Hepatitis B (HBV) is a killer. A viral infection that attacks the liver, it is responsible for more than 800,000 deaths<sup>1</sup> every year. Vaccinations and hepatitis diagnostic tests play a pivotal role in the prevention and early detection of the infection to reduce the spread of disease. HBV diagnostics enable physicians and patients to better manage disease. In conjunction, we are working on a cure for chronic hepatitis, with promising results on three compounds in early clinical development.

Spread by contact with infected blood and other body fluids, hepatitis B (HBV) can be associated with irreversible liver damage, chronic active hepatitis, and the development of cirrhosis and hepatocellular carcinoma.

Great strides have been made in reducing childhood HBV infection through vaccination, but for those already infected early detection is important. HBV diagnostic tests help diagnose and monitor the disease to tell clinicians if treatment is required and if regimens are working.

Although current medications effectively suppress HBV replication, they rarely cure chronic hepatitis B infection, do not eliminate the risk of liver cancer and result in the need for life-long treatment in the majority of patients. Additionally, the cost of long-term treatment puts it beyond the reach of many who need it.

Roche's strategy to achieve a cure with finite, short-term treatment involves combining two very different approaches to eliminating the virus. The first targets the HBV life cycle (direct antivirals), while the second boosts the immune system’s ability to clear HBV (immune enhancers).

Three potential combination partners - novel agents all discovered by Roche - are in Phase 1 clinical development.

HBV is extremely challenging in terms of cure owing to the persistence of its mini-chromosome in human liver cells, its integration into the genome and its suppression of the host immune system.

For all these reasons the search for a cure needs a multi-pronged approach, and achieving it will probably require a combination of novel direct antivirals and immune enhancers, an approach supported by pre-clinical results.

Roche's combinations of diagnostics and novel compounds will now be tested in chronic hepatitis B patients in trials in China and elsewhere. China is home to almost a third of all those infected with HBV in the world. China’s participation in testing and developing these drugs has the potential to save millions of lives.

HBV is the most pathogenic of all hepatitis types, because it is frequently and strongly associated with irreversible liver damage, chronic active hepatitis, and the development of cirrhosis and hepatocellular carcinoma.

Globally only around 9% of those infected have received a diagnosis and are aware of their disease. Frequently they are diagnosed only when they have already suffered serious liver damage and are extremely unwell.

In highly endemic areas, the most common route of HBV infection is from mother to child at birth, or through exposure to infected blood or body fluid. Children infected below the age of five are at high risk of developing chronic infection that will persist into adulthood. Around 20-30% of adults with chronic infection will develop one or both of cirrhosis and liver cancer.

Around 3.5% of the world’s population is infected with HBV, with numbers highest in east Asia and sub-Saharan Africa.

In China, particularly, the disease burden is huge. Of the 2571 million infected worldwide, almost a third live in China, and a recent article in The Lancet claimed that 10 million of them will die by 2030.


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