The U.S. Food and Drug Administration has approved a new oral medication called Baraclude (entecavir) for the treatment of chronic hepatitis B virus (HBV) infection. This approval covers adults and children aged 2 years and older who have active viral replication and signs of liver inflammation or damage. Hepatitis B is a serious liver infection that can lead to cirrhosis or liver cancer if left untreated, so having more treatment options is important.
Baraclude is taken once daily on an empty stomach. The dose depends on factors like age, weight, whether the patient has taken other hepatitis B drugs before, and kidney function. For adults who have not been treated before and have stable liver function, the usual dose is 0.5 mg per day. For those who have not responded to a drug called lamivudine or who have more advanced liver disease, the dose is 1 mg per day. Children receive a weight-based dose, and people with kidney problems may need a lower dose.
The approval is based on clinical trials that showed most patients who had not previously taken similar drugs achieved undetectable levels of the virus in their blood after 48 weeks of treatment, and that effect lasted through 96 weeks. However, the optimal length of treatment is not yet known, and it is unclear whether Baraclude reduces the long-term risks of cirrhosis or liver cancer.
If you or a loved one has chronic hepatitis B, talk to your doctor about whether Baraclude might be a suitable option. Your doctor can help you understand the benefits and risks, and how to take the medication correctly. Remember, this drug controls the virus but does not cure the infection.
