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Extending PEG-IFN Alfa-2a Therapy in Patients With Chronic HBV Can Lead to HBeAg Seroconversion, HBsAg Clearance: Presented at AASLD

By Cheryl Lathrop

BOSTON -- November 3, 2009 -- A 48- to 72-week course of pegylated interferon (PEG-IFN) alfa-2a resulted in significantly higher rates of hepatitis B e antigen (HBeAg) seroconversion than entecavir, researchers stated here at the Liver Meeting 2009, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

PEG-IFN alfa-2a extension therapy (for an additional 24 weeks) was associated with increased HBeAg seroconversion. HBeAg seroconversion and hepatitis B surface antigen (HBsAg) clearance both provide a long-term clinical benefit, including increased survival rates.

Xiao P. Chen, Guangdong Academy of Medical Science, Guangdong General Hospital, Guangzhou, China, and colleagues reported their findings during a poster session here on October 31.

The authors previously presented data comparing entecavir with PEG-IFN alfa-2a in patients with mildly elevated alanine aminotransferase (ALT) levels (ALT <2x upper limit of normal [ULN] = 40 IU/L). At week 48, patients in the PEG-IFN-alfa-2a group achieved significantly higher rates of HBeAg seroconversion than the patients treated with entecavir.

The present study's aim was to determine whether extension of the PEG-IFN-alfa-2a therapy from 48 to 72 weeks could maintain, or increase, response rates in patients with HBeAg seroconversion or hepatitis B virus (HBV) DNA and HBsAg suppression after 48 weeks of therapy.

In the open-label study, Chinese patients with HBeAg-positive chronic hepatitis B (CHB) with mildly elevated ALT (<2x ULN) levels were randomised to receive either PEG-IFN alfa-2a 180 mcg/week (n = 34) for 48 weeks or entecavir 0.5 mg/day (n = 33) for 72 weeks.

The PEG-IFN alfa-2a follow-up group (n = 22) were patients in the PEG-IFN alfa-2a treatment group with HBeAg seroconversion and HBV DNA <1,000 copies/mL and HBsAg levels >1,500 IU/mL or HBV DNA >1,000 copies/mL and without HBeAg seroconversion at week 48 and were followed up for a further 24 weeks.

The PEG-IFN alfa-2a extension group (n = 12) were patients in the PEG-IFN alfa-2a treatment group either not achieving HBeAg seroconversion, but with HBV DNA <1,000 copies/mL, or achieving HBeAg seroconversion and with HBV DNA <1,000 copies/mL and HBsAg <1,500 IU/mL at week 48. They continued PEG-IFN alfa-2a therapy for a further 24 weeks.

PEG-IFN alfa-2a was superior to entecavir in achieving HBeAg seroconversion and HBsAg clearance at week 72. One additional patient in the extension therapy group achieved HBeAg seroconversion between weeks 48 and 72. The rate of response was constant in the follow-up group.

Rates of HBeAg seroconversion at week 48 and 72 were higher in patients with elevated baseline ALT levels and with HBsAg <1,500 IU/mL at either week 12 or 24 of treatment; however, even patients who had not achieved this HBsAg level could achieve HBeAg seroconversion at week 72.

"Although HBeAg seroconversion rates were particularly high in patients with HBeAg levels <1,500 IU/mL during treatment, physicians should be careful when altering the treatment regimen of patients with higher HBsAg levels as some will still gain clinical benefit," the authors stated.

[Presentation title: Extending Peginterferon Alfa-2a Therapy in Patients With HBeAg Positive Chronic Hepatitis B Who Did Not Achieve a Response at Week 48 Can Lead to HBeAg Seroconversion and HBsAg Clearance. Abstract 410]

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