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Baraclude safely reduces HBV DNA among children, adolescents

In a randomized phase 3 study, children and adolescents with chronic hepatitis B virus infection treated with Baraclude showed reduced infection compared with children treated with placebo, according to published findings.

Researchers randomly assigned 180 treatment-naive children and adolescents to a regimen of Baraclude (entecavir, Bristol-Myers Squibb; n = 120) or placebo (n = 60) for a duration of 48 weeks. The primary endpoint of the study was hepatitis B e antigen (HBeAg) seroconversion and reduced HBV DNA levels (less than 50 IU/mL) at 48 weeks. Follow-up was through 96 weeks.

Overall, more children treated with entecavir reached the primary endpoint (24.2%) compared with children who received placebo (3.3%; P = .0008).  Among children who received entecavir and reached HBeAg seroconversion at 48 weeks, 90% maintained said seroconversion through 96 weeks. Among children who received entecavir but did not achieve seroconversion at 48 weeks, 20.5% achieved it on open-label entecavir by 96 weeks.

In addition, patients treated with entecavir had higher response rates compared with placebo for secondary endpoints, including HBV DNA levels less than 50 IU/mL (49.2% vs. 3.3%; P < .0001); alanine aminotransferase normalization (67.5% vs. 23.3%; P < .0001); and HBeAg seroconversion (24.2% vs. 10.0%; P = .021).

An increase in all efficacy endpoints between 48 and 96 weeks, including an increase from 49% to 64% in virological suppression, were observed in patients who received entecavir. The cumulative probability of emergent entecavir resistance was 0.6% at 1 year and 2.6% at 2 years of treatment with entecavir.

Entecavir was well-tolerated with no observed differences in adverse events or changes in growth compared with patients who received placebo. Eleven children (four in the entecavir group) experienced serious adverse events through 48 weeks. One child discontinued treatment with entecavir due to headache.

The researchers concluded: “These results support the use of entecavir as a therapeutic option for children and adolescents with [chronic HBV] disease. Entecavir is now approved in the United States and European Union for the treatment of pediatric [chronic HBV] patients ages 2 to [less than] 18 years.” – by Melinda Stevens

Disclosure: Jonas reports consulting for Gilead Sciences; and receiving grants from Bristol-Myers Squibb, Gilead Sciences and Roche. Please see the full study for a list of all other authors’ relevant financial disclosures.