By John Young, Global Head of Infectious Diseases, Roche Pharma Research & Early Development & Lu Gao, China Head of Infectious Diseases Discovery and HBV Early Development, Roche Pharma Research & Early Development.
Today marks World Hepatitis Day, an annual occasion when members of the global hepatitis community join together to celebrate progress and catalyse action to prevent, diagnose and treat hepatic diseases.
This year’s theme of ‘Find the Missing Millions’ shines a light on the more than quarter billion people living with undiagnosed hepatitis, issuing a clarion call to tackle the main barriers to diagnosis.
As virologists and committed allies of the hepatitis community, it goes without saying that we support the aim of finding these missing patients, many who are suffering in silence. Increased disease awareness and access to testing means that people with HBV can be linked to care, with lives saved and suffering relieved.
On this World Hepatitis Day, however, we wanted to add our voices to the discussion on a related point: the need to develop a cure for chronic hepatitis B virus (HBV) infection.
Let’s start with good news first. The great majority of adults infected with HBV develop protective immunity within weeks or months of infection, successfully clearing the virus from their bodies. The bad news? In about 5-10% of infected adults, and nearly all children infected at birth, there is an absence of an effective immune response to HBV. The virus can therefore persist for a person’s entire life.
While there are currently available medicines that can effectively suppress HBV from replicating, these rarely restore immunity against the virus and patients face long-term, possibly life-long, treatment. Patients are also faced with the continued and significant risk of developing hepatocellular carcinoma (HCC), a liver cancer with particularly devastating effects. It has been possible since the early 1980s to effectively prevent HBV infection by vaccination, and in recent years, the infection rate in infants and children has been largely reduced in the countries applying universal vaccination. Unfortunately, vaccines fail to help those already chronically infected, and many patients are unaware of their status until the disease worsens.
Right now, there are more than 250 million people living with chronic HBV infection, of whom nearly one third live in China. Each year, close to 800,000 die from complications associated with chronic HBV infection, making it the 10th leading cause of death worldwide. Worse yet, patients with HBV in some places may face social and economic impacts due to the stigma associated with infection.
Given these factors, one might wonder what could realistically be done for patients in a health crisis of such monumental scale. However, we believe a lot.
At Roche our goal is to stop the progression of chronic liver disease across the patient journey and we have approaches targeting the earliest stages of the disease, such as NASH and hepatitis, as well as the later setting for patients with HCC. Our team at Roche Pharma Research and Early Development (pRED) is currently in a race to find a cure for chronic HBV infection.
Our programs, which recently began Phase II clinical trials, hinge on a strategy to combine immuno-enhancing molecules with antivirals to create a ‘functional cure’ that eliminates the immunosuppressive viral proteins that impair the body’s ability to fight HBV infection. If successful, our approach could potentially yield a combination therapy that patients with HBV could take for a finite duration, freeing them from lifelong treatment and restoring a greater degree of freedom to their lives.
Diagnostics play a critical role in our approach. We are working closely with an academic partner and our colleagues in Roche Diagnostics to identify new viral biomarkers that could accurately assess the efficacy of potential therapies. These new tests will build on the existing Diagnostics portfolio of blood tests to determine the presence of antibodies in response to HBV infection and molecular tests that determine the amount of HBV in the blood, helping to measure response to treatment.
Over the years, we have had the privilege of hearing directly from patients battling chronic HBV infection - learning about their symptoms, treatment regimens, and experiences with social stigma and exclusion. These conversations have inspired us and infused our work with a deeper understanding of the positive benefit a cure would bring to patients. A cure for HBV would not only cut off progression to more devastating health conditions, such as cancer. It very well could enable patients to live longer, healthier and ultimately more open lives than before.
The scientific and logistical challenges to achieving a cure cannot be understated. But on this World Hepatitis Day, we stand with others in the hepatitis community in our commitment to not only ‘find’ patients with hepatitis, but to treat and cure them as well.