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news.Results from a large international clinical study have shown that Schering-Plough's hepatitis C therapy PegIntron produced sustained responses in patients with chronic hepatitis B.
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The investigator-initiated study, which was published in medical journal The Lancet, is the largest clinical trial to date with peginterferon alfa-2b therapy (PegIntron) for chronic hepatitis B.
“Our study showed that patients with chronic hepatitis B responded to peginterferon alfa-2b, and achieved higher sustained response rates than is typically seen with any other antiviral treatment,” said lead investigator Dr Harry Janssen, from the Erasmus Medical Center in Rotterdam, The Netherlands.
“Based on our findings with peginterferon alfa-2b, it is appropriate to consider this therapy as a first-line treatment for HBeAg-positive chronic hepatitis B,” he continued.
The findings of this study are significant as chronic hepatitis B currently affects an estimated 400 million people worldwide, making it one of the most common infectious diseases and one of the ten leading causes of death. Current antiviral therapies, such as the nucleoside analogues lamivudine (GlaxoSmithKline’s Zeffix) and adefovir, do not achieve a durable response.
The study, organized and sponsored by the Foundation for Liver Research (SLO), is the first to assess whether prolonged treatment with peginterferon alfa-2b, alone or in combination with lamivudine improves sustained treatment response in patients with HBeAg-positive chronic hepatitis B. HBeAg indicates that the virus is actively replicating and the infected person is highly infectious.
In the study, more patients in the lamivudine combination group had a response to therapy at the end of treatment, but the response was not sustained during the follow-up period. There is growing evidence that only a complete and vigorous hepatitis B virus (HBV)-specific immune response is capable of achieving control and elimination of the virus, preventing disease progression.
“This suggests that induction of a host immune response is necessary for sustained response to hepatitis B treatment, which can only be reached by immunomodulatory therapy, such as peginterferon alfa-2b,” Janssen said.