New study uses Lumosity games to detect subtle cognitive impairments in patients with cirrhosis

Provided by News-Medical.net

Published on March 6, 2014 at 12:10 AM

Peer-reviewed study published in the American Journal of Gastroenterology

A new study from the University of Washington has found that performance on Lumosity games can distinguish between patients with cirrhosis of the liver, pre-cirrhotic patients, and healthy controls. The study used Lumosity games as psychometric tests to detect subtle cognitive impairments in patients with cirrhosis. The study is published in the March issue of the American Journal of Gastroenterology.

Studies have found that an estimated 60-80 percent of cirrhosis patients experience cognitive dysfunction, which can range from subtle neurocognitive abnormalities in those with minimal hepatic encephalopathy (MHE) to overt hepatic encephalopathy (OHE), a toxic condition that can lead to confusion, fatigue, or coma. Clinical testing can detect cognitive changes in cirrhotic patients with OHE, but currently no gold standard exists for the clinical assessment of MHE.

"Subtle cognitive impairments in cirrhosis patients are commonly undiagnosed, and are associated with poor self-reported quality of life, driving accidents, falls, or the development of OHE." said George Ioannou, M.D., M.S., Associate Professor at the University of Washington School of Medicine, Division of Gastroenterology and Staff Physician at VA Puget Sound Health Care System, and senior author on the study. "This finding is interesting because it suggests a new, easily accessible and affordable approach to identifying early cognitive impairments in patients with cirrhosis, which can potentially improve quality of life and prevent the onset of OHE."

The study administered three types of psychometric tests in cirrhotic patients without OHE (n = 31), patients with pre-cirrhotic chronic liver disease (n = 28), and normal controls (n = 16). The tests included:

1. The Number Connection Test A (NCT-A) presents test-takers with 25 numbers arranged in an arbitrary sequence that are to be connected as quickly as possible in the correct sequence.

2. The Inhibitory Control Test (ICT) presents a random sequence of letters among which test-takers need to discern interchanging X's and Y's and press a button when either of these two letters follows the other.

3. Five Lumosity games administered on an iPad, including Speed Match - an adaptation of the N-back that challenges speed and information processing; Color Match - an adaptation of the Stroop task that challenges flexibility and response inhibition; Memory Matrix - a visual pattern memory task that challenges memory and spatial recall; Lost in Migration - an adaptation of the Flanker task that challenges attention and selective attention; and Chalkboard Challenge - an arithmetic comparison task that challenges problem solving and quantitative reasoning.

   Unlike the NCT-A or ICT, Lumosity games were able to reliably differentiate cirrhosis patients without OHE from pre-cirrhotic patients. Specifically, the results for Color Match and Memory Matrix were found to be statistically significant in differentiating between those with cirrhosis and pre-cirrhotic patients (p = 0.009 and p = 0.04 for Color Match and Memory Matrix respectively), as well as between normal controls and those with cirrhosis (p = 0.04 and p = 0.04) when adjusted for age and educational attainment. Higher scores on these two games were also associated with a reduced likelihood of cirrhosis, suggesting the combination of Color Match and Memory Matrix may improve cirrhosis detection. Test-retest reliability, as measured by Pearson's r correlation coefficient, for each Lumosity game ranged from r = 0.75 to 0.84 compared to the NCT, where r = 0.75, suggesting repeatability of the Lumosity games.

   "We created Lumosity to be an accessible tool for both consumers and researchers, and we're excited that our cognitive training program can be used in a variety of ways to study cognitive function in specific populations," said Joe Hardy, Ph.D., VP of Research & Development at Lumosity. "This study is a novel use-case of Lumosity and we welcome additional research using Lumosity to detect subtle cognitive impairments in those with cirrhosis of the liver and in other conditions."

   Lumosity's research platform, the Human Cognition Project (HCP), works with researchers from around the world in an effort to better understand the workings of the human mind and brain. Researchers receive free access to Lumosity's tools, and in certain cases, limited data regarding performance on Lumosity's cognitive training games. Current research projects on Lumosity include topics such as decision-making, multitasking, nutrition, TBI, cancer/chemofog, schizophrenia, stroke, MCI, emotion regulation, aging, ADHD, and PTSD.

   Source: Lumosity

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Shorter Treatment Strategy Beats Hepatitis C

Published: Mar 6, 2014
By Ed Susman , Contributing Writer, MedPage Today

BOSTON -- A 6-week treatment regimen appeared to be as effective as the more standard 12 weeks of therapy for patients with hepatitis C virus infection, researchers reported here at the annual Conference on Retroviruses and Opportunistic Infections.

In a pilot study that treated 20 patients in each of three arms, all patients treated with the combination of sofosbuvir (Sovaldi, nucleotide NS5B inhibitor) 400 mg with ledipasvir (NS5A inhibitor) 90 mg once daily for 12 weeks achieved a sustained virologic response at 12 weeks' post-treatment (SVR12), reported Anita Kohli, MD, an infectious disease fellow at the National Institutes of Health Clinical Center in Bethesda, Md.

But she also noted that two regimens using the same backbone and adding either the investigative agent GS-9669 (non-nucleoside NS5B inhibitor) 500 mg once daily or GS-9451 (a protease/NS3/4 inhibitor) 80 mg once daily for 6 weeks had similar outcomes: 95% of patients on GS-9669 achieving an SVR12, and 100% of patients on GS-9451 achieving an SVR12.

The one patient in the study who failed to achieve an SVR12 relapsed before SVR4; that individual had stage 3 liver disease, a high viral load, and unfavorable genotype, Kohli said.

All patients in all 3 arms were naive to treatment for hepatitis C virus. All patients were included in the 12-week arm, but patients diagnosed with cirrhosis were excluded from the 6-week trials.

"These results are not statistically significantly different from each other," Kohli told MedPage Today at a press briefing sponsored by the conference organizers.

"We find these results very promising. This was a pilot study," Kohli said. "We will follow these patients out to 48 weeks to see if the results are maintained."

A cure in the context of HCV is a sustained virologic response -- defined as undetectable viral RNA at some prespecified point after ending therapy, usually 12 or 24 weeks.

"What we have learned from this trial is that we can treat patients for shorter durations of therapy and we see that 6 weeks is effective," Kohli said.

"Secondly, these regimens are very simple -- 1, 2, or 3 pills a day. Third, our patient population is one that is historically very difficult to treat -- more than 80% of the patients were African American, most had genotype 1a, most had high viral loads, 25% to 30% of the patients had advanced-stage liver disease.

"The reason we wanted to look at the short-duration therapies is because we think it is very important in treatment of hepatitis C globally in limited resource settings. We really need very simple treatments for the 150 million to 180 million people globally," she said.

All the treatment regimens avoided the use of interferon, once the mainstay of treatment of hepatitis C virus, but a therapy that is difficult to tolerate for many patients. The use of interferon-free directly acting antiviral agents is an emerging approach to improve the efficacy and tolerability of therapy for hepatitis C virus, Kohli said.

However, she noted that the efficacy of interferon and ribavirin-free regimens shorter than 8 to 12 weeks has not been reported. One study evaluating sofosbuvir, ledipasvir, and ribavirin for 6 weeks showed an SVR12 rate of only 68%, she said. She also noted that the optimal combination of directly acting antiviral agents not been established.

Press conference moderator Jean-Michel Pawlotsky, MD, PhD, professor of medicine at Hopital Henri Mondor Creteil/University of Paris-Est, told MedPage Today that, while the results of the SYNERGY trial look interesting, they are not ready for routine implementation.

"There are very small numbers in this study," he said. "We have to see how this will apply to real-life patients. The danger is always to undertreat patients. If the time is too short and it works in a trial and you start treating real-life patients you can have failures. So we really need to extend this trial. It is interesting because it shows that some people can be cured in a very short duration of treatment."

Pawlotsky said he would not be comfortable treating his patients in this manner without more extensive studies.

Ledipasvir is not currently approved in the U.S. Its manufacturer, Gilead, filed last month for FDA approval of the drug in a fixed-dose combination with sofosbuvir.

The study was funded by the National Institutes of Health.

Kohli disclosed no relevant relationships with industry.

Pawlotsky disclosed no relevant relationships with industry.

Primary source: Conference on Retroviruses and Opportunistic Infections
Source reference: Kohli A, et al "Combination oral, hepatitis C antiviral therapy for 6 or 12 weeks: Final results of the SYNERGY trial" CROI 2014; Abstract 27LB.

Source

BIT225 HIV/HCV Trial Patients Virus Free at Six Months

6 March 2014

The Manager Companies
ASX Limited
20 Bridge Street
Sydney NSW 2000

• Study evaluated BIT225 in patients co-infected with HIV and HCV
• All HCV genotype 3 patients completing treatment are virus-free at 24 weeks
• Preliminary data from subset of patients shows benefit extends out to 48 weeks

Sydney, Australia, 6 March 2014 – Australian drug development company Biotron Limited
(ASX:BIT) today announced additional interim positive data from a key phase 2 trial of its lead
antiviral drug, BIT225, in patients co-infected with HIV and Hepatitis C virus (HCV).

Analysis of blood samples from patients indicated that all of the HCV genotype 3 patients completing treatment are virus free at the 24 week (6 month) time point. This extends previous data
that showed patients had undetectable virus levels at 12 weeks.

Response to treatment at this time point is generally a good indication of final outcome at 48 weeks. Preliminary data from patients who have completed 48 weeks of treatment indicate that they remain virus free at this key time point.

Under the protocol of this open label pilot study, 12 patients received IFN/RBV for 7 days before
commencing treatment with BIT225. They then received 300 mg BIT225 twice daily plus IFN/RBV
for 28 days. After that time, patients continued to take IFN/RBV for 48 weeks.

Biotron Managing Director Dr Michelle Miller commented; "This 24 week data further validates the
efficacy of BIT225 as a potential new therapy for HCV and, in particular, for this difficult to treat
group of HIV/HCV co-infected patients who typically have more serious HCV infection and lower
response rates to treatment with existing standard therapies."

In vitro assays have shown that BIT225 has pan-genotypic activity. Previous clinical trials of
BIT225 have focused on patients infected with the genotype 1 variant of the virus, which is the most
common genotype in Western populations. This data further extends the Company's clinical data
portfolio to include genotype 3, which is endemic in south-east Asia.

In HCV, BIT225 targets the p7 protein which is responsible for virus assembly. BIT225 also
impacts on the assembly of the HIV virus and specifically targets the virus in reservoir cells. No
existing therapy works in this way.

Dr Miller further commented; "Both the HIV and HCV viruses present substantial challenges and there is global demand for novel therapeutics. We look forward to progressing commercialisation of this important compound as a valuable new therapy that is synergistic with current and future treatment strategies."

Enquiries

Dr Michelle Miller
Managing Director
Biotron Limited
+61-2 9805 0488 +61-(0)412313329

Rudi Michelson
Monsoon Communications 
+61-3 9620 3333

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Faldaprevir NDA has been accepted for review by U.S. FDA as part of a combination regimen for patients with chronic hepatitis C

March 06, 2014

Boehringer Ingelheim Announces Phase 3 SVR12 Results in HCV/HIV Co-Infected Patients Treated with Faldaprevir

Additional drug-drug interaction data for faldaprevir combined with commonly prescribed HIV medications also presented at CROI 2014
Faldaprevir NDA has been accepted for review by U.S. FDA as part of a combination regimen for patients with chronic hepatitis C

For U.S. Media Only

Ingelheim, Germany and Ridgefield, CT, March 6, 2014 – Today Boehringer Ingelheim announced results from STARTVerso^®4 in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Patients were enrolled in either 120mg or 240mg faldaprevir dose groups. Further, 80% of all patients were eligible for randomization to a shortened duration of treatment (24 versus 48 weeks) because they achieved protocol-defined early treatment success (ETS)* and 86% of these patients achieved SVR12. STARTVerso^®4 is a Phase 3 trial that enrolled 308 hepatitis C (HCV) treatment-naïve or experienced patients with HCV/HIV co-infection and evaluated the efficacy and safety of the investigational compound faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV).

“The SVR12 data from STARTVerso^®4 are encouraging, especially given the inclusion of patients with cirrhosis,” said Peter Piliero, MD, vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Comprehensive data from our STARTVerso^® clinical trial program, including data from patients with HCV/HIV co-infection, have been filed with the FDA as part of our New Drug Application for faldaprevir.”

In each faldaprevir dose group, 71% (120mg) and 72% (240mg) of patients achieved SVR12. SVR12 results were consistent across patients regardless of HCV genotype-1 subtype (GT1a or GT1b), presence of compensated cirrhosis, dose and duration of faldaprevir, and duration of PegIFN/RBV. In a post hoc analysis, 75% of patients with the Q80K variant achieved SVR12 compared with 71% of patients who did not have the variant.

Serious adverse events (AEs) were reported in 32 patients (10%). To date, 24 patients have prematurely discontinued faldaprevir due to AEs. The most frequent AEs in STARTVerso^®4 were nausea (37%), fatigue (34%), diarrhea (27%), headache (25%) and weakness (23%). Patients will be followed to 24 weeks after the conclusion of treatment (SVR24).

In separate poster presentations at CROI, investigators described the results from analyses that evaluated drug-drug interactions of faldaprevir with common HIV medications, including: efavirenz, atazanavir/ritonavir, darunavir/ritonavir, raltegravir and tenofovir. In each of these analyses, there was no clinically relevant effect of faldaprevir on the pharmacokinetics of any of the HIV medications studied. Patients in STARTVerso^®4 already taking ritonavir-boosted HIV protease inhibitors (darunavir or atazanavir) or efavirenz were enrolled into the 120mg and 240mg faldaprevir groups, respectively.

Boehringer Ingelheim HCV Development Update
The New Drug Application (NDA) for faldaprevir has been accepted for filing by the U.S. Food and Drug Administration (FDA). Faldaprevir is currently under review as a component of a combination antiviral treatment regimen for the treatment of chronic HCV infection in adult patients who are treatment-naïve or have been previously treated with interferon-based treatment, as well as those with compensated liver disease, cirrhosis, or HCV/HIV co-infection. The FDA target action date for faldaprevir is in the fourth quarter of 2014.

The NDA submission for faldaprevir is supported by Boehringer Ingelheim’s STARTVerso^® (NCT01343888, NCT01297270, NCT01358864, NCT01399619) clinical trial program, a multi-study Phase 3 trial program that evaluated faldaprevir for 12 or 24 weeks in combination with pegylated interferon and ribavirin (PegIFN/RBV). The four trials that make up this program studied treatment-naïve, treatment-experienced, and HCV/HIV co-infected patients with chronic genotype-1 (GT1) HCV. The primary efficacy endpoint of each STARTVerso^® trial is viral cure 12 weeks after the conclusion of treatment (SVR12).

In November 2013, Boehringer Ingelheim announced that the faldaprevir application for marketing authorization is under review by the European Medicines Agency (EMA). If authorized by the European Commission, faldaprevir could be available for marketing in the EU in the second half of 2014.

Following an assessment of the blinded Phase 3 trial data from HCVerso^® 1 and 2 for the combination of deleobuvir, faldaprevir and ribavirin, Boehringer Ingelheim has decided to halt further development of deleobuvir-containing HCV regimens. Ongoing regulatory reviews of faldaprevir are not affected by the decision on the deleobuvir-containing regimens.

About Faldaprevir
Faldaprevir is an investigational, oral protease inhibitor that is specifically designed to target viral replication in the liver. Faldaprevir is an investigational compound that has not been approved by the FDA; its safety and efficacy have not been established.

About Boehringer Ingelheim in Hepatitis C Virus (HCV)
In partnership with the scientific community, our clinical trial program is rigorously designed to find answers to the challenges that HCV patients face, including those who are the most difficult to cure. Our pivotal HCV clinical trials for faldaprevir, STARTVerso^®, included four trials that studied treatment-naïve, treatment-experienced, and HCV/HIV co-infected patients with chronic GT1 HCV.

Hepatitis C is a blood-borne infectious disease and a leading cause of chronic liver disease, transplant and failure that affects as many as 150 million people globally. In the United States, approximately 3.2-5.2 million people have chronic HCV infection. Since 1999 there has been a significant increase in deaths due to chronic HCV, which accounts for 15,000 deaths in the United States per year.

STARTVerso^® is a registered service mark of Boehringer Ingelheim International GmbH.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim’s culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

For more information please visit www.us.boehringer-ingelheim.com.
*ETS = protocol-defined early treatment success (week 4 below limit of quantification [BLQ] and week 8 below limit of detection [BLD]).

Source

Omega-3 Fatty Acids in the Prevention of Interferon-Alpha-Induced Depression: Results from a Randomized, Controlled Trial

Biological Psychiatry

Article in Press

Kuan-Pin Su, Hsueh-Chou Lai, Hui-Ting Yang, Wen-Pang Su, Cheng-Yuan Peng, Jane Pei-Chen Chang,  Hui-Chih Chang, Carmine M. Pariante

Received 24 September 2013; received in revised form 6 January 2014; accepted 11 January 2014. published online 27 January 2014.
Corrected Proof

Abstract

Background
Interferon (IFN)-α therapy for chronic hepatitis C virus infection is frequently associated with depression. The routine prophylaxis with antidepressants might expose patients to adverse effects, hence, the need for alternative preventive interventions. Omega-3 polyunsaturated fatty acids are safe and effective essential nutritional compounds used for the treatment of depression, putatively through an anti-inflammatory action. In addition, lower erythrocyte levels of omega-3 polyunsaturated fatty acids have been associated with an increased risk of IFN-induced depression.

Methods
We conducted a 2-week, double-blind, placebo-controlled trial comparing eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and placebo for the prevention of IFN-α-induced depression. A total of 162 patients consented to participate and were randomized to the study. All of the patients completed the 2-week trial; 152 participants were followed throughout the 24 weeks of IFN-α treatment and were included in the analysis.

Results
Compared with placebo, the incident rates of IFN-α-induced depression were significantly lower in EPA-treated but not in DHA-treated patients (10% and 28%, respectively, versus 30% for placebo, p = .037). Both EPA and DHA significantly delayed the onset of IFN-induced depression (week of onset: 12.0 and 11.7, respectively, versus 5.3 for placebo, p = .002). EPA and DHA were both well tolerated in this population. EPA treatment increased both EPA and DHA erythrocyte levels, but DHA only increased DHA erythrocyte levels.

Conclusions
EPA is effective in the prevention of depression in hepatitis C virus patients received IFN-α therapy. Our study confirms the notion that anti-inflammatory strategies are effective antidepressants in the context of depression associated with inflammation.

Key Words: Chronic hepatitis C virus (HCV), clinical trial, omega-3 polyunsaturated fatty acids (n-3 PUFAs), inflammation, interferon-alpha (IFN-α), major depressive disorder (MDD)

Source

Merck’s Investigational Hepatitis C Treatment Regimen MK-5172/MK-8742 Shows Robust Anti-HCV Activity in HIV/HCV Co-Infected Patients with HCV Genotype 1 Infection

Wednesday, March 5, 2014 4:15 pm EST

BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced new data from HIV/HCV co-infected patients in the ongoing C-WORTHY Study, a Phase 2 clinical trial evaluating the efficacy and safety of Merck's all-oral, once-daily regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor. In these co-infected patients, the administration of MK-5172/MK-8742 for 12 weeks resulted in robust HCV suppression, and a safety profile consistent with that observed for patients infected with HCV Genotype 1 infection (GT1) alone.

At 12 weeks, 100 percent (29/29) of co-infected patients who received MK-5172/MK-8742 and ribavirin (RBV), and 90 percent (26/29) of co-infected patients who received MK-5172/MK-8742 alone had HCV RNA levels of less than 25 IU/mL, versus 100 percent (13/13) in patients with HCV alone treated with MK-5172/8742. The data were presented at the 21^st Conference on Retroviruses and Opportunistic Infections (CROI).

“We are encouraged by the potential of MK-5172/MK-8742 for the treatment of people living with HIV/HCV co-infection, where there remains a need for additional therapeutic options,” said Dr. Eliav Barr, vice president, Infectious Diseases, Merck Research Laboratories.

About the MK-5172/MK-8742 Data Presented at CROI

After 4 weeks of treatment, all co-infected patients showed a reduction in HCV RNA levels to below 25 IU/mL with or without RBV administration. HCV kinetics over the first 4 weeks of therapy were similar in patients with or without HIV co-infection.

Virologic Response: Intent-to-Treat Population

*One HIV/HCV co-infected patient had not yet reached TW12; HIV/HCV co-infected (RBV-free) arm: 1 lost to follow-up (HCV RNA undetectable at the last visit on record); 2 breakthroughs with low blood levels of MK-5172 and/or MK-8742; HCV mono-infected (RBV-containing) arm: 3 early discontinuations (day 3 [detectable at the last visit] and days 22 and 35 [undetectable at the last visit]).

There were three treatment failures in the HIV/HCV co-infected study arms; one subject completed the treatment regimen but was lost to follow-up (HCV RNA undetectable at the last visit on record); and two co-infected subjects with low pharmacokinetic levels of MK-5172 and/or MK-8742 experienced virologic breakthrough at the 8 week time point (both cases with low blood levels of MK-5172 and/or MK-8742).

The most common adverse events observed in this cohort were fatigue (7%) and headache (8%). The incidence of these adverse events was not increased in patients with HIV. No co-infected patients discontinued due to either an adverse event or study medication intolerance.

About HIV/HCV Co-Infection

Globally, approximately seven million patients are co-infected with HIV and HCV. HCV is the leading cause of morbidity and mortality among those living with HIV-1, and compared to the general population, the overall prevalence of HCV infection is higher among those infected with HIV-1. Furthermore, HIV/HCV co-infected patients have a three times higher rate of progression to cirrhosis and a six times higher risk of hepatic decompression than HCV patients infected with HCV alone, underscoring the need for new therapeutic options for this patient population.

About the C-WORTHY Clinical Trial

C-WORTHY is a randomized, dose-responsive, parallel-group, multiple-site, open-label trial comparing different patient populations exposed to different durations of treatment of MK-5172 (100 mg QD) in combination with MK-8742 (50 mg QD) with or without RBV in patients with chronic HCV infection. A total of 450 patients with HCV GT1 and HCV RNA levels of ≥10,000 IU/mL have been enrolled in C-WORTHY and randomized across 16 arms to examine difficult-to-treat subpopulations.

The primary objective of C-WORTHY is to evaluate the safety and efficacy of MK-5172 in combination with MK-8742 with or without RBV as assessed by the proportion of patients achieving sustained virologic response at 12 weeks (SVR12) in treatment-naïve patients and more complex patient groups including prior peginterferon alfa and ribavirin treatment failures, cirrhotic patients and co-infected patients. The aim of the HIV/HCV co-infected arms is to compare on-treatment HCV RNA responses (defined as proportion of patients with HCV RNA <25 IU/mL) in GT1 HIV/HCV co-infected patients treated with MK-5712/MK-8742 with or without RBV with those in mono-infected patients.

In the HIV/HCV co-infection arms, 59 treatment-naïve, non-cirrhotic, GT1 HIV/HCV co-infected patients on a stable antiretroviral regimen (raltegravir + tenofovir or abacavir with either 3TC or FTC) were examined. These subjects were randomized at a 1:1 ratio to receive 12 weeks of MK-5172 (100 mg QD) administered concomitantly with MK-8742 (50 mg QD), with or without twice daily (BID) RBV.

Additional data from Merck’s Phase 2 program for MK-5172/MK-8742 will be presented at the 49^th Annual Meeting of the European Association of the Study of the Liver, April 9-13 in London. Details on the C-WORTHY Study, as well as additional Phase 2 trials for MK-5172 and MK-8742, can be viewed on www.merck.com/clinical-trials.

In October 2013, Merck announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to MK-5172/MK-8742 for treatment of chronic HCV infection.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebookand YouTube.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contact:

Merck
Media:
Caroline Lappetito, 267-305-7639
or
Ian McConnell, 908-423-3046
or
Investors:
Carol Ferguson, 908-423-4465
or
Justin Holko, 908-423-5088

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Can low-dose interferon prevent relapse of hepatitis C virus infection?

PUBLIC RELEASE DATE: 5-Mar-2014
Contact: Vicki Cohn
vcohn@liebertpub.com
914-740-2100
Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, March 5, 2014—Chronic hepatitis C virus (HCV) infection can lead to serious diseases such as cirrhosis and cancer of the liver, so viral clearance and prevention of relapse are important treatment goals. Low-dose oral interferon may reduce the risk of HCV relapse in patients with mild liver fibrosis according to a study published in Journal of Interferon & Cytokine Research, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Interferon & Cytokine Research website.

In "A Double-Blind Randomized Controlled Study to Evaluate the Efficacy of Low-Dose Oral Interferon-Alpha in Preventing Hepatitis C Relapse," Chuan-Mo Lee and coauthors from several universities and hospitals in Taiwan present the results of a clinical trial comparing the effects of 24 weeks of treatment with two doses of oral interferon-alpha or placebo in patients who achieved viral clearance after successful HCV therapy.

"This is a highly significant study relevant to the optimal use of IFN for HCV treatment," says Co-Editor-in-Chief Ganes C. Sen, PhD, Chairman, Department of Molecular Genetics, Cleveland Clinic Foundation, Ohio.

###

About the Journal

Journal of Interferon & Cytokine Research (JICR), led by Co-Editors-in-Chief Ganes C. Sen, PhD, and Thomas A. Hamilton, PhD, Chairman, Department of Immunology, Cleveland Clinic Foundation, is an authoritative peer-reviewed journal published monthly online with Open Access options and in print that covers all aspects of interferons and cytokines from basic science to clinical applications. JICR is an official journal of the International Cytokine and Interferon Society. Complete tables of content and a sample issue may be viewed online on the Journal of Interferon & Cytokine Research website.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Viral Immunology, AIDS Research and Human Retroviruses, and DNA and Cell Biology. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

Source

New drugs trump interferon in HCV therapy

By: NEIL OSTERWEIL, Family Practice News Digital Network

03/05/14

The era of interferon and ribavirin in the treatment of hepatitis C viral infections appears to be drawing to a close, and few clinicians will mourn the passing of the effective but highly toxic combination, investigators said at the Conference on Retroviruses and Opportunistic Infections.

In patients with hepatitis C virus infection alone or HCV with HIV coinfection, a host of new interferon-free drugs and new combinations are transforming therapy, reported Dr. Jean-Michel Pawlotsky, professor of medicine at the University of Paris-Est.

"Hepatitis C is living a real therapeutic revolution. Everything is changing very fast. We’re now getting infection cure rates higher than 90% with the classes of drugs we have," he said at a briefing.

STARTVerso4

With all of the drugs, the sustained virologic response (SVR) rates "are exactly the same in coinfected patients as they are in monoinfected patients," said Dr. Douglas Dieterich of Mt. Sinai Medical Center, New York.

Courtesy US. Dept of Veterans Affairs
A host of new interferon-free drugs and new combinations are transforming therapy for patients with hepatitis C viral infections, says Dr. Jean-Michel Pawlotsky.

For example, a combination of the protease inhibitor faldaprevir with pegylated interferon alfa-2a plus ribavirin (PR) produced SVR rates at week 4 of follow-up (SVR4) of 74% in HCV/HIV coinfected patients, said Dr. Dietrich, a principal investigator for the STARTVerso4 trial.

In this phase III open-label trial, 308 patients with HCV/HIV coinfection who were treatment naive or relapsed after prior interferon-based therapy were randomly assigned to receive faldaprevir 120 mg daily for 24 weeks or 240 mg for 12 or 24 weeks according to on-treatment response. In both arms, faldaprevir was given on a PR backbone, with duration guided by response to therapy.

For the primary endpoint of SVR12, the investigators saw a 72% rate, with no significant difference between the two dose groups, compared with approximately 80% in monoinfected patients in other phase III studies. There was also no difference in efficacy between patients with or without cirrhosis, he said.

Adverse events included mild hyperbilirubinemia in some patients and interferon side effects.

Simeprevir in coinfection

Dr. Dietrich was also the lead on study C212, which looked at simeprevir (Olysio) on a PR backbone in coinfected patients. The results were similar to those seen with faldaprevir (73.6% overall SVR12).

Interestingly, the presence of the simeprevir-resistant q80K polymorphism did not make a difference in response rates, he said. Among monoinfected patients in prior studies, those with q80k polymorphism had significantly lower SVR rates. The adverse events were also similar to those seen in patients with monoinfection.

PHOTON-1

The PHOTON-1 trial evaluated the first interferon-free regimen (sofosbuvir plus ribavirin) in patients with HCV genotypes 1-3 and HIV.

In this study, patients with HCV and stable HIV infection received sofosbuvir 400 mg and ribavirin 1,000-1,200 mg daily. Treatment-naive patients with HCV genotype 1 and treatment-experienced patients with genotypes 2 or 3 received treatment for 24 weeks, while treatment-naive genotype 2/3 patients received 12 weeks of treatment. Patients on multiple antiretroviral (ART) regimens and those with compensated cirrhosis were included in the study.

The primary efficacy endpoint, SVR12, was achieved in 88% of treatment-naive genotype 2 patients and 67% of genotype 3 patients. In genotype 1 patients, the SVR was approximately 70%, Dr. Dietrich said.

Adverse events were general and limited to anemias, headache, and other symptoms commonly seen with HCV therapies, he added.

SYNERGY trial

Dr. Anita Kohli presented final results from the SYNERGY trial, which looked at combination oral HCV therapy for 6 or 12 weeks (SVR4 results from this trial were presented at the 2013 Liver Meeting).

In this phase II prospective cohort study, 60 treatment-naive patients with HCV genotype 1 were enrolled into one of three arms to receive either sofosbuvir 400 mg with ledipasvir 90 mg once daily in a fixed-dose combination for 12 weeks (arm A); the same fixed-dose combination plus the non-nucleoside NS5B inhibitor GS-9669 500 mg/day for 6 weeks (arm B); or the fixed-dose combination plus the NS3 protease inhibitor GS-9451 80 mg/day for 6 weeks.

The SVR12 rate among the patients on sofosbuvir/ledipasvir alone (arm A) was 100%, the rate in arm B was 95%, and the rate in arm C was 100%.

"We find these results very promising," said Dr. Kohli of the National Institutes of Health.

She noted that all patients in the trial were treatment naïve, and that all stages of liver disease were included in the 12-week treatment arm, but cirrhotic patients were excluded from the 6-week arms.

"These regimens are very simple. They’re one, two, or three pills a day," she noted. In addition, "our patient population is one that has been historically very difficult to treat, that is, predominantly African American," she noted.

Most of the patients had genotype 1a with a high viral load, and 25%-30% of patients in all treatment arms had advanced-stage liver disease, she added.

PEARL-III

The PEARL III trial looked at 419 treatment-naive, noncirrhotic patients with HCV genotype 1b, who were randomly assigned to receive either a ritonavir-boosted protease inhibitor (ABT-450) with ABT-267, which is an inhibitor of HCV NS5A, coformulated into a single pill; or ABT-333, a non-nucleoside polymerase inhibitor, with or without ribavirin.

In the ribavirin-containing arm, SVR12 was 99.5%, compared with 99% among controls. There was only one virologic failure in the study, and two patients who did not achieve SVR4 were lost to follow-up at week 12, noted Dr. Daniel Cohen of AbbVie Pharmaceuticals.

Adverse events included predominantly mild headache and fatigue in about 25% of patients, with slightly more events seen in the ribavirin combination arm.

STARTVerso4 was sponsored by Boehringer Ingelheim. C212 was sponsored by Janssen. SYNERGY was supported by the National Institutes of Health and Gilead Sciences. Dr. Cohen is employed by AbbVie, which sponsored PEARL III.

Source

Chronic hepatitis C virus infection: it is not only about the liver

Eur J Gastroenterol Hepatol. 2014 Mar;26(3):313-8. doi: 10.1097/MEG.0b013e328362dbff.

Vigani AG¹, Tozzo R, Quezada A, Diaz AC, Mendes L, Lopes I, Riberio E, Espindola GM, Lopes FP, Petoilho EC, Queiroz JL, Castro HM.

Abstract

BACKGROUND AND AIMS: Although hepatitis B virus (HBV) and hepatitis C virus (HCV) are both hepatotropic and quite similar in terms of clinical manifestations and histopathology, their respective infections are distinct in terms of epidemiology and prognosis. Recognizing the differences between patients with HBV and HCV infection with respect to demographic characteristics, prevalence of comorbidities, and presence of lifestyle factors aids the proper treatment of these patients. We aimed to compare two populations with chronic viral liver disease (chronic HCV and chronic HBV), each of them with resolved hepatitis C.

PATIENTS AND METHODS: We included patients referred to a municipal reference clinic from March 2009 through May 2012. Patient data were collected using standardized questionnaires at the patients' first visit to clinic. Questionnaires included epidemiological information, presence of comorbidities, and lifestyle.

RESULTS: A total of 756 patients were included in the study, 348 (46.0%) with chronic HCV infection, 176 (23.3%) with chronic HBV infection, and 232 (30.7%) with resolved HCV infection. Multivariate analysis including patients with chronic HCV infection and chronic HBV infection indicated that age [adjusted odds ratio (AOR)=1.06; 95% confidence interval (CI): 1.03-1.08], alcohol abuse (AOR=1.58; 95% CI: 1.01-2.49), smoking (AOR=1.64; 95% CI: 1.00-2.17), and illicit drug (AOR=2.92; 95% CI: 1.69-5.02) use were associated independently with chronic HCV infection. Multivariate analyses including patients with chronic HCV infection and those patients with resolved HCV infection, presence of at least one comorbidity (AOR=1.94; 95% CI: 1.12-3.3), illicit drug use (AOR=3.24; 95% CI: 1.90-5.54), and age (AOR=1.03; 95% CI: 1.01-1.05) were independently associated with chronic HCV infection. Age (AOR=0.98; 95% CI: 0.96-0.99) and male sex (AOR=1.93; 95% CI: 1.26-2.95) were the only variables associated significantly with chronic HBV infection in the multivariate analysis between patients with chronic HBV infection and resolved HCV infection.

CONCLUSION: Our results highlight that patients with chronic HCV infection are complex and require a multidisciplinary approach during patient follow-up and clinical management.

PMID: 23719563 [PubMed - in process]

Source

Racial Disparities in the Proportion of Current, Unresolved Hepatitis C Virus Infections in the United States, 2003-2010

Dig Dis Sci. 2014 Feb 27. [Epub ahead of print]

Liu G¹, Holmberg SD, Kamili S, Xu F.

Abstract

BACKGROUND: The hepatitis C virus (HCV) antibody test alone does not distinguish current from resolved infections.

AIM: The study aimed to describe the percentage of current HCV infection, defined by HCV RNA positivity, among those tested positive for anti-HCV, and to examine characteristics of those with current infection.

METHODS: Using nationally representative data from the 2003 to 2010 National Health and Nutrition Examination Surveys, descriptive analyses and regressions were performed on data from anti-HCV-positive adults aged ≥40 years.

RESULTS: Of 13,909 participants examined, 304 were anti-HCV-positive. Of these, 238 or 75.3 % [95 % confidence interval (CI) 67.5-81.8 %] had detectable viral RNA. The percentage of current, unresolved HCV infection was highest among non-Hispanic Blacks (91.1 %) and lowest among those with a college education (57.3 %). In multivariate analyses, non-Hispanic Blacks were more likely to have current HCV infection compared to non-Hispanic Whites (adjusted odds ratio 3.9, 95 % CI 1.6-9.2). Among persons with current HCV infection, most had elevated alanine aminotransferase (56.5 %) or aspartate aminotransferase (71.8 %) levels, but only 35.3 % reported having been diagnosed with any abnormal liver conditions. Excessive alcohol drinking was reported by 27.3 % of participants with current HCV infection.

CONCLUSIONS: Among adults aged ≥40 years who had ever been infected with HCV, approximately three-quarters had current, unresolved HCV infection. Non-Hispanic Blacks were more likely to have current infection than non-Hispanic Whites. The majority of those with current infection had abnormal liver function tests but had not received appropriate diagnoses. Many currently infected persons would benefit from lifestyle modifications to avoid the multiplicative effect of alcohol on HCV infection.

PMID: 24573716 [PubMed - as supplied by publisher]

Source

CROI 2014: HCV Abstract and Poster Presentation Coverage by Jules Levin (NATAP)

21st Conference on Retroviruses and
Opportunistic Infections
Boston MA
March 3 - 6, 2014

Reported by Jules Levin

(All links open into new windows)

• ABT-493, a Potent HCV NS3/4A Protease Inhibitor With Broad Genotype Coverage - (03/05/14)
• ABT-530, an HCV NS5A Inhibitor With Potent Pangenotypic Activity and High Genetic Barrier to Resistance - (03/05/14)
• All-Oral Combination of Daclatasvir, Asunaprevir, and BMS-791325 for HCV Genotype 1 Infection - (03/04/14)
• Daclatasvir in Combination With Simeprevir With or Without Ribavirin for Hepatitis C Virus Genotype 1 Infection - (03/04/14)
• All-Oral Therapy With Sofosbuvir Plus Ribavirin For the Treatment of HCV Genotype 1, 2, and 3 Infection in Patients Co-infected With HIV (PHOTON-1) - (03/04/14)
• Three-DAA Regimen (Abbvie) Achieves 99% SVR12 Rates in HCV Genotype 1b Naives - written by Mark Mascolini - (03/04/14)
• Simeprevir Plus PegIFN/RBV Yields 74% SVR12 in HCV/HIV Patients - written by Mark Mascolini - (03/04/14)
• SVR12 72% With Faldaprevir Plus PegIFN/RBV in Naives With HCV/HIV - written by Mark Mascolini - (03/04/14)
• Combination Oral, Hepatitis C Antiviral Therapy for 6 or 12 Weeks: Results of the SYNERGY Trial - (03/04/14)
• Simeprevir plus PegIFN/ribavirin in HCV genotype-1/HIV-1 co-infection (Study C212) - (03/04/14)
• Double or Triple DAA Therapy for HCV-1 Yields 95-100% SVRs in 6 or 12 Weeks (SYNERGY Study) - written by Mark Mascolini - (03/04/14)
• PEARL III: SVR ≥99% AFTER 12 WKS OF ABT-450/R/267 + ABT-333 ± RBV IN TREATMENT-NAIVE HCV GT1B INFECTION - (03/04/14)

Source NATAP

Enanta Pharmaceuticals Announces New Data Presented on Protease Inhibitor ABT-493 at the CROI 2014

Enanta Pharmaceuticals Announces New Data Presented on Protease Inhibitor ABT-493 at the 21st Conference on Retroviruses and Opportunistic Infections (CROI)

WATERTOWN, Mass.--(BUSINESS WIRE)--Mar. 4, 2014-- Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA) a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that new in vitro data on ABT-493, a potent NS3/4 protease inhibitor, was presented today during a poster session at the 21^st Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

ABT-493 is a next-generation HCV NS3/4A protease inhibitor identified within the Enanta-AbbVie collaboration. Designed to enable once-daily dosing without ritonavir, ABT-493 is expected to be co-formulated with AbbVie’s next-generation NS5A inhibitor, ABT-530.

Data from poster number 636 titled “ABT-493, a Potent HCV NS3/4 Protease Inhibitor with Broad Genotypic Coverage”, demonstrates that ABT-493 has a substantially improved in vitro profile compared to earlier generation HCV NS3/4A protease inhibitors and displays potent and broad genotypic activity in genotypes 1a, 1b, 2a, 3a, 4a and 6a, against which many other HCV NS3/4A protease inhibitors have significantly lower potency.In vitro ABT-493 retains potency against most of the clinically important resistance-associated variants in genotype 1 and is fully active against variants resistant to NS5A or NS5B inhibitors. It demonstrates additive to synergistic antiviral activity in vitro when combined with next-generation NS5A inhibitor ABT-530.

About Enanta

Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. Enanta is discovering, and in some cases developing, novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase – as well as a host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistantStaphylococcus aureus) infections.

Forward Looking Statement

This press release contains forward-looking statements, including with respect to our expectation regarding how ABT-493 will be co-formulated with ABT-530 and the prospects for ABT-493’s activity against multiple genotypes of HCV. Statements that are not historical facts are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors that may affect actual results include results of further preclinical and clinical studies of ABT-493-containing regimens, the development, regulatory and marketing efforts of AbbVie (our collaborator on ABT-493 and on our collaboration’s initial protease inhibitor, ABT-450), and clinical development and marketing efforts of others for competitive product candidates. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol Miceli, 617-607-0710
cmiceli@enanta.com
or
Media Contact
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com

Source

One in six clinical trials might fall outside federal oversight, study estimates

NATURE MEDICINE | SPOONFUL OF MEDICINE

04 Mar 2014 | 16:01 EST | Posted by Nicholette Zeliadt | Category: Policy

Bioethicists have long known about a potential regulatory loophole that excludes certain types of clinical trials from federal regulations designed to protect the safety of human research subjects in the US. However, the number of clinical trials that fell into this gap remained unknown. Now, a letter published online today in the Journal of the American Medical Association reveals just how many trials may fall outside federal government supervision at present.

In the US, two federal policies provide oversight for research involving people. One is the so-called Common Rule, which applies to the majority of human studies that are performed or funded by the federal government. The other is the set of regulations issued by the US Food and Drug Administration (FDA) that apply to human tests of drugs, devices and biological products such as vaccines regardless of funding source. Some clinical trials are subject to only one of these regulations; others are governed by both. However, some privately funded trials are neither subject to oversight by the FDA nor the Common Rule.

A team led by Deborah Zarin, director of the site ClinicalTrials.gov—a federal registry of publicly and privately funded human trials—decided to find out just how many active trials fall into each of the various categories of oversight. The researchers compiled a list of some 24,000 US-based clinical trials that were listed as active in that database as of 13 September 2013, and estimated that at least 19% of the sampled trials were covered by both policies. Furthermore, between 1,285 and 3,696 trials, or approximately 5%–16%, were not subject to the Common Rule or the FDA, because they weren’t federally funded and didn’t involve drugs, devices or biologics. “That might include things like surgical interventions,” Zarin says.

The unregulated trials raise concerns for human safety, says Robert Califf, vice chancellor for clinical research at Duke University in Durham, North Carolina. “Put yourself in the shoes of a person that volunteers for a study,” he says. “I think most people would agree it would be good to make sure that there’s an encompassing system so you can be assured that the institution that’s conducting the trial has agreed to a common set of rules about how human studies should be done.”

At the same time that Zarin voices concern about studies falling outside the regulatory domain of both the FDA and Common Rule, she says it’s not ideal for trials to be subject to oversight by both rules. This double oversight, according to Zarin, could create a potential burden to researchers due to differences in reporting requirements and extra paperwork: “When people consider possible changes to the regulatory framework, these are the kinds of things that should be thought about.”

Source

Insurers, Medicaid fear multibillion-dollar hepatitis C drug tab

BY CAROLINE HUMER
Tue Mar 4, 2014 10:58pm GMT

(Reuters) - U.S. health insurers are seeking help from state health officials to foot the bill for a new generation of hepatitis C treatments that could cost the nation $200 billion or more in the next five years.

Several insurers, including Molina Healthcare, which administer health plans for California's Medicaid program for the poor are asking states to step in and pay for Gilead Sciences Inc's Sovaldi, a drug that costs $84,000 per patient. The wrangling has reopened a national debate on how much the United States can afford to spend on the newest, costliest medications.

California, home to more than 9 million of the 62 million people who receive Medicaid benefits nationally, said it is still considering policies on how to reimburse for these new drugs. It is looking both at Sovaldi and a combination of the drug with Olysio from Johnson & Johnson.

Gilead and some health experts argue that the high price represents a worthwhile tradeoff, since the new treatments for the first time can cure nearly all patients who adhere to the 12-week course of drugs. That can help millions of Americans avoid repeated treatment with other therapies, as well as the more serious consequences of liver disease.

"Government systems ... will bear the long-term medical costs of liver cancer, liver failure and transplant, and therefore are the systems that will benefit most from the availability of new therapies for (hepatitis C)," Gregg Alton, executive vice president of corporate and medical affairs at Gilead, said in a statement.

At the same time, state and federally funded Medicaid programs have been straining under a slow economic recovery, repeated budget cuts and rising public-sector costs.

"The challenge is providing the most appropriate treatment for medical members that is also fiscally sound," said Tony Cava, a spokesman with the California Department of Healthcare Services in Sacramento. Cava said in a phone interview that the department received requests to separate, or carve out, the medication from several insurers' plans. Instead, patients would be reimbursed directly by the state for any drug costs.

As many as 3.2 million U.S. patients have hepatitis C. It can take 20 to 30 years for the virus to develop into more serious health problems such as cirrhosis or liver cancer and is the main cause of liver transplants.

Sovaldi was approved in December by the U.S. Food and Drug Administration. AbbVie Inc and Bristol-Myers Squibb Co have developed oral treatments for hepatitis C with cure rates in excess of 90 percent. They are expected on the market over the next year, while Merck & Co and Vertex Pharmaceuticals are also working on new therapies.

Sovaldi's price tag has made headlines, but the actual cost can be higher in many cases. Some patients must take the drug for longer than 12 weeks or require a combination of other drugs for it to be most effective.

Many doctors are requesting a $150,000 combination of Sovaldi (sofosbuvir) and Olysio (simeprevir). The FDA is expected to decide later this year on a Gilead combination drug that will have a similar effect.

A METEOR OUT OF THE SKY

Camilla Graham, co-director of the viral hepatitis center at Beth Israel Deaconess Medical Center at Harvard Medical School, fears that insurers will restrict the treatments.

"There is probably some price point where we as a society say we can afford to treat everyone with hepatitis C, like currently we say everyone needs to be treated with HIV," she said in a phone interview.

Graham estimates that treating two-thirds of U.S. hepatitis C patients at about $100,000 each would cost the country $200 billion. Doctors expect the disease to peak in 2019 or 2020.

Insurers that manage Medicaid plans, including HealthNet Inc, WellPoint Inc and Aetna Inc, say they are talking to the state-based agencies about how to manage these costs. The fear is that the true number of people infected with the virus is not known, making it hard to gauge whether they will lose money by covering the new drug costs.

Molina is based in California and has nearly 2 million Medicaid members nationwide. It has asked for carve-outs, or direct government reimbursements outside of its contracts in all of its 11 states, which also include Texas and Florida.

"The drug was approved in December and it was not factored into our rates for 2014. We are going back to the states and saying, 'How do you want us to handle this?'" said Chief Executive J. Mario Molina in a phone interview.

Medicaid programs nationwide are so far holding off on deciding. They are more likely to allow insurers to renegotiate contracts or build in additional payments based on the risk profiles of Medicaid recipients than turn to carve-outs, Matt Salo, executive director of the National Association of Medicaid directors said in a phone interview.

"We are sensitive to the potential that this is a meteor falling out of the sky and devastating a business model (for insurers) ... but I don't think we are there yet," Salo said.

WellPoint spokeswoman Jill Becher said in a statement that the Sovaldi approval was not included when it negotiated its Medicaid contracts or set rates in its commercial business. The company is covering the Sovaldi and Olysio combination for members with advanced liver disease.

Aetna is paying claims now on Sovaldi and said it will adjust guidelines as the other new drugs come onto the market. It is negotiating Medicaid coverage of the drug on a state-by-state basis.

Ed Pezalla, Aetna's national medical director of pharmaceutical policy, said in a phone interview that insurers are facing a deluge of hepatitis C patients as screening efforts for the disease ramp up, while people already diagnosed had been waiting for an easier-to-tolerate treatment.

Richard Esnard, a 73-year old retired policeman who lives in Rockland County, New York, is part of the early wave of patients who waited for Sovaldi after having failed to be cured in a clinical trial several years ago.

"After the clinical trial ended, there was a long period of time for me to recuperate and then in the interim these drugs became approved," Esnard said in a phone interview. He has a $15 co-pay for each of the three drugs he takes in combination: Sovaldi, Olysio and older drug ribavarin. The rest is covered by his primary and secondary Medicare plans as treatment for his advanced liver disease. "I'm lucky in that way," he said.

U.S. health officials have recommended that all baby boomers born between 1945 and 1965 be screened for the virus, estimating that more than 2 million of them may be infected.

(Reporting by Caroline Humer; Editing by Michele Gershberg and Jonathan Oatis)

Source

Your Liver Delivers Protect It From Harm

Provided by NIH News in Health

March 2014

Your liver works hard to protect your health. It’s a rugged, strong organ. But certain things—like alcohol, drugs, viruses, and excess weight—can damage it. You may not even realize when your liver is struggling, because liver disease usually has no symptoms until the problem becomes severe. Help your liver to guard your health by avoiding the things that might cause it harm.

The liver is the largest organ inside your body. It’s about the size of a football, and rests just under your ribs against the right side of your stomach.

“The liver performs an amazing set of functions that keep you healthy,” says Dr. Jake Liang, a liver specialist and researcher at NIH.

Your liver helps fight infections. It cleans your blood by getting rid of your body’s natural waste products and other harmful substances, including alcohol and drugs. “The liver also transforms the foods you eat into energy and nutrients your body can use, and it regulates how nutrients flow to different parts of the body when needed,” Liang says.

Your liver can keep working even if part of it is damaged or removed. But if it starts to shut down completely—a condition known as liver failure—you can survive for only a day or 2 unless you get emergency treatment.

Many things can affect liver function. Some liver problems are inherited from your parents, some are caused by viruses (certain kinds of hepatitis), and some are related to your behavior. Certain liver diseases go away on their own. Others can last a lifetime and cause serious illness.

Although liver disease often has no symptoms, warning signs can include a swollen abdomen, nausea, itching, or jaundice (having a yellow tint to the skin and the whites of the eyes).

NIH supports large research networks across the country to learn more about liver disease. For instance, teams of scientists nationwide have joined forces to study rare and often-deadly liver disorders that strike newborns and older children.

“Research networks are important because no single medical center has enough patients with rare diseases to do a rigorous study or test new treatments,” says Dr. Edward Doo, a liver disease expert at NIH. “With this large pediatric network, we can combine the efforts and expertise of many clinical centers that specialize in rare childhood liver diseases.”

Other NIH studies are focusing on an increasingly common type of liver disorder—known as fatty liver disease—that affects both children and adults. A healthy liver contains just a little fat or none at all. But too much fat buildup in liver cells can cause swelling and damage. Over time, the excess fat can lead to cirrhosis, liver cancer, and even liver failure.

“Estimates vary, but 2 different studies in the past decade suggest that about 30% to 45% of Americans have excess fat in the liver,” says Dr. Yaron Rotman, an NIH specialist in fatty liver disease. “It’s also becoming a huge problem for children and teens.”

Drinking too much alcohol can cause fatty liver. But a growing number of people who drink little or no alcohol are also being diagnosed with fatty liver. “The rise seems to be tied to the nation’s obesity epidemic,” says Doo.

Studies suggest that fatty liver disease now also affects about 1 in 10 children nationwide. As with adults, most children with fatty liver disease are overweight and resistant to insulin, a critical hormone that regulates energy.

In its early stages, fatty liver disease usually has no symptoms. It’s often first detected by blood tests for liver function. But these tests can’t tell the difference between mild fatty buildup and more serious damage. And some people with fatty liver disease can have normal blood tests. The only sure way to diagnose the severity of fatty liver disease is by getting a liver biopsy. For this test, a doctor inserts a thin needle through the skin and into the liver to remove a small piece of tissue for analysis.

NIH-funded scientists have been searching for simpler ways to measure the severity of fatty liver disease. They’re also conducting clinical studies to assess possible treatments. There are currently no approved medications for fatty liver or its more severe form called NASH, or non-alcoholic steato-hepatitis.

“To treat fatty liver disease, we recommend lifestyle changes: Weight loss for people who are overweight, and exercise and a healthy diet to help reduce fat,” Rotman says. “In many patients, just a 5-8% reduction in body weight will translate into a large improvement to liver damage.” For people with alcohol-related fatty liver, stopping alcohol use can reverse or prevent further liver injury.

Another common type of liver disease—known as viral hepatitis—can be caused by at least 5 different viruses, named hepatitis A, B, C, D, and E. These infections can injure your liver and keep it from working properly.

“Collectively, about 20% of people worldwide may be affected by a hepatitis virus infection,” Liang says. “It’s a major public health problem.” The most common types in the United States are hepatitis A, B, and C.

Each hepatitis virus causes a different form of liver disease. All the viruses can trigger acute, or short-term, hepatitis. Hepatitis B, C, and D can also cause chronic hepatitis, in which the infection lasts a long time, sometimes for your whole life.

People are often exposed to hepatitis A and E viruses through contaminated food or water. “The other hepatitis viruses often pass through some type of break in the skin barrier, sometimes by injections or by close contact with blood or other body fluids,” Liang adds. Hepatitis B, C, and D can spread through sexual contact.

Because many infected people have few symptoms, they may not realize they have viral hepatitis. They can spread the infection to others without even knowing it.

Viral hepatitis is often treated with antiviral medications. Hepatitis A, B, and D infections can be prevented by vaccines. Practicing good hygiene—such as washing your hands and avoiding contact with infected blood—can also help block the spread of viral hepatitis.

Another potentially dangerous type of liver disease can be caused by taking certain drugs or supplements. “It’s important to be aware that a lot of drugs can cause liver injury,” Liang says. “This especially can be a problem for people who are taking several different medications.”

Taking too much acetaminophen (Tylenol) is the most common cause of sudden liver failure. “It’s particularly dangerous if you mix alcohol with acetaminophen or certain other drugs,” Liang adds. Talk with your doctor or pharmacist about all the medications you take and how they might affect your liver.

Maintain a healthy weight, stay physically active, and limit your alcohol use. Keep your liver healthy, and it will protect you for a lifetime.

Source

All-Oral HCV Regimen Works in 9 Out of 10: Daclatasvir+Asunaprevir+BMS-791325 – CROI 2014

Published: Mar 4, 2014
By Ed Susman , Contributing Writer, MedPage Today

BOSTON -- An all-oral, 12-week regimen appears to successfully treat hepatitis C virus (HCV) infection in about 90% of patients, researchers reported here.

Of the 166 treatment-naive patients in the study, 92% achieved a sustained virologic response at 12 weeks (SVR-12) on the combination of the investigative NS5A inhibitor daclatasvir, the protease inhibitor asunaprevir and the non-nucleoside BMS-791325, said Trevor Hawkins, MD, chief medical officer at Southwest CARE Center and professor of medicine at the University of New Mexico in Santa Fe.

"The observed analysis showed a 92% SVR₁₂, and in the modified intent-to-treat analysis -- wherein data at week 12 is counted as failure if it is missing -- [it] was 89%," Hawkins toldMedPage Today at the annual Conference on Retroviruses and Opportunistic Infections.

A cure in the context of HCV is a sustained virologic response (SVR) -- defined as undetectable viral RNA at some prespecified point after ending therapy, usually 12 or 24 weeks.

At the end of treatment in Hawkins' study, 97.5% of those in the low-dose BMS-971325 group showed a complete viral response compared with 94.2% of those taking the high dose; the SVR₄ was 92.4% in the low-dose group and 91.7% in the high-dose-treated patients. The SVR₁₂was achieved by 92.2% in the low-dose treatment group and by 91.7% of those taking high-dose BMS-791325, the researchers reported.

In the trial, Hawkins said that 9% of the patients were diagnosed with cirrhosis. He said that there did not appear to be a difference in outcome among the cirrhotic patients compared with those who were not cirrhotic -- 13 of the 15 cirrhotic patients achieved an SVR₁₂.

Hawkins said that the next trials -- called UNITY 1 and UNITY 2 -- will separate cirrhotic and noncirrhotic patients to examine if there are differences in outcomes depending on the extent of liver disease. These trials will use the 75-mg dose of BMS-791325.

The trial he reported here showed that patients were able to tolerate the regimen. "There were two discontinuations due to adverse events in the entire 166-patient cohort," he said at a press conference.

The patients diagnosed with HCV genotype 1 were randomly assigned to receive a twice-daily regimen of daclatasvir 30 mg, asunaprevir 200 mg and BMS-791325 at 75 mg or 150 mg for 12 weeks. Hawkins said outcomes were similar for the 80 patients on BMS-791325 given 75 mg twice daily and the 86 patients given BMS-791325 at a dose of 150 mg twice daily.

"There were 11 virologic failures and we attempted to find out if there were any predictors of failure," he said. "The only thing that appeared to predict failure was being of genotype 1a. We tried to determine if there were any polymorphisms at baseline that would predict virologic failure, but we were unable to do that. There really was no obvious correlation."

In pilot studies, the 24-week SVR was 94% and the 12-week SVR was 94% with use of the 75-mg dose of BMS-791325; with the 150-mg dose, the 24-week SVR was 94% and the 12- week SVR was 89%.

The patients were about 54 years old, 67% were men, 83% were white, 82% were genotype 1a, and 15 patients in the study -- 9% -- were diagnosed with cirrhosis.

"This looks good," press conference moderator Jean-Michel Pawlotsky, MD, of the Hôpital Henri Mondor Creteil/University of Paris-Est, told MedPage Today. "There are several potential combinations that are going to work in patients with HCV. This combination with three drugs has good potency and a high barrier to resistance. This is promising."

The study was sponsored by Bristol-Myers Squibb.

Hawkins disclosed commercial interests with Gilead, Janssen, AbbVie, Bristol-Myers Squibb, BMS, Vertex, GlaxoSmithKline, Sangamo, Salix, Merck and ViiV. Co-authors include Bristol-Myers Squibb employees.

Pawlotsky had no disclosures.

Source

HIV No Bar to HCV Therapy With New Agents

Published: Mar 4, 2014

By Michael Smith, North American Correspondent, MedPage Today

BOSTON -- New drugs for hepatitis C mean HIV co-infection is no longer a barrier to successful HCV treatment, researchers said here.

Three studies using different medications in co-infected patients all found cure rates similar to the same drugs in people who had only HCV, according to Douglas Dieterich, MD, of Mount Sinai Hospital in New York City.

"All of these drugs work remarkably well in co-infection," Dieterich told reporters at the annual Conference on Retroviruses and Opportunistic Infections.

Dieterich presented some details of phase III studies of faldaprevir, an investigational HCV protease inhibitor used with pegylated interferon-alfa and ribavirin; simeprevir (Olysio), a protease inhibitor approved for use with interferon and ribavirin; and sofosbuvir, an HCV NS5B inhibitor used with ribavirin.

All three medications are "direct-acting agents" -- they target aspects of viral replication, in contrast to interferon, which boosts the patient's immune system, and ribavirin, which is a general antiviral drug.

In all three studies, Dieterich said, the rate of cure was "exactly the same in co-infected patients as they are in mono-infected patients." A cure in the context of HCV is a sustained virologic response (SVR) -- defined as undetectable viral RNA at some prespecified point after ending therapy, usually 12 or 24 weeks.

The results of the trials are "good news" but not entirely surprising, commented Jean-Michel Pawlotsky, MD, PhD, of Henri Mondor University Hospital in Créteil, France, who moderated a press conference at which some details were presented.

Investigators had been seeing similar results with the first approved direct-acting agents, the protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis), Pawlotsky told MedPage Today.

But treatment just with peginterferon and ribavirin -- for years the only available HCV therapy -- was more difficult for people who also had HIV. "The main difference was due to interferon," Pawlotsky said. "These patients were not responding well to interferon."

One implication, he said, is that in the future, separate trials in co-infected patients might not be needed in order to get approval for new direct-acting agents.

"A trial in mono-infected patients might lead to approval for co-infected patients as well," he said.

Dieterich said the so-called STARTVerso4 was intended to test the efficacy and safety of two different doses of faldaprevir, in combination with peginterferon and ribavirin, in 308 patients with genotype 1 of HCV.

Almost all the patients -- 96% -- were also on highly active antiretroviral therapy for HIV.

The overall SVR rate 12 weeks after the end of treatment (SVR₁₂), he said, was 72% and did not differ significantly between the two doses; phase III results in mono-infected patients were about 80%.

The simeprevir trial (dubbed Study C212) was also investigating the safety and efficacy of the drug among 108 HIV patients with genotype 1 HCV. The drug is approved for mono-infected patients.

In the trials used to support approval, the SVR rates were about 80% in treatment-naive and previously treated but relapsed patients, although they were lower -- 53% to 65% -- among patients who responded either partly or not at all to therapy with peginterferon and ribavirin.

In the co-infected cohort, Dieterich said, the SVR₁₂ rate was 74%. Interestingly, a mutation that usually predicts poor response to interferon -- the Q80K polymorphism -- had no effect, he said, although its presence made a significant difference among mono-infected patients.

In both studies, the drugs were well-tolerated, he said, and the safety profile was similar to what has been seen in mono-infected patients, with most of the adverse events related to interferon.

The final study, dubbed PHOTON-1, looked at sofosbuvir and ribavirin in 223 co-infected patients with several HCV genotypes and differing treatment status.

But overall, he said, SVR12 rates ranged from 70% to 90%, depending on genotype, and in most cases were "exactly the same as in mono-infected patients." SVR₂₄ rates did not change, except for one patient with genotype 1 who appeared to be re-infected after achieving SVR₁₂.

The regimen, he noted, is the first interferon-free regimen to be tested in HIV/HCV co-infected patients.

The regimen was well-tolerated, he said, with only a handful of patients stopping treatment owing to adverse events.

Source

SVR12 results from a phase IIa study evaluating Simeprevir and Daclatasvir in Hepatitis C patients of genotype 1 have been presented at CROI 2014

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that study results from a phase IIa trial evaluating simeprevir, a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, in combination with daclatasvir, an investigational once-daily NS5A inhibitor developed by Bristol-Myers Squibb (NYSE: BMY), with and without ribavirin, in patients with hepatitis C (HCV) genotype 1 infection, have been presented at the 21th Conference on Retroviruses and Opportunistic Infections (CROI) on March 4th in Boston, USA. The study was conducted by Bristol-Myers Squibb.

Data from the study demonstrate that sustained virologic response 12 weeks after the end of treatment (SVR12) was reached in 75 to 85 percent of treatment-naïve patients and 65 to 95 percent of prior null responders with HCV genotype 1b after 12 or 24 weeks of treatment.

“We are pleased to report on the successfully completed exploratory phase IIa clinical trial of simeprevir and daclatasvir. The results are promising, but further studies would be required in order to fully assess the potential of the simeprevir/daclatasvir combination.” says Charlotte Edenius, EVP Development, Medivir AB.

Study Design
In this phase IIa open-label study, HCV genotype 1b treatment-naive patients (N=104) and prior null responders (N=43) were randomly assigned (1:1) to receive daclatasvir 30mg QD + simeprevir 150mg QD with or without ribavirin. Two treatment durations were evaluated: patients who completed 12 weeks treatment were re-randomized (1:1) to stop at Week 12 orcontinue treatment through Week 24.

In an exploratory evaluation of HCV genotype 1a patients, treatment naive (N=12) and prior null responder patients (N=9) received daclatasvir + simeprevir + ribavirin for 24 weeks.

Summary – Efficacy
In treatment-naïve HCV genotype 1b patients SVR12 was achieved by 75% (38/51) and 85% (45/53) when treated with simeprevir and daclatasvir, with or without ribavirin, respectively. In HCV genotype 1b prior null responders SVR12 was achieved by 95% (19/20) and 65% (15/23) with or without ribavirin, respectively. Estimated SVR12 rates in HCV genotype 1b patients (adjusted for pre-Week 12 discontinuations) were similar after 12 or 24 weeks of treatment in naive patients but higher after 12 than 24 weeks in prior null responders.

In treatment-naïve HCV genotype 1a patients 67% (8/12) achieved SVR12. All HCV genotype 1a prior null responders were offered pegylated interferon alfa-2a in addition to ribavirin + daclatasvir + simeprevir as rescue therapy due to frequent on-treatment breakthroughs and were counted as treatment failures.

Overall, patients were 92% white, 49% male, 21% cirrhotic, and 76% IL28B non-CC genotype and were well-balanced across treatment groups.

Summary - Safety
The all-oral combination of daclatasvir plus simeprevir, with and without ribavirin, was generally well tolerated. There were two treatment-related serious adverse events (neurotoxicity, liver disorder) and one on-treatment death (unrelated trauma-associated intracranial hematoma). Three patients experienced treatment-related adverse events leading to discontinuation. Seventeen patients experienced grade 3/4 total bilirubin elevations without concurrent transaminase elevations, mostly in patients receiving ribavirin (14/17), consistent with ribavirin-induced hemolysis and known effects of simeprevir on bilirubin transporters.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 18.15 CET on 4 March 2014.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Medivir and Janssen R&D Ireland for the treatment of chronic hepatitis C infection in combination with other antivirals in hepatitis C genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.

Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in the USA and Canada in November. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 and and genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.

About Daclatasvir
Daclatasvir is an investigational NS5A replication complex inhibitor that has been studied in more than 5,500 patients to date as a foundational agent for multiple direct-acting antiviral-based combination therapies and is currently in phase III development. Daclatasvir has shown antiviral potency and pan-genotypic activity across hepatitis C genotypes in vitro. Daclatasvir has a drug-drug interaction profile that supports its continued study in a variety of hepatitis C combination regimens. Daclatasvir-based regimens are currently under review by regulatory authorities in Japan and Europe.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir AB, please visit the Company’s website: www.medivir.com

Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people’s lives.

Source

The face of liver disease could be your own

March 4, 2014 5:59 AM

Canadian Liver Foundation urges Canadians to 'face facts' and recognize own risk factors

TORONTO, March 4, 2014 /CNW/ - Most Canadians are oblivious to their own risks of developing liver disease. Unfortunately, this 'who me?' attitude is leading to a rise in complications and deaths due to advanced liver disease. To help change attitudes, the Canadian Liver Foundation is using Liver Health Month to urge Canadians to recognize that liver disease may have many faces - even their own or someone they love.

"If you were to ask people on the street if they thought they needed to worry about liver disease, the answer would typically be 'no'," says Gary Fagan, president of the Canadian Liver Foundation. "This is alarming because liver disease is a much bigger issue in this country than anyone realizes. Unfortunately people don't understand their own risk factors and few have ever been tested."

The Canadian Liver Foundation is launching a campaign called 'Face it' to promote the facts about liver disease and show Canadians that the 'face' of liver disease might be more familiar than they think. The 'Face It' campaign will use social media to promote liver disease facts under the hashtag #faceliverdisease and will encourage people to visit www.liver.ca/facefacts to learn how to protect themselves and their families.

Currently fatty liver disease, hepatitis B, hepatitis C, liver cancer and alcoholic liver disease are the most common forms of liver disease in Canada. According to the CLF's report, Liver Disease: A Crisis in the Making, deaths from liver disease have risen by almost 30% in a period of only eight years.

"Liver disease is often overlooked and yet every week there are children, teens and adults who are diagnosed with genetic, autoimmune, viral, toxin or obesity-related liver disease," says Mr. Fagan. "There are simple blood tests that can detect problems with the liver but we hear countless stories from people that were stunned to find out they had severe liver disease despite having few, if any, symptoms," says Mr. Fagan. "We want people to face the facts about liver disease before it's too late."

Throughout the month of March, several leading health and wellness experts -- Rose Reisman, Theresa Albert, Bryce Wylde, Stephanie Joanne and Tosca Reno -- will be lending their support to the campaign by helping to dispel the myths and offering liver health advice.

"People are always flabbergasted to learn how many different things can impact your liver health - not the least of which being what you eat," says Theresa Albert, nutritionist, author and member of the CLF's National Board. "One of the best ways to get people thinking beyond the stereotype is asking them 'have you ever'  or ' do you ever' questions about diet,  medication, body art, sex, travel and so on. Once people see how the liver plays a vital role in day-to-day life, they're a step closer to taking action to protect their liver health."

For more information on the Face It campaign and Liver Health Month activities, visit www.liver.ca/facefacts

About the Canadian Liver Foundation
Founded in 1969 by a group of doctors and business leaders concerned about the increasing incidence of liver disease, the Canadian Liver Foundation (CLF) was the first organization in the world devoted to providing support for research and education into the causes, diagnoses, prevention and treatment of all liver disease. Through its chapters across the country, the CLF strives to promote liver health, improve public awareness and understanding of liver disease, raise funds for research and provide support to individuals affected by liver disease.

SOURCE Canadian Liver Foundation

For further information:

Melanie Kearns
416-491-3353 ext. 4923
mkearns@liver.ca

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