July 24, 2013

Galectin Therapeutics Announces First Patient Dosed in Phase 1 Trial of GR-MD-02, a Potential First-in-Class Treatment for Fatty Liver Disease with Advanced Fibrosis

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NORCROSS, Ga., July 24, 2013 /PRNewswire-USNewswire/ -- Galectin Therapeutics (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that the first patient has been successfully dosed in a Phase 1 clinical trial of GR-MD-02. The first-in-man study will evaluate the safety, tolerability, and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease with advanced fibrosis.

GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin proteins play a major role in diseases that involve scaring of organs such as cancer, and inflammatory and fibrotic disorders. The drug binds to galectin proteins and disrupts their function. Preclinical data has shown that GR-MD-02 has robust treatment effects in reversing fibrosis and cirrhosis.

"The successful first patient dosing in the clinical trial of GR-MD-02 is a critical milestone in Galectin's development program. There are currently no treatments for fatty liver disease with advanced fibrosis; this milestone takes us one step closer to bringing a first-in-class treatment to the millions of Americans suffering from this silent epidemic," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "We anticipate that enrollment of the first cohort of eight patients in the Phase 1 trial will be complete by late summer with initial safety and tolerability results available following the 70 day study period and analysis of the data."

The Phase 1 multi-center, partially-blinded clinical trial will be conducted in 24 patients with fatty liver disease and advanced fibrosis who will receive four weekly doses of GR-MD-02. The study, which includes a dose escalation design, will be conducted at six US centers with extensive experience in clinical trials in liver disease. This first patient dosing took place at Indiana University under the direction of the Principal Investigator Dr. Naga Chalasani, a world-renowned expert in NASH.

The trial is titled, "A Multi-Center, Partially Blinded, Maximum Tolerated Multiple Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety of GR-MD-02 in Subjects with Non-Alcoholic Steatohepatitis (NASH) with Advanced Hepatic Fibrosis." Trial design details can be found at http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1.

An estimated 9 to 15 million Americans, including children, are affected by fatty liver disease. Without an available therapeutic treatment, the only alternative for patients with fatty liver disease is a transplant but there are limited donors available and the procedure is costly.

Recently, Galectin submitted a Fast Track application to the FDA to help expedite its clinical development program of GR-MD-02 in fatty liver disease with advanced fibrosis. FDA grants Fast Track designation to help expedite review and approval of drugs in development that treat serious or life threatening diseases and fill an unmet medical need.

About NASH
NASH has become a common disease of the liver with the rise in obesity rates, affecting 9 to 15 million people, including children, in the United States. NASH is characterized by the presence of fat in the liver along with inflammation and damage in people who drink little or no alcohol. Over time, patients with NASH can develop fibrosis, or scarring of the liver, and it is estimated that as many as 3,000,000 will develop cirrhosis, a severe liver disease where transplantation is the only current treatment available. Approximately 6,300 liver transplants are done on an annual basis in the United States.

About Galectin Therapeutics Inc.
Galectin Therapeutics (NASDAQ: GALT) is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company's unique understanding of galectin proteins, key mediators of biologic function. We are leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost effective and efficient development. We are pursuing a clear development pathway to clinical enhancement and commercialization for our lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com. Follow us on Twitter @GalectinGALT.

Forward Looking Statements
This press release contains, in addition to historical information, statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding our plans, expectations and goals regarding the clinical trial, our Fast Track submission and the potential benefits of a Fast Track designation, and our estimates regarding those impacted by NASH. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trial are subject to factors beyond our control. Our clinical trial may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. Also, receipt of a Fast Track designation from the FDA is beyond our control and the FDA may not approve our application. In regard to our clinical trial, we may have difficulty in enrolling candidates for testing, which would impact our estimates regarding timing, and we may not be able to achieve the desired results. Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse impact on our ability to achieve revenues from this proposed indication. Plans regarding development, approval and marketing of any of our drugs, including GR-MD-02, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be impacted by our ability to manage costs and finance our continuing operations. For a discussion of additional factors impacting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.

SOURCE Galectin Therapeutics

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Global Experts to Share HIV/AIDS Updates, Trends at July 30 Event in Washington, DC

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PRESS RELEASE

July 24, 2013, 5:52 p.m. EDT

WASHINGTON, July 24, 2013 /PRNewswire via COMTEX/ -- Distinguished experts and practitioners at the forefront of global HIV programs, research and policy will present emerging trends and potential breakthrough strategies at a special event on July 30 in Washington, D.C., Creative Associates International announced.

Called "Building an AIDS-Free Generation: Science, Care & More," the event will take place at the City Club, 555 13th Street, NW, Washington, D.C., from 8:30 a.m. to 11:30 a.m. Space is limited and advance registration is requested. Free registration at www.CreativeAssociatesInternational.com

"This event will engage donors, national government officials, implementers, advocates and researchers to share scientific advances and their implications for programming as we work to achieve the goal of a future without AIDS," says Charito Kruvant, President & CEO of Creative.

Recent biomedical advances present great promise and opportunity for those working on HIV and AIDS policy, program implementation and research. The ultimate success of these advances depends on multiple other factors -- including resources, systems, psychosocial, behavioral and structural factors.

Creative's July 30 event brings together expert speakers to stimulate a discussion of how best to move forward as we reach the "tipping point" in achieving the goal of an AIDS-free generation.

"We are honored to have this opportunity to host an event to bring together committed technical experts and attendees who are at the forefront of the global AIDS response," says Kruvant. www.CreativeAssociatesInternational.com

Confirmed speakers include:

-- Thomas J. Coates, PhD, Director, Center for World Health, Distinguished Professor of Medicine, Michael and Sue Steinberg Professor of Global AIDS Research, David Geffen School of Medicine and UCLA Health

-- Paul C. Hewett, PhD, Senior Associate, Population Council

-- Charles van der Horst, MD, Professor of Medicine, School of Medicine; Associate Chief, Division of Infectious Diseases; Developmental Core Director, UNC Center for AIDS Research, University of North Carolina at Chapel Hill

-- David Wilson, Global HIV/AIDS Program Director, Health, Nutrition, & Population, Human Development NetworkThe World Bank

-- Nomonde Xundu, MBBCh, Health Attach�, Embassy of South Africa, Washington, D.C.

-- Kendra Phillips, Chief, Implementation and Support Division, Office of HIV/AIDS, U.S. Agency for International Development

To attend "Building an AIDS-Free Generation: Science, Care & More," pre-registration is requested, and space is limited. Please visit: http://tinyurl.com/ovzckmh

Creative's HIV/AIDS Programming

For more than a decade, Creative has served as an implementing partner for HIV and health interventions for children worldwide -- including Nigeria, Zambia and Uganda.

Creative's approach focuses on the "whole child," which uses schools and communities as platforms to keep children in school, support vulnerable children and integrate HIV prevention basics into learning.

"From literacy and economic security to life skills and an enabling environment, our whole child approach recognizes the importance of these to the health and prevention of HIV in households and communities," says Field-Nguer, Creative's HIV/AIDs expert and organizer of the July 30 event.

Critical to Creative's approach is psychosocial support to at-risk youth and addressing stigma, which is often rooted in a community's lack of knowledge, Field-Nguer says. Stigma can be a barrier to testing, care and treatment efforts.

"Creative is committed to contributing to the reality of an AIDS-free generation," says President & CEO Kruvant. "We have focused on primary prevention and value the opportunity to continue this work while embracing collaboration with those on the cutting edge of combination prevention and treatment scale-up."

About Creative

Creative Associates International works with underserved communities by sharing expertise and experience in education, economic growth, governance and transitions from conflict to peace. Creative is the second-largest company owned by women that works with the U.S. government.

Based in Washington, D.C., Creative currently has field offices in 23 countries. Since 1977, it has worked in 85 countries and on nearly every continent. Recognized for its ability to work rapidly, flexibly and effectively in conflictive environments, Creative is committed to generating long-term sustainable solutions to complex development problems.

For additional information, please visit: www.CreativeAssociatesInternational.com

SOURCE Creative Associates International

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Report explores the inequity in treatment access for people living with HIV and Hepatitis C co-infection in Canada

July 24, 2013 5:59 AM

Policy report exposes procedural and institutional barriers in health technology and clinical trials in treatments for people living with both HIV and Hepatitis C

TORONTO, July 24, 2013 /CNW/ - The Canadian Treatment Action Council (CTAC) has produced "Two Standards of Care: toward treatment equity for people living with HIV/HCV co-infection",  a report discussing the current inequities in the world of pharmaceutical regulations and clinical trials for people living with both HIV and Hepatitis C.

The report, which analyzes the two newest Hepatitis C treatments on the market—boceprevir (Victrelis, Merck) and telaprevir (Incivek, Vertex)—acknowledges the advancements that have been made in medical treatments for people living with Hepatitis C, while focusing on the poor record of large pharmaceutical companies and governmental regulatory bodies in creating and recommending effective and efficient drug treatments for those who are suffering from both HIV and Hepatitis C.

The Two Standards of Care policy report outlines several policy recommendations that could aid the efficiency and efficacy of the clinical trial process in Canada.  Among them: enforce regulations on Hepatitis C drug development by regulatory agencies; include people who are considered "hard to treat" in clinical trials, and expand focus on equity at the Canadian Agency for Drugs and Technologies in Health.

"Many current clinical trial designs delay including patients who are harder to treat, and this can include people living with HIV/HCV co-infection," says Paul Sutton, policy researcher at CTAC. "CTAC's work in Two Standards of Care is to show how we can minimize clinical trial delays so we can get new, improved medications to the people who need it as quickly as possible."

The report highlights the enormous length of time between clinical trials for mono-infected patients (Hepatitis C alone) and co-infected patients (HIV and Hepatitis C).  Due to the high cost for testing drugs (between $500 million and $2 billion for per drugi ii) most treatments are initially tested on those living with Hepatitis C alone.  What's more, time delays for clinical trials are lengthy—with co-infected people waiting up to four years upon clinical trial completion for drugs like, boceprevir. This is only after the drug has been tested on Hepatitis C mono-infected patients.

CTAC also stresses its concerns with the restriction of access to ground-breaking treatments for co-infected people by health technology assessment bodies like the Common Drug Review (CDR).  Between late-2011 and early-2012, the CDR decided not to recommend Hepatitis C treatment medications boceprevir and telaprevir for co-infected patients despite the fact that there was no evidence saying that the drugs were harmful.  In June 2013, the CDR reversed its decision and recommended the use of the two drugs for people living with HIV and Hepatitis C.  The 18-month lapse caused a serious delay for co-infected people to access new and effective treatment.

The official launch date of the Two Standards of Care Report is August 9th, 2013.

CTAC is Canada's national civil society organization addressing access to treatment, care and support for people living with HIV and HCV.  In operation since 1996,  CTAC works to engage community members, service providers, policymakers and other relevant stakeholders to identify, develop and implement policy and program solutions.

_____________________________

iAdams C, Brantner V (2006). "Estimating the cost of new drug development: is it really 802 million dollars?". Health Aff (Millwood) 25 (2): 420-8
iiAdams, Christopher Paul; Brantner, Van Vu (February 2010). "Spending on new drug development". Health Economics 19 (2): 130-141.

SOURCE Canadian Treatment Action Council

For further information:

Kimberly Bennett
Communications Coordinator
CTAC
Ph: 416-410-6538, ext. 234
Email: kimberly@ctac.ca

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Hepatitis treatment debuts on WHO Model Essential Medicines List

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July 2013

Good news has emerged for the 150 million people worldwide who have hepatitis C – a lifelong condition that is transmitted through contact with the blood of an infected person and can lead to cirrhosis, liver cancer, and even death.

For the first time, the WHO’s Model Essential Medicines List – a globally agreed list that helps individual nations identify priority medicines for their citizens – now includes pegylated interferon. The application to include interferon notes that a combination of interferon alfa 2a or 2b and ribavirin is the current first line and only commercially available treatment for hepatitis C. Without treatment, the virus kills more than 350 000 people every year. However, treatment with the two drugs can reverse liver injury and prevent these serious consequences.

The 2013 edition of the WHO list (it is updated and issued every two years), provides an internationally recognizable set of safe, cost-effective medicines to help countries choose how to treat their most critical health needs.

The importance of the Model Essential Medicines List

The Model Essential Medicines List serves as a cornerstone for countries to develop their own national Essential Medicines Lists. It can assist national decision-makers in reducing costs by helping them identify priority medicines to meet their country’s health needs. Conversely, removal from the list can send a clear signal that a product is no longer appropriate. In high-income settings, the list helps to provide insurance companies with a neutral, gold-standard list for reimbursement in countries that have their own National Reimbursement Medicines List.

Guidance is issued in 30 categories. The newly-issued report contains 29 of the categories analyzed, and an additional category will be made available in the third quarter of 2013, with the final report. Changes to the list over the years have reflected evolving public health challenges – adding in, for example, antiretroviral medicines for HIV and formulations to treat noncommunicable diseases.

How the Essential Medicines List Expert Committee works

The Essential Medicines List Expert Committee meets every two years to update the Model List, using a transparent process, including an open comment period. Any entity may propose an addition – including individuals, governments, pharmaceutical companies, or medical associations and they must provide evidence of the proposed drug’s safety, efficacy and cost-effectiveness. They also need to show that the medicine is both essential to meeting priority health-care needs and available in adequate amounts.

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Ahead of World Hepatitis Day, UN urges greater efforts to fight ‘silent epidemic’

07-24-2013hepatitis

Testing for hepatitis in Togo. Photo: IRIN/Isidore Akollor

24 July 2013 – Only one-third of the world’s countries have national strategies for viral hepatitis, the United Nations health agency today said urging Governments to scale up measures to tackle this ‘silent epidemic,’ in particular the five types that, over time, cause chronic and debilitating illnesses.

“The fact that many hepatitis B and C infections are silent, causing no symptoms until there is severe damage to the liver, points to the urgent need for universal access to immunization, screening, diagnosis and antiviral therapy,” UN World Health Organization (WHO) Assistant Director-General for Health Security and the Environment, Dr. Keiji Fukuda, said ahead of World Hepatitis Day.

Hepatitis is an inflammation of the liver, most commonly caused by a viral infection. There are five main hepatitis viruses, referred to as types A, B, C, D and E. These five types are of greatest concern, WHO said, because of the burden of illness and death they cause and the potential for outbreaks and epidemic spread. These severe infections lead to 1.4 million deaths every year.

Hepatitis A and E are food and water borne infections, while Hepatitis B, C, and D are spread by infected body fluids including blood, by sexual contact, mother-to-child transmission during birth, or by contaminated medical equipment.

The World Health Assembly – the decision-making body of WHO – designated 28 July as World Hepatitis Day. The Day serves to promote greater understanding of hepatitis as a global public health problem and to stimulate the strengthening of preventive and control measures against infection in countries throughout the world.

Thirty-seven per cent of countries surveyed have national strategies for viral hepatitis, and more work is needed in treating hepatitis, the UN agency announced releasing its first-ever country hepatitis survey. Covering 126 countries, the Global policy report on the prevention and control of viral hepatitis in WHO member States identifies successes as well as gaps at country level in the implementation of four priority areas: raising awareness, evidence-based data for action, prevention of transmission, and screening, care and treatment.

The findings show that while 82 per cent of the countries have established hepatitis surveillance programmes, only half of them include the monitoring of chronic hepatitis B and C, which are responsible for most severe illnesses and deaths.

“Many of the measures needed to prevent the spread of viral hepatitis disease can be put in place right now, and doing so will offset the heavy economic costs of treating and hospitalizing patients in future,” said Dr. Sylvie Briand, Director of Pandemic and Epidemic Diseases at WHO.

“The findings underline the important work that is being done by Governments to halt hepatitis through the implementation of WHO recommended policies and actions,” Dr. Briand added.

In addition, WHO has been working on developing networks and is exploring with international funding agencies avenues that could allow hepatitis to be included in their current programme of activities, the UN agency said in its statement.

In June 2013, WHO launched the Global Hepatitis Network, and one of its aims is to support countries with planning and implementation of viral hepatitis plans and programmes.

WHO is currently developing new hepatitis C screening, care and treatment guidelines, which will provide recommendations on seven key areas such as testing approaches; behavioural interventions (alcohol reduction); non-invasive assessment of liver fibrosis; and the selection of hepatitis C drug combinations.

”New, more effective medicines to prevent the progression of chronic hepatitis B and C are in the pipeline,” said Dr. Stefan Wiktor, team lead in WHO’s Global Hepatitis Programme. “However, these will be expensive and therapy will require monitoring with sophisticated laboratory tests. To cure and reduce the spread of these viruses, medicines must become more accessible.”

Source

Knowledge About Infection Is the Only Predictor of Treatment in Patients With Chronic Hepatitis C

Z. M. Younossi, M. Stepanova, M. Afendy, B. P. Lam, A. Mishra

J Viral Hepat. 2013;20(8):550-555.

Abstract and Introduction
Abstract

HCV is the leading cause of cirrhosis and liver cancer in the U.S. The Center for Disease Control (CDC) has recently recommended 'Birth Cohort Screening' of the U.S. Adult population to reduce the future burden of undiagnosed HCV infections in the U.S. Our aim was to assess independent predictors of receiving treatment in a cohort of HCV-infected patients. The Hepatitis C follow-up questionnaires of the National Health and Nutrition Examination Surveys (NHANES) conducted from 2001 to 2010 were used. The NHANES participants who tested positive for HCV RNA were followed by CDC 6 months after initial testing with questions related to their awareness of their infection and history or intention to receive treatment. A total of 500 NHANES participants tested positive for HCV RNA and were targeted for follow-up. Of these, only 203 had completed the follow-up questionnaire (response rate of 40.6%). Of these, only 101 (50%) knew about their HCV positivity before NHANES, and from them, only 34 (17%) had received treatment. In multivariate analysis, prior knowledge about their HCV infection in HCV-positive individuals was independently associated with receiving routine care from a doctor or HMO, with higher income, female gender, being in poor or fair health and not consuming excessive amounts of alcohol. On the other hand, the knowledge about HCV infection was the only independent predictor of receiving anti-HCV treatment (odds ratio 6.14). Knowledge about having HCV infection is the only independent predictor of receiving treatment. Therefore, birth cohort screening of the U.S. General population could lead to wider identification of HCV and potentially better management of the future burden of HCV and its complications.

Introduction

Chronic hepatitis C is a major cause of chronic liver disease, cirrhosis and hepatocellular carcinoma with tremendous economic burden.[1–6] Over the past two decades, anti-HCV treatment regimens with better efficacy and shorter duration of treatment have been developed.[7–15] Despite the increasingly better treatment regimens, it is estimated that the 2.4 million Americans with HCV remain unaware of their HCV status and are undiagnosed [16]. This issue has led to the recent recommendations to screen the Baby Boomers born between 1945 and 1965.[17–19] Although this new screening strategy is expected to increase the identification of HCV-infected patients, a number of barriers to treatment remain.[20–27] The aim of this study was to assess the follow-up of patients diagnosed with HCV during NHANES screening and identify factors that potentially led to HCV treatment.

Methods

Study Population

In this study, five continuous cycles of National Health and Nutrition Examination Survey (NHANES) conducted between 2001 and 2010 were used. In these NHANES cycles, in addition to extensive demographic, clinical and laboratory data, a follow-up hepatitis C questionnaire was submitted to eligible participants. Hepatitis C was diagnosed with an HCV-enzyme-linked immunosorbent assay with positive tests confirmed with HCV-RNA testing.[28, 29]

As a part of NHANES, all HCV patients received a Report of Findings letter informing them of their HCV test result and encouraging them to seek medical follow-up. Six months after examination, a number of attempts to administer a Hepatitis C Follow-Up telephone questionnaire.[30]

The NHANES participants were also asked about the history and primary source of receiving healthcare and were requested to evaluate their general health status on the scale from excellent to poor (all included into the Hospital Utilization and Access to Care questionnaire). The type of health insurance coverage the participants reported having at the time of examination was collected from the Health Insurance questionnaire. The presence of depression was ascertained using the PHQ-9 questionnaire.[31]

Statistical Analysis

Pairwise comparisons were made using chi-square or, in case of a sample of five or less subjects, Fisher's exact test for binary parameters (such as presence vs. absence of a condition) and nonparametric Mann–Whitney test for continuous parameters (such as AST). To identify clinical and socio-demographic factors that could be independently associated with being aware of HCV infection and having received anti-HCV treatment, we selected the parameters that returned a statistically significant difference after pairwise comparison and included them into a logistic regression. The level of statistical significance was set at P-value of 0.05 or less. As recommended by NHANES, the described population was used only for a cross-sectional study, and all reported percentages are not population estimates but the percentages of the respondents in the study cohort. The analysis was run using SAS 9.1 (SAS Institute, Cary, NC, USA). The study was considered exempt by the Inova Institutional Review Board.

Results

From the NHANES cohort screened between 2001 and 2010, 500 were anti-HCV positive and, thus, were sent a respective letter. The Hepatitis C Follow-Up questionnaire was completed by 203 (response rate of 40.6%). The major reason for the absence of follow-up was unavailability of a participant for a contact (80–95%). However, the proportion of those who were successfully contacted and refused to participate in the follow-up increased from 3.2% in 2001–2002 to 24.0% in 2009–2010, and these findings were consistent with a previous report.[32]

Of those who completed the Hepatitis C Follow-Up questionnaire, 101 (49.8%) reported that they were aware of their infection before receiving the letter from NHANES. Compared with those who found out about their HCV status for the first time, these individuals had higher income and were more likely to be non-Mexican Hispanic, female, college-educated and married (). They were also less likely to report excessive alcohol consumption, more likely to be insured, by a private insurance provider in particular, more likely to see a doctor or HMO for healthcare and less likely to report good to excellent health ().

Table 1.  Comparison of individuals who were and were not aware of their HCV infection before being tested for NHANES

  Knew before NHANES Did not know before NHANES P
n 101 102 <0.0001
   Proportion, % 49.75 50.25  
   Received treatment, % 28 (27.7) 6 (5.9)  
Demographics
   Age, years 51.4 ± 10.2 48.75 ± 13.6 0.1744
   Male, % 57 (56.4) 74 (72.5) 0.0164
   White, % 47 (46.5) 48 (47.1) 0.9403
   Black, % 25 (24.8) 32 (31.4) 0.2940
   Mexican American, % 15 (14.9) 17 (16.7) 0.7227
   Other hispanic, % 10 (9.9) 2 (2.0) 0.0164
   Were in military service, % 23 (23.0) 21 (21.0) 0.7328
   Have college degree, % 10 (10.0) 2 (2.0) 0.0189
   Married, % 47 (46.5) 31 (31.0) 0.0238
   Income-to-poverty ratio 2.17 ± 1.52 1.73 ± 1.39 0.0360
Social history
   Excessive alcohol consumption, % 5 (7.9) 26 (36.6) <0.0001
   Smoking, % 49 (76.6) 55 (78.6) 0.7805
   Injected drug history, % 44 (51.2) 36 (45.0) 0.4272
Health insurance
   Insured, % 86 (86.9) 61 (60.4) <0.0001
   Private insurance, % 49 (49.5) 29 (29.0) 0.0031
   Medicare/Medicaid, % 34 (34.3) 26 (26.0) 0.1997
   Government-sponsored insurance, % 14 (14.1) 12 (12.0) 0.6540
Healthcare access
   Source of healthcare: clinic or health centre, % 19 (18.8) 23 (22.5) 0.5110
   Doctor's office or HMO, % 66 (65.3) 39 (38.2) 0.0001
   Hospital ER, % 4 (4.0) 6 (5.9) 0.5270
   Hospital outpatient department, % 7 (6.9) 7 (6.9) 0.9848
   Was in hospital overnight (last year), % 20 (19.8) 13 (12.7) 0.1730
   Saw a mental health specialist (last year), % 20 (19.8) 11 (10.8) 0.0741
General health
   Self-reported health: fair or poor, % 49 (48.5) 28 (27.5)  
   Good to excellent, % 52 (51.5) 74 (72.5) 0.0020
   ALT, SI 48.7 ± 37.0 55.9 ± 45.4 0.2396
   AST, SI 47.3 ± 34.5 54.7 ± 46.3 0.3289

In multivariate analysis, male gender (OR: 0.302 [0.126–0.725]), excessive alcohol consumption (OR: 0.207 [0.068–0.636]) and being in good to excellent health (OR: 0.368 [0.149–0.912]) were all independently associated with the lack of knowledge about being infected with HCV. On the other hand, seeing a doctor or HMO rather than a clinic or a hospital ER or outpatient department (OR: 2.481 [1.087–5.662]) and having higher income-to-poverty ratio (OR: 1.447 [1.077–1.944]) were associated with being aware of the HCV-positive status.

Of the study cohort, 34 individuals (16.7%) reported receiving treatment, whilst 44 (21.7%) reported not having seen a doctor and 107 (52.7%) were not recommended by a healthcare provider to do anything about the infection. The reasons for not receiving treatment are listed in . Those who were recommended and chose to get treated were more likely to be college-educated and more likely to report suboptimal (fair or poor) health ().

Table 2.  Comparison of those who did and did not receive treatment for HCV infection

  Treated Not treated P
n 34 169  
   Proportion, % 16.75 83.25  
Demographics
   Age, years 52.2 ± 9.2 49.6 ± 12.5 0.2226
   Male, % 20 (58.8) 111 (65.7) 0.4457
   White, % 18 (52.9) 77 (45.6) 0.4314
   Black, % 8 (23.5) 49 (29.0) 0.5176
   Mexican American, % 5 (14.7) 27 (16.0%) 0.8528
   Other hispanic, % 2 (5.9) 10 (5.9) 0.9937
   Were in military service, % 10 (29.4) 34 (20.5) 0.2521
   Have college degree, % 5 (14.7) 7 (4.3) 0.0202
   Married, % 17 (50.0) 61 (36.5) 0.1417
   Income-to-poverty ratio 2.25 ± 1.57 1.89 ± 1.45 0.1400
Social history
   Excessive alcohol consumption, % 2 (10.5) 29 (25.2) 0.1594
   Smoking, % 16 (76.2) 88 (77.9) 0.8648
   Injected drug history, % 16 (51.6) 64 (47.4) 0.6725
Health insurance
   Insured, % 29 (85.3) 118 (71.1) 0.0871
   Private insurance, % 17 (50.0) 61 (37.0) 0.1564
   Medicare/Medicaid, % 8 (23.5) 52 (31.5) 0.3555
   Government-sponsored insurance, % 6 (17.6) 20 (12.1) 0.3839
General health
   Self-reported health: fair or poor, % 16 (47.1) 110 (65.1)  
   Good to excellent, % 18 (52.9) 59 (34.9) 0.0480
   ALT, SI 61.5 ± 50.6 50.4 ± 39.3 0.6281
   AST, SI 59.0 ± 47.0 49.4 ± 39.5 0.4243
Chronic conditions
   Arthritis, % 15 (44.1) 62 (37.8) 0.4919
   Asthma, % 6 (17.6) 25 (14.8) 0.6729
   Cancer, % 4 (11.8) 15 (9.1%) 0.6370
   Chronic hepatitis B, % 0 (0.0) 0 (0.0) NA
   COPD, % 5 (15.2) 21 (13.5) 0.7979
   Congestive heart failure, % 0 (0.0) 16 (9.8) 0.0574
   Depression, % 1 (4.0) 4 (5.8) 0.7315
   Severe depression, % 1 (4.0) 1 (1.4) 0.4489
   Diabetes, % 6 (17.6) 20 (11.8) 0.3547
   HIV, % 0 (0.0) 3 (1.9) 0.4239
   Ischaemic heart disease, % 1 (2.9%) 19 (11.6) 0.1279
   Kidney failure, % 1 (2.9) 15 (9.1) 0.2269
   Obesity, % 12 (35.3) 33 (20.8) 0.0687
   Stroke, % 1 (2.9) 9 (5.5) 0.5371
HCV infection management
   Aware of HCV infection before NHANES, % 28 (82.4) 73 (43.2) <0.0001
   Had liver biopsy, % 28 (82.4) 16 (9.5) <0.0001
Reason for not receiving treatment
   Did not go to doctor, % NA 44 (26.0) NA
   Doctor did not recommend treatment, % NA 105 (62.1) NA
   Fear of side effects, % NA 10 (5.9) NA
   Treatment must be self-injected,% NA 5 (3.0) NA
   Treatment cost, % NA 13 (7.7) NA
   Expect better treatment, % NA 4 (2.4) NA
   Other reason, % NA 17 (10.1) NA

NA, not applicable.

The percentages do not add up to 100% because a participant might have chosen more than one reason.

Finally, there was a significant association between awareness of being infected with HCV and history of treatment: 82.4% of those who received anti-HCV treatment were aware of their infection before being tested for NHANES. In contrast to those who did not receive any treatment, regardless of a reason, only 43.2% knew they were infected. On the other hand, of those who were aware of their infection before receiving a letter from NHANES, 27.7% reported having been treated, whilst of those who did not know about their HCV before NHANES, only 5.9% reported any anti-HCV treatment (P < 0.0001).

In multivariate analysis, prior knowledge about being infected with HCV was the only variable which was independently associated with having received treatment: OR (95% CI) = 6.137 (2.415–15.598), P = 0.0001.

Discussion

This study assesses the follow-up of patients who were identified as having hepatitis C during NHANES screening surveys. Our data suggest that a number of clinical and demographic factors are associated with lack of treatment for hepatitis C. However, after controlling for confounders by multivariate analysis, only previous knowledge of HCV was independently associated with treatment. This data highlight the importance of screening for HCV that could lead to increased knowledge about HCV and potentially result in higher likelihood of receiving appropriate treatment.

Our data also suggest that being male, feeling in excellent health and excessive alcohol consumption are independently associated with lack of knowledge about HCV infection. Again, this is an important finding that highlights the importance of screening in individuals with CH-C who are especially at risk of progressive liver disease and mortality, that is, individuals with HCV infection who excessively drink alcohol. Our data also indicate that access to care and higher income are independent factors associated with awareness of HCV infection and therefore receiving appropriate care. This conundrum highlights the dilemma of HCV infection. The population with the highest prevalence of HCV and the greatest need for appropriate treatment also belong to the lower socioeconomic group with more limited access to care and less likely to become aware of their HCV status. This dilemma should be addressed by health policy makers to widely implement the 'birth cohort' screening strategies for HCV. Additionally, access to appropriate care, including advice against alcohol consumption and anti-viral treatment, must be provided. Without a comprehensive policy to deal with the burden of CH-C, the toll on health, health-related quality of life and the socioeconomic burden of HCV will continue to rise.

The limitation of our study is the lack of direct patient data in the follow-up. Additionally, the relatively small sample size and a short follow-up may have resulted in our inability to show some important association. Nevertheless, the design of the study includes the use of an established database, although, given the low response rate, we could not make population-wide conclusions.

In summary, our data suggest that HCV knowledge of infection is the most important predictor of receiving treatment. This data provide additional support for the recently recommended screening of U.S. Population based on birth cohort.

References

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Abbreviations
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J Viral Hepat. 2013;20(8):550-555. © 2013  Blackwell Publishing

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U.S. Congress Moves Closer to Lifting Ban on Transplanting Organs From HIV-Positive Donors

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Wikimedia

Surgical policy. Congress is advancing legislation that would make organs from HIV-positive donors available to surgeons.

2013-07-19 12:00

Senah Yeboah-Sampong

A U.S. House of Representatives committee this week unanimously approved a bill approving transplants using organs taken from people infected with HIV. The HIV Organ Policy Equity Act would lift a nearly 3-decade-old federal ban on such transplants and allow expanded research into the outcomes of transplant patients. Similar legislation has already passed the Senate, and the bill's advocates say that the policy shift could save hundreds of lives each year if it ultimately makes it into law.

"The shortage of organ donations in our country is a critical matter," said Representative Lois Capps (D-CA), who introduced the bill, in a statement. "We need to begin to research the feasibility and safety of these transplants in hopes that more people can receive transplants, and more lives can be saved."

Congress banned transplant of HIV-infected organs in 1988, when AIDS was rapidly spreading and little was known about how to prevent and treat it. A concerted effort to lift the ban began about 2 years ago, after a 2011 study published in the American Journal of Transplantation (AJT) concluded that the ban was outdated and that these organs could help fill a gap between supply and demand.

Today, there are more than 118,000 people in the United States on the waiting list of the Organ Transplant and Procurement Network, a nonprofit established to coordinate the transplant system. Perhaps 1000 people on the list are HIV-positive, researchers estimate. Antiretroviral drugs can extend the lives of these patients, physicians say, but many are vulnerable to kidney failure, and adding more HIV-positive organ donors to the pool would give them a better chance of survival.

"We should really offer them transplants as a cure for kidney failure," says Mohamed Atta, an associate professor of medicine at Johns Hopkins University in Baltimore, Maryland. In the past, he says such "positive-to-positive" transplants were "not even an option for those patients and that was discrimination."

The pool of potential HIV-positive organ donors is about 500 per year, according to the 2011 study by researchers at Johns Hopkins that was published in AJT. These donors could provide an additional 1000 organs, says transplant surgeon Dorry Segev of Johns Hopkins, who worked on the study. "If we were able to successfully use all those organs, we would at least be able to transplant everybody with HIV that is currently on the waiting list," says Segev, who has urged Congress to fix what he calls "a mistake in the law."

Segev and his allies have found supporters in Congress. A Senate bill lifting the transplant ban (S.330), sponsored by Senator Barbara Boxer (D-CA), won unanimous approval in June. Now, the House bill (H.R. 698) has passed its first major hurdle, winning unanimous approval from the Energy and Commerce Committee on 17 July.

"Our current organ transplant polices are outdated and do not reflect the most current research and clinical outcomes," said Representative Michael Burgess (R-TX), a co-sponsor, in a statement. Initially, Burgess said that he was "concerned" about the idea of lifting the ban, "but it does seem to be sound, science-based policy." He noted that surgeons are already able to do positive-to-positive transplants with donors and recipients infected with the hepatitis C virus, which is spread by means similar to those of HIV.

Lifting the HIV transplant ban would also be "good fiscal policy" because it could reduce treatment costs, Burgess said. For patients with HIV and kidney failure who get government-subsidized dialysis, for instance, a successful kidney transplant could save the government $500,000 per patient, says Kim Miller, policy officer for the HIV Medicine Association in Arlington, Virginia, one group backing the bill.

Several studies have suggested that positive-to-positive transplants work. A team of doctors in South Africa transplanted HIV-positive kidneys into four HIV-positive recipients in 2010; a year later the patients were still doing well. Another 2010 study published in The New England Journal of Medicine followed 150 HIV-positive kidney transplant recipients for 3 years, finding that most were successful. One big challenge, the study found, was determining how to balance antiretroviral drugs that the patients took to combat HIV with the immunosuppressive drugs meant to thwart organ rejection.

To address such problems, both the House and Senate bills would task the organ network with monitoring research on positive-to-positive transplants. The U.S. Department of Health and Human Services, which oversees the network, would use the findings to develop new healthcare standards for the transplants 2 years after the bill became law. Researchers say that lifting the ban could also ease studies that could help improve pre- and post-transplant treatments, donor selection criteria, and preventing HIV-infected organs from being transplanted into patients without the disease.

One difference between the House and Senate bills is that the Senate version makes it clear that surgeons who transplant HIV-infected organs would not be subject to criminal charges, as they are under the current law, if research shows that the transplants pose no health risks. That and other differences between the bills could be cleared up if the full House passes its version, allowing the two bodies to negotiate a final bill. The legislation's backers are optimistic that it will win final approval in the House later this year. The Obama administration has yet to take a formal position on the proposal.

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WHO urges governments to act on hepatitis threat

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World Hepatitis Day 2013

News release

24 July 2013 | GENEVA - On World Hepatitis Day (28 July), WHO is urging governments to act against the five hepatitis viruses that can cause severe liver infections and lead to 1.4 million deaths every year. Some of these hepatitis viruses, most notably types B and C, can also lead to chronic and debilitating illnesses such as liver cancer and cirrhosis, and in addition to, loss of income and high medical expenses for hundreds of millions of people worldwide.

Viral hepatitis is referred to as a ‘silent epidemic’ because most persons do not realize that they are infected and, over decades, slowly progress to liver disease. Many countries are only now realizing the magnitude of the disease burden and devising ways to address it.

“The fact that many hepatitis B and C infections are silent, causing no symptoms until there is severe damage to the liver, points to the urgent need for universal access to immunization, screening, diagnosis and antiviral therapy,” says Dr Keiji Fukuda, WHO Assistant Director-General for Health Security and the Environment.

"Many of the measures needed to prevent the spread of viral hepatitis disease can be put in place right now, and doing so will offset the heavy economic costs of treating and hospitalizing patients in future."

Dr Sylvie Briand, Director, WHO Pandemic and Epidemic Diseases

This year, in the run up to World Hepatitis Day, the Organization is releasing its first-ever country hepatitis survey, covering 126 countries. The WHO "Global policy report on the prevention and control of viral hepatitis in WHO Member States" identifies successes as well as gaps at country level in the implementation of four priority areas. The priority areas are raising awareness, evidence-based data for action, prevention of transmission, and screening, care and treatment.

The findings show that 37% of the countries have national strategies for viral hepatitis, and more work is needed in treating hepatitis. It also highlights that while most of the countries (82%) have established hepatitis surveillance programmes, only half of them include the monitoring of chronic hepatitis B and C, which are responsible for most severe illnesses and deaths.

“Many of the measures needed to prevent the spread of viral hepatitis disease can be put in place right now, and doing so will offset the heavy economic costs of treating and hospitalizing patients in future,” says Dr Sylvie Briand, Director, Pandemic and Epidemic Diseases at WHO. “The findings underline the important work that is being done by governments to halt hepatitis through the implementation of WHO recommended policies and actions.”

The challenges posed by hepatitis were formally acknowledged by the World Health Assembly in 2010 when it adopted its first resolution on viral hepatitis, and called for a comprehensive approach to prevention and control. This has promoted a new era of awareness with more governments proactively working to address the disease. Reinforcing that call for action, WHO has been collaborating closely with countries and partners to build a strong global response. As a result, the new report notes, 38% of countries observe World Hepatitis Day (an annual event that began in 2010) with even more countries expected to mark the day this year.

In addition to collaborating closely with countries, WHO has been working on developing networks and mechanisms that can deliver results. The Organization is exploring with international funding agencies avenues that could allow hepatitis to be included in their current programme of activities. In June 2013, WHO launched the Global Hepatitis Network. One of its aims is to support countries with planning and implementation of viral hepatitis plans and programmes.

WHO is currently developing new hepatitis C screening, care and treatment guidelines, which will provide recommendations on seven key areas such as testing approaches; behavioural interventions (alcohol reduction); non-invasive assessment of liver fibrosis; and the selection of hepatitis C drug combinations.

”New, more effective medicines to prevent the progression of chronic hepatitis B and C are in the pipeline. However, these will be expensive and therapy will require monitoring with sophisticated laboratory tests. To cure and reduce the spread of these viruses, medicines must become more accessible,” says Dr Stefan Wiktor, Team lead of WHO’s Global Hepatitis Programme.

Additional background information

The complexity of hepatitis disease lies in the existence of different types of viruses. Hepatitis A and E are foodborne and waterborne infections which cause millions of cases of acute illness every year, sometimes with several months needed for a person to fully recover.

Hepatitis B, C, and D are spread by infected body fluids including blood, by sexual contact, mother-to-child transmission during birth, or by contaminated medical equipment. Hepatitis B and C have a greater health burden in terms of death because they can cause life-long infection (called chronic infection), which can lead to liver cirrhosis and cancer. In fact, chronic hepatitis is the leading cause of liver cirrhosis and cancer.

WHO-approved vaccines are available to prevent hepatitis A and B, while screening of blood donors, assuring clean needle and syringes, and condom use can prevent bloodborne and sexual transmission.

  • Hepatitis B can be prevented by reaching every child with immunization programmes that include hepatitis B vaccine. There is no vaccine for hepatitis C. In addition, infections can be prevented by protecting against mother-to-child transmission of the virus and ensuring the safety of blood, transfusion services, organ donation and injection practice (treatment can include antiviral medications if needed).
  • Hepatitis A and E can be prevented by avoiding contaminated food and water; in addition, there is an effective WHO approved vaccine for hepatitis A.
  • Hepatitis medicines are now included in the WHO Essential Medicines List, which Member States are encouraged to adopt. Essential medicines are selected based on disease prevalence, safety, efficacy, and comparative cost-effectiveness. The WHO Model List can be used by countries as a guide for the development of their own national list.
For more information please contact:

Mr Glenn Thomas
Communications Officer
WHO, Geneva
Telephone: +41 22 791 3983
Mobile: +41 79 509 0677
E-mail: thomasg@who.int

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Viral hepatitis requires more attention in the WHO European Region

24-07-2013
 

There is a silent epidemic of viral hepatitis types B and C in the WHO European Region, where 13.3 million people are estimated to live with chronic hepatitis B and 15 million people with hepatitis C. Worldwide, hepatitis B and C lead to chronic disease in about 500 million people. Together, they are the most common causes of liver cirrhosis and cancer.

Although a blood test shows when someone has viral hepatitis, most people infected with hepatitis B and C do not know it. Only 1 infected person in 5 is estimated to display acute symptoms. Even among such people, testing often does not occur, since acute symptoms are often mild or confused with influenza-like illness. If left untreated, hepatitis B and C may become chronic, and can lead to disease, cirrhosis and cancer of the liver.

There are five strains of viral hepatitis (types A– E), but types B and C account for the largest burden of disease in the WHO European Region, and thus are the main focus of effort.

While hepatitis A and E typically result from ingestion of contaminated food or water, contact with contaminated blood or body fluids typically causes types B, C and D. Hepatitis B is transmitted mainly by sexual contact, from mother to child and through contaminated blood. Hepatitis C is spread primarily by blood-to-blood contact, and less commonly by sexual contact.

Viral hepatitis: a growing problem

Current worldwide estimates indicate that viral hepatitis causes close to 1 million deaths every year: on par with those caused by HIV/AIDS and exceeding the number caused by tuberculosis and malaria.

Each year, hepatitis B causes an estimated 36 000 deaths and hepatitis C, 86 000 deaths in the WHO European Region. In addition, the prevalence of both hepatitis B and C is considerably higher in some groups, particularly people who inject drugs and men who have sex with men. Two thirds of the people with hepatitis B and C in the Region live in eastern Europe and central Asia.

Owing to the high burden of disease, viral hepatitis deserves more attention in Europe. Zsuzsanna Jakab, WHO Regional Director for Europe, said, “Hepatitis B and C each affects up to 2% of the population in the WHO European Region, and together they kill over 120 000 people every year. We need to take urgent action, in close collaboration with our partners, to address this neglected and silent epidemic.”

Addressing the silent epidemic

A safe and effective vaccine against hepatitis B virus infection has been available for over 20 years. Most countries in the European Region have introduced routine immunization of newborn babies and children: a great achievement that will ultimately lead to generations free of hepatitis B. At present, no vaccine against hepatitis C is available, so current efforts focus on improving prevention, diagnosis and treatment.

Efforts to fight viral hepatitis should focus on raising awareness of the disease and preventing it from spreading further. This means promoting vaccination, and safe sex and safe injecting practices.

While new medications to treat chronic hepatitis B and C are becoming available, the burden of disease remains high. Access to medication and the cost of treatment remain important problems. Ensuring accessible testing facilities and accessible and affordable treatment services should remain a priority.

Burden of hepatitis B and C on health care systems

Since hepatitis B and C infections can lead to a state of chronic infection, they can cause several long-term health issues. They are estimated to cause 57% of cases of liver cirrhosis and 78% of cases of primary liver cancer.

Viral hepatitis not only affects the individual, but also places a heavy burden on the health care system because of the costs of treating liver failure and chronic liver disease. In many countries, viral hepatitis is the leading cause of liver transplants. In addition, chronic viral hepatitis results in productivity losses, and necessitates end-stage treatments that can cost hundreds of thousands of dollars.

WHO response to the epidemic

Recognizing the tremendous burden caused by viral hepatitis, the World Health Assembly adopted resolution WHA63.18 in 2010, calling for a comprehensive approach to prevention and control. WHO then established the Global Hepatitis Programme and increased its efforts to address the largely neglected epidemic. These included 2 publications launched in 2012: “Guidance on prevention of viral hepatitis B and C among people who inject drugs” and “Prevention and control of viral hepatitis infection: framework for global action”.

On World Hepatitis Day, 28 July 2013, WHO will launch the “Global hepatitis policy report”, which evaluates policies in more than 120 countries; 44 out of the 53 Member States of the WHO European Region participated in this initiative.

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UN health agency urges greater efforts to fight hepatitis

Provided  by Associated Press of Pakistan

UNITED NATIONS, July 24 (APP): Only one-third of the world’s countries have national strategies for viral hepatitis, the United Nations health agency said Wednesday, urging Governments to scale up measures to tackle this “silent epidemic,” in particular the five types that, over time, cause chronic and debilitating illnesses. “The fact that many hepatitis B and C  infections are  silent, causing no symptoms until there is severe damage to the liver, points to the urgent need for universal access to immunization, screening, diagnosis and antiviral therapy,” UN World Health Organization (WHO) Assistant Director-General for Health Security and the Environment, Dr Keiji Fukuda, said ahead of World Hepatitis Day. 

Hepatitis is an inflammation of the liver, most commonly caused  by a viral infection. There are five main hepatitis viruses, referred  to as types A, B, C, D and E.  These five types are of greatest  concern, WHO said, because of the burden of illness and death they  cause and the potential for outbreaks and epidemic spread. 

These severe infections lead to 1.4 million deaths every year. Hepatitis A and E are food and water borne infections, while Hepatitis B, C, and D are spread by infected body fluids including blood, by sexual contact, mother-to-child transmission during birth, or by contaminated medicalequipment.

The World Health Assembly - the decision-making body of WHO - designated 28 July as World Hepatitis Day. The Day serves to promote greater understanding of hepatitis as a global public health problem and to stimulate the strengthening of preventive and control measures against infection in countries throughout the world.

Thirty-seven per cent of countries surveyed have national strategies for viral hepatitis, and more work is needed in treating hepatitis, the UN agency announced releasing its first-ever country hepatitis survey. Covering 126 countries, the Globalpolicy report on the prevention and control of viral hepatitis in WHO member States identifies successes as well as gaps at country level in the implementation of four priority areas: raising awareness, evidence-based data  for action, prevention of transmission, and screening, care and treatment. 

The findings show that while 82 per cent of the countries have established hepatitis surveillance programmes, only half of them include the monitoring of chronic hepatitis B  and C,  which are responsible for most severe illnesses and deaths. “Many of the measures needed to prevent the spread of viral hepatitis disease can be put in place right now, and doing so will offset the heavy economic costs of treating and hospitalizing patients in future,” said Dr.  Sylvie Briand, Director of Pandemic and Epidemic Diseases at WHO. 

“The findings underline the important work that is being done by Governments to halt hepatitis through the implementation  of WHO recommended policies and actions,” Dr. Briand added. In addition, WHO has been working on developing networks and is exploring with international funding agencies avenues that could allow hepatitis to be included in their current programme of activities, the UN agency said in its statement. 

In June 2013, WHO launched the Global Hepatitis Network, and one of its aims is to support countries with planning and  implementation of viral hepatitis plans and programmes.  WHO is currently developing new hepatitis C screening, care and treatment guidelines, which will provide recommendations on seven key areas such as testing approaches; behavioural interventions; non-invasive assessment of liver fibrosis; and the selection of hepatitis C drug combinations.

“New, more effective medicines to prevent the progression of chronic hepatitis B and C are in the pipeline,” said Dr.  Stefan Wiktor, team lead in WHO’s Global Hepatitis Programme. “However, these will be expensive and therapy will require monitoring with sophisticated laboratory tests. To cure and reduce the spread of these viruses, medicines must become more accessible.”

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