Public release date: 24-Feb-2011 [ | E-mail | Share ] Contact: Dawn Petershealthnews@wiley.com781-388-8408Wiley-Blackwell

New research has determined that patients in the U.S. with hepatitis C virus (HCV) are twice as likely to not have health insurance coverage compared with those without the disease. In fact researchers found only a third of HCV infected Americans have access to antiviral therapy; the remaining are either uninsured or not candidates for therapy due to treatment contraindications. Details of this study are published in the March issue of Hepatology, a peer-reviewed journal of the American Association for the Study of Liver Diseases (AASLD).

HCV is the most common cause of chronic liver disease, hepatocellular (liver) cancer, and liver transplantation in the U.S., with up to 85% of HCV-positive individuals (3.5 million) developing chronic HCV infection. Symptoms of chronic HCV are non-specific which can inhibit diagnosis and as many as 75% of patients are unaware of their HCV infection (Hagan et al., 2006). Furthermore, the Centers for Disease Control and Prevention (CDC) estimates that HCV causes 12,000 deaths in the U.S. each year.

“Successful treatment with antiviral therapy improves health-related quality of life in patients with HCV and could potentially reduce morbidity and mortality in patients,” said Zobair Younossi, MD, MPH, from the Center of Liver Diseases at Inova Fairfax Hospital in Virginia and lead author of the study. “A significant number of HCV patients, however, may not even have access to antiviral therapy due to lack of adequate health insurance coverage.” It is estimated to cost up to $48,000 per year for monitoring and treatment of HCV.

For the current study, researchers analyzed health insurance status and treatment candidacy of HCV-positive individuals using 2005-2008 data collected from the National Health and Nutritional Examination Survey (NHANES). This information was collected via household interviews, physical examinations and extensive laboratory sample data from subjects who were 18 years of age or older and living in the U.S.

Analysis showed that 1.16% of study subjects were infected with HCV. Among those with HCV only 61% were insured compared to 81% of HCV-negative individuals. HCV infection was an independent predictor of being uninsured even after adjusting for demographic disparity in the HCV-positive group. Approximately 67% of HCV-positive patients were eligible for treatment, however only 54% of those treatment candidates had insurance coverage.

Some individuals with HCV may not be eligible for antiviral therapy due to contraindications to treatment. Previous studies have found that only half of HCV patients exhibit a positive response to peginterferon/ribavirin treatment. “The side effect profile of the current antiviral therapy requires careful selection of treatment candidates with a number of chronic conditions,” said Dr. Younossi. the authors noted that patients with comorbidities such as active cardiac disease, severe depression, or renal failure are typically ineligible for antiviral therapy due to severe adverse events that may occur with treatment.

Research showed that only 36% of HCV-positive patients who were eligible for antiviral therapy had health insurance. “Access to care for HCV patients is critical. Our results have important implications for HCV-infected patients and should be considered as new health care reform legislation takes effect,” Dr. Younossi concluded.

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Article: “Insurance Status and Treatment Candidacy of Hepatitis C Patients: Analysis of Population-based Data from the United States.” Maria Stepanova, Fasiha Kanwal, Hashem B. El-Serag, Zobair M. Younossi. Hepatology; Published Online: February 11, 2011 (DOI: 10.1002/hep.24131); Print Issue Date: March 2011. onlinelibrary.wiley.com/doi/10.1002/hep.24131/abstract.

This study is published in Hepatology. Media wishing to receive a PDF of the articles may contact .

About the Journal

Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3350 .

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What is Hepatitis a – Hepatitis B – Hepatitis C:

Hepatitis a – an inflammatory viral disease of the liver with a short incubation period. Hepatitis a might be transmitted by eating contaminated food, by fecal-oral contact, and/or by way of household contact. Hepatitis a may be mild to severe; symptoms involve fever, nausea, and jaundice.

Hepatitis B – formerly called serum hepatitis, it’s induced by the hepatitis B virus. About 12% of instances progress to chronic hepatitis. it is spread through shared needles, through sexual contact with infected individuals, by way of exposure to infected physique fluids, and from mother to child.

a particularly harmful type of viral hepatitis, it is induced by an RNA virus. Hepatitis C can lead to serious, permanent liver damage, and in several cases, death. More than 82 % of people who are infected will progress to chronic liver disease. it is suspected that there are, at present, a lot more than 4.5 million folks within the United States which might be infected with hepatitis C, and far more than 200 million around the world.

What causes Hepatitis a – Hepatitis B – Hepatitis C:

the virus that causes hepatitis a is referred to as the hepatitis a virus. Hepatitis a is spread by close private get in touch with with somebody else who has the infection.

Hepatitis B – is very easily spread by direct contact with the blood or physique fluids of an infected person. for example, hepatitis B may be transmitted from an infected mother to her baby at birth, by means of unprotected sex with an infected person, by sharing needles for injecting street drugs, and by occupational contact with blood in a health-care setting. Hepatitis B is just not spread through food or water or by casual contact. People can have hepatitis B and spread the disease with out figuring out it. sometimes, men and women who’re infected with hepatitis B virus in no way recover fully from the infection.

Hepatitis B is the inflammation, swelling and irritation of the liver due to the fact of the hepatitis B virus (HBV). Lots of persons who have persistent hepatitis B encompass small to no indicators and symptoms; as they could not even appear sick. as an effect, they may well not discern they are infected. on the other hand, they can nonetheless multiply the virus can spread to other people.

Hepatitis C – is among the viruses that causes hepatitis, or inflammation of the liver. it is spread predominantly by contact with infected blood and considerably less from other physique fluids.

Symptoms might not emerge for up to six months following the point of infection. Early signs and symptoms might consist of loss of appetite, fatigue, low-grade fever, joint and muscle aches, nausea and vomiting, yellow skin and dark urine mainly because of jaundice. People having chronic hepatitis could show no symptoms, despite the fact that continuing liver harm may take place. they may acquire some or all the signs and symptoms of acute hepatitis.

Hepatitis a – a whole lot of men and women with Hepatitis a show no signs and symptoms at all, or they go unnoticed mainly because the signs and symptoms are so mild. Older persons are far more probably to have signs and symptoms than children. People who do not have symptoms can still spread the Hepatitis a virus. Symptoms of hepatitis a generally develop between 2 and 7 weeks after infection. Essentially the most widespread symptoms to seem are the following: Nausea or vomiting, Diarrhea, Fever, Rash, Fatigue, Jaundice, Dark Urine.

Hepatitis B – Like Hepatitis a, some persons show no signs and symptoms when they are infected with hepatitis B, or the signs and symptoms might be incredibly mild and flu-like.

Hepatitis a – Hepatitis B – Hepatitis C – Treatment:

Hepatitis a – There’s no distinct remedy for Hepatitis a. Rest is suggested throughout the worse phase of the illness when the signs and symptoms are most severe. People with acute hepatitis really should prevent alcohol and any substances which are toxic towards the liver, which includes acetominophen. Fatty foods may possibly cause vomiting simply because secretions from the liver are needed to digest fats.

If you were inspired by this information then you may also like finding out about Types of Hepatitis and also Cdc Hepatitis.

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Posted on: Tuesday, 14 December 2010, 09:19 CST

WASHINGTON, Dec. 14, 2010 /PRNewswire-USNewswire/ — to improve the care for individuals infected with the hepatitis C virus, a major health problem and a leading cause of chronic liver disease around the world, nearly 200 international hepatitis experts have taken an important step in escalating the introduction of a new class of targeted therapies for HCV – direct-acting antivirals (DAAs).

December 6 at a major scientific meeting – Advancing HCV Drug Development: a Collaborative Approach - convened by the Forum for Collaborative HIV Research, researchers, hepatitis advocates, members of industry and representatives from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) created the roadmap for accelerating the development of DAAs, agreeing that this new class of drugs targeting specific hepatitis C virus proteins has the same potential to improve treatment outcomes for people with HCV as antiretroviral drugs changed the standard of care in HIV. currently, two DAA compounds have advanced into phase 3 development in the United State and EU, and many more are in phase 2 trials and likely to advance to phase 3 research in the near future.

“If there was ever a time when we can change the course of HCV, it is now,” said Veronica Miller, Ph.D., Director of the Forum. “We are now where we were with HIV more than a decade ago and can apply many of the lessons learned from HIV drug development to significantly accelerate the progress in bringing new and better HCV therapies to market.”

DAAs directly attack the ability of the hepatitis C virus to replicate and can increase the cure rate in certain HCV patients to between 60 and 70 percent- a major advance over the 40 percent success rate associated with the currently recommended treatment for chronic HCV infection, the combination of pegylated interferon and ribavirin. although the first DAAs still require concomitant use with current HCV medications, these new compounds will shorten the length of time on pegylated interferon and ribavirin therapy, which hepatitis specialists noted is often difficult to tolerate and has significant adverse event profiles that limit treatment in many patients. According to the latest data, between 15 and 30 percent of HCV patients started on current HCV therapy are unable to complete the year of treatment now required because they cannot tolerate the side effects.

Charting the future of HCV drug development, the meeting participants applied FDA’s new guidance on conducting clinical trials on DAAs, which was issued in September 2010 in draft form and expected to be finalized in 2011. According to Jeffrey S. Murray, M.D., M.P.H., Deputy Director of the Division of Antiviral Drug Products in FDA’s Center for Drug Evaluation and Research, the draft guidance follows the same approach FDA uses in developing HIV and oncology drugs. For early clinical testing, FDA recognizes that most if not all DAAs for HCV will be used in combination with other approved drug and therefore, recommends studies examining the relationship between the new DAA agent and both pegylated interferon and ribavirin as well as testing the combination antiviral activity. FDA’s draft guidance also calls for using the results from proof-in-concept trials (meaning a study in HCV infected patients that demonstrates initial activity as measured by reductions in the HCV viral load) to guide dose selection for subsequent Phase 2 trials in which DAAs are studied for longer durations as part of a combination regimen. FDA is further encouraging drug sponsors to design development plans for combinations of two or more DAAs.

“The good news for the HCV community is that more drugs are coming,” said Jur Strobos, MD, JD, FACEP, Deputy Director of the Forum. “The bad news is we don’t know how to combine them and that is what we need to study.”

With FDA’s guidance as the framework, the hepatitis experts also identified the major factors researchers must take into account when designing clinical trials for DAAs and other new HCV therapies. Among the major issues cited are the emergence of resistant virus and its potential management, and including in future DAA clinical trials those special populations with significant unmet needs in HCV therapy. These patients include individuals co-infected with HIV, liver transplant recipients, patients with decompensated cirrhosis, opioid users and those on opiate substitution therapy, and children. According to the Centers for Disease Control and Prevention (CDC), between 5 and 6 percent of infants born to HCV infected women contract the infection from their mothers and the majority of those infants will develop a chronic infection.

Focusing on the special needs of pediatric patients, leaders from both FDA and EMA agreed that the time to start investigating DAAs in children is when sufficient safety data exist in adults. as explained by specialists in pediatric liver disease, children with HCV often tolerate drug therapy better than adults, which is why the ideal age to start children in pediatric trials for DAAs is when they are 3 years old. According to hepatitis experts, the beneficial impact of a ‘cure’ for children, preferably before they start school, cannot be overestimated.

Reducing Disparities in HCV Clinical Trials

Because identifying potential differences among groups treated with a therapeutic regimen is an important goal of human studies, the HCV community singled out the under-representation of women, older people and different ethnic subgroups in clinical trials as the problem requiring immediate attention and change at a systemic level. although there is a higher prevalence of HCV in men than women, women metabolize HCV drugs differently and are more affected by autoimmune diseases, which share similar symptoms with HCV. Women also are twice as likely as men to suffer from depression, which is a common side effect of treatment with HCV medications.

Even more challenging for the HCV community is increasing the representation of older HCV-infected adults in HCV clinical trials, even though Baby Boomers constitute the majority of hepatitis C infections in the United States and are often less responsive than younger generations to antiviral treatment. Compounding the problem, older HCV patients are more difficult to treat, due to the increased prevalence of co-morbid conditions, such as diabetes, dyslipidemia, and other metabolic conditions that are correlated to chronic liver disease. Aging is also strongly associated with liver fibrosis progression, which means older HCV patients are likely to have advanced liver disease and a high risk for impending liver complications. But despite this reality, few studies have examined the age-specific factors of chronic HCV infection and the clinical management of the infection in this patient population.

More than an issue of fairness, HCV experts associate better designed clinical research studies with the increased ability of scientists to catalog and understand the influence of genetic and non-genetic factors on individual and group responses to new treatments. Findings from the large amount of genetic data generated to date show that more than 90 percent of the observed genetic variations occur within, rather than between groups. This underscores the fact that gender and ethnicity have biomedical consequences when evaluating patients with more resistant virus and with more severe disease.

Designing the Research Roadmap to Address a Growing Public Health Threat

Accelerating the development of DAAs to improve HCV treatment outcomes is especially warranted now that the hepatitis C virus has become the most common chronic blood borne infection in the U.S. According to new government estimates, approximately 4.1 million Americans are infected with HCV, of whom 60 to 70 percent will develop chronic liver disease. currently, almost half of all liver transplants in the U.S. are performed for end-stage hepatitis C. Moreover, because liver disease is one of the leading causes of death in the U.S., the CDC predicts that deaths from chronic liver disease attributed to hepatitis C will double or triple over the next 15 to 20 years.

To change these statistics, hepatitis specialists focused on ways to advance HCV drug development so DAAs and other new classes of drugs for HCV can reach the market quickly. Here, the experts reached agreement on a number of issues:

• Exposure to new single agents – because HCV remains sensitive to ribavirin and pegylated interferon, longer initial studies may be recommended to evaluate single drugs and novel combinations of drugs
• Composition of patients in early studies (phase 1 and 2a) – early studies should be large enough so results with one type of virus or one group of patients can be easily discerned. Focusing on specific genetic sub-populations will also ensure that early studies do not produce confusing results
• Drug resistance in HCV patients – unlike HIV, drug resistance in HCV may not be as large a concern because HCV does not integrate into host DNA as HIV does. Thus, resistant strains are not archived and there is the potential that resistant patients can be retreated with different combinations regimens, as and when they become available
• Baseline parameters – there is the need to develop predictive algorithms based on baseline characteristics such as gender, body weight, HCV genotypes and subtypes
• Exclusion of former and current drug users in clinical trials – exclusion is unnecessary and does not serve the field well. over 60 percent of patients with HCV are infected through drug use, indicating the need to have quality data to guide treatment decisions in this patient population

As a next step, the Forum for Collaborative HIV Research will publish the consensus of this scientific meeting to advance the research agenda. Once published, the report will be distributed widely to the Forum’s many constituencies – government, industry, patient advocates, healthcare providers, foundations, health insurers and academia – with the goal of advancing research on HCV and driving public policy.

About the Forum for Collaborative HIV Research

Now part of the University of California (UC), Berkeley School of Public Health and based in Washington, DC, the Forum was founded in 1997 as the outgrowth of a White House initiative which called for an ongoing collaboration among stakeholders to address emerging issues in HIV/AIDS and set the research strategy. Representing government, industry, patient advocates, healthcare providers, foundations and academia, the Forum is a public/private partnership that is guided by an Executive Committee that sets the research agenda. the Forum organizes roundtables and issues reports on a range of global HIV/AIDS issues, including treatment-related toxicities, immune-based therapies, health services research, co-infections, prevention, and the transference of research results into care. Forum recommendations have changed how clinical trials are conducted, accelerated the delivery of new classes of drugs, heightened awareness of TB/HIV co-infection, and helped to spur national momentum toward universal testing for HIV. hivforum.org

SOURCE Forum for Collaborative HIV Research

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