| Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. | |
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MedLine Citation:
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PMID: 23281974 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The standard treatment for hepatitis C virus (HCV) infection is interferon, which is administered subcutaneously and can have troublesome side effects. We evaluated sofosbuvir, an oral nucleotide inhibitor of HCV polymerase, in interferon-sparing and interferon-free regimens for the treatment of HCV infection. METHODS: We provided open-label treatment to eight groups of patients. A total of 40 previously untreated patients with HCV genotype 2 or 3 infection were randomly assigned to four groups; all four groups received sofosbuvir (at a dose of 400 mg once daily) plus ribavirin for 12 weeks. Three of these groups also received peginterferon alfa-2a for 4, 8, or 12 weeks. Two additional groups of previously untreated patients with HCV genotype 2 or 3 infection received sofosbuvir monotherapy for 12 weeks or sofosbuvir plus peginterferon alfa-2a and ribavirin for 8 weeks. Two groups of patients with HCV genotype 1 infection received sofosbuvir and ribavirin for 12 weeks: 10 patients with no response to prior treatment and 25 with no previous treatment. We report the rate of sustained virologic response 24 weeks after therapy. RESULTS: Of the 40 patients who underwent randomization, all 10 (100%) who received sofosbuvir plus ribavirin without interferon and all 30 (100%) who received sofosbuvir plus ribavirin for 12 weeks and interferon for 4, 8, or 12 weeks had a sustained virologic response at 24 weeks. For the other patients with HCV genotype 2 or 3 infection, all 10 (100%) who received sofosbuvir plus peginterferon alfa-2a and ribavirin for 8 weeks had a sustained virologic response at 24 weeks, as did 6 of 10 (60%) who received sofosbuvir monotherapy. Among patients with HCV genotype 1 infection, 21 of 25 previously untreated patients (84%) and 1 of 10 with no response to previous therapy (10%) had a sustained virologic response at 24 weeks. The most common adverse events were headache, fatigue, insomnia, nausea, rash, and anemia. CONCLUSIONS: Sofosbuvir plus ribavirin for 12 weeks may be effective in previously untreated patients with HCV genotype 1, 2, or 3 infection. (Funded by Pharmasset and Gilead Sciences; ClinicalTrials.gov number, NCT01260350.). |
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Authors:
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Edward J Gane; Catherine A Stedman; Robert H Hyland; Xiao Ding; Evguenia Svarovskaia; William T Symonds; Robert G Hindes; M Michelle Berrey |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The New England journal of medicine Volume: 368 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2013-01-03 Completed Date: 2013-01-17 Revised Date: 2013-05-16 |
Medline Journal Info:
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Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
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Languages: eng Pagination: 34-44 Citation Subset: AIM; IM |
Affiliation:
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New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand. edgane@adhb.govt.nz |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT01260350 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antiviral Agents / adverse effects, therapeutic use* Drug Therapy, Combination Female Genotype Hemoglobins / metabolism Hepacivirus / genetics, isolation & purification Hepatitis C, Chronic / blood, drug therapy* Humans Interferon-alpha / adverse effects, therapeutic use Male Middle Aged Polyethylene Glycols / adverse effects, therapeutic use RNA, Viral / metabolism Recombinant Proteins / adverse effects, therapeutic use Ribavirin / adverse effects, therapeutic use* Uridine Monophosphate / adverse effects, analogs & derivatives*, therapeutic use Viral Load Viral Nonstructural Proteins / antagonists & inhibitors* |
| Chemical | |
Reg. No./Substance:
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0/2-((5-(2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-ylmethoxy)phenoxyphosphorylamino)propionic acid isopropyl ester; 0/Antiviral Agents; 0/Hemoglobins; 0/Interferon-alpha; 0/NS-5 protein, hepatitis C virus; 0/Polyethylene Glycols; 0/RNA, Viral; 0/Recombinant Proteins; 0/Viral Nonstructural Proteins; 0/peginterferon alfa-2a; 36791-04-5/Ribavirin; 58-97-9/Uridine Monophosphate |
| Comments/Corrections | |
Comment In:
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N Engl J Med. 2013 May 16;368(20):1931-2
[PMID:
23607592
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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