, S., Labriola-Tompkins, E., Donatacci, L., Shikhman, A., Tucker, E., Chiu, Y. Y., Chung, J., Rowell, L., DeMasi, R., Graham, N., & Salgo, M. (2008). Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clinical Trials, 9(2), 73-82. https://doi.org/10.1310/hct0902-73