The Journal of Infectious Diseases 2005;191:686-693
© 2005 by the Infectious Diseases Society of America. All rights reserved. 0022-1899/2005/19105-0006$15.00

MAJOR ARTICLE

Pilot Study of Low-Dose Interleukin-2, Pegylated Interferon2b, 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, and Kenneth E. Sherman for the AIDS Clinical Trials Group A5088 Protocol Team

Weill Medical College of Cornell University, New York, and Frontier Science and Technology Research Foundation, Buffalo, New York; Harvard School of Public Health, Boston, Massachusetts; University of Cincinnati, Cincinnati, Ohio; Schering-Plough Research Institute, Kenilworth, New Jersey; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, and Johns Hopkins University School of Medicine, Baltimore, Maryland; 8University of Texas Southwestern Medical Center at Dallas, Dallas

Background. Patients infected with hepatitis C virus (HCV) and human immunodeficiency virus have a diminished HCV virologic response to standard interferon (IFN)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/2b 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.