| Exploratory study of oral combination antiviral therapy for hepatitis C. | |
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MedLine Citation:
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PMID: 23281975 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Background There is a need for interferon-free treatment regimens for hepatitis C virus (HCV) infection. The goal of this study was to evaluate ABT-450, a potent HCV NS3 protease inhibitor, combined with low-dose ritonavir (ABT-450/r), in addition to ABT-333, a nonnucleoside NS5B polymerase inhibitor, and ribavirin, for the treatment of HCV infection. Methods We conducted a 12-week, phase 2a, open-label study involving patients who had HCV genotype 1 infection without cirrhosis. All patients received ABT-333 (400 mg twice daily) and ribavirin (1000 to 1200 mg per day) and one of two daily doses of ABT-450/r. Groups 1 and 2 included previously untreated patients; group 1 received 250 mg of ABT-450 and 100 mg of ritonavir, and group 2 received 150 mg and 100 mg, respectively. Group 3, which included patients who had had a null or partial response to previous therapy with peginterferon and ribavirin, received daily doses of 150 mg of ABT-450 and 100 mg of ritonavir. The primary end point was an undetectable level of HCV RNA from week 4 through week 12 (extended rapid virologic response). Results A total of 17 of the 19 patients in group 1 (89%) and 11 of the 14 in group 2 (79%) had an extended rapid virologic response; a sustained virologic response 12 weeks after the end of treatment was achieved in 95% and 93% of the patients, respectively. In group 3, 10 of 17 patients (59%) had an extended rapid virologic response, and 8 (47%) had a sustained virologic response 12 weeks after therapy; 6 patients had virologic breakthrough, and 3 had a relapse. Adverse events included abnormalities in liver-function tests, fatigue, nausea, headache, dizziness, insomnia, pruritus, rash, and vomiting. Conclusions This preliminary study suggests that 12 weeks of therapy with a combination of a protease inhibitor, a nonnucleoside polymerase inhibitor, and ribavirin may be effective for treatment of HCV genotype 1 infection. (Funded by Abbott; ClinicalTrials.gov number, NCT01306617 .). |
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Authors:
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Fred Poordad; Eric Lawitz; Kris V Kowdley; Daniel E Cohen; Thomas Podsadecki; Sara Siggelkow; Michele Heckaman; Lois Larsen; Rajeev Menon; Gennadiy Koev; Rakesh Tripathi; Tami Pilot-Matias; Barry Bernstein |
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Publication Detail:
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Type: Journal Article |
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: - Revised Date: - |
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: 45-53 Citation Subset: AIM; IM |
Affiliation:
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From the University of Texas Health Science Center, San Antonio (F.P., E.L.); the Digestive Disease Institute, Virginia Mason Medical Center, Seattle (K.V.K.); and Abbott, Abbott Park, IL (D.E.C., T.P., S.S., M.H., L.L., R.M., G.K., R.T., T.P.-M., B.B.). |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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