After decades of research, scientists are closer than ever to a solution to chronic hepatitis B, a silent disease that affects more than 240 million people worldwide. Leading to liver cancer and often asymptomatic, it is nicknamed the “silent killer” because only 13% of those infected are aware of their condition.
A study published in the New England Journal of Medicine and relayed by National Geographic reveals the results of the phase III clinical trial of a new drug called bepirovirsen. Tested on 1,838 adults in 29 countries, the treatment, added to standard care, allowed around one in five patients to achieve what is called “functional cure”: the immune system controls the virus without medication for more than six months.
This functional cure rate of 20% is significantly higher than the 3% obtained with standard treatment alone, after 8 to 10 years of therapy. “We have never had a treatment that comes close to this level of curesays Seng Gee Lim, co-author of the study and director of hepatology in Singapore. My patients will be extremely pleased to have this treatment available.”
Hepatitis B is the most common and contagious hepatitis virus. Transmitted through blood and bodily fluids, it can survive for up to a week outside the human body. Once infected, the patient risks developing a chronic form that silently damages the liver for years, potentially leading to cirrhosis, liver failure and cancer.
More than a million people die each year from complications of hepatitis B, the virus of which is particularly dangerous for babies: 90% of infections transmitted from mother to child during childbirth become chronic, compared to only 5% in adults. More than half of infected people are unaware of their condition and can therefore transmit the virus without knowing it.
Beware of side effects
Tools already exist to control the disease: a vaccine introduced in 1981 provides almost 100% protection for decades, simple blood tests and effective antiviral drugs are also available. Yet these tools are not easily accessible where they are most needed, notably in sub-Saharan Africa and the Western Pacific region.
Bepirovirsen works in an innovative way by binding to the virus’s messenger RNA to reduce the production of viral proteins, while stimulating the immune system. However, the results cannot be generalized to all patients. The study excluded from its panel people with cirrhosis, HIV co-infection or severe illness. The drug works best in those whose disease is already controlled, reinforcing the importance of early diagnosis and regular monitoring.
Manufacturer GSK has submitted the data to regulatory agencies in the United States, Canada, Europe, Japan and China, with approval decisions expected later this year. The drug may have side effects on platelets and kidney function, requiring close monitoring.
Experts emphasize that despite this promising advance, the immediate priority remains finding people living with hepatitis B, connecting them to appropriate care and supporting them before the development of liver disease or liver cancer. “This must not remain a silent epidemic”concludes Jane Davies, infectious diseases specialist in Australia.
