Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/12780
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dc.contributor.authorPoordad, Fred-
dc.contributor.authorSievert, William-
dc.contributor.authorMollison, Lindsay-
dc.contributor.authorBennett, Michael R-
dc.contributor.authorTse, Edmund-
dc.contributor.authorBräu, Norbert-
dc.contributor.authorLevin, James-
dc.contributor.authorSepe, Thomas-
dc.contributor.authorLee, Samuel S-
dc.contributor.authorAngus, Peter W-
dc.contributor.authorConway, Brian-
dc.contributor.authorPol, Stanislas-
dc.contributor.authorBoyer, Nathalie-
dc.contributor.authorBronowicki, Jean-Pierre-
dc.contributor.authorJacobson, Ira-
dc.contributor.authorMuir, Andrew J-
dc.contributor.authorReddy, K Rajender-
dc.contributor.authorTam, Edward-
dc.contributor.authorOrtiz-Lasanta, Grisell-
dc.contributor.authorde Lédinghen, Victor-
dc.contributor.authorSulkowski, Mark-
dc.contributor.authorBoparai, Navdeep-
dc.contributor.authorMcPhee, Fiona-
dc.contributor.authorHughes, Eric-
dc.contributor.authorSwenson, E Scott-
dc.contributor.authorYin, Philip D-
dc.date.accessioned2015-05-16T02:31:13Z
dc.date.available2015-05-16T02:31:13Z
dc.date.issued2015-05-05-
dc.identifier.citationJama; 313(17): 1728-35en_US
dc.identifier.otherPUBMEDen
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/12780en
dc.description.abstractThe antiviral activity of all-oral, ribavirin-free, direct-acting antiviral regimens requires evaluation in patients with chronic hepatitis C virus (HCV) infection.To determine the rates of sustained virologic response (SVR) in patients receiving the 3-drug combination of daclatasvir (a pan-genotypic NS5A inhibitor), asunaprevir (an NS3 protease inhibitor), and beclabuvir (a nonnucleoside NS5B inhibitor).This was an open-label, single-group, uncontrolled international study (UNITY-1) conducted at 66 sites in the United States, Canada, France, and Australia between December 2013 and August 2014. Patients without cirrhosis who were either treatment-naive (n = 312) or treatment-experienced (n = 103) and had chronic HCV genotype 1 infection were included.Patients received a twice-daily fixed-dose combination of daclatasvir, 30 mg; asunaprevir, 200 mg; and beclabuvir, 75 mg.The primary study outcome was SVR12 (HCV-RNA <25 IU/mL at posttreatment week 12) in patients naive to treatment. A key secondary outcome was SVR12 in the treatment-experienced cohort.Baseline characteristics were comparable between the treatment-naive and treatment-experienced cohorts. Patients were 58% male, 26% had IL28B (rs12979860) CC genotype, 73% were infected with genotype 1a, and 27% were infected with genotype 1b. Overall, SVR12 was observed in 379 of 415 patients (91.3%; 95% CI, 88.6%-94.0%): 287 of 312 treatment-naive patients (92.0%; 95% CI, 89.0%-95.0%) and 92 of 103 treatment-experienced patients (89.3%; 95% CI, 83.4%-95.3%). Virologic failure occurred in 34 patients (8%) overall. One patient died at posttreatment week 3; this was not considered related to study medication. There were 7 serious adverse events, all considered unrelated to study treatment, and 3 adverse events (<1%) leading to treatment discontinuation, including 2 grade 4 alanine aminotransferase elevations. The most common adverse events (in ≥10% of patients) were headache, fatigue, diarrhea, and nausea.In this open-label, nonrandomized, uncontrolled study, a high rate of SVR12 was achieved in treatment-naive and treatment-experienced noncirrhotic patients with chronic HCV genotype 1 infection who received 12 weeks of treatment with the oral fixed-dose regimen of daclatasvir, asunaprevir, and beclabuvir.clinicaltrials.gov Identifier: NCT01979939.en_US
dc.language.isoenen
dc.titleFixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleJAMAen_US
dc.identifier.affiliationMonash Health and Monash University, Melbourne, Australiaen_US
dc.identifier.affiliationRoyal Adelaide Hospital, Adelaide, Australiaen_US
dc.identifier.affiliationUniversity of Calgary, Calgary, Alberta, Canadaen_US
dc.identifier.affiliationVancouver Infectious Diseases Centre, Vancouver, British Columbia, Canadaen_US
dc.identifier.affiliationLAIR Centre, Vancouver, British Columbia, Canadaen_US
dc.identifier.affiliationFremantle Hepatitis Services, School of Medicine and Pharmacology, University of Western Australia, Fremantle, Australiaen_US
dc.identifier.affiliationAustin Healthen_US
dc.identifier.affiliationTexas Liver Institute, University of Texas Health Science Center, San Antonio.en_US
dc.identifier.affiliationMedical Associates Research Group, San Diego, California.en_US
dc.identifier.affiliationJames J. Peters Veterans Affairs Medical Center, Bronx, New York7Icahn School of Medicine at Mount Sinai, New York, New York.en_US
dc.identifier.affiliationDean Foundation, Madison, Wisconsin.en_US
dc.identifier.affiliationUniversity Gastroenterology, Providence, Rhode Island.en_US
dc.identifier.affiliationUniversité Paris Descartes, AP-HP, Unité d'Hépatologie, Hôpital Cochin, INSERM UMS-20, Institut Pasteur, Paris, France.en_US
dc.identifier.affiliationService d'Hépatologie, Hôpital Beaujon, Clichy, France.en_US
dc.identifier.affiliationINSERM U954, Centre Hospitalier Universitaire de Nancy, Université de Lorraine, Vandoeuvre les Nancy, France.en_US
dc.identifier.affiliationWeill Cornell Medical College, New York, New York.en_US
dc.identifier.affiliationDuke University Medical Center, Durham, North Carolina.en_US
dc.identifier.affiliationUniversity of Pennsylvania, Philadelphia.en_US
dc.identifier.affiliationFundacion de Investigacion, San Juan, Puerto Rico.en_US
dc.identifier.affiliationHôpital Du Haut-Leveque, Pessac, France.en_US
dc.identifier.affiliationJohns Hopkins University School of Medicine, Baltimore, Maryland.en_US
dc.identifier.affiliationBristol-Myers Squibb, Princeton, New Jersey.en_US
dc.identifier.affiliationBristol-Myers Squibb, Wallingford, Connecticut.en_US
dc.identifier.doi10.1001/jama.2015.3860en_US
dc.description.pages1728-35en
dc.relation.urlhttps://pubmed.ncbi.nlm.nih.gov/25942723en
dc.contributor.corpauthorUNITY-1 Study Groupen
dc.type.contentTexten_US
dc.type.austinJournal Articleen
local.name.researcherAngus, Peter W
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
crisitem.author.deptVictorian Liver Transplant Unit-
crisitem.author.deptGastroenterology and Hepatology-
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