Source:http://linkedlifedata.com/resource/pubmed/id/20367790
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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
4
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| pubmed:dateCreated |
2011-3-11
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| pubmed:abstractText |
Better convenience and tolerability and sustained therapeutic concentrations might improve interferon (IFN) treatment for chronic hepatitis C virus (HCV) infection. In an open-label, randomized study, controlled release free (chemically unmodified) recombinant human IFN-?(2b) in poly(ether-ester) microspheres (CR-rhIFN-?(2b)), was injected at doses of 160, 320, 480 or 640 ?g every 2 weeks for 12 weeks with concomitant weight-based oral ribavirin in 32 treatment-naïve patients with chronic HCV genotype 1. Treatment was well tolerated, with 31 patients (97%) successfully completing the study. Full doses of CR-rhIFN-?(2b) were administered on 96% of scheduled occasions. Flu-like symptoms were generally mild and brief. Injection site reactions developed in 13 patients (41%), and neutropenia occurred in six of eight patients receiving 640 ?g. In the 320, 480 and 640 ?g groups, 62-75% of patients achieved a ?2 log(10) HCV RNA reduction by 4 weeks and 88-100% by 12 weeks. For those groups, the pooled median time to ?2 log(10) reduction was 11 days (95% confidence interval, 7-35 days). In those groups, viral reduction below the limit of detection was accomplished in 25% of patients by 4 weeks and in 62% by 12 weeks. The 160-?g dose was less potent. After CR-rhIFN-?(2b) injection, stable plateau levels of serum IFN-?(2b) were generally reached within 72 h. Treatment-emergent neutralizing antibodies to IFN-?(2b) were observed in one patient. No antibodies to host plant proteins were detected. CR-rhIFN-?(2b) with ribavirin cotherapy was well tolerated and displayed potent early antiviral activity in patients with chronic HCV genotype 1.
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| pubmed:language |
eng
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| pubmed:journal | |
| pubmed:citationSubset |
IM
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| pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Antiviral Agents,
http://linkedlifedata.com/resource/pubmed/chemical/Delayed-Action Preparations,
http://linkedlifedata.com/resource/pubmed/chemical/Interferon-alpha,
http://linkedlifedata.com/resource/pubmed/chemical/Recombinant Proteins,
http://linkedlifedata.com/resource/pubmed/chemical/Ribavirin,
http://linkedlifedata.com/resource/pubmed/chemical/interferon alfa-2b
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| pubmed:status |
MEDLINE
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| pubmed:month |
Apr
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| pubmed:issn |
1365-2893
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| pubmed:author | |
| pubmed:copyrightInfo |
© 2010 Blackwell Publishing Ltd.
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| pubmed:issnType |
Electronic
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| pubmed:volume |
18
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| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
271-9
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| pubmed:dateRevised |
2011-11-17
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| pubmed:meshHeading |
pubmed-meshheading:20367790-Adolescent,
pubmed-meshheading:20367790-Adult,
pubmed-meshheading:20367790-Aged,
pubmed-meshheading:20367790-Aged, 80 and over,
pubmed-meshheading:20367790-Antiviral Agents,
pubmed-meshheading:20367790-Delayed-Action Preparations,
pubmed-meshheading:20367790-Drug Therapy, Combination,
pubmed-meshheading:20367790-Female,
pubmed-meshheading:20367790-Genotype,
pubmed-meshheading:20367790-Hepacivirus,
pubmed-meshheading:20367790-Hepatitis C, Chronic,
pubmed-meshheading:20367790-Humans,
pubmed-meshheading:20367790-Interferon-alpha,
pubmed-meshheading:20367790-Male,
pubmed-meshheading:20367790-Middle Aged,
pubmed-meshheading:20367790-Recombinant Proteins,
pubmed-meshheading:20367790-Ribavirin,
pubmed-meshheading:20367790-Treatment Outcome,
pubmed-meshheading:20367790-Young Adult
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| pubmed:year |
2011
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| pubmed:articleTitle |
Controlled release recombinant human interferon-?2b for treating patients with chronic hepatitis C genotype 1: a phase 2a clinical trial.
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| pubmed:affiliation |
City Clinical Hospital 5, Department of Virology, Kiev, Ukraine.
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| pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Clinical Trial, Phase II
|