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Pegylated interferon alfa-2b plus ribavirin in the retreatment of interferon-ribavirin nonresponder patients.
- Source :
-
Gastroenterology [Gastroenterology] 2006 Apr; Vol. 130 (4), pp. 1098-106. - Publication Year :
- 2006
-
Abstract
- Background & Aims: Inadequate data are available about retreatment of nonresponders to interferon (IFN) and ribavirin. Thus, this study evaluated the efficacy and tolerability of a 48-week therapy with pegylated IFN-alpha-2b plus high-dose ribavirin in patients who have failed to respond to the combination. Treatment up to 48 weeks also in patients who have failed to clear hepatitis C virus (HCV) RNA by week 24 was also evaluated.<br />Methods: One hundred forty-one patients who previously did not respond to IFN and ribavirin, 86% with genotype 1 or 4 infection, 52% with high viral load (>800.000 IU/mL), 22% with cirrhosis, were retreated with pegylated IFN-alpha-2b 1.5 microg/kg per week and ribavirin 1000-1200 mg/day for 48 weeks and followed up for 24 weeks.<br />Results: By intent-to-treat analysis, 20% of patients achieved a sustained virologic response (SVR). SVR of genotype 1 patients was 19%. Independent predictors of SVR were low gamma-glutamyltransferase levels (OR, 22.9; 95% CI: 6.6-79.6) and low viral load (OR, 3.8; 95% CI: 1.1-12.6). Twelve (23%) out of 51 patients who were HCV RNA positive after 24 weeks of therapy achieved a late virologic response (after week 24) and 5 (10%) of them, all with genotype 1, achieved an SVR. Genotype was not associated with response (P = .2) or with early response (P = .3).<br />Conclusions: Retreatment with pegylated IFN-alpha-2b and ribavirin of multi-experienced and "difficult to treat" nonresponder patients produced a very promising SVR. Accurate selection of patients, such as those with low viral load and low gamma-glutamyltransferase levels, and prolongation of therapy beyond 24 weeks also in HCV RNA-positive patients may further increase the rate of SVR.
- Subjects :
- Adult
Aged
Antiviral Agents adverse effects
Drug Therapy, Combination
Female
Genotype
Hepacivirus genetics
Hepatitis C, Chronic blood
Hepatitis C, Chronic virology
Humans
Interferon alpha-2
Interferon-alpha adverse effects
Male
Middle Aged
Polyethylene Glycols
RNA, Viral blood
Recombinant Proteins
Retreatment
Ribavirin adverse effects
Time Factors
Treatment Failure
Treatment Outcome
Viral Load
gamma-Glutamyltransferase blood
Antiviral Agents therapeutic use
Hepatitis C, Chronic drug therapy
Interferon-alpha therapeutic use
Interferons therapeutic use
Ribavirin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 0016-5085
- Volume :
- 130
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 16618404
- Full Text :
- https://doi.org/10.1053/j.gastro.2006.02.016