50th INTERNATIONAL LIVER CONGRESS HIGHLIGHTS ADVANCES IN FIGHT AGAINST LIVER DISEASE
Nearly 11,000 of the world’s leading liver clinicians and scientists converged in Vienna on April 21-26, 2015, to share the latest research on liver disease.
For the first time, the American Liver Foundation (ALF) attended the International Liver Congress (ILC), which is organized by the European Association for the Study of the Liver (EASL). Here we highlight the big news from the meeting.
VIRAL HEPATITIS- HEPATITIS B/C
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
The emerging public health challenge of non-alcoholic fatty liver disease (NAFLD) was a hot topic at the meeting.
NAFLD, a build-up of excessive fat in liver cells (steatosis) affects some 30% of Americans, including children, and is the leading cause of cirrhosis. NAFLD is the most common cause of chronic liver disease in most of the Western world, and, while it is largely associated with lifestyle factors, such as obesity, there is also a strong genetic component. A study of 96 pairs of twins by Rohit Loomba, MD, associate professor of clinical medicine and associate director of clinical research at the University of California, San Diego, presented at the ILC, found that hepatic steatosis and hepatic fibrosis are heritable traits, thus increasing the genetic susceptibility of NAFLD in people with a family history of the disease. In prior studies, Dr. Loomba, who is also a member of the ALF national medical advisory committee and national board of directors, found that family members of children diagnosed with NAFLD are at high risk for the disease and should be tested for it as part of a routine medical examination, even if they don’t show symptoms.
The good news is that in most cases, NAFLD can be reversible through lifestyle changes such as increased exercise and modifications in diet.
- Uncontrolled, NAFLD increases the risk for hepatocellular carcinoma (liver cancer), and, for those already diagnosed, reduces the chances for survival. In fact, NAFLD is emerging as a major cause of hepatocellular carcinoma in the United States; a new study presented at the ILC showed that, in a five-year period (2004 to 2009), the annual increase in hepatocellular carcinoma in fatty liver disease patients was approximately 5%.
Survival is shorter for patients with fatty liver disease who develop cancer than it is for patients with hepatitis B or hepatitis C who develop hepatocellular carcinoma.
- Data presented at the ILC showed that NAFLD plays a role in the early stages of coronary atherosclerosis. In its more severe form it can also promote the development of coronary artery calcification.
- In non-alcoholic steatohepatitis (NASH), a more progressive form of NAFLD, a study of one million people conducted in the UK found that the chances of dying from NASH over a 14-year period, was approximately 50% higher than for those with NAFLD.
Medications for Diabetes Show Promise in NAFLD and NASH
It isn’t all that surprising that medications used in the management of diabetes could prove effective for NAFLD and NASH. All are connected to obesity and insulin resistance.
- Remogliflozin etabonate, an investigational drug being studied as a treatment for type 2 diabetes, might offer potential for the management of NAFLD and NASH.
- And a drug already approved to treat type 2 diabetes could prove to be a powerful new treatment option for NASH. In a randomized controlled clinical trial – the Liraglutide Efficacy and Action in NASH (LEAN) trial, patients who received liraglutide had a substantial improvement in liver function and no worsening in fibrosis after 48 weeks compared to patients who received a placebo.
These are very exciting developments – and ones to watch -- as there are currently no approved treatments to treat NAFLD and NASH – meaning that the U.S. Food and Drug Administration (FDA) has not approved a drug specifically designed to treat these diseases.
Diet and Exercise Key
Simple lifestyle changes could improve NASH.
- A study presented at the ILC found that a 10% reduction in body weight substantially improved NASH after one year.
- On the holistic front, results from a double-blind, placebo-controlled study of silymarin, an herbal remedy derived from the milk thistle plant, showed that it may be a useful treatment option for NASH.
- After 48 weeks of treatment with silymarin, a significantly higher percentage of patients experienced NASH resolution and improvement in fibrosis compared to those on a placebo.
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Viral Hepatitis- Hepatitis C and Hepatitis B News
News about hepatitis C is changing at a rapid pace. There are many treatments being investigated and more calls to action about testing.
A Global Public Health Challenge
According to the World Health Organization (WHO), 130 - 150 million people globally have chronic hepatitis C infection. In the United States, an estimated 3.2 million Americans are infected with hepatitis C. MMany do not know that they have it.
There are several different genotypes (strains) of hepatitis C, with genotype 1 being the most prevalent in the U.S.
- The dearth of research on hepatitis B and C testing in many European countries could be hampering efforts to identify infected individuals, according to a comprehensive review of 136 studies. The results indicate that some high-risk populations have been studied much more than others, but mostly only in a small number of countries. At a press conference, Jeffrey Lazarus, professor of International Health Systems at Copenhagen University in Denmark, commented, “It’s clear from our review that there are crucial gaps in our knowledge on hepatitis B and C testing and we do not yet have enough information to plan effective public health responses in Europe.”
- Supporting this view, another study found that many European countries are not prepared to prevent and control the spread of viral hepatitis. According to World Health Organization researchers, many countries in its European region are facing limitations in conducting chronic viral hepatitis disease surveillance, assessing the burden of disease and measuring the impact of interventions for both hepatitis B and hepatitis C. The study highlighted that only 64% of WHO European Member States have a national surveillance system in place.
New medications for any disease take years of scientific investigation. At the ILC, there were a lot of presentations about promising results for potential therapies, including many that included the drug sofosbuvir, which most of the public knows by its brand name Sovaldi. Research about sofosbuvir in combination with other agents generated quite a bit of excitement.
- Preliminary results of a drug trial showed that combination therapy of ledipasvir and sofosbuvir in combination with ribavirin is well-tolerated and effective in hepatitis C.
- Sofosbuvir, in combination with daclatasvir, proved effective in patients with recurrence of genotype 3 hepatitis C following a liver transplant. This offers another treatment option for post transplant recurrence in addition to medications already in use: the drugs ledipasvir/sofosbuvir combination (brand name Harvoni) and combination ombitasvir/paritaprevir/ritonavir (brand name Viekira Pak). Hepatitis C recurrence is one of the main complications following liver transplants and seriously affects patient survival. Researchers are hopeful that this will translate into more successful transplants for people with chronic hepatitis C in the near future.
The combination sofosbuvir and declatasvir has also been shown to be effective as a first-line treatment for patients with genotype 3 hepatitis C (who do not need a liver transplant).
Using the same drug combination of sofosbuvir and declatasvir, researchers reported that it is also an effective treatment option for difficult-to-treat hepatitis C patients with hepatitis C (genotype 1.
On July 24, 2015, the U.S. Food and Drug Administration (FDA) approved this combination as another treatment for hepatitis C genotypes 1, 2, 3 and 4. The brand name is Daklinza.
- Also very big news at the meeting was the effectiveness of ombitasvir/paritaprevir/ritonavir (Viekira Pak) in patients with renal (kidney) failure, including dialysis patients. Up to now, there has not been a treatment that could be safe and effective in patients with renal disease. mono-infected patients).
According to a member of the meeting’s scientific committee (who was not involved in the study), “This research was significant because it is one of the first studies to look at this drug combination and demonstrated that it is a good treatment option for certain patients.”
- A combination of daclatasvir, sofosbuvir and ribavirin was found to be very effective and well-tolerated in hepatitis C patients with advanced cirrhosis or post-liver transplant recurrence. These results confirm that this combination therapy addresses an unmet need for these patients. This research came out of a lot of very prestigious research institutions, including University of Texas Health Science Center, University of Miami, Baylor and Stanford.
- For patients with genotype 3 hepatitis C, sofosbuvir in combination with peginterferon and ribavirin showed the strongest sustained virologic response rates. This was found in both patients with and without cirrhosis. What's more is that it was a 24 week-trial and the researchers saw this response in patients at 12 weeks. This combination may also prove useful in the treatment of patients resistant to non-interferon treatments. Very exciting news indeed
- Results of a Phase III clinical trial demonstrated that a once daily, oral tablet, taken for 12 weeks – a combination of grazoprevir and elbasvir – was effective and well-tolerated in hepatitis C patients who had not undergone other treatment. This is really exciting news as it will offer a fourth treatment option for genotype 1 hepatitis C, joining the already FDA-approved sofosbuvir (Sovaldi), ledipasvir/sofosbuvir combination (Harvoni) and ombitasvir/paritaprevir/ritonavir (Viekira Pak). This treatment would be in pill form taken once per day, has few side effects and may be useful in other genotypes as well. It is expected to receive FDA approval in the first quarter of 2016.
- While a little technical because it is aimed at clinicians, it is still good to know about new hepatitis C treatment guidelines that were announced at the ILC though it will not include the use of the newly approved combination sofosbuvir and declatasvir (Daklinza) since that occurred after the meeting. Take a look and ask your doctor about the recommendations.
- Alcohol use disorders are a much more accurate indicator of mortality in chronic hepatitis C infection, according to researchers from Paris and Toronto, which points to the need to encourage patients with chronic hepatitis C to stop drinking. And speaking of drinking, the World Health Organization reported that, for the general population, drinking just one or two alcoholic beverages per day is linked to liver disease and that 6% of global deaths are caused by drinking.
- Hepatitis C screening is essential to helping catch patients with advanced liver fibrosis, particularly among high-risk groups, say researchers at Stanford University.
- Kaiser Permanente researchers reported that cancer rates among patients with hepatitis C are significantly increased compared to those not infected. In addition to liver cancer, cancers most associated with hepatitis C include non-Hodgkins lymphoma, renal and prostate cancers. But they said that the findings should be interpreted with caution and take into account other factors such as alcohol use, tobacco, obesity and diabetes.
Public Perception: We Have Come a Long Way but Have Miles to Go
People living with hepatitis C are much more open about their condition in years past and want to help others. Members of the American Liver Foundation’s national patient advisory committee (NPAC) can attest to that (hear their stories here). Yet discrimination persists.
A patient survey showed that half of people with hepatitis B or C suffer from discrimination and 25% said that family members have avoided physical contact with them after finding out that they had the infection. Stigma and discrimination also extends to the workplace. Ten percent of patients surveyed said that they lost their jobs.
The study was conducted by the Ministry of Health in Brazil of 1,217 people infected with hepatitis B or C in Europe and the U.S.
“Few studies have evaluated the circumstances and the degree to which stigma and discrimination are present for those living with viral hepatitis,” said Carlos Varaldo, president of Grupo Otimismo Support Group for People Who Live with Hepatitis and lead investigator of the study. “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.”
Some of our NPAC members have certainly felt the sting. “In the beginning I felt embarrassed,” says Michelle Carver, member of the NPAC. “However, the more I shared my story, and the many ways of contracting hepatitis C, the more I felt confident. I tell everyone that at one time people thought it was an end to the life they always wanted to live. But now it's all about the journey of empowerment and creating a positive and beautiful life being hepatitis C free.”
“We underestimate the emotional toll that liver disease, particularly hepatitis C, takes on people,” says Tom Nealon, chief executive officer and national chair of the board of directors of the American Liver Foundation. “We are so grateful to members of our NPAC. , who are living with or were cured of the disease. Their speaking out really lifts the stigma of a hepatitis C diagnosisthe disease, encourages people to get tested and offers hope to the millions living with the disease.”
And in Hepatitis B News (with a little Hepatitis C News)
- European researchers were talking about how the lack of research on hepatitis B and hepatitis C testing is hampering efforts to identify infected individuals.They looked at a lot of studies on the subject -- 136 in fact from published papers and conference abstracts from scientists in Turkey, Germany, Italy, France, the Netherlands and the UK -- and their presentation was a systematic review of all these studies.
What they learned was that some high-risk populations have been studied a lot more than others, but mostly in a small number of countries. So there are concerning gaps in knowledge on hepatitis B and hepatitis C testing and this is stymieing public health officials’ efforts to develop effective programs in Europe.
There was no data presented about how this compares to the U.S. hepatitis B population. Though not as big a public health problem as it is for European countries, there are still an estimated 700,000-1.4 million Americans infected with the virus, which is more prevalent in people of Asian descent.
- Scientists at EASL issued a call to action for the treatment and prevention of hepatitis B saying that it has the potential to prevent 13 million deaths globally. The American Liver Foundation has been sounding the alarm about this as well. Read about our hepatitis B initiative.
- An early phase of a study of a novel immunotherapeutic agent in early development for chronic hepatitis B called TG1050, has been shown to be effective. Please note that this is still very early. The study was conducted in mice and is still years away from being tested in humans. Human studies are known as clinical trials and there are four phases of a clinical trial before a drug is proved safe and effective and approved for use in the United States.
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Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is a chronic disease that primarily occurs in women. It is characterized by the destruction of bile ducts in the liver, which in turn leads to liver scarring. Long-term damage from PBC can result in cirrhosis and liver failure.
There was some promising research about a potential new treatment for PBC, which is exciting because currently there is only one treatment available for this disease.
· Results from an international Phase III study showed that obeticholic acid (OCA) given patients suffering from PBC who previously had an inadequate response to, or had been unable to tolerate ursodeoxycholic acid (UDCA), produced meaningful biochemical and clinical improvements. UDCA is the only therapy currently approved to treat PBC and it has been in use for the past 20 years. A significant number of patients fail to get an adequate response with treatment with UDCA. So new therapies are needed to prevent PBC from progressing to cirrhosis and liver failure.
These are the highlights. You can find more information about these and many other types of liver disease on our website, www.liverfoundation.org. And please call our national toll-free Helpline, 1-800-GO-LIVER (1-800-465-4837).
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Page updated: August 5th, 2015