Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Positive Chronic Hepatitis B
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with
HBeAg positive CHB, with the overall HBeAg seroconversion far from satisfactory. Therefore,
efforts on the various combinations with the currently available drugs are needed to improve
the overall response rates. The simultaneous combination therapy with oral nucleoside and
peginterferon alfa-2a from large-scaled randomized trials did not show a superior response
rate over peginterferon alfa-2a monotherapy. Recently, sequential monotherapy with lamivudine
for the first 4 weeks, followed by weekly peginterferon alfa-2a has shown favorable HBeAg
seroconversion rate over peginterferon alfa-2a monotherapy, based on the assumption that
early viral suppression by lamivudine can restore the immune function to facilitate the later
immunomodulatory response by peginterferon alfa-2a. With the recent introduction of
entecavir, the more potent oral nucleoside with few drug resistance, sequential monotherapy
with entecavir can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate
the response of peginterferon alfa-2a to achieve HBeAg seroconversion. Therefore, we aimed to
conduct a placebo controlled randomized control trial to evaluate of adding entecavir early
in the course of therapy can improve the treatment response.