Journal article
Peginterferon alfa-2a plus ribavirin versus interferon alfa-2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons
The New England journal of medicine, Vol.351(5), pp.451-459
2004
DOI: 10.1056/NEJMoa032653
PMCID: PMC4113392
PMID: 15282352
Abstract
BACKGROUND
Chronic hepatitis C virus (HCV) infection is a cause of major complications in persons who are also infected with the human immunodeficiency virus (HIV). However, the treatment of HCV infection in such persons has been associated with a high rate of intolerance and a low rate of response. We conducted a multicenter, randomized trial comparing peginterferon plus ribavirin with interferon plus ribavirin for the treatment of chronic hepatitis C in persons coinfected with HIV.
METHODS
A total of 66 subjects were randomly assigned to receive 180 μg of peginterferon alfa-2a weekly for 48 weeks, and 67 subjects were assigned to receive 6 million IU of interferon alfa-2a three times weekly for 12 weeks followed by 3 million IU three times weekly for 36 weeks. Both groups received ribavirin according to a dose-escalation schedule. At week 24, subjects who did not have a virologic response (those who had an HCV RNA level greater than or equal to 60 IU per milliliter) underwent liver biopsy, and medications were continued in subjects with either a virologic response or histologic improvement.
RESULTS
Treatment with peginterferon and ribavirin was associated with a significantly higher rate of sustained virologic response (an HCV RNA level of less than 60 IU per milliliter 24 weeks after completion of therapy) than was treatment with interferon and ribavirin (27 percent vs. 12 percent, P=0.03). In the group given peginterferon and ribavirin, only 14 percent of subjects with HCV genotype 1 infection had a sustained virologic response (7 of 51), as compared with 73 percent of subjects with an HCV genotype other than 1 (11 of 15, P<0.001). Histologic responses were observed in 35 percent of subjects with no virologic response who underwent liver biopsy.
CONCLUSIONS
In persons infected with HIV, the combination of peginterferon and ribavirin is superior to the combination of interferon and ribavirin in the treatment of chronic hepatitis C. These regimens may provide clinical benefit even in the absence of virologic clearance. The marked discrepancy in the rates of sustained virologic response between HCV genotypes indicates that strategies are needed to improve the outcome in persons infected with HCV genotype 1.
Details
- Title: Subtitle
- Peginterferon alfa-2a plus ribavirin versus interferon alfa-2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons
- Creators
- Raymond T CHUNG - Massachusetts General Hospital, Boston, United StatesJanet ANDERSEN - Harvard School of Public Health, Boston, United StatesDodi COLQUHOUN - Frontier Science Technology and Research Foundation, Amherst, N.Y., United StatesTom NEVIN - Social and Scientific Systems, Rockville, Md, United StatesGeorge HARB - Roche Laboratories, Nutley, N.J., United StatesCharles VAN DER HORST - University of North Carolina, Chapel Hill, United StatesPaul VOLBERDING - University of California, San Francisco, San Francisco, United StatesGregory K ROBBINS - Massachusetts General Hospital, Boston, United StatesTUN LIU - Harvard School of Public Health, Boston, United StatesKenneth E SHERMAN - University of Cincinnati, Cincinnati, United StatesMarion G PETERS - University of California, San Francisco, San Francisco, United StatesMargaret J KOZIEL - Beth Israel Deaconess Medical Center, Boston, United StatesAtul K BHAN - Massachusetts General Hospital, Boston, United StatesBeverly ALSTON - National Institute of Allergy and Infectious Diseases, Bethesda, Md, United StatesAIDS Clinical Trials Group A5071 Study Team
- Contributors
- Jack Stapleton (Contributor) - University of Iowa, Internal Medicine
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.351(5), pp.451-459
- Publisher
- Massachusetts Medical Society
- DOI
- 10.1056/NEJMoa032653
- PMID
- 15282352
- PMCID
- PMC4113392
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Language
- English
- Date published
- 2004
- Academic Unit
- Microbiology and Immunology; Infectious Diseases; Internal Medicine
- Record Identifier
- 9984094494802771
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