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Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: a multicentre independent study supported by the Italian Drug Agency.
- Source :
-
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver [Dig Liver Dis] 2014 Sep; Vol. 46 (9), pp. 826-32. Date of Electronic Publication: 2014 Jun 28. - Publication Year :
- 2014
-
Abstract
- Background: Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in "real world" chronic hepatitis C patients in Italy.<br />Methods: Independent observational multicentre study including consecutive patients receiving Peg-interferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study.<br />Results: 4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase. Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%). During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and γ-glutamil-transpeptidase >2 times the normal limit were associated with poorer response.<br />Conclusions: The response to Peg-interferon/ribavirin therapy in "real world" clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-to-treat than among difficult-to-treat hepatitis C virus genotypes.<br /> (Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)
- Subjects :
- Antiviral Agents therapeutic use
Drug Carriers
Drug Therapy, Combination
Female
Follow-Up Studies
Genotype
Hepatitis C, Chronic virology
Hepatitis Viruses genetics
Humans
Italy
Male
Middle Aged
Prospective Studies
RNA, Viral analysis
Recombinant Proteins therapeutic use
Treatment Outcome
Hepatitis C, Chronic drug therapy
Interferon-alpha therapeutic use
Polyethylene Glycols therapeutic use
Registries
Ribavirin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1878-3562
- Volume :
- 46
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
- Publication Type :
- Academic Journal
- Accession number :
- 24986781
- Full Text :
- https://doi.org/10.1016/j.dld.2014.05.014