Information on the use of entecavir in children down to age 2 years has been added to the prescribing information for the chronic hepatitis B drug, the Food and Drug Administration has announced.
The changes include a revised indication, which now states that entecavir is indicated for treating chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older, who have evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alanine aminotransferase or aspartate aminotransferase) or histologically active disease. The pediatric indication is based on "clinical trial data in nucleoside-inhibitor treatment–naive and in a limited number of lamivudine-experienced subjects with HbeAg [hepatitis B e antigen]-positive chronic HBV infection and compensated liver disease," according to the revised label.
Previously, the label included the statement that safety and effectiveness of entecavir in pediatric patients under age 16 have not been established. Now, the label states that the efficacy and safety have not been established in patients under age 2, and that the drug has not been studied in this age group because the need to treat children this young is rarely necessary.
Entecavir, a nucleoside analogue, was approved in 2005 and is marketed as Baraclude by Bristol-Myers Squibb. It is administered once-daily orally, in a tablet or solution formulation. The label says that the oral solution should be used for children who weigh up to 30 kg.
The revised label is available at http://packageinserts.bms.com/pi/pi_baraclude.pdf.