According to a press release from Eiger Biopharmaceuticals, the American Food and Drug Administration (FDA) recently granted the Company’s experimental hepatitis delta virus drug (hepatitis D), peginterferon lambda, breakthrough therapy designation. Drugs that receive this special FDA designation are entitled to receive certain significant benefits, such as an expedited review process along with clinical trial design and organizational guidance.

About Hepatitis Delta Virus

The hepatitis delta virus (HDV) may be better known to you as hepatitis D. Like other hepatitis infections, it is characterized by the inflammation of liver cells, which can jeopardize patients’ liver health in the long term. Cases of hepatitis D may be acute or progressive — symptoms tend to be worse in episodic cases. Frequently, hepatitis D patients eventually develop cirhossis (advanced scarring of the liver), which can have serous health consequences.

Interestingly, however, in many countries hepatitis D is relatively rare. That’s partially because the only people who can contract hepatitis D are people who have already been infected with hepatitis B (HBV). HDV can only occur in people with HBV because the hepatitis D virus requires proteins from hepatitis B to replicate itself.

However, the rarity of the virus doesn’t downplay its severity. HBV-HDV coinfection is considered to be the most severe form of viral hepatitis infection, due to the greatly elevated risk of liver cancer and liver-related death experienced by hepatitis D patients.

Currently, no cure exists — and response rates to existing treatments are poor. The best way to prevent the development and progression of hepatitis D is to vaccinate against hepatitis B.

About Peginterferon Lambda

“Lambda” is Eiger Biopharmaceuticals’ name for their brand of peginterferon lambda. The drug is a type III interferon. Interferons are a type of cytokine that signal for immune responses to certain stimuli.

Eiger’s research suggests that type III interferon receptors are densely concentrated in the liver, with relatively little expression in the central nervous system or in nascent blood cells. The thinking is that peginterferon lambda might stimulate an enhanced immune response in a targeted area, limiting the collateral damage to surrounding tissues compared to a more general artificially-stimulated immune response.

Eiger Biopharmaceuticals hopes to bring the drug to phase 3 clinical study soon.

Although hepatitis D is preventable with inoculation, why is it still important to develop treatments? Share your thoughts with Patient Worthy!