About: Randomized, double‐blind, placebo‐controlled trial of interferon Alfa2a with and without amantadine as initial treatment for chronic hepatitis C

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About: Randomized, double‐blind, placebo‐controlled trial of interferon Alfa2a with and without amantadine as initial treatment for chronic hepatitis C Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Randomized, double‐blind, placebo‐controlled trial of interferon Alfa2a with and without amantadine as initial treatment for chronic hepatitis C
Creator	Zeuzem, Stefan Hartmann, Susanne Berg, Thomas Hopf, Uwe Naumann, Uta Raedle, Jochen Teuber, Gerlinde
Source	Medline; PMC
abstract	Although the antiviral effects of amantadine sulphate (1‐aminoadamantan sulphate) have not been characterized for the hepatitis C virus (HCV), previous pilot studies have suggested promising results in patients with chronic hepatitis C. The aim of the present study was to compare the efficacy, safety, and health‐related quality of life (HRQOL) of interferon alfa (IFN‐α) alone or in combination with oral amantadine for treatment of chronic hepatitis C. One hundred nineteen previously untreated patients with chronic hepatitis C were randomly allocated to treatment with IFN‐α2a at a dose of 6 megaunits 3 times a week subcutaneously for 24 weeks, followed by 3 megaunits thrice weekly for an additional 24 weeks plus amantadine sulphate administered orally 100 mg twice a day for 48 weeks or the same IFN regimen plus a matched placebo. The primary endpoint was undectable serum HCV RNA (<1,000 copies/mL) at week 24 after treatment. At the end of treatment and the 24‐week follow‐up period serum HCV RNA was undetectable in 20 (34%) and 6 (10%) of the 59 patients treated with the combination IFN‐α plus amantadine and in 20 (33%) and 13 (22%) of the 60 patients treated with IFN‐α alone, respectively (P = n.s.). Discontinuation of therapy for adverse events was similar in both treatment groups. Although treatment with IFN‐α worsened HRQOL, combination with amantadine showed a substantial trend to improve fatigue and vigor. In conclusion, combination therapy IFN‐α plus amantadine is as effective as IFN‐α monotherapy in previously untreated patients with chronic hepatitis C.
has issue date	2003-12-30(xsd:dateTime)
bibo:doi	10.1053/jhep.2000.17740
bibo:pmid	11003631
has license	no-cc
sha1sum (hex)	42976e370f669c17360f2ab9d8942e64063e9bda
schema:url	https://doi.org/10.1053/jhep.2000.17740
resource representing a document's title	Randomized, double‐blind, placebo‐controlled trial of interferon Alfa2a with and without amantadine as initial treatment for chronic hepatitis C
has PubMed Central identifier	PMC7165866
has PubMed identifier	11003631
schema:publication	Hepatology
resource representing a document's body	covid:42976e370f669c17360f2ab9d8942e64063e9bda#body_text
is schema:about of	named entity 'adverse events' named entity 'hepatitis C virus' named entity '2000' named entity 'IFN' named entity 'IFN' named entity 'patients' named entity 'sulphate' named entity 'combination therapy' named entity 'pilot studies' named entity 'chronic hepatitis C' named entity 'patients' named entity 'IFN' named entity 'HCV' named entity 'vigor' named entity 'thrice' named entity 'placebo' named entity 'IFN' named entity 'weekly' named entity 'combination' named entity 'Although' named entity 'weeks' named entity 'follow-up' named entity 'sulphate' named entity 'RNA' named entity 'amantadine' named entity 'HCV' named entity 'sulphate' named entity 'health-related quality of life' named entity 'subcutaneously' named entity 'IFN' named entity 'serum' named entity 'serum' named entity 'placebo' named entity 'interferon alfa' named entity 'Double-Blind, Placebo-Controlled' named entity 'Interferon' named entity 'RNA' named entity 'clinically significant' named entity 'psychiatric disease' named entity 'chronic hepatitis' named entity 'RNA' named entity 'virologic' named entity 'liver biopsy' named entity 'HCV' named entity 'administered orally' named entity 'type II error rate' named entity 'end point' named entity 'HCV' named entity 'IFN' named entity 'treatment groups' named entity 'ribavirin' named entity 'chronic hepatitis' named entity 'IFN' named entity 'Adverse Events' named entity 'virologic' named entity 'fatigue' named entity 'antiviral' named entity 'combination therapy' named entity 'IFN' named entity 'HCV' named entity 'trans-Golgi' named entity 'RNA' named entity 'virologic' named entity 'prognosis' named entity 'HCV' named entity 'monotherapy' named entity 'adverse events' named entity 'liver transplantation' named entity 'SF-36' named entity 'Virologic' named entity 'infection' named entity 'virologic' named entity 'M2 protein' named entity 'follow-up' named entity 'coronaviruses'

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