Policy Guidelines and Recommendations

EU & Global Policy

Current Situation Regarding Access to Hepatitis C Treatment in Eastern Europe and Central Asia,
Dasha Ocheret, Damir Bikmukhametov, Aibar Sultangaziev, Erika Matuizaite, Eurasian Harm Reduction Network, 2013

This policy brief summarizes key findings from an assessment of hepatitis C treatment accessibility in EECA undertaken by the Eurasian Harm Reduction Network (EHRN). It also refers to recommendations from the World Health Organization (WHO) on how to support national governments and affected communities in order to improve hepatitis C treatment access.


Global Commission on Drugs; Demand Reduction and Harm Reduction,
Dr. Alex Wodak January 2011

People who use drugs have the same human rights as people who have never used drugs. These rights include the right to the highest attainable standard of health, to social services, to work, to benefit from scientific progress, to freedom from arbitrary detention and freedom from cruel inhuman and degrading treatment.


The War on Drugs and HIV/AIDS: How theCriminalization ofDrug Use Fuels theGlobal Pandemic,
Report of the Global Commission on Drug Policy, 2012

The global war on drugs is driving the HIV/AIDS pandemic among people who use drugs and their sexual partners. While the annual number of new infections has been falling since the late 1990s, HIV incidence increased by more than 25 percent in seven countries over this time span, largely as a result of HIV transmission related to intravenous drug use.1 Five of these countries are in Eastern Europe and Central Asia, where the war on drugs is being aggressively fought and, as a result, the number of people living with HIV in this part of the world has almost tripled since 2000.


Council of the European Union EU Drug Strategy 2013 – 2020,
Brussels 11 December 2012

Delegations will find enclosed the EU Drugs Strategy for the period 2013-2020, as adopted by the Council on 7 December 2012.


Temporal Changes and Regional Differences in Treatment Uptake of Hepatitis C Therapy in EuroSIDA,
D Grint et al., HIV Medicine 2013

All HIV/hepatitis C virus (HCV)-coinfected patients with chronic HCV infection and _ F2 fibrosis should be considered for HCV therapy. This study aimed to determine the rate of HCV treatment uptake among coinfected patients in Europe.


Health Consumer Powerhouse, Euro Hepatitis Index Report 2012,
Beatrix Cebolla, Ph.D and Arne Bjornberg, Ph.D, Health Consumer Powerhouse 2012

The Euro Hepatitis Index makes a comprehensive diagnosis of 30 European countries with regard to the capacity to handle the hepatitis threat. The Index not only provides a cross-Europe description of problems and opportunities but also offers an analysis of each country, with a recipe for forming a national hepatitis agenda.


Prevention and Control of Viral Hepatitis Infection:
A Framework for Global Action, WHO 2012

This framework provides a global vision for the prevention and control of viral hepatitis and an overview of the global burden, current efforts and remaining challenges in the global response to viral hepatitis. It also outlines four axes for action with suggested approaches for Member States to adopt or adapt as they see fit.


The Negative Impact of the War on Drugs on Public Health:
The Hidden Hepatitis C Epidemic, Report of the Global Commission of Drug Policy, 2013

Instead of investing in effective prevention and treatment programmes to achieve the required coverage, governments continue to waste billions of dollars each year on arresting and punishing drug users – a gross misallocation of limited resources that could be more efficiently used for public health and preventive approaches. At the same time, repressive drug policies have fuelled the stigmatisation, discrimination and mass incarceration of people who use drugs. As a result, there are very few countries that have reported significant declines in new infections of hepatitis C among this population. This failure of governments to prevent and control hepatitis disease has great significance for future costs to health and welfare budgets in many countries


Best Strategies for Global HCV Eradication,
Liesl M. Hagan and Raymond F. Schinazi, Liver International (2013)

Worldwide eradication of hepatitis C virus (HCV) is possible through a combination of prevention education, universal clinical and targeted community screening, effective linkage to care and treatment with promising new directacting antiviral drug regimens.


Policy Brief on Hepatitis C Infection among Injecting Drug Users,
Xavier Majo Roca, Eberhard Schatz, Dasha Ocheret, Jason Farrell, Correlation Network 2011

This policy briefing paper is developed in accordance with the mission and framework of Correlation – European Network Social Inclusion & Health. The paper is prepared to offer information and guidance for policy makers, health care professionals and others who work in regard to the management of the epidemic of Hepatitis C (HCV) among injecting drug users (IDUs).


Janssen Hepatitis C in European Union,
Janssen Pharmaceuticals 2012

EU HCV Policy Landscape Overview


Hepatitis C among People who Use Drugs:
Key Messages from Practitioners, Correlation working group on Hepatitis C, 2011 www.correlation‐net.org

The key messages included in this report represent the most important aspects of interventions targeting injecting drug users. These have been identified through field work, the day to day experience of practitioners and a literature review.


Hepatitis C among Injecting Drug Users in the New EU Member States and Neighboring Countries:
Situation, Guidelines and Recommendations, CEEHRN 2007

To help assess the situation related to HCV among IDUs in the region, the Central and Eastern European Harm Reduction Network (CEEHRN) carried out a survey in 13 countries of the European Union (EU) and neighboring countries, looking at the availability of HCV prevention, treatment, care and support for IDUs. The countries assessed were: Belarus, Bulgaria, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Slovenia, Slovakia, and Ukraine.


An Overview of Policies for Prevention, care and Treatment of Hepatitis B and C,
Angelos Hatzakis, MD and Harry Janssen, MD, Hepatitis B and C Policy Association 2013

Slide presentation showing overview of facts and policy


Scaling-up Access to High Quality Harm Reduction,
Treatment and Care for Injecting Drug Users in the European Region, WHO 2013

End of project executive summry. Findings and recommendations from three linked studies investigating the social contexts of access to treatment and care for HIV, hepatitis C and tuberculosis among people who inject drugs in European cities.


The Silent Pandemic:
Tackling Hepatitis C with Policy Innovation, The Economist 2012

A report from the Economist Intelligence Unit


Viral Hepatitis: Global Policy,
World Hepatitis Alliance 2013

This report summarises the results of a study undertaken by the Alliance for the World Health Organization (WHO) across all 193 Member States. It examines their policies and programmes aimed at preventing and controlling viral hepatitis and the areas in which the WHO might assist with this.


European Action Plan for HIV/AIDS 2012 – 2015,
WHO Europe 2011

The Action Plan is anchored in the guiding principles of: equity in health; community participation; human rights; evidence-informed policies and ethical public health approaches. It is structured around four strategic directions: optimize HIV prevention, diagnosis, treatment and care outcomes; leverage broader health outcomes through HIV responses; build strong and sustainable systems; and reduce vulnerability and remove structural barriers to accessing services (addressing social determinants of health). The Plan puts into action in the WHO European Region both the UNAIDS HIV/AIDS Strategy for 2011–2015 and the WHO Global Health Sector Strategy on HIV/AIDS 2011–2015. It is coherent with the European Commission communication on HIV/AIDS 2009–2013.


Global Policy Report on the Prevention and Control of Viral Hepatitis in WHO Member States 2013

This report sets out the results of a survey conducted in mid-2012 by the World Health Organization and the World Hepatitis Alliance. The survey aimed to gather country-specific baseline data on hepatitis policies in WHO Member States in all six regions. Survey data also offer insight into conditions in specific countries that may have hindered past efforts to achieve hepatitis policy objectives. Gaps that need to be filled are identified, as are specific areas of policy development where WHO assistance is needed. Such baseline data will serve as a solid benchmark as countries, supported by WHO and its partners, seek to make the “silent” epidemic of viral hepatitis more visible – and more manageable.


Guidance on Prevention of Viral Hepatitis B and C among People who Inject Drugs 2012,
WHO

This Guidance on prevention of viral hepatitis B and C among people who inject drugs is the first step in the provision of comprehensive guidance on viral hepatitis surveillance, prevention and treatment by the World Health Organization. These recommendations are based on systematic reviews of scientific evidence, community values and preferences and implementation issues. Although the focus of this guidance is on low- and middle-income countries, this guidance applies equally to high-income settings.


 

National Policy & Guidelines
 
Overview of France’s national hepatitis action plans (French language)

Nobody Left Behind,
MDM and INPUD 2014

The importance of integrating people who inject drugs into HCV treatment programs.
Arguments from a public health and human rights perspective.


Interim Clinical Commissioning Policy Statement:
Sofosbuvir + Daclatasvir/Ledipasvir +/- Ribivirin for defined patients with Hepatitis C, April 2014, Reference: NHS ENGLAND A02/PS/b

House NHS England will commission Sofosbuvir, Daclatasvir/Ledipasvir +/- Ribivirin for the treatment of Hepatitis C in adults in accordance with the criteria outlined in this document.  This policy outlines the arrangements for funding of this treatment for the population in England.


Public Health Report on Commissioning of HCV services in London for People who Inject Drugs, London Joint Working Group on Substance Misuse and Hepatitis C,
NHS 2013

Under the new commissioning arrangements in England there is an opportunity to work collectively to provide effective evidence based equitable services for anyone with chronic hepatitis C infection, including some of the most vulnerable in our society. Detailed recommendations are made in this report for each commissioner audience.


Access to Drugs Treating Hepatitis C in Russia, Treatment Preparedness Coalition.
Access to Drugs for Treating Hepatitis C in Russia in 2013.

The purpose of this report was to investigate the situation regarding access to drugs treating the hepatitis C virus (HCV) in Russia. To this end, Treatment Preparedness Coalition made an overview of the applicable legislation, and likewise analyzed the data relating to governmental drug procurements, statistics on the prevalence and incidence of hepatitis C in various territories of the Russian Federation, and data regarding the financing of HCV treatment programs.


Hepatitis C Action Plan for Scotland Phase 1: September 2006 – August 2008,
NHS Scotland 2006

This document sets out the first Scottish Executive’s Hepatitis C Action Plan for the period September 2006 – August 2008.


Hepatitis C Action Plan for Scotland Phase 2: May 2008 – March 2011,
NHS Scotland 2006

This document sets out the Scottish Executive’s Hepatitis C Action Plan for the period May 2008 – March 2011.  A significant strand of the plan is about improving testing, treatment, care and support services for those infected, with a major emphasis being placed on increasing the number of people receiving treatment.


American Association for the Study of Liver Disease Recommendations for Testing,
Managing and Treating Hepatitis C, 2014

AASLD recommendations for US doctors and clinicians


Treatment of Chronic Hepatitis C Virus Infection – Dutch National Guidelines,
J. de Bruijne et al.,  The Netherland Journal of Medicine 2008

The development of this guideline was initiated and coordinated by the Netherlands Association of Gastroenterologists and Hepatologists.  The aim is the establishment of practical guidelines in the evaluation and antiviral treatment of patients with chronic hepatitis C virus (HCV) infection. This includes recommendations for the initial evaluation of patients, the choice and duration of antiviral therapy and the follow-up after antiviral therapy.


Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention Care and Treatment of Viral Hepatitis,
United States Department of Health and Human Services, 2011

To prepare the report Combating the Silent Epidemic of Viral Hepatitis: U.S. Department of Health and Human Services Action Plan for the Prevention, Care and Treatment of Viral Hepatitis (referred to as the Viral Hepatitis Action Plan), the Working Group convened expert panels from various HHS agencies and offices. Panel members were tasked with developing components of the action plan specific to their area of expertise.


Action Plan for the Prevention Care and Treatment of Viral Hepatitis:
Updated 2014-2016, United States Department of Health and Human Services

In May 2013, reflecting on their progress to date and encouraged by emerging opportunities for even greater progress resulting from the promise of emerging hepatitis C treatments as well as the expansion of access to viral hepatitis prevention, care, and treatment offered by the Affordable Care Act, the partners agreed to propel these efforts further by renewing the Action Plan for another 3 years by outlining specific actions for 2014–2016.


 

Treatment & Prevention

Past The Finish Line: Benefits of a Hepatitis C Cure,
Benjamin Ryan, HEP Magazine July 2013

Much attention is focused on the effort to achieve a sustained virologic response, or cure, for hepatitis C.  But what actually happens after the virus in finally gone?


Breaking Down the Barriers to Hepatitis C Virus (HCV) Treatment Among Individuals With HCV/HIV Coinfection: Action Required at the System, Provider, and Patient Levels,
Jason Grebely et al., The Journal of Infectious Diseases 2013;207(S1):S19–25

Advances in HCV therapy will have a limited impact on the burden of HCV-related disease at the population-level unless barriers to HCV education, screening, evaluation, and treatment are addressed and treatment uptake increases.  This review will outline barriers to HCV care in HCV/HIV coinfection, with a particular emphasis on persons who inject drugs, proposing strategies to enhance HCV treatment uptake and outcomes


EASL Clinical Practice Guidelines: Management of Hepatitis C Virus Infection, European Association for the Study of the Liver,
Journal of Hepatology 2013

These EASL Clinical Practice Guidelines (CPGs) are intended to assist physicians and other healthcare providers, as well as patients and other interested individuals, in the clinical decision-making process by describing the optimal management of patients with acute and chronic HCV infections.


EASL Recommendations on Treatment of Hepatitis C 2014,
European Association for the Study of the Liver

These EASL Recommendations on Treatment of Hepatitis C are intended to assist physicians and other healthcare providers, as well as patients and other interested individuals, in the clinical decision making process by describing the optimal management of patients with acute and chronic HCV infections.


Eradication of Hepatitis C Infection: The Importance of Targeting People who Inject Drugs,
Margaret Hellard, PhD, et al., Hepatology 2013

To achieve eradication, public health efforts must focus on PWID, the key drivers of HCV
transmission. A sustained, multipronged approach could substantially reduce HCV infection in PWID over the next 10–20 years through a focus on HCV treatment as prevention, meaning improved access to more effective and well-tolerated HCV treatment. Other major elements include increasing coverage of opiate substitution therapy (OST), needle and syringe programs (NSPs), and regular HCV screening and counseling.


Guidelines for the Treatment of Hepatitis C Virus
Jens Reimer et al., Clinical Infectious Diseases 2005; 40:S373–8

This study was conducted to analyze guidelines for the treatment of hepatitis C virus (HCV) infection in injection drug users (IDUs) in the European Union (EU) countries as a component of treatment access. National and international databases, expert contacts, professional societies, and health administrations were approached to acquire guidelines. According to their quality standard, guidelines were divided into expert opinions, semiofficial guidelines, official guidelines, and consensus processes.


New Treatments for Hepatitis C Virus: Strategies for Achieving Universal Access,
Pauline Londeix and Chloé Forette, Médecins du Monde 2014

This article examines various possible strategies for gaining and expanding access to new HCV treatments, and compares them in order to determine which approach might be most beneficial to the greatest number of people.


2014 Pipeline Report: HIV, Hepatitis C Virus, and Tuberculosis Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-based and Gene Therapies in Development;
By Polly Clayden, Simon Collins, Colleen Daniels, Mike Frick, Mark Harrington, Tim Horn, Richard Jefferys, Karyn Kaplan, Erica Lessem, Lindsay McKenna, and Tracy Swan, Edited by Andrea Benzacar, July 2014
TAG and HIV – iBase

The research pipelines described in this year’s report show substantial progress in new treatments and preventive interventions against HIV. Revolutionary changes are afoot in the treatment of HCV, which allow—for the first time—the prospect of universal cure and disease eradication—if only cost and access
barriers can be overcome.


Recommendations for the Management of Hepatitis C Virus Infection Among People Who Inject Drugs,
Geert Robaeys et al., Clinical Infectious Diseases 2013

Given the burden of HCV-related disease among PWID, strategies to enhance HCV assessment and treatment in this group are urgently needed. These recommendations demonstrate that treatment among PWID is feasible and provides a framework for HCV assessment, management, and treatment.


Treating Hepatitis C in Lower-Income Countries,
Channa R. Jayasekera, M.D., et al., The New England Journal of Medicine May 2014

Low- and middle-income countries account for more than 80% of the global HCV burden,
with the most infections in South Asia, East Asia, North Africa, the Middle East, and Southeast Asia HCV genotypes 4, 5, and 6 are particularly common in these areas, but the new treatment regimens can achieve responses in patients infected with those genotypes that are similar to those achieved in patients with the genotype 1 infections that predominate in the United States and Europe.


Treatment as Prevention and Cure towards Global Eradication of Hepatitis C Virus,
Liesl M. Hagan et al., Trends in Microbiology December 2013, Vol. 21, No. 12

The availability of curative, direct-acting antiviral drugs against hepatitis C virus (HCV) sparks an ethical call for HCV eradication and provides essential tools to spearhead the effort. Challenges include increasing awareness of the chronic hepatitis C epidemic, garnering sufficient public, private, and governmental financial will to invest in the necessary resources, developing pangenotypic drug regimens for global application, and mitigating ethical concerns.


Understanding Barriers to Hepatitis C Virus Care and Stigmatization From a Social Perspective,
Carla Treloar, Jake Rance, and Markus Backmund, Clinical Infectious Diseases 2013

This review argues that the relationship between the person living with HCV and their health worker can work to ameliorate the effects of stigma. We draw on an emerging literature that examines the positive association between a patient’s “trust” in their health worker and outcomes such as increased healthcare utilization and reduced risk behaviors. We investigate a growing body of health services research that acknowledges the importance of stigma and demonstrate ways to build positive, enabling relationships between patient, health worker, and health setting.


Defuse Hepatitis C, the Viral Time Bomb!
Test and Treat Hepatitis C: Position Paper for the 67th World Health Assembly May 19-24, 2014; MdM, TAG, ACTUP Basel, APN+, INPUD and ITPC

Position paper outlining agreed upon consensus of issues to be presented at the 67th World Health Assembly meeting


Sixty-Third World Health Assembly WHA 63.18 – Agenda item 11.12 21 May 2010 – Viral Hepatitis

Detailed manuscript of WHA resolution on viral hepatitis May 2010


Guidance on Prevention of Viral Hepatitis B and C among People who Inject Drugs,
WHO 2012

This Guidance on prevention of viral hepatitis B and C among people who inject drugs is the first step in the provision of comprehensive guidance on viral hepatitis surveillance, prevention and treatment by the World Health Organization. These recommendations are based on systematic reviews of scientific evidence, community values and preferences and implementation issues.  Although the focus of this guidance is on low- and middle-income countries, this guidance applies equally to high-income settings.


Guidelines for the Screening, Care and Treatment of Persons with Hepatitis C,
WHO April 2014

These are the first guidelines dealing with hepatitis C treatment produced by the World Health Organization (WHO) and complement existing guidance on the prevention of transmission of bloodborne viruses, including HCV. They are intended for policy-makers, government officials, and others working in low- and middleincome countries who are developing programmes for the screening, care and treatment of persons with HCV infection.


 

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Correlation
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Disclaimer

Correlation - European Harm Reduction Network is co-funded by the European Union, receives financial support by Gilead Science Ltd. and by Abbvie Biochemicals Sarl for training purposes from time to time.

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