000			05629nam a22009017a 4500
008			220124s20212021 xxu||||| |||| 00| 0 eng d
022			_a0270-9139
024			_a10.1002/hep.32053 [doi]
024			_aNIHMS1752507 [mid]
024			_aPMC8639765 [pmc]
040			_aOvid MEDLINE(R)
099			_a34255381
245			_aA Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study.
251			_aHepatology. 74(6):2952-2964, 2021 12.
252			_aHepatology. 74(6):2952-2964, 2021 12.
252			_zHepatology. 74(6):2952-2964, 2021 12.
253			_aHepatology (Baltimore, Md.)
260			_c2021
260			_fFY2022
260			_p2021 12
265			_sppublish
266			_d2021-07-26
268			_aHepatology. 74(6):2952-2964, 2021 12.
269			_fFY2022
520			_aAPPROACH AND RESULTS: We conducted a pragmatic randomized controlled trial (NCT02786537) to compare the effectiveness of DAAs for HCV genotype 1a or 1b on viral response, safety, tolerability, and medication nonadherence. Adults with compensated liver disease, HCV genotype 1, not pregnant or breastfeeding, and with health insurance likely to cover ledipasvir/sofosbuvir (LDV/SOF) were recruited from 34 US viral hepatitis clinics. Participants were randomized (+/- ribavirin) to LDV/SOF, elbasvir/grazoprevir (EBR/GZR), and paritaprevir/ritonavir/ombitasvir+dasabuvir (PrOD; treatment arm stopped early). Primary outcomes included sustained viral response at 12 weeks (SVR12), clinician-recorded adverse events, patient-reported symptoms, and medication nonadherence. Between June 2016 and March 2018, 1,609 participants were randomized. Among 1,128 participants who received >=1 dose of EBR/GZR or LDV/SOF (+/- ribavirin), SVR12 was 95.2% (95% CI, 92.8%-97.6%) and 97.4% (95% CI, 95.5%-99.2%), respectively, with a difference estimate of 2.2% (-0.5% to 4.7%), falling within the "equivalence" interval (-5% to 5%). While most (56%) participants experienced adverse events, few were serious (4.2%) or severe (1.8%). In the absence of ribavirin, discontinuations due to adverse events were rare. Patient-reported symptoms and medication nonadherence were similar. Study limitations were dropout due to insurance denial and loss to follow-up after treatment, limiting the ability to measure SVR12.
520			_aBACKGROUND AND AIMS: Multiple direct-acting antiviral (DAA) regimens are available to treat HCV genotype 1 infection. However, comparative effectiveness from randomized controlled trials of DAA regimens is unavailable.
520			_aCONCLUSIONS: This pragmatic trial demonstrated high SVR12 for participants treated with EBR/GZR and LDV/SOF with few adverse effects. Overall, the two regimens were equivalent in effectiveness. The results support current HCV guidelines that do not distinguish between ribavirin-free EBR/GZR and LDV/SOF. Copyright (c) 2021 The Authors. Hepatology published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases.
546			_aEnglish
650			_a*Antiviral Agents/ad [Administration & Dosage]
650			_a*Hepacivirus/ip [Isolation & Purification]
650			_a*Hepatitis C, Chronic/dt [Drug Therapy]
650			_a2-Naphthylamine/ad [Administration & Dosage]
650			_aAdministration, Oral
650			_aAdolescent
650			_aAdult
650			_aAged
650			_aAged, 80 and over
650			_aAnilides/ad [Administration & Dosage]
650			_aBenzimidazoles/ad [Administration & Dosage]
650			_aBenzofurans/ad [Administration & Dosage]
650			_aCyclopropanes/ad [Administration & Dosage]
650			_aDrug Combinations
650			_aDrug Therapy, Combination/mt [Methods]
650			_aFemale
650			_aFluorenes/ad [Administration & Dosage]
650			_aFollow-Up Studies
650			_aGenotyping Techniques
650			_aHepacivirus/ge [Genetics]
650			_aHepatitis C, Chronic/bl [Blood]
650			_aHepatitis C, Chronic/di [Diagnosis]
650			_aHepatitis C, Chronic/vi [Virology]
650			_aHumans
650			_aImidazoles/ad [Administration & Dosage]
650			_aLactams, Macrocyclic/ad [Administration & Dosage]
650			_aMale
650			_aMiddle Aged
650			_aProline/aa [Analogs & Derivatives]
650			_aProline/ad [Administration & Dosage]
650			_aQuinoxalines/ad [Administration & Dosage]
650			_aRibavirin/ad [Administration & Dosage]
650			_aRNA, Viral/bl [Blood]
650			_aSofosbuvir/ad [Administration & Dosage]
650			_aSulfonamides/ad [Administration & Dosage]
650			_aSustained Virologic Response
650			_aTreatment Outcome
650			_aUracil/aa [Analogs & Derivatives]
650			_aUracil/ad [Administration & Dosage]
650			_aValine/ad [Administration & Dosage]
650			_aYoung Adult
651			_aMedStar Health Research Institute
657			_aJournal Article
657			_aResearch Support, N.I.H., Extramural
657			_aResearch Support, Non-U.S. Gov't
700			_aFishbein, Dawn
790			_aDarling JM, Di Bisceglie A, Dong M, Evon DM, Fishbein DA, Fried MW, Hinestrosa F, Horne PM, Khalili M, Kixmiller S, Lok AS, Michael L, Moon JS, Morelli G, Muir AJ, Nelson DR, Pearlman B, Peter J, PRIORITIZE Study Team, Rajender Reddy K, Segal JB, Sherman KE, Shiffman ML, Sloan A, Stewart PW, Sulkowski MS, Vainorius M, Wadsworth S
856			_uhttps://dx.doi.org/10.1002/hep.32053 _zhttps://dx.doi.org/10.1002/hep.32053
942			_cART _dArticle
999			_c6667 _d6667