International Liver Congress Media Site

New real world data show sofosbuvir/daclatasvir combination is an effective treatment option for difficult-to-treat hepatitis C patients

Zoe Sycamore — Sat, 25 Apr 2015 05:02:31 +0000

Study looks into further treatment option amongst hepatitis C virus genotype-1 mono-infected patients

April 25, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015 show that the sofosbuvir (SOF)/daclatasvir (DCV) treatment combination is effective amongst hepatitis C virus (HCV) genotype-1 mono-infected patients. These results are significant because whilst other combinations have been widely reported on, there have been few data until now regarding the use of SOF/DCV combination in real world situations.

Overall, the sustained virologic response rate at 4 weeks (SVR4) for SOF/DCV was 81.6% after 12 weeks of treatment and 93.9% following 24 weeks of treatment. The SVR4 rate for SOF/DCV with ribavirin (RBV) was 100% and 96.6% after 12 and 24 weeks, respectively. The 12-week combination of SOF/DCV/RBV achieved a 100% SVR4 rate in cirrhotic patients without the additive effect of extension of the treatment to 24 weeks with or without RBV (95.7% and 92.5%, respectively), and this was also true in experienced patients. All non-cirrhotic patients achieved 100% SVR4 at 12 weeks, demonstrating that the 12-week combination of SOF/DCV is a proven therapeutic option. Importantly, the SVR12 rate was 100% for SOF/DCV/RBV after both 12 and 24 weeks.

“The cohort study has found that the sofosbuvir/daclatasvir combination is associated with a high rate of SVR4 in difficult-to-treat patients infected by genotype-1 hepatitis C. We also found that the combination with ribavirin increases the SVR rate in cirrhotic or experienced patients without the additive effect of the extension of the treatment from 12 to 24 weeks. We hope that this helps support further treatment options for difficult-to-treat patients,” said Professor Stanislas Pol, Hôpital Cochin, Paris, France, principal investigator of the French ANRS CO-22 Hepather cohort.

409 HCV genotype-1 mono-infected patients were given a combination of SOF (400 mg/d) and DCV (60 mg/d) without ribavirin (n=318) or with ribavirin (1-1.2 g/d, n=91). 318 patients had cirrhosis and 306 were previously treated with peginterferon-ribavirin (PR) (n=134) or PR + a first generation protease inhibitor (PI) (n=172).

“This study shows very positive results for hepatitis C genotype-1 mono-infected patients. This is one of the first real-life studies looking into sofosbuvir/daclatasvir combinations and has demonstrated that this is a good therapeutic option for these patients. It represents another treatment option to help patients beat hepatitis C,” said Professor Tom Hemming Karlsen, Scientific Committee Member, European Association for the Study of the Liver.

Serious adverse events were reported in 9% of patients and treatment discontinuation related to adverse events in 3.1%.

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 (www.easl.eu)
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
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Late breakers, Hall D
Presentation time: 16:30-16:45
Presenter: Stanislas Pol (France)
Abstract LB3: SAFETY AND EFFICACY OF THE COMBINATION DACLATASVIR-SOFOSBUVIR IN HCV GENOTYPE 1-MONO-INFECTED PATIENTS FROM THE FRENCH OBSERVATIONAL COHORT ANRS CO22 HEPATHER*

Researchers highlight need for better evidence to guide European efforts to increase hepatitis B and C testing

Zoe Sycamore — Sat, 25 Apr 2015 05:02:02 +0000

Review presented at The International Liver Congress^TM 2015 documents lack of information about hepatitis B and C testing in many countries

April 25, 2015, Vienna, Austria: The apparent dearth of research on hepatitis B and C testing in many European countries could be hampering efforts to identify infected individuals, according to results from a comprehensive review of 136 studies presented today at The International Liver CongressTM 2015.

The systematic review concluded that the current evidence base on hepatitis B and C testing appears to be lacking in many European countries. At present it is informed primarily by published articles and conference abstracts from just 6 out of 53 member countries of the World Health Organization (WHO) European Region: Turkey, Germany, Italy, France, the Netherlands and the United Kingdom.

The results indicate that some high-risk populations have been studied much more than others, but mostly only in a small number of countries. The results also appear to show high median testing uptake levels across Europe. However, since almost all of the studies used methodologies that required or encouraged study participants to undergo testing, high median testing uptake levels are not likely to be representative of the overall testing uptake in most populations.

“It’s clear from our review that there are crucial gaps in our knowledge on hepatitis B and C testing – we do not yet have enough information to plan effective public health responses in Europe,” commented Professor Jeffrey Lazarus, Professor of International Health Systems at Copenhagen University, Denmark. “Our research team is particularly concerned about the low numbers of published studies looking at migrants, prison inmates and men who have sex with men – all populations that might benefit greatly from targeted hepatitis testing interventions.”

Professor Tom Hemming Karlsen, Scientific Committee Member, European Association for the Study of the Liver, added: “Viruses that affect the liver, such as hepatitis B and C, can cause real problems if not identified and treated early. We need to raise awareness of the threat posed by these viruses and actively encourage testing across Europe. This is not only vital to diagnosis and treatment but also to prevention – to stopping the viruses spreading through populations and generations to come.”

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EU Public Health, Hall C
Presentation time: 12:45-13:00
Presenter: Jeffrey Lazarus (Denmark)
Abstract O0125: A SYSTEMATIC REVIEW OF HEPATITIS B AND C TESTING IN THE COUNTRIES OF THE WHO EUROPEAN REGION

Sofosbuvir + peginterferon/ribavirin for 12 weeks demonstrates strongest sustained virologic response rates in genotype-3 hepatitis C patients

Zoe Sycamore — Sat, 25 Apr 2015 05:01:33 +0000

Results from the ground-breaking new BOSON study

April 25, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015 demonstrate that hepatitis C (HCV)-infected genotype-3 (GT-3) patients, with and without cirrhosis, receiving 24 weeks of sofosbuvir (SOF) in combination with ribavirin (RBV) and peginterferon (PEG) achieved the highest sustained virologic response rates at 12 weeks (SVR12), observed in a Phase 3 study, to date.

Among GT-3 patients, SVR12 rates were highest in those receiving SOF+PEG/RBV for 12 weeks (93%) as compared to SOF+RBV for 24 (84%, p = 0.008) or 16 weeks (71%, p <0.001). “Sofosbuvir in combination with ribavirin and with and without peginterferon have never been directly compared before to determine sustained virologic response 12 weeks after treatment. This study highlights that sofosbuvir with ribavirin and peginterferon should be considered for interferon-eligible GT-3 patients, particularly for those with cirrhosis and/or prior treatment failure,” said Graham Foster, Professor of Hepatology, Queen Marys University of London, UK. Of 592 patients randomised and treated, 92% had GT-3 HCV, 67% were male, 84% white, 53% treatment experienced, 62% had non-CC IL28B genotypes and 37% had cirrhosis. The study also evaluated the safety and efficacy of SOF+PEG/RBV for 12 weeks vs SOF+RBV for 16 or 24 weeks in treatment-experienced genotype-2 (GT-2) HCV-infected patients with cirrhosis. GT-2 treatment-experienced patients with cirrhosis had high SVR12 rates in all treatment arms; 87% of those receiving SOF+RBV for 16 weeks, 100% of those receiving SOF+RBV for 24 weeks and 94% of those receiving SOF+PEG/RBV for 12 weeks. “BOSON is a ground-breaking new study that provides information about how we can ensure the best outcomes for both GT-2 and GT-3 hepatitis C-infected patients. It has confirmed that 24 weeks is the optimal duration for a sofosbuvir and ribavirin combination in GT-3 patients, whilst also finding that sofosbuvir and ribavirin with peginterferon for 12 weeks resulted in the highest SVR12 rates observed to date in a Phase 3 study,” said Professor Tom Hemming Karlsen, Scientific Committee Member, European Association for the Study of the Liver (EASL). 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 (www.easl.eu) 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 Late breakers, Hall D Presentation time: 17:00-17:15 Presenter: Graham Foster (United Kingdom) Abstract L05: SOFOSBUVIR + PEGINTERFERON/RIBAVIRIN FOR 12 WEEKS VS SOFOSBUVIR + RIBAVIRIN FOR 16 OR 24 WEEKS IN GENOTYPE 3 HCV INFECTED PATIENTS AND TREATMENT-EXPERIENCED CIRRHOTIC PATIENTS WITH GENOTYPE 2 HCV: THE BOSON STUDY

Alcohol use disorders are a stronger predictor of mortality than chronic hepatitis C virus infection in the general population

Zoe Sycamore — Sat, 25 Apr 2015 05:01:09 +0000

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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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

Use of direct-antiviral agents helps overcome hepatitis C recurrence in liver transplant patients

Zoe Sycamore — Sat, 25 Apr 2015 05:00:39 +0000

New study showcases efficacy and safety of sofosbuvir and daclatasvir in patients with recurrent hepatitis C

April 25, 2015, Vienna, Austria: New data presented today at The International Liver Congress™ 2015, supports the use of sofosbuvir (SOF)- and daclatasvir (DCV)-based regimens in patients with recurrence of the hepatitis C virus (HCV) following liver transplantation (LT). The results are based on data from patients with HCV being treated with second-generation DAAs in the large French prospective ANRS CO23 CUPILT study. Among them, 296 patients were treated with a combination of SOF+DCV, with or without ribavirin.

SOF- and DCV-based regimens offered high rates of sustained virologic response (SVR) coupled with good tolerance. The presented results focus on 130 patients who achieved SVR12; end of treatment therapy and SVR12 rates are 98% and 96%, respectively.

“The use of interferon-free regimens using DAAs has dramatically improved the management of liver transplant patients infected with HCV. The outstanding efficacy and safety results that sofosbuvir- and daclatasvir-based regimens demonstrated in patients with recurrent hepatitis C are impressive and will help us identify optimal treatment strategies using these new therapies,” said Audrey Coilly, MD, Paul Brousse Hospital, Villejuif.

“HCV recurrence is one of the main complications following liver transplantation and can seriously affect patient survival. So it is very encouraging to see such positive results from this study. We hope it will mean more successful future transplants for people with chronic HCV infection,” said Professor Tom Hemming Karlsen, Scientific Committee Member, European Association for the Study of the Liver.

Serious adverse events were experience by 23% of patients, mainly haematological events in patients treated with ribavirin. Interestingly, attention should be paid to renal function, as a significant decrease has been observed during therapy. Although no drug-drug interaction has been remarked, changes in dosage of immunosuppressive drugs in more than 50% of patients still require close monitoring.

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General session 3, Hall D
Presentation time: 10.15-10.30
Presenter: Audrey Coily (France)
Abstract G15: THE ASSOCIATION OF SOFOSBUVIR AND DACLATASVIR FOR TREATING SEVERE RECURRENCE OF HCV INFECTION AFTER LIVER TRANSPLANTATION: RESULTS FROM A LARGE FRENCH PROSPECTIVE MULTICENTRIC ANRS CO23 CUPILT COHORT

Drinking just one or two alcoholic drinks a day linked to liver disease

Zoe Sycamore — Sat, 25 Apr 2015 04:59:44 +0000

New data highlights why reducing heavy drinking should be considered an important target for public health monitoring and policies

April 25, 2015, Vienna, Austria: According to the World Health Organization, excessive alcohol drinking is the most common cause of cirrhosis worldwide. A new worldwide study presented at The International Liver Congress ^TM 2015 has shown the significant influence of daily drinking on this disease burden. New data shows that the cirrhosis burden caused by alcohol increased by 11.13% when moving from the moderate to heavy daily drinking (up to one drink/day for women; two drinks/day for men) classification (p<.001). Most studies assessing the prevalence of alcohol abuse as a risk factor for alcoholic cirrhosis focus on total annual amount drunk per person. However, the researchers highlight that clinical studies suggest that it is a high daily consumption which is the strongest predictor of alcoholic cirrhosis. This new research concluded that heavy daily drinkers most significantly and independently influence a country’s cirrhosis burden. According to the World Health Organization’s Global Status Report on Alcohol and Health, around 6% of global deaths are caused by drinking alcohol, the majority from alcoholic cirrhosis – scarring of the liver as a result of continuous, long-term liver damage. Half of all cases of cirrhosis are caused by alcohol. The researchers analysed the WHO’s Global Status Report on Alcohol and Health, which included parameters of alcohol consumption and drinking patterns from 193 countries. Reducing heavy drinking should therefore be considered as an important target for public health monitoring and policies. 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 (www.easl.eu) 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 EU and Public Health: Hall C (Plenary) Presentation time: 13:15 – 13:30 Presenter: Eva Stein (United States) Abstract O127: A WORLDWIDE STUDY REVEALS THAT THE AMOUNT OF DAILY ALCOHOL INTAKE IS A BETTER PREDICTOR OF THE WEIGHT OF ALCOHOL IN THE CIRRHOSIS BURDEN THAN THE TOTAL PER CAPITA COMSUMPTION

Use of pocket-sized ultrasound device helps reduce the need for further testing in a variety of clinical settings

Zoe Sycamore — Sat, 25 Apr 2015 04:59:09 +0000

Pocket-sized ultrasound device (PUD) use assists physicians in making more accurate diagnoses

April 25, 2015, Vienna, Austria: Results from a study presented today at The International Liver Congress™ 2015 demonstrate that the use of a pocket-sized ultrasound device (PUD) helps to reduce the need for further testing in both the inpatient and outpatient setting.

The study evaluated the effectiveness of the PUD when testing for the following conditions: biliary-duct dilation, gallstones, ascites, splenomegaly, pleural effusion, pericardial effusion, urinary retention, urinary stones, abdominal mass and aortic aneurysm.

PUDs offer a comparable performance to standard ultrasonography, however the accuracy of a physical examination is often poor meaning that further tests are required. This study assessed whether adding the use of PUD to physical examination could lead to a reduction in the rate of additional tests.

Of the 1,962 patients included in the study:
• 726 (37%) were inpatients, 510 (26%) were hepatology outpatients and 726 (37%) were recruited from GPs
• Gallstones (37%), ascites – excessive accumulation of fluid in the abdominal cavity (17%), pleural effusion (13%), urinary stones (13%) and urinary retention (12%) accounted for more than 90% of the clinical questions, confirmed by PUD in 66% of cases
• The overall frequency of further tests needed after PUD was 37%
• The rate of agreement between findings of the PUD and additional tests was 89%

This study found that after basic training, the use of a PUD offers a simple and effective way to improve the accuracy of diagnosis and reduce the number of tests a patient needs.

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EU and Public Health: Hall C (Plenary)
Presentation time: 11:45 – 12:00
Presenter: Agostino Colli (Italy)
Abstract O121: THE USE OF A POCKET-SIZED ULTRASOUND DEVICE IMPROVES PHYSICAL EXAMINATION: RESULTS OF AN IN- AND OUTPATIENT STUDY

Hepatitis C screening essential to help catch patients with advanced liver fibrosis

Zoe Sycamore — Sat, 25 Apr 2015 04:58:46 +0000

Research validates the current recommendation that screening for hepatitis C, particularly among high-risk groups, is vital

April 25, 2015, Vienna, Austria: Study results presented today at The International Liver Congress™ 2015 show that the occurrence of advanced liver fibrosis is similar for patients infected with the hepatitis C virus (HCV), whether or not they have been diagnosed.

Most individuals with HCV remain asymptomatic, which makes the diagnosis difficult. The study authors used the hypothesis that individuals whose HCV is not diagnosed are less likely to have advanced fibrosis than those who have been diagnosed. They then compared liver fibrosis between respondents of the National Health and Nutrition Examination Survey (NHANES) in the USA, in patients with diagnosed and undiagnosed HCV infection.

Of the respondents with known HCV infection, the proportion with a high, intermediate and low probability of advanced fibrosis was 14.5%, 40.3%, 45.2%, respectively; in those with undiagnosed HCV the results were 19.1%, 30.9%, 50.0%, respectively.

The study highlights that even if people are unaware they are infected with HCV, the virus affects their liver in the same way, resulting in advanced fibrosis. These results validate the current recommendation that screening for HCV, particularly among high-risk groups, is vital.

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EU and Public Health: Hall C (Plenary)
Presentation time: 11:30 – 11:45
Presenter: Prowpanga Udompap (United States)
Abstract O120: ADVANCED FIBROSIS IS COMMON IN INDIVIDUALS WHOSE HEPATITIS C HAS NOT BEEN DIAGNOSED: RESULTS FROM THE NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY 2001-2012

Daclatasvir, sofosbuvir and ribavirin combination is highly effective and well tolerated in hepatitis C patients with advanced cirrhosis or post-liver transplant recurrence

Zoe Sycamore — Sat, 25 Apr 2015 04:58:29 +0000

Results from ALLY-1 confirm combination addresses a high unmet therapeutic need for these patients

April 25, 2015, Vienna , Austria: Phase 3 results presented today at The International Liver Congress™ 2015 show that a combination of daclatasvir (DCV), sofosbuvir (SOF) and ribavirin (RBV) for 12 weeks was effective and well tolerated amongst patients with hepatitis C virus (HCV) infection with advanced cirrhosis and post-transplant recurrence. Sustained virologic response rates at 12 weeks (SVR12) were >90% in patients with Child-Pugh class A or B cirrhosis but lower in Child-Pugh class C. SVR12 was achieved by 94% of liver transplant recipients with HCV recurrence.

ALLY-1 is an open-label study, including treatment-naive or -experienced adults with HCV infection of any genotype.

The most common adverse events (AEs) were headache, fatigue, anaemia, diarrhoea and nausea. There were no treatment-related serious AEs. One post-transplant patient discontinued all therapy after 31 days due to headache but achieved SVR12.

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Late Breakers: Hall D
Presentation time: 17:45 – 18:00
Presenter: Fred Poordad (United States)
Abstract LO8: DACLATASVIR, SOFOSBUVIR, AND RIBAVIRIN COMBINATION FOR HCV PATIENTS WITH ADVANCED CIRRHOSIS OR POSTTRANSPLANT RECURRENCE: PHASE 3 ALLY-1 STUDY

Preliminary findings suggest interferon-free direct-acting antiviral combination is well tolerated in patients with chronic hepatitis C and severe renal impairment or end-stage renal disease

Zoe Sycamore — Fri, 24 Apr 2015 17:44:19 +0000

Safety findings from the ongoing RUBY-1 study evaluating ombitasvir / paritaprevir / ritonavir in combination with dasabuvir (3D) in chronic hepatitis C virus (HCV) genotype 1 (GT1) patients with severe renal impairment or end-stage renal disease

April 25, 2015, Vienna, Austria: Preliminary data from an ongoing study revealed today at The International Liver Congress™ 2015 suggest that a combination of three direct-acting antivirals (DAAs) is well tolerated in patients with severe renal impairment or end-stage renal disease when used either with or without ribavirin. In addition, the combination led to rapid hepatitis C viral load suppression with no virological failures seen in the preliminary data from the ongoing open-label study.

In the study, treatment naïve non-cirrhotic adults with chronic HCV GT1 infection and chronic kidney disease (CKD) classified as stage 4 or stage 5, received 12 weeks of treatment with ombitasvir / paritaprevir / ritonavir and dasabuvir (3D) either with or without ribavirin. There was a 24-week post-treatment follow-up period. As of February 18 2015, 17 of a planned 20 patients in Cohort 1 had received treatment and six had completed treatment. The combination has been well tolerated to date, with no treatment-related serious adverse events, one hemoglobin decline to <8 g/dL, and no premature discontinuations of DAAs. Limited data are available on the safety for treating hepatitis C infection (HCV) in patients with severe renal impairment or end-stage renal disease and many of these patients currently go untreated and are vulnerable to disease progression. 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 (www.easl.eu) 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 Late Breakers: Hall D Presentation time: 18:00-18:15 Presenter: Paul Pockros (United States) Abstract LO1: SAFETY OF OMBITASVIR/PARITAPREVIR/RITONAVIR PLUS DASABUVIR FOR TREATING HCV GT1 INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT OR END-STAGE RENAL DISEASE: THE RUBY-I STUDY

Cancer rates among patients with hepatitis C are significantly increased compared to those not infected

Amy O'Connor — Fri, 24 Apr 2015 05:05:19 +0000

Researchers suggest an extrahepatic manifestation of hepatitis C may be an increased risk of cancer

April 24, 2015, Vienna , Austria: Results announced today at The International Liver Congress^TM 2015 show that cancer rates in patients with the hepatitis C virus (HCV) were significantly increased compared to the non-HCV cohort. The researchers suggest an extrahepatic manifestation of HCV may be an increased risk of cancer.

The aim of the study was to describe the rates of all cancers in the cohort of HCV patients compared to the non-HCV population. Known cancer types associated with hepatitis C include non-Hodgkin’s lymphoma, renal and prostate cancers, as well as liver cancer.

A retrospective study at Kaiser Permanente, Southern California, USA, was conducted. The study authors recorded all cancer diagnoses in patients over 18 years of age with or without HCV during 2008-2012. Within the timeframe of the study 145,210 patient years were included in the HCV cohort, and 13,948,826 patient years were included in the non-HCV cohort.

In the HCV cohort there were 2,213 cancer diagnoses (1,524/100,000) during the 5-year period and 1,654 cancer diagnoses when liver cancer was excluded (1,139/100,000). In the non-HCV cohort there were 84,419 cancer diagnoses (605/100,000) during the same 5-year period and 83,795 (601/100,000) when liver cancer was excluded. When all cancers are considered the rate is 2.5 times higher in the HCV cohort; when liver cancers are excluded, the rate is still almost 2 times higher.

Lisa Nyberg, MD, MPH, Kaiser Permanente, Southern California, senior author of the study, explains: “The results suggest that cancer rates are increased in the cohort of hepatitis C patients versus the non-hepatitis C patients, both including and excluding liver cancers. These findings certainly point to the suggestion that hepatitis C may be associated with an increased risk of cancer. However, the findings must be interpreted with caution, as the study also showed that confounding factors such as alcohol abuse, tobacco, obesity, and diabetes modified the results.”

Dr Laurent Castera, Vice-Secretary, European Association for the Study of the Liver, commented: “This data adds to the evidence bank linking hepatitis C with an increased risk of cancer, and highlights that there is still a long way to go in order to fully understand this complex and devastating disease.”

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Viral Hepatitis C: Clinical, Hall D
Presentation time: 16:30 – 16:45
Presenter: Anders H. Nyberg (United States)
Abstract O058: INCREASED CANCER RATES IN PATIENTS WITH CHRONIC HEPATITIS C: AN ANALYSIS OF THE CANCER REGISTRY IN A LARGE U.S. HEALTH MAINTENANCE ORGANIZATION

Novel therapeutic candidate targets key driver of hepatocellular carcinoma in genomically defined subset of patients

Amy O'Connor — Fri, 24 Apr 2015 05:04:58 +0000

Preclinical data demonstrate that BLU-554 is first potent and selective FGFR4 inhibitor

April 24, 2015, Vienna, Austria: Findings were presented today at The International Liver Congress^TM 2015 on a novel therapeutic candidate for a genomically defined subset of hepatocellular carcinoma (HCC) patients with an aberrant fibroblast growth factor receptor 4 (FGFR4) pathway. BLU-554, a small molecule inhibitor of FGFR4, has been identified as a potential treatment option for up to 30% of HCC patients. In preclinical studies, the investigational drug was shown to be potent and ‘exquisitely selective’ for FGFR4 compared to other kinases targeting the FGFR family.

Overexpression of fibroblast growth factor 19 (FGF19), the ligand for FGFR4, can promote liver tumour formation (as observed in genetically-engineered mice), a process that can be blocked by knocking out the FGFR4 gene. This suggests that FGFR4 inhibition might be an effective treatment strategy in HCC patients whose tumours have an active FGF19/FGFR4 signalling axis.

The study authors found that BLU-554 had significant anti-tumour activity in liver cancer models that are dependent on FGFR4 signalling pathway and was well tolerated at the highest dose level.

Klaus Hoeflich, PhD, Director of Biology at Blueprint Medicines, explains: “HCC is a disease with a high unmet need and no approved genomically targeted therapies. These findings support the investigation of BLU-554 in clinical studies of patients with hepatocellular carcinoma driven by aberrant FGFR4 signalling. By identifying patients most likely to respond to therapy based on the molecular profile of their cancer, we hope to make a meaningful difference for HCC patients.”

With limited treatment options available to patients with HCC, these findings provide a new avenue of hope; Phase I clinical trials with BLU-554 are planned to start in mid-2015.

“Most people are diagnosed with hepatocellular carcinoma once the cancer is at an advanced stage and the outlook is poor. Median survival from time of diagnosis is about six months. Finding new disease drivers and treatment options for patients with hepatocellular carcinoma is critical to make strides against this devastating disease” said Dr Laurent Castera, Vice-Secretary, European Association for the Study of the Liver.

Liver tumours: Clinical, Lehar 1 & 2
Presentation time: 16:00 – 16:15
Presenter: Klaus Hoeflich (United States)
Abstract O048: FIRST SELECTIVE SMALL MOLECULE INHIBITOR OF FGFR4 FOR THE TREATMENT OF HEPATOCELLULAR CARCINOMAS WITH AN ACTIVATED FGFR4 SIGNALING PATHWAY

Once-daily grazoprevir/elbasvir is effective and well-tolerated in patients infected with chronic hepatitis C virus

Amy O'Connor — Fri, 24 Apr 2015 05:04:12 +0000

Positive results from the Phase 3 C-EDGE TN study in treatment-naive patients

April 24, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015 show that a 12-week oral regimen of once-daily single tablet grazoprevir/elbasvir (GZR/EBR) is effective and well-tolerated in treatment-naive (TN) patients infected with chronic hepatitis C virus (HCV) genotypes (GT)-1, -4 or -6, including those with compensated cirrhosis.

Based on preliminary results from 316 GZR/EBR recipients in the immediate treatment arm, 299 patients (95%) achieved a sustained virologic response at 12 weeks (SVR12).

“These initial results show that once-daily grazoprevir/elbasvir offers significant advantages over older treatments, demonstrating the ideal combination of high efficacy with good tolerability and convenience in treatment-naive patients infected with chronic HCV,” said Rajender Reddy, MD, FAASLD Professor of Medicine, Professor of Medicine in Surgery, Director of Hepatology, Medical Director of Liver Transplantation, University of Pennsylvania, USA.

Serious adverse events (AEs) occurred in 9 (3%) and 3 (3%) patients in the active (immediate treatment) and placebo (deferred treatment) arms, respectively.

“Newer antiviral regimens such as the combination of grazoprevir/elbasvir offer much hope to people living with hepatitis C. They have shown great efficacy and tolerability for the treatment of this chronic infection,” said Dr Laurent Castera, Vice-Secretary, European Association for the Study of the Liver.

C-EDGE TN is an international, randomised, blinded, placebo-controlled, parallel-group trial of an oral fixed-dosed combination of GZR 100 mg/EBR 50 mg once-daily in TN patients infected with HCV GT-1, -4 or -6, including cirrhotic and non-cirrhotic patients.

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General Session 2, Hall D
Presentation time: 08:30 – 08:45
Presenter: Stefan Zeuzem (Germany)
Abstract G07: THE PHASE 3 EDGE TREATMENT-NAÏVE (TN) STUDY OF A 12-WEEK ORAL REGIMEN OF GRAZOPREVIR (GZR, MK-5172)/ELBASVIR (EBR, MK-8742) IN PATIENTS WITH CHRONIC HCV GENOTYPE (GT) 1, 4, OR 6 INFECTION

Non-alcoholic steatohepatitis associated with a 50% higher chance of death compared with non-alcoholic fatty liver disease

Amy O'Connor — Fri, 24 Apr 2015 05:03:55 +0000

Large population-based cohort provides important new insights into mortality and cardiovascular disease over the non-alcoholic fatty liver disease spectrum

April 24, 2015, Vienna, Austria: Results from a large population-based cohort of almost a million people in the UK found that the chances of dying from non-alcoholic steatohepatitis (NASH), over a 14-year period, was approximately 50% higher than for those with non-alcoholic fatty liver disease (NAFLD).

Reported today at The International Liver CongressTM 2015, the large study analysed the overall burden of cardiovascular disease and all-cause mortality across the spectrum of NAFLD. The four stages of NAFLD are steatosis (or simple fatty liver), non-alcoholic steatohepatitis (NASH), fibrosis and cirrhosis.

Data from over 900,000 patients in England was obtained from a local computerised hospital activity analysis register. Data was processed to identify patients with NAFLD, NASH and NAFLD cirrhosis throughout the study period. Cardiovascular comorbidities were coded and their prevalence were analysed over 14 years.

During the 14-year study period, 2,701 patients were diagnosed with NAFLD-spectrum conditions: 1,294 with NAFLD, 122 with NASH and 1,285 with cirrhosis. All-cause mortality was higher in people with NASH than NAFLD (22.1% vs 14.5%) and in those with cirrhosis than NAFLD (53.1% vs 14.5%). Congestive cardiac failure was less prevalent in NAFLD than NASH and cirrhosis.

Dr Jake Mann, University of Cambridge, UK, concluded: “Non-alcoholic fatty liver disease is recognised as a risk factor for cardiovascular disease. Our results suggest that non-alcoholic steatohepatitis conveys an even greater risk. This study provides important new insights into mortality and burden of cardiovascular disease in patients across the non-alcoholic fatty liver disease spectrum.”

Dr Laurent Castera, Vice-Secretary, European Association for the Study of the Liver, commented: “In non-alcoholic fatty liver disease, fat builds up in the liver which can cause inflammation and, eventually, lead to permanent scarring. Non-alcoholic fatty liver disease has four stages and these findings clearly link the severity of the disease with the increased risk of cardiovascular disease and death. It is therefore imperative that we identify people in the early stages of non-alcoholic fatty liver disease so they can be treated through diet and lifestyle interventions before their condition becomes potentially deadly.”

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General Session 2, Hall D
Presentation time: 10:15 – 10:30
Presenter: Jake P. Mann (United Kingdom)
Abstract G12: THE BURDEN OF CARDIOVASCULAR DISEASE AND MORTALITY ACROSS A SPECTRUM OF NON-ALCOHOLIC FATTY LIVER DISEASE: A 14-YEAR FOLLOW-UP POPULATION STUDY OF 929,465 INDIVIDUALS

Ledipasvir-sofosbuvir combination proves highly effective in subset of patients with chronic hepatitis C

Amy O'Connor — Fri, 24 Apr 2015 05:03:36 +0000

Simple, ribavirin- and interferon-free, all-oral regimen provides new treatment option for people with hepatitis C, genotypes 4 and 5

April 24, 2015, Vienna, Austria: A new study presented today at The International Liver Congress™ 2015 has demonstrated that ledipasvir (LDV) in combination with sofosbuvir (SOF) achieves sustained virologic response rates 12 weeks after treatment (SVR12; primary endpoint), of 93% and 95% in patients chronically infected with hepatitis C virus (HCV) genotypes 4 or 5, respectively.

In the study, LDV/SOF was administered in a once-daily, fixed-dose combination tablet for 12 weeks to treatment-naive and treatment-experienced patients with or without cirrhosis. A total of 85 patients were enrolled in the study: 44 patients had GT-4 and 41 patients had GT5 chronic HCV infection. SVR12 rates were similar across all patient types.

HCV GT-4 is estimated to account for 8% to 13% and GT-5 for about 1% of all chronic HCV infections globally. Clinical studies evaluating the treatment outcome with new direct-acting antiviral agents in GT-4 and especially GT-5 HCV infection have been limited, to date.

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Viral Hepatitis C: Clinical, Hall D
Presentation time: 16:00 – 16:15
Presenter: Armand Abergel (France)
Abstract O056: LEDIPASVIR/SOFOSBUVIR TREATMENT RESULTS IN HIGH SVR RATES IN PATIENTS WITH CHRONIC GENOTYPE 4 AND 5 HCV INFECTION

Investigational anti-diabetic compound may offer potential for management of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis

Zoe Sycamore — Thu, 23 Apr 2015 05:09:27 +0000

Remogliflozin etabonate shown to reverse insulin resistance and provide anti-oxidant activity

April 23, 2015, Vienna, Austria: Data presented today at The International Liver Congress™ 2015 demonstrates that remogliflozin etabonate, an investigational drug in type 2 diabetes, is a potential treatment option for the management of patients with non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD).

In clinical studies, remogliflozin etabonate was shown to significantly improve insulin sensitivity and beta cell function, as well as reduce body weight and levels of alanine aminotransferase (ALT). In pre-clinical studies, remogliflozin etabonate significantly reduces fat accumulation in the liver and causes a marked reduction in the levels of circulating markers of oxidative stress. Unlike other drugs of its class (SGLT2 inhibitors), remogliflozin etabonate has intrinsic anti-oxidant activity, which may reverse the steatohepatitis and oxidative stress associated with the maintenance and progression of NASH.

The clinical study consisted of 336 treatment-naive subjects with type 2 diabetes and an HbA1c between 7.0% and 9.5%. Subjects were equally randomised to each of the remogliflozin etabonate treatments (50, 100, 250, 500 or 1000 mg twice daily), matching placebo or 30 mg pioglitazone (once daily). At Week 12, remogliflozin etabonate improved insulin sensitivity by 6-33% and beta cell function by 23-43%. Patients receiving remogliflozin etabonate also had significant weight loss (1.4-3.6 kg vs placebo). Importantly, post-hoc analysis of changes in ALT indicated that remogliflozin etabonate-treated subjects with elevated ALT showed statistically significant (p < 0.049) reductions of 32-42% at Week 12 as compared to placebo. “In multiple trials to date, remogliflozin etabonate has been shown to be a safe and potent anti-diabetic compound. In addition to its ability to reverse insulin resistance and cause weight loss, it also uniquely offers intrinsic anti-oxidant activity, which may prove useful in the treatment of patients with NAFLD and NASH,” said William Wilkison, Ph.D., COO, Islet Sciences, Inc. “NAFLD and NASH are both closely associated with diabetes and obesity, and together are now considered the number one cause of liver disease in Western countries. Consequently there is an urgent need for effective treatment options for these diseases. We know that NASH is due, in part, to insulin resistance and oxidative stress resulting from steatosis. Given the mode of action of remogliflozin etabonate, it could potentially offer benefits when treating patients with both NASH and NAFLD,” said Professor Markus Peck, Secretary General, European Association for the Study of the Liver. 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 (www.easl.eu) 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

Genomic analyses point to the potential of personalised care for liver cancer patients

Zoe Sycamore — Thu, 23 Apr 2015 05:08:53 +0000

Use of exome sequencing helps determine which hepatocellular carcinoma patients could benefit from targeted anticancer treatments

April 23, 2015, Vienna, Austria: A new study presented today at The International Liver Congress™ 2015 shows that by using genomic analyses to understand how and when carcinogenic mutations occur in patients with hepatocellular carcinoma (HCC), it is possible to identify specific molecular profiles. It is hoped that these molecular profiles will help identify which patients would benefit from specific anticancer treatments.

Using exome sequencing – a technique for sequencing all the protein-coding genes in a genome – the study identified relationships between environmental exposures, such as tobacco smoke and alcohol use, and mutational patterns in HCC. It also determined the landscape of driver genes and pathways altered in different clinical stages and aetiological backgrounds. Out of eight mutational signatures identified in the study, two new mutational signatures for HCC were found.

Professor Jessica Zucman-Rossi, director of the INSERM/university Paris Descartes “Functional Genomics of Solid Tumors” laboratory explained: “Mutational signatures help with understanding the biological history of a cancer and can enable differentiation between ongoing mutational processes and historical ones. This helps identify potential new targets for anticancer therapies.”

In the study, most patients had at least one damaging alteration which could potentially be treated with either an FDA-approved drug (28% of patients) or an investigational drug (86% of patients) which has been studied in Phase I to Phase III clinical trials.

“Hepatocarcinogenesis is a multi-step process in which pre-cancerous lesions can ultimately transform into liver cancer. Genomic analyses, such as exome sequencing, allow us to better understand the mutational processes involved in the development of cancers. This detailed knowledge then helps us to unravel the mutagenic processes and to optimise personalised patient care,” said Professor Markus Peck, Secretary General, European Association for the Study of the Liver.

The study authors hope that the use of exome sequencing will lead to the identification of potential new targets for anticancer therapy and create optimised personalised patient care.

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 (www.easl.eu)
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

Combination therapy offers new hope for difficult-to-treat patients with chronic hepatitis C

Zoe Sycamore — Thu, 23 Apr 2015 05:08:25 +0000

Preliminary results from the SOLAR 2 trial show that ledipasvir/sofosbuvir in combination with ribavirin is safe and effective in patients with decompensated liver disease or who have undergone liver transplantation

April 23, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015 show that the use of the fixed-dose combination of ledipasvir/sofosbuvir (LDV/SOF) in combination with ribavirin (RBV) was well tolerated and demonstrated high sustained virologic response rates 12 weeks post treatment (SVR12) in patients with chronic hepatitis C virus (HCV) infection who have decompensated liver disease (cirrhosis) or have undergone liver transplantation.

SOLAR 2 data are presented for 328 HCV genotype-1 or -4 treatment-naive or treatment-experienced patients with decompensated liver disease or recurrent HCV following a liver transplant. More than 75 percent of patients in the study were treatment-experienced.

The participants were randomized to receive either 12 or 24 weeks of LDV/SOF plus RBV. Ten patients were excluded from the analysis because of transplantation (n=7) or because they were pre-transplantation, but not decompensated (n=3); an additional 27 of these patients have not yet reached post-treatment week 12. The number and proportion of genotype 1 patients with available data achieving SVR12 are summarized in the table below:

Of the 32 genotype 4 patients, 27 (84%) achieved SVR12. Additionally, among patients with cirrhosis and decompensated cirrhosis before and after liver transplantation, virologic response was associated with improvements in Model for End-Stage Liver Disease (MELD) and CPT scores.

“Current treatment options are limited for HCV patients with decompensated liver disease or in those where the virus persists even after having a liver transplant,” said Professor Michael Manns, Professor and Chairman, Department of Gastroenterology, Hepatology and Endocrinology,
Hannover Medical School, Germany. “We are therefore pleased that the combination of LDV/SOF+RBV has proved to be so effective, and consider this a significant step forward in the management of these difficult-to-treat patients,” he added.

“As we constantly seek to improve the lives of people with chronic HCV, results from trials such as SOLAR 2 give hope to those with an advanced form of the disease such as cirrhosis and disease persisting even after a liver transplant,” said Professor Markus Peck, Secretary General, European Association for the Study of the Liver.
In the study, the most common adverse events were fatigue, anaemia, nausea and headache. Sixty-nine patients (21 percent) experienced serious adverse events (SAEs). Nine patients had SAEs considered to be related treatment-related: anaemia (five), fall, diarrhoea, vomiting and hyperbilirubemia. Six patients have discontinued treatment.

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 (www.easl.eu)
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:
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New survey shows that half of people with hepatitis suffer from discrimination

Zoe Sycamore — Thu, 23 Apr 2015 05:08:09 +0000

Findings reveal the extent to which stigma and discrimination affect those living with viral hepatitis

April 23, 2015, Vienna, Austria: As many as half of people infected with viral hepatitis have suffered discrimination and one-quarter admit that family members have avoided physical contact with them after finding out they had the infection. A shocking patient survey presented at The International Liver CongressTM 2015 has shown the devastating impact the infection has on their daily lives.

Research conducted with the Ministry of Health in Brazil questioned 1,217 people infected with hepatitis B or C in Europe and America using an online survey tool. The aim of the research was to find out, from those infected, when and with what intensity stigma and discrimination affect their quality of life.

The survey revealed that nearly half (49.6%) of those infected have suffered some kind of discrimination. Of the 94.1% who told their family they had the infection, a quarter (24.6%) said that relatives started to avoid physical contact. Furthermore, of the 73.7% who told friends about their condition, nearly half (46.9%) said they suffered discrimination and 23.8% said they were no longer invited to social events.

“Few studies have evaluated the circumstances and the degree to which stigma and discrimination are present for those living with viral hepatitis. This is one of the first studies that listens to the voice of the patient in order to find out from them the context and intensity of stigma and discrimination that they experience and how it affects their quality of life,” said Carlos Varaldo, president of Grupo Otimismo ‘Support Group for People Who Live with Hepatitis’.

Of the 57.4% of those infected with viral hepatitis who told their partner about their condition, 33.3% said it affected their relationship and nearly half (42.7%) said it had an impact on their sex life.

Stigma and discrimination was also found to heavily impact the workplace. Of the 46.1% who told work colleagues, 10.1% lost their jobs. Self-image was affected in 55.8% of the cases and 41.4% said they felt ashamed of their condition.

The survey indicates that 70% of health professionals looked after sufferers properly; however, 24.6% of those health professionals have maintained a certain distance from the patient and 6.9% denied care to people infected with hepatitis, the survey revealed.

“This shocking survey highlights the true toll viral hepatitis can have on people’s lives. Not only are these people dealing with the illness, it is very evident that viral hepatitis infection still has a major stigma attached to it across all areas of people’s lives, including their family life and even the workplace,” said Marcelo C. M. Naveira – Viral Hepatitis Coordination, Secretariat for Disease Surveillance Ministry of Health of Brazil.

“The stigma and discrimination faced by people living with hepatitis is all too often based on misunderstandings about the virus and its transmission. Not only is this damaging to people diagnosed with the disease, but it may also discourage others from getting tested and accessing treatment and support. There is a pressing need to educate the general public about hepatitis to erode this stigma and break down barriers to timely testing, treatment and care for those who need it,” said Professor Markus Peck, Secretary General, European Association for the Study of the Liver.

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 (www.easl.eu)
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:
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Diabetes drug shows promise in the treatment of non-alcoholic steatohepatitis

Zoe Sycamore — Thu, 23 Apr 2015 05:07:52 +0000

In a randomised controlled trial, liraglutide met the primary endpoint of histological clearance of non-alcoholic steatohepatitis, and a reduction in progression of fibrosis

April 23, 2015, Vienna, Austria: A drug approved to treat type 2 diabetes could prove to be a powerful new treatment option for non-alcoholic steatohepatitis (NASH), according to research presented today at The International Liver CongressTM 2015. Results from a randomised controlled trial showed liraglutide met the primary endpoint of histological clearance of NASH, and a reduction in the progression of fibrosis. The research was supported by the Wellcome Trust and the NIHR.

In the Liraglutide Efficacy and Action in NASH (LEAN) trial, overweight patients with biopsy-confirmed NASH were randomised (1:1) to receive a 48-week treatment with once-daily, subcutaneous injections of either 1.8 mg liraglutide or liraglutide-placebo (control). The primary outcome was improvement in liver histology, defined as ‘resolution of definite NASH’ and no worsening in fibrosis from baseline to end-of-treatment.

Of the 52 randomised patients, 45 underwent end-of-treatment liver biopsies. The primary endpoint was met, and 9 (39%) of 23 patients on liraglutide had resolution of definite NASH with no worsening of fibrosis compared to 2 (9%) of the 22 patients on placebo. Only 2 (9%) patients on liraglutide had worsening of fibrosis compared to 8 (36%) on placebo. Moreover, liraglutide was shown to reduce weight, BMI and fasting glucose compared to placebo. There were no drug-related serious adverse events in patients on liraglutide.

Dr Matthew Armstrong, LEAN co-investigator, NIHR Birmingham Liver Biomedical Research Unit, University of Birmingham, commented: “Although NASH is the most common cause of chronic liver disease, there are still no licensed drugs to treat it. Results from the LEAN trial are a major breakthrough and point towards a potential treatment option for this disease. A Phase 3 trial is now needed to confirm the potential of this class of medication, known as human glucagon-like peptide-1 analogues, as a valid therapeutic option for patients with NASH.”

Professor Philip Newsome, LEAN Chief Investigator, NIHR Birmingham Liver Biomedical Research Unit, University of Birmingham, added: “Clearance of NASH in this study was very encouraging and means we are a step closer to new treatments for patients suffering with non-alcoholic fatty liver disease.”

“NASH occurs when the liver becomes inflamed due to the accumulation of fat. Over time, persistent inflammation can lead to the formation of fibrous scar tissue in the liver and around its blood vessels, which can eventually cause cirrhosis. In Europe, the prevalence of NASH is approximately 5% so we welcome the ongoing research and development in this area to help the millions of people affected by this disease,” said Professor Markus Peck, Secretary General, European Association for the Study of the Liver.

Notes to editors

The study research was supported by the Wellcome Trust and the National Institute for Health Research (NIHR) Birmingham Liver Biomedical Research Unit.

About the National Institute for Health Research
The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).

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 (www.easl.eu)
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

Pooled analysis confirms vitamin E as a treatment for non-alcoholic steatohepatitis

Zoe Sycamore — Thu, 23 Apr 2015 05:07:32 +0000

Study found that vitamin E is a safe and effective treatment for both adults and children

April 23, 2015, Vienna, Austria: Results revealed today at The International Liver Congress™ 2015 show that vitamin E (d-alpha-tocopherol) is an effective treatment for non-alcoholic steatohepatitis (NASH). NASH occurs when the liver becomes inflamed due to the accumulation of fat. Over time, persistent inflammation can lead to the formation of fibrous scar tissue in the liver and around its blood vessels, which can eventually cause cirrhosis.

A pooled analysis of data from two randomised trials comparing vitamin E versus placebo, and the placebo group from another trial comparing vitamin E use versus non-use, demonstrates that the efficacy of vitamin E is comparable to other treatments for NASH, including pioglitazone, metformin and obeticholic acid. In addition, treatment with vitamin E is associated with significant improvements in both NASH histology (45% vs 22% in those not treated with vitamin E) and resolution of disease (38% vs 20% in those not treated with vitamin E). There was no increase in cardiovascular events and no adverse lipid profiles were observed with vitamin E treatment.

A total of 347 patients (155 treated with vitamin E, 192 not treated with vitamin E) were included in the analysis which compared data from three clinical trials that investigated the efficacy and safety of vitamin E as a treatment for NASH: the PIVENS, TONIC and FLINT trials. Histologic improvement was defined as ≥ 2 point improvement in NAS with no worsening of fibrosis, and NASH resolution measured effectiveness.

The study supports the use of vitamin E as a treatment for NASH.

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 (www.easl.eu)
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:
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Daclatasvir-sofosbuvir combination is highly effective and well tolerated in patients with hepatitis C and HIV co-infection

Zoe Sycamore — Thu, 23 Apr 2015 05:07:15 +0000

Results from ALLY-2 confirm drug was well tolerated and effective across genotypes 1-4

April 23, 2015, Vienna, Austria: Phase III results revealed today at The International Liver Congress™ 2015 show that once-daily treatment with daclatasvir (DCV) plus sofosbuvir (SOF) resulted in an overall 97% sustained virologic response (SVR) at 12 weeks post-treatment in patients with hepatitis C virus (HCV) and HIV co-infection, including cirrhotic patients.

HIV co-infection more than triples the risk of hepatitis C-related liver disease, liver failure and liver-related death. Co-infection can also complicate the management of HIV infection.

In the ALLY-2 randomised, open-label study, the combination of DCV+SOF was well tolerated and effective across the four different genotypes. Importantly, due to their limited pharmacokinetic interactions with other agents, DCV+SOF was able to work effectively across a broad range of concomitant combination antiretroviral therapy (cART) regimens without compromising HIV virologic control (98% of patients were on cART).

The study included treatment-naive (n = 151) and treatment-experienced (n = 52) adults co-infected with HIV and HCV. Treatment-naive patients were randomised 2:1 to receive 12 or 8 weeks of SOF 400 mg + DCV 60 mg (dose adjusted for cART); experienced patients received DCV+SOF for 12 weeks. The primary endpoint was SVR at post-treatment week 12 in treatment-naive genotype-1 patients who received 12 weeks of DCV+SOF.

A total of 98% of patients completed the study treatment. In genotype-1 patients, SVR was achieved by 96% of treatment-naive and 98% of experienced patients after 12 weeks of DCV+SOF. These positive results were also seen in genotype-2, -3 and -4 patients, with SVR at post-treatment week 12 reaching 100% (13/13), 100% (10/10) and 100% (3/3), respectively. Eight weeks of treatment appeared less effective with an SVR at 12 weeks post treatment of 76% in genotype-1 patients.

There were no treatment-related serious adverse events (AEs) and none of the patients stopped treatment due to AEs.

The results show that 12 weeks of DCV-SOF is a highly effective and well-tolerated treatment regimen for HCV in patients with HIV co-infection, including cirrhotic patients.

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 (www.easl.eu)
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

Herbal remedy derived from milk thistle demonstrates efficacy in non-alcoholic steatohepatitis

Zoe Sycamore — Thu, 23 Apr 2015 05:07:01 +0000

Silymarin results in resolution of non-alcoholic steatohepatitis and improvement in fibrosis

April 23, 2015, Vienna, Austria: Results from a double-blind, placebo-controlled study of silymarin, which is derived from the milk thistle plant, have shown that this herbal remedy may be a useful treatment option for non-alcoholic steatohepatitis (NASH).

An interim analysis of the study, revealed today at The International Liver Congress™ 2015, shows a significantly higher percentage of patients experienced NASH resolution and improvement in fibrosis after 48 weeks of treatment with silymarin compared to placebo.

NASH occurs when the liver becomes inflamed due to the accumulation of fat. Over time, persistent inflammation can lead to the formation of fibrous scar tissue in the liver and around its blood vessels, which can eventually cause cirrhosis.

A total of 64 patients (silymarin = 30, placebo = 34) with biopsy-proven NASH had completed the study at the time of interim analysis. Silymarin has already demonstrated anti-oxidant, anti-inflammatory and anti-fibrotic properties, and these latest study results show that it may be a useful treatment for NASH.

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 (www.easl.eu)
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

Preliminary results show Civacir® prevents recurrence of hepatitis C in liver transplant patients

Zoe Sycamore — Thu, 23 Apr 2015 05:06:45 +0000

Phase III data demonstrate prophylactic efficacy of Civacir® in patients who undergo antiviral therapy prior to transplantation

April 23, 2015, Vienna, Austria: New data from an ongoing Phase III trial revealed today at The International Liver CongressTM 2015 show that the use of hepatitis C immune globulin (HCIG, Civacir®) can effectively prevent hepatitis C virus (HCV) recurrence in patients following a liver transplant (LT). The data demonstrate that intravenous Civacir given both peri- and post-LT prevents HCV-reinfection in patients who also received antiviral therapy (AVT) before their transplant operation.

Civacir is a hepatitis C immune globulin (HCIG) produced from pooled plasma from hundreds of screened donors who have high antibody titers against HCV. In this trial, patients received AVT before their LT and those in the active treatment groups received 16 infusions of Civacir in the peri- and immediate post-LT period for 10 weeks. The control group received current standard of care (no treatment) post-LT.
The preliminary results suggest that Civacir provides an effective alternative approach as compared to current standard of care to prevent HCV recurrence in post-LT patients. Civacir was well tolerated with no drug-related serious adverse events observed during the study.

Hepatitis C virus (HCV) remains the leading cause for liver transplantation (LT) and recurrent HCV disease is the most frequent cause of graft loss. Prevention of recurrence independent of genotype and severity of cirrhosis is highly desirable because it simplifies post-LT management.

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 (www.easl.eu)
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

All-oral, direct-acting antivirals show promise for hepatitis C and HIV co-infected, cirrhotic patients

Zoe Sycamore — Thu, 23 Apr 2015 05:06:31 +0000

Latest results show sofosbuvir-based combinations are effective and well tolerated in difficult-to-treat patients

April 23, 2015, Vienna, Austria: A new study revealed today at The International Liver CongressTM 2015 shows that sofosbuvir (SOF)-based regimens are effective and well tolerated in hepatitis C and HIV co-infected, cirrhotic patients. Sustained virologic response at 4 weeks (SVR4) was observed in 98% of patients and in 95% at 12 weeks (SVR12).

The results are particularly encouraging as this patient group is considered difficult-to-treat and has a high mortality rate. The study included 142 patients of different hepatitis C virus (HCV) genotypes who were initiated onto SOF-based regimens.

Adverse events were reported in 42 patients (digestive 10%, anaemia 19%, asthenia 24%, others 48%). Treatment was stopped in 3 patients and dose-adjusted in 13.

These results show that direct-acting antivirals (DAAs) such as SOF-based regimens are effective and well tolerated in HIV-HCV co-infected, cirrhotic patients; however, it is important to note that surveillance for liver-related events should continue in these patients.

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 (www.easl.eu)
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

Many European countries ill-prepared to prevent and control the spread of viral hepatitis

Zoe Sycamore — Thu, 23 Apr 2015 05:06:13 +0000

Comprehensive national strategies are urgently needed to manage the growing burden of disease

April 23, 2015, Vienna, Austria: Many countries in the World Health Organization (WHO) European Region are facing limitations in conducting chronic viral hepatitis disease surveillance, assessing the burden of disease and measuring the impact of interventions, according to results revealed today at The International Liver Congress™ 2015.

The study highlights that less than one-third (27%) of WHO European Member States have national strategies in place that contain a surveillance component. Furthermore, only 64% have a national surveillance system for chronic hepatitis B and 61% for chronic hepatitis C.

The study also reveals the main areas in which governments would like the WHO’s support:
• Development of national plans for viral hepatitis prevention and control (39%)
• Estimation of the national burden of viral hepatitis (34%)
• Surveillance (23%)

The results were obtained by analysing the responses to surveillance-related questions in the WHO Global Hepatitis Policy Survey. In total, 44 out of 53 (83%) of the WHO European Member States responded to the survey.

The study demonstrates a clear need for better disease surveillance and improvements in the development of national strategies to help prevent and control the spread of viral hepatitis in the WHO European region.

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 (www.easl.eu)
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

Global expansion of hepatitis vaccination and treatment is needed to make progress towards elimination of hepatitis B

Zoe Sycamore — Thu, 23 Apr 2015 05:05:53 +0000

Expansion of existing interventions could prevent 13 million deaths due to hepatitis B

April 23, 2015, Vienna, Austria: Results revealed today at The International Liver Congress™ 2015 demonstrate current treatment and prevention programmes need to be scaled up in order to make elimination of hepatitis B virus (HBV) possible.

The study conducted by Imperial College Scientists, highlights that if existing interventions, such as infant hepatitis B vaccination and treatment programmes, were scaled up, the number of new chronic HBV infections could be reduced by 90% and mortality levels could be reduced by 65% by 2030. Globally, this would mean 13 million deaths could be prevented, including 6 million cancer cases.

Although universal infant vaccination programmes have proved successful in decreasing the number of new HBV infections, without further intervention the study estimates that the number of people infected with HBV will remain at the current level for the next 40 to 50 years, resulting in 20 million deaths by 2030.

The results were generated using a mathematical model of the worldwide HBV epidemic, which incorporated data on epidemiology, vaccination coverage, treatment, regional demography and the natural history of the virus. Predictions for incidence of new chronic infections, prevalence and HBV-related mortality were developed for interventions remaining at current levels. The researchers then explored what scaling up of treatment and prevention would be needed to achieve control and elimination of HBV by 2030.

The study highlights the need to increase current levels of interventions, including the expansion of vaccination and treatment programmes, in order to significantly reduce the transmission of HBV and lower mortality.

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 (www.easl.eu)
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

Delaying treatment for hepatitis C puts patients’ lives at risk

Zoe Sycamore — Thu, 23 Apr 2015 05:05:36 +0000

Analyses from the Veterans Administration healthcare system in the USA highlights dangers of delaying treatment to save costs

April 23, 2015, Vienna, Austria: Data revealed today at The International Liver Congress™ 2015 highlights the impact of delaying treatment for the hepatitis C virus (HCV). Researchers found that treatment delays have a serious detrimental effect on treatment efficacy, increasing the risk of morbidity and mortality among patients.

The study was conducted using retrospective patient data from the Veterans Administration in the USA to estimate the impact on risk of morbidity and death depending on whether treatment was initiated before or after a patient’s FIB4 levels became elevated. The FIB4 index is a simple formula used to predict liver damage (fibrosis) based on standard biochemical values and age.

Researchers found that delaying treatment until after a patient’s FIB4 level exceeds 3.25 has a clear detrimental effect on treatment effectiveness. Delaying therapy until after the patient’s FIB4 level exceeds 1.45 or 1.00 has a smaller detrimental effect on treatment effectiveness.

The study demonstrates that delaying HCV treatment in an attempt to save costs has a serious adverse impact on patients, with the most serious effect being the speeding up of time to death. Once HCV diagnosis has been confirmed the most suitable treatment should be initiated as soon as feasible balancing budgetary cash-flow issues against adverse impacts on patients.

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 (www.easl.eu)
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

All-oral, direct-acting antiviral treatment options for hepatitis C proven to be highly effective and well tolerated in patients with decompensated cirrhosis

Zoe Sycamore — Thu, 23 Apr 2015 05:05:18 +0000

Interim report from the HCV-TARGET real world experience

April 23, 2015, Vienna, Austria: Interim data presented today at The International Liver CongressTM 2015 from the HCV-TARGET study show that all-oral, direct-acting antiviral therapy for hepatitis C (HCV) is well tolerated and highly effective in patients with decompensated cirrhosis. Sustained virologic response (SVR) at 4 weeks was shown to be: sofosbuvir/ribavirin: 75%; sofosbuvir/simeprevir: 77%; sofosbuvir/simeprevir/ribavirin: 81%.

These results demonstrate that all-oral, direct-acting antiviral regimens are better tolerated and achieve higher rates of SVR in HCV patients with decompensated cirrhosis than older interferon-based therapy.

Importantly, markers of hepatic and synthetic liver function such as bilirubin and albumin values also improved during short-term follow-up. The analyses were restricted to patients with cirrhosis and a MELD score (scoring system to assess the severity of chronic liver disease) of ≥ 10 who had not undergone liver transplantation. Such well tolerated and highly efficacious therapy which can improve liver function presents an excellent option for many patients who do not have access to liver transplantation.

HCV-TARGET is an international research consortium of leading HCV investigators who have established a common research database and are conducting a longitudinal observational study to answer important questions about HCV therapy with direct-acting antiviral agents.

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 (www.easl.eu)
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

Novel immunotherapeutic, TG1050, shows early signs of potential for chronic hepatitis B cure

Zoe Sycamore — Thu, 23 Apr 2015 05:04:52 +0000

Study results show TG1050 achieves key clinical goals in mouse models

April 23, 2015, Vienna, Austria: A novel immunotherapeutic in early development for chronic hepatitis B (CHB), TG1050, has been shown to reach the clinical goals that are considered to be the hallmarks of a cure for CHB, according to results revealed today at The International Liver Congress™ 2015.

The hallmarks of a CHB cure are:
• Elimination of HBsAg – the surface antigen of the hepatitis B virus, and
• HBsAg seroconversion – which occurs when a specific antibody becomes detectable in the blood and the corresponding antigen becomes undetectable, in this case HBsAg

In the study, decrease of HBsAg and HBsAg seroconversion was achieved in 30% of TG1050-injected mice.

Earlier studies have proven that TG1050 is able to induce a robust, multi-specific and long-lasting immune response against the hepatitis B virus. These latest results, which show that TG1050 is able to decrease HBsAg and lead to anti-HBsAg seroconversion in HBV persistent mouse models, support the move to a first-in-man study and the start of clinical development.

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 (www.easl.eu)
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