TY - JOUR
T1 - 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
AU - Glesby, Marshall J.
AU - Bassett, Roland
AU - Alston-Smith, Beverly
AU - Fichtenbaum, Carl
AU - Jacobson, Elizabeth L.
AU - Brass, Clifford
AU - Owens, Susan
AU - Sulkowski, Mark
AU - Race, Elizabeth M.
AU - Sherman, Kenneth E.
N1 - Funding Information:
Financial support: National Institute of Allergy and Infectious Diseases (grants AI-38858 to the AIDS Clinical Trials Group, AI-46386 to Columbia and Cornell Universities, AI-38855 to Harvard School of Public Health, Statistical and Data Analysis Center, AI-27668 to Johns Hopkins University, AI-27660 to University of California at Los Angeles, School of Medicine, AI-25897 to University of Cincinnati, AI-27661 to University of Iowa Hospitals and Clinics, and AI-25903 to Washington University); National Institutes of Health, National Center for Research Resources (General Clinical Research Center grant M01-RR00052 to Johns Hopkins University). a Protocol team members are listed after the text.
PY - 2005/3/1
Y1 - 2005/3/1
N2 - 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.
AB - 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.
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U2 - 10.1086/427812
DO - 10.1086/427812
M3 - Article
C2 - 15688281
AN - SCOPUS:13944251642
SN - 0022-1899
VL - 191
SP - 686
EP - 693
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 5
ER -