Monday, September 15, 2014

Australia: New Strategies for HCV and HBV Launched in NSW

The Hon Jilian Skinner MP, NSW Minister for Health and Minister for Medical Research, launched the NSW Hepatitis C Strategy 2014-2020 and the NSW Hepatitis B Strategy 2014-2020 on 15 September 2014.

Both Strategies aim to prevent new infections and improve the health of people living with hepatitis C and B. Each of the Strategies have three priority areas focusing on Prevention, Testing and Management, and Treatment.

This is an exciting time for hepatitis B and C with new hepatitis C treatments on the horizon, and together we can make a difference.

Click on images to access the Strategies


Friday, September 12, 2014

NeuroVive signs USD 150 m agreement with OnCore BioPharma for the outlicensing of NVP018 for the treatment of chronic Hepatitis B virus infection

NeuroVive Pharmaceutial AB, a leading mitochondrial medicine company, has signed an exclusive global outlicensing agreement with the US biotechnology company OnCore BioPharma, Inc. related to the development and commercialization of NeuroVive’s drug candidate NVP018 for oral treatment of chronic Hepatitis B Virus (HBV) infection. The agreement can give NeuroVive in total $150 million in conditional milestone payments plus royalties on future drug sales.

“After extensive discussions with a number of leading pharmaceutical companies, I am delighted to announce that we have signed this agreement with OnCore, a strong partner that provides optimal resources to develop NVP018 from a stage of a promising drug candidate to a complete treatment for a global medical challenge. This confirms the financial potential inherent in our pharmaceuticals portfolio, and the revenues will allow us to further intensify our work in prioritized areas of mitochondrial medicine. I would also like to take the opportunity to put the spotlight on our COO Jan Nilsson, whose work has been critical to get this agreement in place,” commented NeuroVive’s CEO Mikael Brönnegård.

The licensing agreement provides OnCore with the exclusive global rights to develop oral formulations of NVP018 for the treatment of chronic Hepatitis B infection. The compensation to NeuroVive consists of an initial upfront payment plus a number of conditional payments based on pre-determined milestones and as well payments relating to sales targets. In addition, NeuroVive will receive incremental royalty payments based on gross revenue from future sales of NVP018. The total value of the agreement is $150 million excluding royalty payments. The exact terms of the agreement regarding payments and royalty figures are not disclosed.

“OnCore stood out in the negotiations, which included several leading pharmaceutical companies, because of its exclusive focus on Hepatitis B and its plan to bring the drug candidate to market as quickly and efficiently as possible. In addition, the company’s senior managers have delivered exceptionally strong results in the form of a pioneering treatment for Hepatitis C while working at Pharmasset. I am convinced that OnCore is the right collaboration partner for us,” commented Jan Nilsson, NeuroVive’s Chief Operating Officer.

“We perceive considerable potential in NVP018 and consider this agreement to be an important step towards developing a successful treatment for chronic Hepatitis B. Our objective is to cure chronic Hepatitis B, building on our success in Hepatitis C at Pharmasset.” commented Dr. Michael Sofia, Chief Scientific Officer at OnCore.

Cyclophilin inhibitors and NVP018NVP018 is an orally-available, sangamide-based, second generation cyclophilin inhibitor with a well-differentiated preclinical profile when compared to other cyclophilin inhibitors. Data presented in April at The International Liver Congress™ 2014, the annual meeting of the European Association for the Study of the Liver (EASL), showed that NVP018 appears to inhibit the Hepatitis B virus by two mechanisms in vitro. First, NVP018 directly inhibits several stages of viral replication in liver cells and second, NVP018 acts indirectly by strengthening the host immune response via interferon regulatory factors (IRFs), including potent inhibition of an interaction between cyclophilin A and IRF9, a key component of the Jak/Stat pathway that transports chemical signals through the cell membrane. Data also indicates that the risk of developing resistance, a significant clinical problem with current therapies for Hepatitis B, is very low with NVP018.

Wednesday, September 10, 2014

Recommendations to Improve Liver Health in Hepatitis B, Hepatitis C Patients

Although it is widely understood that hepatitis B virus (HBV) and hepatitis C virus (HCV) are the leading causes of liver cirrhosis and liver cancer, a study published in Cancer Nursing reports an alarming number of HBV and HCV carriers have unhealthy habits that result in poor liver health.

To learn about the behavior and attitudes of HBV and HCV carriers, a team of researchers in China conducted interviews with 6,805 participants from August 2011 to July 2012. The participant pool was limited to candidates aged 20 years or older who were able to live independently, could either complete the questionnaire in Mandarin or Taiwanese, had access to their community hospital, and did not have a learning disability.

According to the researchers, a notable percentage of participants had either HBV (18.7%) or HCV (20.8%). Despite reporting risk factors for poor liver function among HBV and HCV carriers that included “being overweight, fasting blood sugar levels >110 mg/dL, systolic blood pressure >140 mm Hg, smoking, betel nut chewing and alcohol consumption,” the investigators discovered a large percentage of the study subjects participated in those modifiable hazardous behaviors.

 - See more at:

Monday, September 8, 2014

Nerve Damage Prompts Warning Against Telbivudine-Interferon Combo Treatment

— Christine M. Kukka, Project Manager, HBV Advocate

A drug trial that combined the antiviral telbivudine and pegylated interferon was found to cause nerve damage in seven of 50 patients treated with the combination, according to a report published in the August issue of the Journal of Hepatology.

The high rate of peripheral neuropathy, which causes damage to the nerves that transmit information from the brain and spinal cord to other parts of the body, prompted the study's global team to caution against the use of this drug combination.

Investigators compared outcomes in three groups of hepatitis B patients treated with the drug combination (50), only interferon (54) and only telbivudine (55). After 24 weeks, peripheral neuropathy occurred in seven of the 50 patients receiving combination treatment, in one of the telbivudine-treated patients and in none of the interferon-treated group.

However, 71% of the combination group achieved undetectable HBV DNA during the study period, compared to 35% in the telbivudine-only group and 7% of the interferon-treated group.

"Despite the rapid and profound reductions in HBV DNA levels, combination therapy with telbivudine and PegIFN should not be used," researchers cautioned.

Scientists Create Viable Liver Cells in a Lab for HBV Research

— Christine M. Kukka, Project Manager, HBV Advocate

A new technique for studying the lifecycle of HBV could help researchers develop a cure for the disease. In a report published in the Proceedings of the National Academy of Sciences, researchers describe using microfabricated cell cultures to sustain HBV in human liver cells in a lab, which allows them to study how the HBV-infected liver cells respond to drug treatments.

To develop new drugs, researchers need to study how infected liver cells respond to experimental treatments. Until now, researchers have been unable to maintain HBV-infected liver cells in a lab setting. The cells are unstable and need the entire liver to sustain them.

Using a process researchers developed when studying the hepatitis C virus, the researchers developed a system that uses liver cells from livers donated for transplant plus stem cells derived from human skin samples and introduced into the liver-like cells.

Researchers will now use these liver cells to investigate new treatments for HBV.

Friday, September 5, 2014

Access to Healthy Food Vital for HBV Patients, but Many Live in Food "Deserts"

— Christine M. Kukka, Project Manager, HBV Advocate

In the first study of its kind, researchers have documented that people with liver disease who have easy access to fresh, healthy food markets and avoid fast foods have healthier eating habits and better health than those whose only options are fast food outlets or convenience stores, according to a report in the September-October issue of the Annals of Hepatology.

Researchers surveyed 267 people with hepatitis B, hepatitis C or non-alcoholic fatty liver disease (NAFLD) living in the greater Washington DC area about their eating and shopping habits. Using Geographic Information Systems (GIS) technology they also plotted what food sources–ranging from fast food places, ethnic groceries, convenience stores, restaurants, and fresh food groceries–were near their homes in these heavily developed urban and suburban areas.

Not surprisingly, people who live close to fresh food markets have healthier diets than those who must depend on convenience stores or fast food restaurants for meals. Healthy diets, low in salt and fats, are critical for people living with viral hepatitis. NAFLD patients ate more prepared food and less fresh food, probably because of geographic distance from healthier food sources.

Based upon these findings, it is important for health care providers serving a chronic liver disease population to investigate a patient’s food environment, fresh food consumption, and primary food source choices and “aggres-sively refer patients for dietetic services for effective life-style change management," researchers from George Mason University reported.


Tenofovir or Telbivudine Recommended for Pregnant Women with High Viral Loads

— Christine M. Kukka, Project Manager, HBV Advocate

A comprehensive overview of ways to prevent mother-to-newborn hepatitis B infection recommends the use of either tenofovir or telbivudine (Tyzeka) in pregnant women who have high levels of HBV. While treating HBV-infected pregnant women with antivirals has not yet been approved by the U.S. Food and Drug Administration, increasingly doctors are treating women with high viral loads (with HBV DNA exceeding 10 million international units per milliliter–IU/mL) in order to prevent infection of newborns.

Current medical guidelines call for screening all pregnant women for hepatitis B and immediate immunization and use of hepatitis B immune globulin (HBIG) in babies born to infected mothers.
This approach works to prevent infections in about 97% of births, but according to a recent study in the International Journal of Women's Health, about 3% of babies born to women with a 1 million IU/mL viral load will still become infected. That percentage increases to 9% among babies born to women with viral loads exceeding 100 million IU/mL.

Since 1989, antivirals have been safely used in pregnant, HIV-infected women to prevent infection of newborns, and doctors use some of those same antivirals to treat hepatitis B. So starting about five years ago, doctors began treating HBV-infected women with antivirals to tamp down their viral load before delivery.

Today, researchers recommend telbivudine and tenofovir for use in pregnant women. There is no risk of fetal toxicity with those two drugs, while animal studies have found embryo or fetal toxicity associated with lamivudine (Epivir-HBV), entecavir, and adefovir (Hepsera). Additionally, lamivudine has been found to be a weak antiviral when used during pregnancy and has caused drug resistance.

Early studies have found no transmission of HBV infection to infants when mothers are treated with either telbivudine or tenofovir.

Researchers stressed the importance of a collaborative approach by all doctors involved in a pregnant woman's care to screen for hepatitis B, immunize newborns and administer HBIG, and treat women with high viral loads with antivirals.