Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Negative 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 negative CHB, with the overall ALT normalization and HBV viral suppression 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. Furthermore,
prior studies using 24 months of standard interferon alfa showed better ALT normalization and
HBV suppression rates to 12 months of therapy. 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 HBV viral suppression. Therefore, we aimed to conduct a
placebo controlled randomized control trial to evaluate if adding entecavir early in the
course of therapy or extending the treatment duration of peginterferon alfa-2a can improve
the treatment response.