A platform in the use of medicines to treat chronic hepatitis C (PLATINUM C) protocol for a prospective treatment registry of real world o

Article

Ramsay, J., Marsh, J., Pedrana, A., Andric, N., Norman, R., Cheng, W., Webb, S., Zeps, N., Bellgard, M., Graves, T., Hellard, M. and Snelling, T. 2020. A platform in the use of medicines to treat chronic hepatitis C (PLATINUM C) protocol for a prospective treatment registry of real world o. BMC Infectious Diseases. 20 (Art. 802). https://doi.org/10.1186/s12879-020-05531-4
AuthorsRamsay, J., Marsh, J., Pedrana, A., Andric, N., Norman, R., Cheng, W., Webb, S., Zeps, N., Bellgard, M., Graves, T., Hellard, M. and Snelling, T.
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.

JournalBMC Infectious Diseases
Journal citation20 (Art. 802)
ISSN1471-2334
Year2020
PublisherBioMed Central
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Supplemental file
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Digital Object Identifier (DOI)https://doi.org/10.1186/s12879-020-05531-4
Publication dates
Online29 Oct 2020
Publication process dates
Accepted20 Oct 2020
Deposited02 May 2023
Funder Government of Western Australia, Department of Health Research Translation Projects (RTP)
Copyright holder© 2020, The Authors
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