Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B
Status:
Unknown status
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
Currently, seven medications are approved for the treatment of hepatitis B: two formulations
of interferon and five nucleons(t)ide analogues. The current treatment strategy of chronic
hepatitis B is now standard: initial selection of entecavir, tenofovir, or peginterferon
alfa-2a (peg-IFNα-2a). Interferon is administered for a finite duration while nucleotide
analogues are usually administered for many years. But among hepatitis B e antigen （HBeAg）
positive patients with high serum hepatitis B virus DNA levels, the rates of virological
response are poor. And antiviral drug resistance is a major limiting factor to the success of
nucleotide analogue treatment. Therefore, combination therapy using peginterferon with an
oral agent with a high genetic barrier to resistance might be superior to standard current
monotherapy. However, the addition of lamivudine to peg-IFNα-2a therapy led to a greater
decrease in serum HBV DNA levels during treatment but did not increase the rate of HBeAg
sero¬conversion. Entecavir is a nucleoside analogue superior to lamivudine and adefovir in
achieving higher virological response, histological improvement and normalisation of ALT.
Moreover, Entecavir has a high genetic barrier with a very low incidence of drug resistance.
This study is aimed to investigate the efficacy of combination or sequential therapy using
peg-IFNα-2a and entecavir in HBeAg-positive chronic hepatitis B(CHB) patients.