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. 

For more information visit fda.gov.