Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C/Hepatitis B Co-Infection and Chronic Hepatitis C
Status:
Unknown status
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
The investigators' pilot study indicates that hepatitis C virus (HCV)- and hepatitis B virus
(HBV)-coinfected patients with predominantly active hepatitis C and those with predominantly
active hepatitis B may need different anti-viral regimens. Since in the majority of these
coinfected patients the hepatitis activity is more likely due to HCV than to HBV, the optimal
therapeutic regimen for HCV- and HBV-coinfected patients with predominantly active hepatitis
C will first be investigated. The combination therapy using pegylated interferons (IFNs) such
as PEG-IFN alfa-2a has been shown to have a superior efficacy than that using conventional
IFN in the treatment of monoinfected chronic hepatitis C. This new combination therapy might
also further enhance the treatment efficacy in HCV- and HBV- coinfected patients. The
investigators therefore propose to initiate a trial comparing the efficacy of pegylated IFN
plus ribavirin (RBV) in dual chronic hepatitis B and C versus that in chronic hepatitis C
only, for both HCV genotype 1 and 2/3 patients. The efficacy using a 24-week combination
therapy in the sustained clearance of serum HCV RNA is equivalent to that using a 48-week
combination therapy in patients with HCV genotype non-1 [Hadziyannis et al, EASL 2002]. A
48-week course of pegylated IFN and RBV combination therapy, in contrast, has been shown to
yield a better efficacy in the sustained clearance of serum HCV RNA in patients with HCV
genotype 1 than a 24-week combination therapy in western countries [Hadziyannis et al, EASL
2002; Poynard et al, 1998]. The primary objective of the current proposal is to investigate
and compare the efficacy of combination therapy using pegylated IFN plus RBV on the clearance
of serum HCV RNA in both dually infected patients with a dominant HCV infection and HCV
monoinfected patients. Therefore, in this proposal, the treatment duration will be 24 weeks
for HCV genotype 2/3 in patients with dual chronic hepatitis C and B and in patients with
monoinfected HCV, and will be 48 weeks for HCV genotype 1 in patients with dual chronic
hepatitis C and B and in patients with monoinfected HCV.