Extended
Duration Pegylated Interferon Alfa-2a (Pegasys) for Patients with HBeAg Negative
Chronic Hepatitis B
The
standard course of pegylated interferon for the treatment of chronic
hepatitis B virus (HBV) infection is 48 weeks, but researchers have explored
individualized therapy tailored based on various factors that predict successful
outcomes. Studies have shown that conventional interferon alfa is more effective
in treating hepatitis B "e" antigen (HBeAg) negative chronic hepatitis
B when given for longer than 1 year.
In the present study, reported in
the December 2007 American Journal of Gastroenterology, researchers evaluated
pegylated interferon alfa-2a (Pegasys)
for 60 weeks, alone or in combination with lamivudine
(Epivir-HBV). A total of 13 participants with HBeAg negative chronic hepatitis
B either received 180 mcg/week pegylated interferon for 60 weeks as monotherapy,
or else took pegylated interferon alone for 12 weeks then added lamivudine and
continued combination therapy for an additional 48 weeks.
The primary endpoint
was sustained virological response (SVR), defined as a reduction in HBV DNA of
> 2 log10 copies/mL and HBV DNA < 20,000 copies/mL 24 weeks after
completion of treatment (week 84). Hepatitis B surface antigen (HBsAg) concentrations
were analyzed and correlated with changes in HBV DNA.
Results
• 9 of 13 patients (69%) achieved SVR.
• At week 84, 5 of 13 (38%) had undetectable
HBV DNA by polymerase chain reaction.
•
3 additional patients had a sustained 2-3 log reduction in HBV DNA.
•
5 patients demonstrated a > 90% decrease in HBsAg at week 60.
•
3 of these had undetectable HBV DNA at week 84 and a fourth met criteria
for SVR.
Conclusion
Based
on these findings, the authors concluded, "Sixty weeks of peginterferon alfa-2a
with or without lamivudine resulted in a higher rate of SVR compared to historical
controls with HBeAg negative chronic hepatitis B treated with 48 weeks of pegylated
interferon."
However, they added that, "Larger studies are necessary
to assess if longer duration therapy is more effective than the standard regimen
and results in a greater decline in HBsAg concentration."
01/11/08
Reference RG
Gish, DT Lau, P Schmid, and others. A Pilot Study of Extended Duration Peginterferon
Alfa-2a for Patients With Hepatitis B e Antigen-Negative Chronic Hepatitis B.
American Journal of Gastroenterology 102(12): 2718-2723. December 2007.
