Virologic and immunologic activity of PegIntron in HIV disease

Jonathan B. Angel, Wayne Greaves, Jianmin Long, Douglas Ward, Allan E. Rodriguez, Daniele Scevola, Edwin Dejesus

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

OBJECTIVE: The primary objectives of this study were to evaluate the safety, tolerability, and antiviral activity of pegylated interferon-α (PegIntron) in HIV-1 treatment-experienced patients failing their current antiretroviral regimen. DESIGN: This was a phase II, multicenter, randomized, double-blind, placebo-controlled study. METHODS: Patients were randomized to receive either weekly subcutaneous PegIntron 0.5, 1.0, 1.5, or 3 μg/kg or placebo added to their failing antiretroviral regimen for the first 4 weeks of study. Individuals who achieved more than 0.5 log10 reduction in HIV RNA at week 4 were allowed to continue study medication with optimization of their antiretroviral therapy for an additional 24 weeks. RESULTS: In the 259 patients included in the intent-to-treat analysis, changes in plasma HIV RNA from baseline to week 4 were-0.25 (P > 0.5),-0.46 (P = 0.024),-0.39 (P = 0.008),-0.53 (P < 0.001), and-0.17 (P > 0.5) log10 copies/ml in the 0.5, 1.0, 1.5, and 3.0 μg/kg and placebo arms, respectively. No significant changes were seen in CD4 T-cell parameters in any of the treatment or control arms. Adverse events (most commonly fever, flu-like symptoms, other constitutional symptoms, and psychiatric symptoms) resulted in discontinuation of study medication in 13, 17, 16, 28, and 2% of patients in the 0.5, 1.0, 1.5, 3.0 μg/kg, and placebo group, respectively. CONCLUSION: The demonstration of significant antiviral activity in a heavily pretreated patient population with acceptable toxicity and only weekly dosing makes PegIntron a potentially valuable therapy for patients with HIV infection that warrants further investigation in a broader population of patients.

Original languageEnglish (US)
Pages (from-to)2431-2438
Number of pages8
JournalAIDS
Volume23
Issue number18
DOIs
StatePublished - Nov 1 2009

Keywords

  • Antiretroviral therapy
  • Interferon
  • PegIntron

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

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    Angel, J. B., Greaves, W., Long, J., Ward, D., Rodriguez, A. E., Scevola, D., & Dejesus, E. (2009). Virologic and immunologic activity of PegIntron in HIV disease. AIDS, 23(18), 2431-2438. https://doi.org/10.1097/QAD.0b013e32832f30ca