Entecavir (Baraclude) for Chronic Hepatitis B Provides Continued Benefits through 96 Weeks

Entecavir (Baraclude), approved by the U.S. Food and Drug Administration in 2005, is a nucleoside analog used to treat chronic hepatitis B. Entecavir demonstrated superior benefit compared with lamivudine (Epivir-HBV) at 48 weeks in nucleoside-naive patients with hepatitis B "e" antigen (HBeAg) positive chronic hepatitis B. In the November 2007 issue of Gastroenterology, researchers reported continued outcomes through 96 weeks.

In this study, 709 HBeAg positive chronic hepatitis B patients were randomly assigned to receive 0.5 mg entecavir (n=354) or 100 mg lamivudine (n=355) once daily. At Week 52, virological responders could continue blinded treatment for up to 96 weeks. Patients continuing in Year 2 (243 taking entecavir, 164 taking lamivudine) were assessed for serum HBV DNA, alanine aminotransferase (ALT) normalization, HBeAg seroconversion, and safety parameters.

Results

• Among patients treated in Year 2, 74% in the entecavir arm achieved HBV DNA < 300 copies/mL by PCR, compared with 37% in the lamivudine arm.

• 79% of entecavir-treated subjects and 68% of lamivudine-treated patients experienced ALT normalization.

• Similar proportions of patients in both groups achieved HBeAg seroconversion (11% with entecavir vs 12% with lamivudine).

• Higher proportions of entecavir-treated subjects than lamivudine-treated patients achieved cumulative confirmed HBV DNA < 300 copies/mL (80% vs 39%; P < 0.0001) and ALT normalization (87% vs 79%; P = 0.0056) through 96 weeks.

• Cumulative confirmed HBeAg seroconversion occurred in 31% of entecavir-treated versus 25% of lamivudine-treated patients (P = non-significant).

• Through Week 96, no patients experienced virological breakthrough due to entecavir resistance.

• Safety profiles were favorable, and comparable in both groups.

Conclusion

Based on these findings, the researchers concluded, "Entecavir treatment through 96 weeks results in continued benefit for patients with HBeAg positive chronic hepatitis B.

12/11/07

Reference
RG Gish, AS Lok, TT Chang, and others. Entecavir therapy for up to 96 weeks in patients with HBeAg-positive chronic hepatitis B. Gastroenterology 133(5): 1437-1444. November 2007.