Pegasys Plus Entecavir Versus Entecavir Alone for Hepatitis Be Antigen-Positive Chronic Hepatitis B
Status:
Unknown status
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
Although the best treatment choice for chronic hepatitis B is not clarified yet, certain
therapeutic concepts could be derived from the experience of treating patients with chronic
hepatitis C or human immunodeficiency virus (HIV) infection. A major advancement in treating
hepatitis C or HIV infection has been the development of combination therapy. Whether the
combination therapy using Peg-IFN alfa-2a plus ETV can achieve a long-term beneficial effect
against ETV alone is not clarified. A prior single-arm pilot study suggested that similar
combination therapy may be beneficial in patients with chronic hepatitis B. In this proposal,
we thus hypothesize that the efficacy by using combination therapy with pegylated IFN alfa-2a
plus ETV is superior to that by using ETV alone in that Peg-IFN may restore host immunity
against HBV and prolonged ETV can maximize viral suppression.
The objective of this clinical trial is to evaluate the efficacy of the combination of
Peg-IFN alfa-2a at a dose of 180 mcg administered subcutaneously per week and ETV 0.5 mg
daily for 24 weeks followed by ETV 0.5 mg daily monotherapy for an additional 120 weeks
versus ETV 0.5 mg daily monotherapy for 144 weeks in patients with HBeAg-positive chronic
hepatitis B. It will be an open-label, randomized, comparative, multi-center clinical trial.
The recruited patients will be equally randomized into two treatment groups. Treatment-free
follow-up period will be 48 weeks in both groups of patients. All subjects will be assessed
for loss of HBeAg, presence of anti-HBe, loss of HBsAg, presence of anti-HBs, suppression of
HBV DNA, and normalization of serum ALT at the end of treatment and end of follow-up.
Genotypic and virologic resistance to ETV will also be assessed at baseline and at end of
years 1, 2 and 3. The primary efficacy will be HBeAg seroconversion.