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Approval of Baraclude (entecavir) for Treatment of Chronic Hepatitis B Virus Infection

On March 29, 2005, FDA approved Baraclude (entecavir) for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication, and either evidence of persistent elevations in serum aminotransferases (ALT or AST), or histologically active disease.

This indication is based on histologic, virologic, biochemical, and serologic responses after one year of treatment in nucleoside-treatment-naive and lamivudine-resistant adult patients with HBeAg*-positive, or HBeAg-negative chronic HBV infection with compensated liver disease, and on more limited data in adult patients with HIV/HBV co­infection who have received prior lamivudine therapy. *(hepatitis B e antigen)

Limited data about Baraclude in patients with HIV/HBV co-infection who received prior lamivudine therapy are presented in the label. Please refer to the attached label (pdf 303 KB) and the Special Population section under Description of Clinical Studies for information on HIV/HBV co-infected patients.

In summary, Study AI463038 was a randomized, double-blind, placebo-controlled study of Baraclude versus placebo in 68 patients co-infected with HIV and HBV who experienced recurrence of HBV viremia while receiving a lamivudine-containing highly active antiretroviral therapy (HAART) regimen. Patients continued their lamivudine-containing HAART regimen (lamivudine dose 300 mg/day) and were assigned to add either BARACLUDE 1 mg once daily (51 patients) or placebo (17 patients) for 24 weeks followed by an open-label (non-blinded) phase for an additional 24 weeks where all patients received BARACLUDE.

At baseline, patients had a mean serum HBV DNA level by PCR of 9.13 log10 copies/mL. Ninety-nine percent of patients were HBeAg-positive at baseline, with a mean baseline ALT level of 71.5 U/L. Median HIV RNA level remained stable at approximately 2 log10 copies/mL through 24 weeks of blinded therapy.

The proportion of HIV/HBV co-infected patients with HBV DNA < 300 copies/mL was 6% for the BARACLUDE 1 mg group versus 0% for the placebo group. The mean change from baseline for HBV DNA was -3.65 log10 copies/mL for the BARACLUDE 1 mg group versus +0.11 log10 copies/mL for the placebo group. Thirty-four percent of patients in the Baraclude 1 mg group had ALT normalization (< 1 x ULN) compared to 8% of patients in the placebo group.

There are no data for patients with HIV/HBV co-infection who have not received prior lamivudine therapy.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration