Baraclude Long-Term Safety Data Included in Updated Labeling

HepatitisB paper
HepatitisB paper

The Food and Drug Administration (FDA) has approved revisions to the Postmarketing Experience section of the product labeling for Baraclude (entecavir; Bristol-Myers Squibb) tablets and oral solution.

The Postmarketing Experience section has been updated to include data from the global, open-label, randomized, observational phase 4 study (Study AI463080) that evaluated the long-term risks and benefits of Baraclude (0.5mg/day or 1mg/day) treatment in patients with chronic HBV infection (N=12,378). Patients were randomized to receive either Baraclude (n=6,216) or other standard-of-care HBV nucleos(t)ide analogues (non-entecavir [ETV]; n=6,162) for up to 10 years.

Results from the long-term observational study showed that Baraclude was not significantly associated with an increased risk of malignant neoplasms compared to other standard-of-care HBV nucleos(t)ides (hazard ratio [HR] 0.93; 95% CI 0.800, 1.084). Hepatocellular carcinoma (HCC) was the most commonly reported malignancy in both the Baraclude and non-ETV treatment groups followed by gastrointestinal malignancies. In addition, long-term Baraclude use was not associated with a lower occurrence of HBV disease progression (HR 0.89; 95% CI 0.769, 1.030) or a lower rate of death overall (HR 0.85; 95% CI 0.713, 1.012) compared with other HBV nucleos(t)ides.

The updated labeling also highlights the study limitations, including population changes over the long-term follow-up period and more frequent post-randomization treatment changes in the non-ETV group. Moreover, “the study was underpowered to demonstrate a difference in the non-HCC malignancy rate because of the lower than expected background rate.”

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Baraclude, a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor, is indicated for the treatment of chronic hepatitis B virus infection in adults and children aged ≥2 years with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. 

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