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 Infectious Diseases

Todd Graves¹  Wendy Cheng²  Alisa Pedrana³  Margaret Hellard⁴  Nikolajs Zeps⁵  Nada Andric⁶  Steve Webb⁷  Richard Norman⁸  Jessica Ramsay⁹  Julie Marsh⁹  Tom Snelling^1,10  Matthew Bellgard^1,11 

[1] Berry Consultants, Austin, TX, USA;Department of Gastroenterology and Hepatology, Royal Perth Hospital, Perth, Australia;UWA Medical School, University of Western Australia, Perth, Australia;School of Medical and Health Sciences, Edith Cowan University, Perth, Australia;Disease Elimination Program, Burnet Institute, Melbourne, Australia;School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia;Disease Elimination Program, Burnet Institute, Melbourne, Australia;School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia;Department of Infectious Diseases, The Alfred and Monash University, Melbourne, Australia;Peter Doherty Institute for Infection and Immunity, Melbourne, Australia;School of Population and Global Health, University of Melbourne, Melbourne, Australia;Epworth HealthCare, Eastern Clinical School of Monash University, Melbourne, Australia;Homeless Healthcare, West Leederville, Perth, Australia;School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia;St John of God Hospital, Subiaco, Perth, Australia;School of Public Health, Curtin University, Bentley, Australia;Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, The University of Western Australia, Perth, Australia;Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, The University of Western Australia, Perth, Australia;School of Public Health, Curtin University, Bentley, Australia;Menzies School of Health Research, Charles Darwin University, Darwin, Australia;Department of Infectious Diseases, Perth Children’s Hospital, Perth, Australia;School of Public Health, University of Sydney, Camperdown, 2006, Sydney, New South Wales, Australia;eResearch Office, Queensland University of Technology, Brisbane, Australia;

关键词: Hepatitis C;    Direct-acting antiviral treatment;    Treatment registry;    Platform trial;   

DOI  :  10.1186/s12879-020-05531-4

来源: Springer

【 摘 要 】

BackgroundSafe, 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.MethodsPLATINUM 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).DiscussionPLATINUM 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 registrationThe trial is registered with the Australia and New Zealand Clinical Trials Register (ACTRN12619000023156). Date of registration: 10/01/2019.

【 授权许可】

CC BY