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Sherman, M. et al.

Sherman, Yurdaydin, Sollano, Silva, Liaw, Cianciara, Boron-Kaczmarska, Martin, Goodman, Colonno, Cross, Denisky, Kreter, Hindes,

Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B.

BACKGROUND & AIMS: Lamivudine treatment is associated with frequent development of resistant hepatitis B virus (HBV) and loss of treatment benefit. In preclinical and phase II studies, entecavir demonstrated potent antiviral activity against lamivudine-resistant HBV. METHODS: In this phase III, double-blind trial, hepatitis B e antigen-positive patients who were refractory to lamivudine therapy (persistent viremia or documented YMDD mutations while receiving lamivudine) were randomized to switch to entecavir 1 mg daily (n = 141) or continue lamivudine 100 mg daily (n = 145) for a minimum of 52 weeks. Two coprimary end points were assessed at 48 weeks: histologic improvement and a composite end point (HBV branched DNA <0.7 MEq/mL and alanine aminotransferase [ALT] <1.25 times the upper limit of normal). RESULTS: Histologic improvement occurred in 55% (68/124) of entecavir-treated vs 28% (32/116) of lamivudine-treated patients (P < .0001). More patients on entecavir than lamivudine achieved the composite end point: 55% (77/141) vs 4% (6/145), respectively (P < .0001). Mean change from baseline in HBV DNA was -5.11 log(10) copies/mL for entecavir-treated patients and -0.48 log(10) copies/mL for lamivudine-treated patients (P < .0001). Virologic rebound because of entecavir resistance substitutions occurred in 2 of 141 of entecavir-treated patients, and genotypic evidence of resistance was detected in 10 patients. The safety profile of entecavir was comparable to lamivudine with fewer ALT flares on treatment. CONCLUSIONS: In patients with lamivudine-refractory chronic hepatitis B, switching to entecavir provides superior histologic improvement, viral load reduction, and ALT normalization compared with continuing lamivudine, with a comparable adverse event profile.[1]

References

Entecavir for treatment of lamivudine-refractory, HBeAg-positive chronic hepatitis B. Sherman, M., Yurdaydin, C., Sollano, J., Silva, M., Liaw, Y.F., Cianciara, J., Boron-Kaczmarska, A., Martin, P., Goodman, Z., Colonno, R., Cross, A., Denisky, G., Kreter, B., Hindes, R. Gastroenterology (2006) [Pubmed]

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