TITLE

A Pilot Study of Extended Duration Peginterferon Alfa-2a for Patients With Hepatitis B e Antigen-Negative Chronic Hepatitis B

AUTHOR(S)
Gish, Robert G.; Lau, Daryl T.-Y.; Schmid, Peter; Perrillo, Robert
PUB. DATE
December 2007
SOURCE
American Journal of Gastroenterology;Dec2007, Vol. 102 Issue 12, p2718
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
OBJECTIVES: Forty-eight weeks of peginterferon alfa-2a is the approved regimen for chronic hepatitis B (CHB). Standard interferon is more effective for hepatitis B e antigen (HBeAg)-negative CHB when given for longer than 1 yr. This study evaluated peginterferon alfa-2a for 60 wk, alone or in combination with lamivudine. METHODS: Thirteen patients with HBeAg-negative CHB received peginterferon alfa-2a (180 μg/week) for 60 wk or peginterferon alfa-2a (180 μg/week) for 12 wk followed by 48 wk of peginterferon alfa-2a plus lamivudine. The primary end point, sustained virologic response (SVR), was defined as a reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA) of ≥2 log10 copies/mL and HBV DNA <20,000 copies/mL at 24 wk of follow-up (week 84). Hepatitis B surface antigen (HBsAg) concentrations were analyzed and compared to changes in HBV DNA. RESULTS: SVR was achieved by 9/13 patients (69%). At week 84, HBV DNA was undetectable by polymerase chain reaction in 5/13 (38%) patients, and 3 additional patients had a sustained 2–3 log reduction in HBV DNA. Five patients demonstrated a >90% decrease in HBsAg concentration at week 60, including 3 with undetectable HBV DNA at week 84 and a fourth who met criteria for SVR. CONCLUSIONS: Sixty weeks of peginterferon alfa-2a with or without lamivudine resulted in a higher rate of SVR compared to historical controls with HBeAg-negative CHB treated with 48 wk of pegylated interferon. 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.
ACCESSION #
27609320

 

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