MARC details
000 -LEADER |
fixed length control field |
05629nam a22009017a 4500 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
220124s20212021 xxu||||| |||| 00| 0 eng d |
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
International Standard Serial Number |
0270-9139 |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
10.1002/hep.32053 [doi] |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
NIHMS1752507 [mid] |
024 ## - OTHER STANDARD IDENTIFIER |
Standard number or code |
PMC8639765 [pmc] |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
Ovid MEDLINE(R) |
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
PMID |
34255381 |
245 ## - TITLE STATEMENT |
Title |
A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study. |
251 ## - Source |
Source |
Hepatology. 74(6):2952-2964, 2021 12. |
252 ## - Abbreviated Source |
Abbreviated source |
Hepatology. 74(6):2952-2964, 2021 12. |
252 ## - Abbreviated Source |
Former abbreviated source |
Hepatology. 74(6):2952-2964, 2021 12. |
253 ## - Journal Name |
Journal name |
Hepatology (Baltimore, Md.) |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Year |
2021 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Manufacturer |
FY2022 |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Publication date |
2021 12 |
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
Publication status |
ppublish |
266 ## - Date added to catalog |
Date added to catalog |
2021-07-26 |
268 ## - Previous citation |
-- |
Hepatology. 74(6):2952-2964, 2021 12. |
269 ## - Original dates |
Original fiscal year |
FY2022 |
520 ## - SUMMARY, ETC. |
Abstract |
APPROACH 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 ## - SUMMARY, ETC. |
Abstract |
BACKGROUND 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 ## - SUMMARY, ETC. |
Abstract |
CONCLUSIONS: 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 ## - LANGUAGE NOTE |
Language note |
English |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Antiviral Agents/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Hepacivirus/ip [Isolation & Purification] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
*Hepatitis C, Chronic/dt [Drug Therapy] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
2-Naphthylamine/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Administration, Oral |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Adolescent |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Adult |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Aged |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Aged, 80 and over |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Anilides/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Benzimidazoles/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Benzofurans/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Cyclopropanes/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Drug Combinations |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Drug Therapy, Combination/mt [Methods] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Female |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Fluorenes/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Follow-Up Studies |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Genotyping Techniques |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Hepacivirus/ge [Genetics] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Hepatitis C, Chronic/bl [Blood] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Hepatitis C, Chronic/di [Diagnosis] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Hepatitis C, Chronic/vi [Virology] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Humans |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Imidazoles/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Lactams, Macrocyclic/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Male |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Middle Aged |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Proline/aa [Analogs & Derivatives] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Proline/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Quinoxalines/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Ribavirin/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
RNA, Viral/bl [Blood] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Sofosbuvir/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Sulfonamides/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Sustained Virologic Response |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Treatment Outcome |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Uracil/aa [Analogs & Derivatives] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Uracil/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Valine/ad [Administration & Dosage] |
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Young Adult |
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
Institution |
MedStar Health Research Institute |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Journal Article |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Research Support, N.I.H., Extramural |
657 ## - INDEX TERM--FUNCTION |
Medline publication type |
Research Support, Non-U.S. Gov't |
700 ## - ADDED ENTRY--PERSONAL NAME |
Local Authors |
Fishbein, Dawn |
790 ## - Authors |
All authors |
Darling 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 ## - ELECTRONIC LOCATION AND ACCESS |
DOI |
<a href="https://dx.doi.org/10.1002/hep.32053">https://dx.doi.org/10.1002/hep.32053</a> |
Public note |
https://dx.doi.org/10.1002/hep.32053 |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Koha item type |
Journal Article |
Item type description |
Article |