hepinion: Patients have an important role to play in the development of a hepatitis B cure

2 May 2019 Lucy Ferrier

Blog by Dr. Su Wang, WHA President-elect 

In April the International Coalition to Eliminate Hepatitis B (ICE-HBV) launched the ‘Global Scientific Strategy to Cure hepatitis B’, setting out a roadmap for the global scientific community to discover a cure for hepatitis B. I spoke at the launch in my dual roles as a medical professional, who sees the impact of hepatitis B on patients every day, and as someone living with hepatitis B myself.

This strategy should be welcomed by those of us affected by hepatitis B (HBV), and we need to be involved in the process to find a cure. Across the globe, 257 million people live with hepatitis B, with 900,000 people dying every year from the disease. We have a preventative vaccine for the disease and effective treatments exist that are relatively low cost, but patients, myself included, hope for a cure. Research is underway, but the pace is slow.

The ICE-HBV strategy calls for more research to accelerate the development of a cure. It’s shocking how little we know about this global killer due, in part, to a lack of research funding for hepatitis B. In the USA last year $4 billion was spent on HIV research; in the same period only $47 million was spent on hepatitis B research. Patients, the affected community and civil society have an important role to play in advocating for more money to be allocated to hepatitis B research. Our collective voices and stories can call on research institutions, funders and governments to prioritise hepatitis B funding. We also need to use our voices to ensure that countries and health systems do not neglect the need for a cure for hepatitis B. It is tempting for health systems to continue the status quo, but it also effectively condemning a generation to a life with limitations.

In 2015, of the 257 million people living with HBV infection, only 9% (22 million) knew their diagnosis. Of those diagnosed, the global treatment coverage was only 8% (1.7 million). Lack of access to viral load testing (HBV DNA) is a major barrier to many people globally. This means patients do not know their disease severity and whether they need medications based on professional guidelines, so we must continue to advocate for availability of diagnostics and simplified guidelines. We have had effective hepatitis B vaccines for decades, yet we fall shockingly short in administering the crucial birth dose which reaches only 38% of babies born worldwide. This means we will not be the last generation of people living with hepatitis B; a lost opportunity. A cure will become an important tool to make the elimination of hepatitis B a reality.

We are seeing the results of research – a ‘functional cure’ for hepatitis B is on the horizon, with some organisations saying it may be available within the next decade. A functional cure would mean virus production is suppressed and there is a loss of the Hepatitis B surface antigen (HBsAg), the marker currently used to screen and diagnose people with hepatitis B infection. However, in the functional cure, particles of the virus called covalently closed circular DNA (cccDNA) will remain in the liver. This scenario is also the case in the millions of people who have also naturally resolved hepatitis B infection, leaving them with a small chance of disease reactivation under immune suppression; remember, 2 billion people in the world have had hepatitis B infection at some point, though 357 million are currently infected. A ‘sterilizing cure’ is eradication of cccDNA and for many in the scientific community, would be the true cure. This is a much higher task to achieve. Because cccDNA is not detectable by current tests, there is little awareness about it. The wider patient community is desperate for the loss of HBsAg which is currently the ‘scarlet letter’ (identifier) leading to stigma and discrimination they face.

It’s important for the community to understand that the hepatitis B virus is much more complicated than the hepatitis C virus, and thus cure will not be as simple. The hepatitis B virus has a complex interplay with the immune system, and current thinking is that it will take both a direct acting antiviral and another modality to boost the immune system to achieve control over the virus. Regimens to achieve functional and sterilizing cure may be a combination of oral medications and injections. There is much unknown about the virus and significant research still needs to be done to know what will work. At this time, there are a number of therapies in early stage clinical trials with the furthest along in phase 2.

"Our input is important so that the drugs developed to cure us actually work for us and are accessible to all of us"

We as the affected community need to be educated and involved in the development process – we can actually help accelerate the process to cure. We are a part of raising awareness to show there is a great demand and need for these therapies. We need to make sure that policy makers, funders, payers all see the importance and urgency of relieving the burden of this disease. We welcome collaborative efforts like the new ICE-HBV strategy as a sign of the commitment to scale up the necessary research and collaboration to get us there. The inclusion of the patient community in the ICE-HBV strategy is also an important example of partnering with patients on the road to hepatitis B cure. It’s imperative for patients to use our voices and lived experiences to inform the process. Our input is important so that the drugs developed to cure us actually work for us and are accessible to all of us.