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Alan Franciscus

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HCV Advocate



Thursday, April 30, 2015

Indiana lawmakers OK needle exchange programs for communities with HIV, hepatitis C outbreaks

INDIANAPOLIS — Lawmakers looking to prevent a repeat of an HIV outbreak that has rocked a southern Indiana county sent Republican Gov. Mike Pence a measure Wednesday that would allow communities to implement needle-exchange programs if they can prove they're in the midst of an epidemic tied to intravenous drug use.

Pence, who opposes needle exchanges as part of anti-drug policy, said in a statement Wednesday that he looks forward to signing the legislation into law.

He said his office worked with lawmakers to develop "a legal framework" that would give state health officials the resources and flexibility they need to handle health emergencies.

Read more...

May 2015 Recognized as Hepatitis C Awareness Month: Chicago Lawmaker Continues to Bring the “Silent Epidemic” to the Forefront

Springfield, IL … Yesterday, the Illinois House of Representatives adopted House Resolution 214 which designates next month as "Hepatitis C Awareness Month. The initiative, which was led by State Representative Michael McAuliffe (R-Chicago), received unanimous support as it continues to shine light upon a disease which, up until recently, received very little attention.
"Hepatitis C has been affecting people for decades. However, due to a lack of awareness, there is large segment of the population that is considered at-risk of having unknowingly contracted the virus," explained McAuliffe. "Hepatitis C became known as the 'Silent Epidemic' due to a general lack of knowledge of the at-risk groups and treatment options, and in recent years, the medical community has identified veterans of the Vietnam-era and anyone born between the years of 1945 and 1965 to be at increased risk of carrying the virus."

McAuliffe has been a leader in tackling awareness, treatment and prevention issues for the Hepatitis C virus since 2013 when he pioneered the creation of the Hepatitis C Task Force in Springfield. The task force, which was the first of its kind in Illinois, was inspired by his own personal story of how he saw the effects of the disease on close family members. Since its creation, the bipartisan task force members have successfully recommended thoughtful legislation. The group was recently recognized by the House for their positive work by receiving an extension to continue their work until 2017.

Read more...

Study results promising for hepatitis C patients awaiting or completing liver transplant

Public Release: 

UT Health Science Center San Antonio doctor presents results of daclatasvir regimen

University of Texas Health Science Center at San Antonio

SAN ANTONIO (April 30 2015) -- A number of new, highly effective oral treatments for various types of hepatitis C have been approved in the past few years. However, two groups who have not benefitted from the new treatments are patients with hepatitis C who have advanced liver disease and patients who have received a liver transplant but the advanced liver disease has returned because of hepatitis C.

"The problem for these patients is that unless the hepatitis C is cured, the virus continues circulating in their blood infecting the new liver, usually within a few months of transplant. One-third of them have cirrhosis again within five years," explained Fred Poordad, M.D., clinical professor of medicine and chief of hepatology at The University of Texas Health Science Center at San Antonio.

"This puts these patients back at high risk of dying from chronic hepatitis C or liver disease," said Dr. Poordad, principal investigator of the ALLY-1 study, who presented the results April 25 at The International Liver CongressTM of the European Association for the Study of the Liver (EASL) in Vienna, Austria.

The Phase III clinical trial evaluated a 12-week course of daclatasvir - the new drug being evaluated - combined with sofosbuvir and ribavirin for patients with chronic hepatitis C. Patients accepted into the trial either had a liver transplant with returning hepatitis C or had hepatitis C with advanced cirrhosis (scarring of the liver).

Study results showed an overall cure rate of 94 percent for patients with a liver transplant and returning hepatitis C, and 83 percent for patients with advanced cirrhosis.

The study's primary endpoints also were reached, with 95 percent of post-transplant genotype 1 patients and 82 percent of genotype 1 patients with advanced cirrhosis being cured 12 weeks after treatment. Patients with other genotypes of the disease were enrolled as well, with benefits seen in all groups.

Genotypes are subgroups or strains of a disease, such as hepatitis C. There are many subtypes of hepatitis C based on the geographic regions where the strain is most prevalent. Over time, each strain evolved differently so that treatments are based on the genotype of the disease. For example, genotype 1 is the type of hepatitis C most common in the United States and is the most difficult to treat.

The study regimen was well tolerated and showed few serious side effects. "Transplant patients take a variety of medications to prevent organ rejection that can complicate the treatment of hepatitis C. In ALLY-1, we saw no drug-to-drug interactions between transplant and hepatitis C therapies and no need to make close adjustments to patients' transplant-related drugs while they received the hepatitis C regimen," Dr. Poordad said.

The ALLY-1 study was conducted at five major transplant centers in San Antonio and Houston, Texas; Miami, Fla.; Ann Arbor, Mich., and Seattle, Wash.

Hepatitis C is a liver disease found worldwide that is spread though contact with blood or semen, such as shared drug injection needles, inadequate sterilization of medical equipment, unscreened blood and blood products, accidental needle sticks in the health profession, and sexual intercourse with a person who has hepatitis C. The disease also can be passed from mothers to their children through the birthing process.

According to the U.S. Centers for Disease Control and Prevention, 3.2 million people in the U.S. have chronic hepatitis C, and 70 to 80 percent do not have symptoms. Nonetheless, it is a serious disease that can lead to long-term health problems such as liver damage, liver failure, liver cancer and death. It is often discovered later, after significant liver damage has occurred.

In the U.S., people born between 1945 and 1965 have the highest risk of hepatitis C due to higher drug use. People in this age group are urged to have a one-time blood test for hepatitis C to detect the virus and begin receiving treatment, if necessary, before significant liver damage occurs. There is no vaccine to prevent hepatitis C.

Daclatasvir, a drug developed by Bristol-Myers Squibb, was approved in Europe in 2014 for use with other medications for genotypes 1 through 4 for the treatment of chronic hepatitis C in adults. It is also approved in Japan as well as many countries in Central and South America, the Middle East and Asia Pacific. Daclatasvir regimens also have been included in the EASL's recommendations for the treatment of hepatitis C in Europe.

The U.S. Food and Drug Administration is reviewing daclatasvir for possible approval in the United States.
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For current news from the UT Health Science Center San Antonio, please visit our news release website, like us on Facebook or follow us on Twitter.

The University of Texas Health Science Center at San Antonio, one of the country's leading health sciences universities, ranks in the top 13 percent of academic institutions receiving National Institutes of Health (NIH) funding. The university's schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced more than 29,000 graduates. The $787.7 million operating budget supports eight campuses in San Antonio, Laredo, Harlingen and Edinburg. For more information on the many ways "We make lives better®," visit http://www.uthscsa.edu.

The Texas Liver Institute's mission is to set the standard of excellence in care and innovative research in the field of liver disease. The institute is affiliated with The University of Texas Health Science Center at San Antonio. The physicians are professors and teach at University Hospital of the University Health System and are involved with the liver transplantation program of the University Transplant Center, a partnership of the Health Science Center and the University Health System. For more information, visit http://www.txliver.com.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Source: http://www.eurekalert.org/pub_releases/2015-04/uoth-srp043015.php

Hepatitis C: Drug Prices, Lack of Testing are Challenges

The tougher challenge, discussed at a closing day session led by the World Health Organization is finding a way to step up testing.  “Treating patients is not difficult; finding them is,” Peck said, "You can't treat what you haven't found."

Despite the wealth of choices physicians have in finding drugs to treat hepatitis C infection, two challenges remain in eradicating the disease—drug price and lack of global screening for the virus.
“Price is solvable,” said Markus Peck, MD, the outgoing secretary of the European Society for the Study of the Liver (EASL) interviewed at the International Liver Congress in Vienna, Austria.
“Pharma has to make some money on these drugs,” Peck said, since their cost of developing them has been high, “but as there is more competition we are quite sure the price will go down.”

There are currently 7 different classifications of drugs that fight hepatitis C. Those are nucleoside and nucleotide NS5B polymerase inhibitors, nucleoside analogs, protease inhibitors, nucleoside analogs, pegylated interferon, NS5A inhibitors, non-nucleoside NS5B inhibitors, and combination drugs that draw on two or more of those classes.

Not counting interferon, there are also 7 drugs or drug combos approved by the US Food and Drug Administration and another 14 in phase 3 drug trials.

 - See more at: http://www.hcplive.com/conference-coverage/easl-2015/Hepatitis-C-Price-Lack-of-Testing-are-Challenges#sthash.ggeNy7xf.dpuf

Tuesday, April 28, 2015

Patients infected with Hepatitis C after visiting Santa Barbara doctor

At least five patients tested positive for Hepatitis C after receiving injections at a Santa Barbara doctor’s medical office, public health officials said.

Now, the Santa Barbara County Public Health Department is urging any patients who visited the medical office of Allen Thomashefsky to get tested for Hepatitis B, Hepatitis C and HIV.

Public health officials performed two inspections at Thomashefsky’s office in November 2014 after they received information that a patient with no known risk factors developed Hepatitis C following a  visit. The patient underwent multiple injections at his office.

Read more...

Living Liver Donors Report Lower Sexual Function in Early Months Post-Surgery

Donor Education Pre-Transplant May Help Improve Recovery, Reduce Concerns

A new study found that sexual function in adult living donors was lower at the evaluation phase and at three months following liver transplantation. Results published in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society, suggest that donor education prior to surgery may improve recovery and ease concerns about sexual function following the transplant.

Living liver donors provide a healthy portion of their liver to an individual with end-stage liver disease. These donors make a personal sacrifice to help save another individual from certain death. Much of the medical literature focuses on the health-related quality of life of donors, but limited evidence is available regarding sexual function. A prior single-center study found that nearly 50% of donors reported a worsening of sexual function one week to one month following donation, returning to normal at three months post-operation.

“To further knowledge in this important area, our study sought to identify the extent of sexual concerns for liver donors,” said lead author Dr. Andrea DiMartini with Western Psychiatric Institute and Clinic in Pittsburgh, Pa. “Our investigation examined sexual functioning of liver donors before and after donation using data from a multi-site investigation, known as the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL).

For this study the team examined the sexual function of 208 liver donors and any changes that may occur during the first year following donation using self-reported surveys. A group of 155 non-donors also completed the survey that included questions regarding sexual desire, satisfaction, orgasm, and erectile function in men.

Analyses show that donor sexual performance was lower at the time of evaluation and three months after transplant surgery than at one year following donation. Researchers found that during the early recovery phase, abdominal pain was linked to difficulty reaching orgasm; concerns over appearance was associated with lower sexual desire; and not feeling back to normal correlated to a dissatisfaction with sexual life.

Dr. DiMartini concludes, “The goal of all donor teams is to create a positive experience, both mentally and physically, and reduce stress for organ donors. Our findings suggest that providing more information to donors about what to expect with sexual function will help ease concerns and prepare themselves for the early days following liver transplant surgery.”

This study was funded in part by the National Institute of Diabetes & Digestive & Kidney Diseases (grants U01-DK62444, U01-DK62467, U01-DK62483, U01-DK62484, U01-DK62494, U01-DK62496, U01-DK62498, U01-DK62505, U01-DK62531, U01-DK085587, U01-DK85515, and U01-DK62536), the Health Resources and Services Administration (HRSA), and the American Society of Transplant Surgeons (ASTS).


Access the full study on the Wiley Press Room here. (To access PDFs and embargoed stories you must be logged in to the Press Room before clicking the link. Request a login here.)
Full citation: “Patterns and Predictors of Sexual Function after Liver Donation: the Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL).” AF DiMartini, MA Dew, Z Butt, MA Simpson, DP Ladner, AR Smith, P Hill-Callahan and BW Gillespie. Liver Transplantation; (DOI: 10.1002/lt.24108).

URL: http://doi.wiley.com/10.1022/lt.24108

Author Contact: Media wishing to speak with Dr. DiMartini may contact Jenya Abramovich with Arbor Research at jenya.abramovich@arborresearch.org.

About the Journal
Liver Transplantation is published by Wiley on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AASLD and the ILTS, Liver Transplantation delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit http://wileyonlinelibrary.com/journal/lt.


About Wiley
Wiley is a global provider of knowledge and knowledge-enabled services that improve outcomes in areas of research, professional practice and education. Through the Research segment, the Company provides digital and print scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising. The Professional Development segment provides digital and print books, online assessment and training services, and test prep and certification. In Education, Wiley provides education solutions including online program management services for higher education institutions and course management tools for instructors and students, as well as print and digital content.

Monday, April 27, 2015

EASL 2015: Alcohol use disorders – stronger predictor of mortality than chronic hepatitis C virus infection

Chronic hepatitis C infection is associated with increased risk of mortality when severe comorbidities and/or alcohol use disorders are also present

April 25, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015, show that alcohol use disorders (AUD) have a serious, negative prognostic outcome with higher mortality risks in the general population and patients with hepatitis C virus (HCV) infection in particular.

The study found that chronic HCV infection has a limited impact on mortality, unless the patient also has other severe comorbidities, such as HIV infection, cancer or chronic kidney disease. In contrast, those with AUDs are at significant risk of death with a higher mortality risk observed across all the study subgroups.

Michaël Schwarzinger, Director, THEN (Translational Health Economics Network) and Vincent Mallet, Professor of Hepatology, Université Paris Descartes and Assistance Publique – Hôpitaux de Paris, France, commented: "There is an epidemiological relationship between chronic HCV infection and AUD. However, the burden of chronic HCV infection analyses barely take into account the potential confounding role of AUD on prognosis. Our primary aim was to study the confounding role of severe comorbidities and AUD on prognosis in Hep C patients in a real-life setting."

Between 2008 and 2012, 28,953,755 adults residing in Metropolitan France were hospitalised and 1,506,453 died at hospital. All hospitalised patients were characterised by severe comorbidities and their trajectory was tracked according to chronic HCV infection and/or AUD. Chronic HCV infection was present in 112,146 (0.39%) of hospitalised patients, AUD in 705,259 (2.44%), and both chronic HCV infection and AUD in 23,351 (i.e., 20.8% AUD recorded in Hep C patients).

The researchers found that:
  • Chronic HCV infection was mostly associated with higher mortality risks in the presence of severe comorbidities (e.g., HIV/AIDS, liver transplant receipt)
  • In the absence of severe comorbidities, the prognostic value of chronic HCV infection was mostly explained by the presence of AUD (end-stage liver disease and mortality)
  • More broadly, AUD was associated with higher mortality risks in all hospitalized patients, and alcohol withdrawal or abstinence was significantly associated with lower mortality risks
"These results show that alcohol use disorders are a much more accurate indicator of mortality in chronic HCV infection, and highlight the need to encourage alcohol withdrawal and abstinence in all patients," said Professor Tom Hemming Karlsen, Scientific Committee Member, European Association for the Study of the Liver.
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About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.

About EASL
Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Contact
For more information, please contact the ILC Press Office at:
ilc.press@easloffice.eu or
+44 (0)20 3580 5444

General session 3, Hall D Presentation time: 09:45-10:00 Presenter: Michaël Schwarzinger (France)

Abstract G16:THE COUNFOUNDING ROLE OF SEVERE COMORBIDITIES AND ALCOHOL USE DISORDERS ON PROGNOSIS IN CHRONIC HEPATITIS C VIRUS INFECTION: AN ANALYSIS OF THE 2008-2012 FRENCH NATIONAL HOSPITAL DISCHARGE DATABASE
Michaël Schwarzinger* 1, Sophie Thiébaut2, Vincent Mallet3, Jürgen Rehm4 1THEN (Translational Health Economics Network), Paris, Canada, 2THEN (Translational Health Economics Network), 3Hepatology, Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Paris, France, 4Social and Epidemiological Research (SER) Department, Centre for Addiction and Mental Health, Toronto, Canada

Background and Aims: There is an epidemiological relationship between chronic hepatitis C virus (HCV) infection and alcohol use disorders (AUD). AUD is a leading cause of liver disease and death. However, burden of chronic HCV infection analyses barely take into account the potential confounding role of AUD on prognosis. Our aim was to compare the prognostic value of chronic HCV infection and AUD in the general population.

Methods: In 2008-2012, 28,953,755 adult individuals residing in Metropolitan France were hospitalized and 1,506,453 died at hospital (51.6% and 55.7% of National Vital Statistics, respectively). We characterized all hospitalized patients by severe comorbidities (see Table), and tracked their trajectory according to chronic HCV infection and/or AUD (including withdrawal/abstinence). Age at death was analyzed in multivariate Cox proportional hazards model from January 2008 to last discharge or transplantation with stratification by gender, main French regions, and having received care in teaching hospitals.

Results: Chronic HCV infection was present in 112,146 (0.39%) of hospitalized patients, AUD in 705,259 (2.44%), both chronic HCV infection and AUD in 23,351(0.08%; i.e., 20.8% of HCV and 3.3% of AUD). Overall, the adjusted hazard ratio of in-hospital death (aHR) was 1.90 (95% confidence interval 1.86-1.94), for chronic HCV infection and 3.13 (3.10-3.15) for AUD, with a negative interaction effect between chronic HCV infection and AUD (aHR, 0.93; 0.90-0.97). Alcohol withdrawal or abstinence was significantly associated with lower mortality risks (HR, 0.66; 0.65-0.67). Subgroup analyses by severe comorbidities revealed that chronic HCV infection was only associated with higher mortality risks in presence of severe comorbidities (Table: groups 1 to 4, and 7 to 12). In absence of severe comorbidities, the prognostic value of chronic HCV infection at all liver disease stages was either not statistically significant among patients with cirrhosis and milder liver disease stage (groups 13 to 17). In contrast, AUD was associated with higher mortality risks in all prognostic subgroups, including all liver disease stages.

Conclusions: AUD has a dismal prognostic value in the general population and in the minority group of patients with chronic HCV infection. Alcohol withdrawal and abstinence increase survival regardless of HCV treatment.

Disclosure of Interest: None Declared

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Source:  http://www.eurekalert.org/pub_releases/2015-04/eaft-aud042415.php