Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe

To access publisher's full text version of this article click on the hyperlink belowAll-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver.UNSW (Sydney, Australia) CanHepC Trainee Program (Canada) National Health and Medical Research Council Australian Government Department of Healt

Clinical effectiveness, cost effectiveness and acceptability of community-based treatment of Hepatitis C Virus infection: a mixed method systematic review

Several community-based models for treating Hepatitis C Virus (HCV) infection have been implemented to improve treatment accessibility and health outcomes. However, there is a lack of knowledge regarding how well these models achieve the desired goals. We conducted a mixed-method systematic review of quantitative and qualitative evidence about clinical effectiveness, cost effectiveness and acceptability of community-based HCV treatment models. Seventeen databases were researched for published and unpublished studies. Methodological quality was assessed using The Joanna Briggs Institute Critical Appraisal tools. Quantitative findings were synthesised in narrative form and qualitative findings were synthesised using meta-synthesis. Forty-two quantitative and six qualitative studies were included. No relevant cost effectiveness studies were found. Five categories of community-based models were identified: telehealth, integration of HCV and addiction services, integration of HCV and HIV services, integration of HCV and primary care, and implementation by a home care and health care management company. The range of reported outcomes included; end of treatment response: 48.7% to 96%, serious side effects: 3.3% to 27.8%, sustained virological response: 22·3% to 95·5%, relapse: 2·2% to 16·7%, and treatment completion: 33·4% to 100%. Inconsistent measures of uptake and adherence were used; uptake ranged from 8·3% to 92%, and 68·4% to 100% of patients received ≥80% of prescribed doses. Patient reported experiences included trusted and supportive care providers, safe and trusted services, easily accessible care, and positive psychological and behavioural changes. The clinical effectiveness and acceptability reported from the included studies are similar to or better than reported outcomes from systematic reviews of studies in tertiary settings. Studies of the cost-effectiveness of community-based models for treating HCV are needed. This article is protected by copyright. All rights reserved

Money Talks: A synthesis report assessing humanitarian funding flows to local actors in Bangladesh and Uganda

International humanitarian agencies and donors have made a series of global commitments to local actors as part of the localization agenda, including to increase their access to greater direct funding by 2020. This briefing paper reviews 2015 national financial data for Bangladesh and Uganda to better understand how to target international investments in localization. It presents key findings from Oxfam-commissioned research on which factors affect local actors' ability to access international humanitarian funding. It concludes that in order for global commitments to translate into practice, investments should look at changing the terms of the funding relationship, as well as be based on a context-specific, national analysis of the financial environment

Clinical laboratory testing in the era of directly acting antiviral therapies for hepatitis c

Directly acting antiviral (DAA) combination therapies for chronic hepatitis C virus (HCV) infection are highly effective, but treatment decisions remain complex. Laboratory testing is important to evaluate a range of viral, host, and pharmacological factors when considering HCV treatment, and patients must be monitored during and after therapy for safety and to assess the viral response. In this review, we discuss the laboratory tests relevant for the treatment of HCV infection in the era of DAA therapy, grouped according to viral and host factors