HBF is pleased to connect our blog readers to Christine Kukka’s monthly HBV Journal Review that she writes for the HBV Advocate. The journal presents the latest in hepatitis B research, treatment, and prevention from recent academic and medical journals. This month, the following topics are explored:
- New Treatments Targeting Hepatitis B Start Clinical Trials Soon
- Experts Urge Doctors to Screen Pregnant Women for Both Hepatitis B and High Viral Loads
- Using Antivirals Early in a Pregnancy Reduces Infection of Newborns
- Some Pregnant Women in U.S. Still Not Getting Screened for HBV and STIs
- High Viral Loads in Men Increase the Amount of HBV DNA in Their Sperm
- Despite Vaccine, Rural States See Rise in Hepatitis B Due to Heroin Use
- More Than Half of Young Drug Users Are Not Vaccinated Against Hepatitis A and B
- Shorter Vaccination Schedule Works to Prevent Infection Among Drug Users
- Generic Entecavir Could Treat All Patients Worldwide for $36 a Year
- Reformulated Tenofovir Appears Better at Fighting Infection in Liver Cells
- Another Report Calls for Doctors to Screen All Patients for HBV Before Starting Chemotherapy
- Study Confirms Aflatoxins Increase Liver Cancer in Hepatitis B Patients
Volume 12, No 5
by Christine M. Kukka
New Treatments Targeting Hepatitis B Start Clinical Trials Soon
A Pennsylvania firm will soon start clinical trials of a unique drug called birinapant that helps liver cells infected with the hepatitis B virus (HBV) self-destruct, according to two reports published in the April edition of the Proceedings of the National Academy of Sciences.
The treatment, which employs tiny molecules to force the infected liver cells to die while leaving normal liver cells intact, has eradicated hepatitis B infection in mice, according to TetraLogic Pharmaceuticals Corp. officials and their partner researchers at the University of Melbourne in Australia.
The current treatment evolved from cancer research that developed ways to make abnormal cancer cells die–a process called apoptosis. The human body uses apoptosis every day to clear away abnormal or unwanted cells, but cancer cells and HBV-infected liver cells have unique proteins that prevent apoptosis, which allows tumors and HBV infection to spread. (1)
TetraLogic developed a molecule called Smac that counteracts these apoptosis-stopping proteins in HBV-infected liver cells. In their mouse models, birinapant treatment with the SMAC molecule resulted in the complete eradication of all HBV-infected liver cells. When birinapant was used along with the antiviral entecavir (Baraclude), HBV infection disappeared even faster from the liver. (2)
Researchers report that birinapant treatment in mice, “resulted in loss of HBV-DNA, loss of the hepatitis B surface antigen (HBsAg) and the appearance of hepatitis B surface antibodies,” which signal the infection has been cleared from the body.
Phase I clinical trials, which will begin in Australia and expand to the U.S., will involve HBV-infected adults who are currently treated with either entecavir or the antiviral tenofovir (Viread). Participants will receive either a placebo or varying levels of birinapant intravenously to test safety and determine what dose is most effective.
Another new hepatitis B drug scheduled to start human clinical trials this year is the immunotherapy drug TG1050, developed by the French company Transgene SA and presented to The International Liver Congress 2015 in Vienna in late April.
According to their report, TG1050 spurs the body’s immune system to fight the infection. In animal experiments, the drug significantly reduced HBV DNA and HBsAg, leading to production of surface antibodies, an indication that the infection has been eradicated.
Transgene officials said they expect to enroll patients in clinical trials in mid-2015. It will assess the effectiveness of the drug alone or possibly with antivirals. (3)
Source 1: www.pnas.org/content/early/2015/04/15 /1502390112.full.pdf?sid=683e56b9-6a97-4370-9add-7a3df97f2f5d
Source 2: www.pnas.org/content/early/2015/04/15 /1502400112.full.pdf?sid=683e56b9-6a97-4370-9add-7a3df97f2f5d
Source 3: www.transgene.fr/wp-content/uploads /2015/04/20150423-US-EASL2015-TG10501.pdf
Experts Urge Doctors to Screen Pregnant Women for Both Hepatitis B and High Viral Loads
An editorial in the April issue of Pediatrics calls for doctors to not only test all pregnant women for hepatitis B infection, but to also measure viral loads in women found to be infected so they can be treated with antivirals to lower their risk of infecting their newborns.