Washington

TheUnited States has approved a new treatment for chronic hepatitis B that could allow some patients to stop taking antiviral medicines while maintaining control over the virus.

The US Food and Drug Administration (FDA) announced Tuesday that it had approved Hibsago (bepirovirsen), an injectable medicine developed by GSK, for certain adults with chronic hepatitis B who do not have cirrhosis. The treatment is the first FDA-approved antisense oligonucleotide for hepatitis B, using a technology designed to interfere with the genetic instructions that allow the virus to reproduce and produce viral proteins.

The new approach offers some eligible patients the possibility of maintaining viral control after stopping all hepatitis B therapy.

"For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed," said Wendy Carter, acting director of the FDA's Office of Infectious Diseases.

"Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease," she said.

The approval applies to adults without cirrhosis who have received antiviral therapy for at least six months and have suppressed levels of hepatitis B virus in their blood.

Patients must also have hepatitis B surface antigen levels of 3,000 international units per millilitre or less, established through an FDA-authorised diagnostic test.

The FDA said the treatment was evaluated in two clinical trials comparing Hibsago with a placebo.

Patients received injections under the skin for up to 24 weeks while continuing their existing antiviral medication.

They were required to remain on their regular antiviral treatment for at least another 24 weeks after the final Hibsago injection.