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Abstract Details
A platform in the use of medicines to treat chronic hepatitis C (PLATINUM C): protocol for a prospective treatment registry of real-world outcomes for hepatitis C
BMC Infect Dis. 2020 Oct 29;20(1):802. doi: 10.1186/s12879-020-05531-4.
Jessica Ramsay1, Julie Marsh1, Alisa Pedrana23, Nada Andric4, Richard Norman5, Wendy Cheng678, Steve Webb39, Nikolajs Zeps10, Matthew Bellgard11, Todd Graves12, Margaret Hellard23131415, Tom Snelling1617181920
Author information
1Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, The University of Western Australia, Perth, Australia.
2Disease Elimination Program, Burnet Institute, Melbourne, Australia.
3School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
4Homeless Healthcare, West Leederville, Perth, Australia.
5School of Public Health, Curtin University, Bentley, Australia.
6Department of Gastroenterology and Hepatology, Royal Perth Hospital, Perth, Australia.
7UWA Medical School, University of Western Australia, Perth, Australia.
8School of Medical and Health Sciences, Edith Cowan University, Perth, Australia.
9St John of God Hospital, Subiaco, Perth, Australia.
10Epworth HealthCare, Eastern Clinical School of Monash University, Melbourne, Australia.
11eResearch Office, Queensland University of Technology, Brisbane, Australia.
12Berry Consultants, Austin, TX, USA.
13Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Australia.
14Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
15School of Population and Global Health, University of Melbourne, Melbourne, Australia.
16Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, The University of Western Australia, Perth, Australia. tom.snelling@sydney.edu.au.
17School of Public Health, Curtin University, Bentley, Australia. tom.snelling@sydney.edu.au.
18Menzies School of Health Research, Charles Darwin University, Darwin, Australia. tom.snelling@sydney.edu.au.
19Department of Infectious Diseases, Perth Children's Hospital, Perth, Australia. tom.snelling@sydney.edu.au.
20School of Public Health, University of Sydney, Camperdown, Sydney, New South Wales, 2006, Australia. tom.snelling@sydney.edu.au.
Free PMC article
Abstract
Background: Safe, highly curative, short course, direct acting antiviral (DAA) therapies are now available to treat chronic hepatitis C. DAA therapy is freely available to all adults chronically infected with the hepatitis C virus (HCV) in Australia. If left untreated, hepatitis C may lead to progressive hepatic fibrosis, cirrhosis and hepatocellular carcinoma. Australia is committed to eliminating hepatitis as a public health threat by 2030 set by the World Health Organization. However, since the introduction of funded DAA treatment, uptake has been suboptimal. Australia needs improved strategies for testing, treatment uptake and treatment completion to address the persisting hepatitis C public health problem. PLATINUM C is a HCV treatment registry and research platform for assessing the comparative effectiveness of alternative interventions for achieving virological cure.
Methods: PLATINUM C will prospectively enrol people with active HCV infection confirmed by recent detection of HCV ribonucleic acid (RNA) in blood. Those enrolled will agree to allow standardised collection of demographic, lifestyle, treatment, virological outcome and other relevant clinical data to better inform the future management of HCV infection. The primary outcome is virological cure evidenced by sustained virological response (SVR), which is defined as a negative HCV PCR result 6 to 18 months after initial prescription of DAA therapy and no less than 12 weeks after the completion of treatment. Study participants will be invited to opt-in to medication adherence monitoring and quality of life assessments using validated self-reported instruments (EQ-5D-5L).
Discussion: PLATINUM C is a treatment registry and platform for nesting pragmatic trials. Data collected will inform the design, development and implementation of pragmatic trials. The digital infrastructure, study procedures and governing systems established by the registry will allow PLATINUM C to support a wider research platform in the management of hepatitis C in primary care.
Trial registration: The trial is registered with the Australia and New Zealand Clinical Trials Register ( ACTRN12619000023156 ). Date of registration: 10/01/2019.