Interferon Alpha 2b Plus Ribavirin for Chronic Hepatitis B
Status:
Completed
Trial end date:
2001-06-01
Target enrollment:
Participant gender:
Summary
Hepatitis B virus (HBV) causes a wide spectrum of liver diseases, such as fulminant or acute
hepatitis, chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. The number of
individuals infected with this virus has been estimated to be as high as 350 million. Thus,
in addition to global hepatitis B vaccination, effective treatment of chronic hepatitis B is
also needed.
Currently, there are no effective antiviral treatments to cure HBV infection in patients with
chronic hepatitis B. Five drugs have been approved for the treatment of chronic hepatitis B
at present: conventional interferon (IFN) alpha, lamivudine, adefovir dipivoxil, pegylated
IFN alpha and recently entecavir. Overall, satisfactory virologic and serologic responses
could be achieved using pegylated IFN alpha alone in around 20-44% of these patients.
Nevertheless, better treatment options are still needed for the remaining >50%
non-responders.
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. A major advancement in treating hepatitis C virus (HCV) infection has been the
development of combination therapy with IFN and ribavirin. IFN monotherapy is limited by poor
sustained virologic responses, even when higher doses of IFN are used. IFN plus ribavirin
combination therapy, in contrast, results in much improved treatment outcomes. In our
previous study and others, sustained remission rate after cessation of therapy were
significantly higher in patients receiving combination therapy than those receiving IFN
alone. Therefore, combination therapy with IFN and ribavirin has been recommended as the
standard treatment regimen for chronic hepatitis C. Furthermore, we have used ribavirin and
IFN combination for the treatment of dual chronic hepatitis B and C, and the results also
revealed that the efficacy of clearing HCV RNA was not affected by the presence of HBV
infection. Interestingly, after a little more than 2-year post-treatment follow-up, we found
that a significant portion (21%) of the responsive patients also cleared HBsAg. These
findings imply that this combination regimen might be also effective for the control of
chronic hepatitis B. We thus conducted a randomized, multi-center, placebo-controlled study
in patients with HBeAg-positive chronic hepatitis B.