Development of a new drug for the treatment of Hepatitis B virus

5 June, 2025

Hepalatide, used with pegylated interferon-alpha, shows promise for curing chronic hepatitis B by eliminating cccDNA from liver cells, according to early study results presented in a European liver congress.

Chronic hepatitis B virus infection affects approximately 300 million people worldwide. There is a highly effective vaccine against this virus, which protects 95% of vaccinated individuals against infection.

Hepatitis B virus infection can present with high or low levels of viral DNA in the blood (viral load): in the presence of the virus’s e antigen (HBeAg), levels are high, while in the presence of antibodies to the e antigen (anti-HBe), levels are generally low

There are effective drugs (Entecavir, Tenofovir) that inhibit hepatitis B virus replication, but although they are able to reduce DNA levels in blood, making them undetectable, they generally (in 90% of cases) do not eradicate the virus (cure), so patients must be treated indefinitely. This is because these drugs cannot eliminate the cccDNA (covalently closed circular DNA) of hepatitis B virus from liver cells. Therefore, it is necessary to find new drugs or drug combinations that can eliminate hepatitis B virus DNA from the liver.

New study about Hepalatide

A study administering Hepalatide (a drug that blocks the entry of the hepatitis B virus into liver cells) together with pegylated interferon-alpha (Peg-IFN-alpha) was presented at the annual meeting of the European Association for the Study of Liver Diseases. The study included 96 patients aged 18 to 60 years with chronic hepatitis B and hepatitis B virus DNA levels ≥20,000 IU/ml (HBeAg positive) or ≥2,000 IU/ml (HBeAg negative). The patients were divided into several groups that received various doses of Hepalatide (2.1 mg, 4.2 mg, 6.3 mg) or placebo by subcutaneous injection for 24 weeks. In addition, all patients received a weekly injection of Peg-IFN-alpha for 48 weeks.

At the end of treatment with Hepalatide, patients underwent liver biopsies to determine the possible disappearance of hepatitis B cccDNA (key to cure). Hepatitis B DNA was found to have disappeared from the liver in 33% and 40% of samples in the group treated with 4.2 mg and 6.3 mg of Hepalatide, respectively. However, cccDNA remained detectable in the liver biopsies of patients receiving 2.1 mg of Hepalatide or placebo.

These preliminary data indicate that Hepalatide administered with Peg-IFN-alpha has a curative potential for chronic hepatitis B, although results from studies with larger numbers of patients will have to be awaited.

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