Pilot study of low-dose interleukin-2, pegylated interferon-α2b, and ribavirin for the treatment of hepatitis C virus infection in patients with HIV infection

Marshall J. Glesby, Roland Bassett, Beverly Alston-Smith, Carl Fichtenbaum, Elizabeth L. Jacobson, Clifford Brass, Susan Owens, Mark Sulkowski, Elizabeth M. Race, Kenneth E. Sherman

Research output: Contribution to journalArticlepeer-review

Abstract

Background. Patients infected with hepatitis C virus (HCV) and human immunodeficiency virus have a diminished HCV virologic response to standard Interferon (IFN)-based therapies. We explored the strategy of initial immunostimulatory therapy with interleukin (IL)-2, followed by the addition of specific anti-HCV therapy, as a possible synergistic approach to treatment. Methods. Coinfected subjects (n = 23) with CD4 cell counts >300 cells/μL received low-dose IL-2 daily for 12 weeks, followed by pegylated IFN-α2b and ribavirin for an additional 48 weeks. The primary end point was permanent discontinuation of treatment before week 24 due to toxicity or intolerance. Results. Six subjects (26.1%) discontinued treatment before week 24, and 11 (47.8%) discontinued treatment before week 60. Overall, 4 subjects discontinued because of adverse events. Four of 23 (17%; 95% confidence interval [CI], 5%-39%) had sustained virologic responses. Of 17 subjects with increased levels of alanine aminotransferase at baseline, 13 had follow-up measurements at week 60, of which 6 (46%) were normal. Conclusions. Low-dose IL-2 plus PEG-IFN and ribavirin was associated with a high discontinuation rate. Although the study was not powered for efficacy, CIs surrounding the treatment response rate suggest that this strategy should not be pursued in larger trials.

Original languageEnglish (US)
Pages (from-to)686-693
Number of pages8
JournalJournal of Infectious Diseases
Volume191
Issue number5
DOIs
StatePublished - Mar 1 2005

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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