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A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study

dc.contributor.authorSulkowski, Mark S.
dc.contributor.authorMoon, Juhi S.
dc.contributor.authorSherman, Kenneth E.
dc.contributor.authorMorelli, Giuseppe
dc.contributor.authorDarling, Jama M.
dc.contributor.authorMuir, Andrew J.
dc.contributor.authorKhalili, Mandana
dc.contributor.authorFishbein, Dawn A.
dc.contributor.authorHinestrosa, Federico
dc.contributor.authorShiffman, Mitchell L.
dc.contributor.authorDi Bisceglie, Adrian
dc.contributor.authorRajender Reddy, K.
dc.contributor.authorPearlman, Brian
dc.contributor.authorLok, Anna S.
dc.contributor.authorFried, Michael W.
dc.contributor.authorStewart, Paul W.
dc.contributor.authorPeter, Joy
dc.contributor.authorWadsworth, Summer
dc.contributor.authorKixmiller, Scott
dc.contributor.authorSloan, Anquenette
dc.contributor.authorVainorius, Monika
dc.contributor.authorHorne, Patrick M.
dc.contributor.authorMichael, Larry
dc.contributor.authorDong, Meichen
dc.contributor.authorEvon, Donna M.
dc.contributor.authorSegal, Jodi B.
dc.contributor.authorNelson, David R.
dc.date.accessioned2021-12-02T02:28:59Z
dc.date.available2023-01-01 21:28:58en
dc.date.available2021-12-02T02:28:59Z
dc.date.issued2021-12
dc.identifier.citationSulkowski, Mark S.; Moon, Juhi S.; Sherman, Kenneth E.; Morelli, Giuseppe; Darling, Jama M.; Muir, Andrew J.; Khalili, Mandana; Fishbein, Dawn A.; Hinestrosa, Federico; Shiffman, Mitchell L.; Di Bisceglie, Adrian; Rajender Reddy, K.; Pearlman, Brian; Lok, Anna S.; Fried, Michael W.; Stewart, Paul W.; Peter, Joy; Wadsworth, Summer; Kixmiller, Scott; Sloan, Anquenette; Vainorius, Monika; Horne, Patrick M.; Michael, Larry; Dong, Meichen; Evon, Donna M.; Segal, Jodi B.; Nelson, David R. (2021). "A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study." Hepatology (6): 2952-2964.
dc.identifier.issn0270-9139
dc.identifier.issn1527-3350
dc.identifier.urihttps://hdl.handle.net/2027.42/170968
dc.publisherFDA Drug Safety Communication
dc.publisherWiley Periodicals, Inc.
dc.titleA Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelInternal Medicine and Specialties
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/170968/1/hep32053_am.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/170968/2/hep32053.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/170968/3/hep32053-sup-0001-Supinfo.pdf
dc.identifier.doi10.1002/hep.32053
dc.identifier.sourceHepatology
dc.identifier.citedreferenceHofmeister MG, Rosenthal EM, Barker LK, Rosenberg ES, Barranco MA, Hall EW, et al. Estimating prevalence of hepatitis C virus infection in the United States, 2013‐2016. Hepatology 2019; 69: 1020 ‐ 1031.
dc.identifier.citedreferenceDang H, Yeo YH, Yasuda S, Huang CF, Iio E, Landis C, et al. Cure with interferon free DAA is associated with increased survival in patients with HCV related HCC from both east and west. Hepatology 2020; 71: 1910 ‐ 1922.
dc.identifier.citedreferencePolaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol 2015; 2017: 161 ‐ 176.
dc.identifier.citedreferenceEvon DM, Sarkar S, Amador J, Lok AS, Sterling RK, Stewart PW, et al. Patient‐reported symptoms during and after direct‐acting antiviral therapies for chronic hepatitis C: the PROP UP study. J Hepatol 2019; 71: 486 ‐ 497.
dc.identifier.citedreferenceUS Food and Drug Administration. FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease. FDA Drug Safety Communication. https://www.fda.gov/drugs/drug‐safety‐and‐availability/fda‐warns‐about‐rare‐occurrence‐serious‐liver‐injury‐use‐hepatitis‐c‐medicines‐mavyret‐zepatier‐and. Published August 28, 2019. Accessed August 2, 2020.
dc.identifier.citedreferenceZeuzem S, Ghalib R, Reddy KR, Pockros PJ, Ben Ari Z, Zhao Y, et al. Grazoprevir‐elbasvir combination therapy for treatment‐naive cirrhotic and noncirrhotic patients with chronic hepatitis C virus genotype 1, 4, or 6 infection: a randomized trial. Ann Intern Med 2015; 163: 1 ‐ 13.
dc.identifier.citedreferenceO’Brien TR, Lang Kuhs KA, Pfeiffer RM. Subgroup differences in response to 8 weeks of ledipasvir/sofosbuvir for chronic hepatitis C. Open Forum Infect Dis 2014; 1: ofu110.
dc.identifier.citedreferenceFox DS, McGinnis JJ, Tonnu‐Mihara IQ, McCombs JS. Comparative treatment effectiveness of direct acting antiviral regimens for hepatitis C: data from the Veterans Administration. J Gastroenterol Hepatol 2017; 32: 1136 ‐ 1142.
dc.identifier.citedreferenceZeuzem S, Mizokami M, Pianko S, Mangia A, Han KH, Martin R, et al. NS5A resistance‐associated substitutions in patients with genotype 1 hepatitis C virus: prevalence and effect on treatment outcome. J Hepatol 2017; 66: 910 ‐ 918.
dc.identifier.citedreferenceUS Department of Health and Human Services. Viral hepatitis national strategic plan for the United States: A roadmap to elimination (2021‐2025). Washington, DC; 2020.
dc.identifier.citedreferenceWilder J, Saraswathula A, Hasselblad V, Muir A. A systematic review of race and ethnicity in hepatitis C clinical trial enrollment. J Natl Med Assoc 2016; 108: 24 ‐ 29.
dc.identifier.citedreferenceSegal JB, PRIORITIZE HCV Study Group. Formulary restrictions may impact enrollment in pragmatic trials and limit generalizability of findings to vulnerable populations. Clin Trials 2020; 17: 729 ‐ 731.
dc.identifier.citedreferenceLu K. On efficiency of constrained longitudinal data analysis versus longitudinal analysis of covariance. Biometrics 2010; 66: 891 ‐ 896.
dc.identifier.citedreferenceFirth D. Bias reduction of maximum likelihood estimates. Biometrika 1993; 80: 27 ‐ 38.
dc.identifier.citedreferenceWhite IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomized trials with missing outcome data. BMJ 2011; 342: d40.
dc.identifier.citedreferenceInternational Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals. http://www.icmje.org/icmje‐recommendations.pdf. Published December 2019. Accessed July 9, 2020.
dc.identifier.citedreferenceWasserstein RL, Schirm AL, Lazar NA. Moving to a world beyond “ p < 0.05.” Am Stat 2019; 73 ( Suppl. 1 ): 1 ‐ 19.
dc.identifier.citedreferenceWasserstein RL, Lazar NA. The ASA statement on p ‐values: context, process, and purpose. Am Stat 2016; 70: 129 ‐ 133.
dc.identifier.citedreferenceIt’s time to talk about ditching statistical significance. Nature 2019; 567: 283.
dc.identifier.citedreferenceAmrhein V, Greenland S, McShane B. Scientists rise up against statistical significance. Nature 2019; 567: 305 ‐ 307.
dc.identifier.citedreferenceSchulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMJ 2010; 340: c332.
dc.identifier.citedreferenceVoils CI, Maciejewski ML, Hoyle RH, Reeve BB, Gallagher P, Bryson CL, et al. Initial validation of a self‐report measure of the extent of and reasons for medication nonadherence. Med Care 2012; 50: 1013 ‐ 1019.
dc.identifier.citedreferenceVoils CI, King HA, Thorpe CT, Blalock DV, Kronish IM, Reeve BB, et al. Content validity and reliability of a self‐report measure of medication nonadherence in hepatitis C treatment. Dig Dis Sci 2019; 64: 2784 ‐ 2797.
dc.identifier.citedreferenceAnderson RT, Baran RW, Dietz B, Kallwitz E, Erickson P, Revicki DA. Development and initial psychometric evaluation of the hepatitis C virus‐patient‐reported outcomes (HCV‐PRO) instrument. Qual Life Res 2014; 23: 561 ‐ 570.
dc.identifier.citedreferenceSpiegel BM, Hays RD, Bolus R, Melmed GY, Chang L, Whitman C, et al. Development of the NIH Patient‐Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales. Am J Gastroenterol 2014; 109: 1804 ‐ 1814. Erratum in: Am J Gastroenterol 2015;110:608.
dc.identifier.citedreferenceReeve BB, Hays RD, Bjorner JB, Cook KF, Crane PK, Teresi JA, et al. Psychometric evaluation and calibration of health‐related quality of life item banks: plans for the Patient‐Reported Outcomes Measurement Information System (PROMIS). Med Care 2007; 45 ( 5 Suppl. 1 ): S22 ‐ S31.
dc.identifier.citedreferenceCella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, et al. The Patient‐Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self‐reported health outcome item banks: 2005‐2008. J Clin Epidemiol 2010; 63: 1179 ‐ 1194.
dc.identifier.citedreferenceBjorner JB, Kosinski M, Ware JE Jr. Using item response theory to calibrate the Headache Impact Test (HIT™) to the metric of traditional headache scales. Qual Life Res 2003; 12: 981 ‐ 100.
dc.identifier.citedreferenceKosinski M, Bayliss MS, Bjorner JB, Ware JE Jr, Garber WH, Batenhorst A, et al. A six‐item short‐form survey for measuring headache impact: the HIT‐6. Qual Life Res 2003; 12: 963 ‐ 974.
dc.identifier.citedreferenceMishra P, Florian J, Peter J, Vainorius M, Fried MW, Nelson DR, et al. Public–private partnership: targeting real‐world data for hepatitis C direct‐acting antivirals. Gastroenterology 2017; 153: 626 ‐ 631.
dc.identifier.citedreferenceAASLD/IDSA HCV Guidance Panel Recommendations for testing, managing, and treating hepatitis C website. Published 2017. Accessed June 13, 2017. http://hcvguidelines.org
dc.working.doiNOen
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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