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Hepatitis B Breakthrough: Stop Antivirals, Keep Control
21 Oct
Summary
- New injectable treatment approved for chronic hepatitis B patients.
- Some eligible patients may stop antivirals while maintaining viral control.
- Serious risks include liver reactions and bleeding due to low platelets.
The United States has approved Hibsago (bepirovirsen), an injectable antisense oligonucleotide, for adults with chronic hepatitis B who do not have cirrhosis. This marks a significant advance, offering some patients the potential to stop long-term antiviral medications while still controlling the virus.
The treatment works by interfering with the virus's genetic instructions. It is approved for patients on antivirals for at least six months with suppressed viral levels and specific surface antigen levels. Clinical trials showed 24% of recipients could stop antivirals, with 19% maintaining viral control weeks later.
However, Hibsago carries boxed warnings for serious liver reactions and reduced platelet counts, increasing bleeding risk. It also carries warnings for kidney function and inflammatory reactions. Patients require regular monitoring. The FDA also authorized a companion diagnostic test to identify eligible patients.
