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Hepatitis B: Four trials to watch over the next 12 months
I recommend the following article:https://www.clinicaltrialsarena.com/features/hepatitis-b-trials-to-watch/
The biggest unmet need for Hepatitis B patients is a cure, but there are a number of trials looking to achieve functional cure for the disease. GSK’s bepirovirsen, which is looking for a functional cure, showed very promising results during a Phase II readout in June 2022 and has now initiated a Phase III trial due to end in 2025. Functional cure is defined as loss of hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) after six months off therapy.
The need for a cure for Hepatitis B could not be emphasised enough after the WHO estimated that 296 million people were living with chronic hepatitis B (CHB) infection in 2019, resulting in approximately 820,000 deaths.
Dr Henry Janssen, professor of medicine at the University of Toronto and chief of hepatology and director of the Toronto Centre for Liver Disease at Toronto General Hospital, says that the challenge will not be HBsAg and HBV loss but sustainment of that. “To get it sustained, we think that we need an immune modifier to get that done,” Janssen explains “So you have to tickle the immune response in such a way that it takes control over the virus, and that the virus doesn’t bounce back.”
While Dr Antonio Bertoletti, professor at the Duke-NUS Medical School in Singapore and an infectious disease doctor who has been working on Hepatitis B trials for 30 years, said he thinks that it is more important for trials in Hepatitis B to find patient populations in which they may be most effective rather than seek a one-size fits all treatment. “A single bullet is not good for everyone,” Bertoletti says. “There are patients that need treatments, there are patients that probably do not need treatment and there will be patients that will have to be treated by activating adaptive immunity and others that will respond by activated innating. I think this [patient selection] is what the research community should aim to do.”
The biggest unmet need for Hepatitis B patients is a cure, but there are a number of trials looking to achieve functional cure for the disease. GSK’s bepirovirsen, which is looking for a functional cure, showed very promising results during a Phase II readout in June 2022 and has now initiated a Phase III trial due to end in 2025. Functional cure is defined as loss of hepatitis B surface antigen (HBsAg) and undetectable hepatitis B virus (HBV) after six months off therapy.
The need for a cure for Hepatitis B could not be emphasised enough after the WHO estimated that 296 million people were living with chronic hepatitis B (CHB) infection in 2019, resulting in approximately 820,000 deaths.
Dr Henry Janssen, professor of medicine at the University of Toronto and chief of hepatology and director of the Toronto Centre for Liver Disease at Toronto General Hospital, says that the challenge will not be HBsAg and HBV loss but sustainment of that. “To get it sustained, we think that we need an immune modifier to get that done,” Janssen explains “So you have to tickle the immune response in such a way that it takes control over the virus, and that the virus doesn’t bounce back.”
While Dr Antonio Bertoletti, professor at the Duke-NUS Medical School in Singapore and an infectious disease doctor who has been working on Hepatitis B trials for 30 years, said he thinks that it is more important for trials in Hepatitis B to find patient populations in which they may be most effective rather than seek a one-size fits all treatment. “A single bullet is not good for everyone,” Bertoletti says. “There are patients that need treatments, there are patients that probably do not need treatment and there will be patients that will have to be treated by activating adaptive immunity and others that will respond by activated innating. I think this [patient selection] is what the research community should aim to do.”
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