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HBV DNA suppression in HBeAg-positive chronic hepatitis B patients treated with peginterferon or placebo

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J Med Virol. 2011 Nov;83(11):1917-23. doi: 10.1002/jmv.22208.

HBV DNA suppression in HBeAg-positive chronic hepatitis B patients treated with

peginterferon or placebo.

Hansen BE, Rijckborst V, Ter Borg MJ, Janssen HL.

Source

Department of Gastroenterology and Hepatology, Erasmus MC University Medical

Center, Rotterdam, The Netherlands; Department of Biostatistics, Erasmus MC

University Medical Center, Rotterdam, The Netherlands.

Abstract

The aim of the present study was to compare the decline of HBV DNA during

peginterferon (PEG-IFN) therapy with spontaneous HBV DNA decline in

placebo-treated patients with hepatitis B e antigen (HBeAg)-positive chronic

hepatitis B. A total of 136 patients who participated in a randomized trial were

treated with PEG-IFN alfa-2b for 52 weeks. These patients were compared with 167

patients who received a placebo for 48 weeks using linear mixed regression

analysis. Response was defined as loss of HBeAg at the end of treatment (EOT).

Overall, decline of HBV DNA at the EOT was significantly greater in the PEG-IFN

group than in the placebo group (mean decline 2.3 log vs. 1.0 log,

P < 0.001) and varied according to HBV genotype. Viral suppression was

greater in the PEG-IFN group from week 4 throughout the entire treatment period

(P < 0.001). The response rate was 32% for the PEG-IFN group and 11% for the

placebo group (P < 0.001). Among responders, HBV DNA decline was greater for

patients treated with PEG-IFN than with a placebo: the mean difference in HBV

DNA decline was 0.7 log (P = 0.001) at 4 weeks and 2 log (P < 0.001)

at the EOT. ALT flares (>5 times the upper limit) were associated with a greater

HBV DNA decline during PEG-IFN. In conclusion, PEG-IFN therapy resulted in a

greater HBV DNA decline in positive HBeAg patients than a placebo. The decline

of HBV DNA was greater in patients with HBeAg loss or who exhibited an ALT flare

during PEG-IFN than in patients with spontaneous HBeAg loss or flares during

placebo therapy.

J. Med. Virol. 83:1917-1923, 2011. © 2011 Wiley-Liss, Inc.

Copyright © 2011 Wiley-Liss, Inc.

PMID: 21915866 [PubMed - in process]

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J Med Virol. 2011 Nov;83(11):1917-23. doi: 10.1002/jmv.22208.

HBV DNA suppression in HBeAg-positive chronic hepatitis B patients treated with

peginterferon or placebo.

Hansen BE, Rijckborst V, Ter Borg MJ, Janssen HL.

Source

Department of Gastroenterology and Hepatology, Erasmus MC University Medical

Center, Rotterdam, The Netherlands; Department of Biostatistics, Erasmus MC

University Medical Center, Rotterdam, The Netherlands.

Abstract

The aim of the present study was to compare the decline of HBV DNA during

peginterferon (PEG-IFN) therapy with spontaneous HBV DNA decline in

placebo-treated patients with hepatitis B e antigen (HBeAg)-positive chronic

hepatitis B. A total of 136 patients who participated in a randomized trial were

treated with PEG-IFN alfa-2b for 52 weeks. These patients were compared with 167

patients who received a placebo for 48 weeks using linear mixed regression

analysis. Response was defined as loss of HBeAg at the end of treatment (EOT).

Overall, decline of HBV DNA at the EOT was significantly greater in the PEG-IFN

group than in the placebo group (mean decline 2.3 log vs. 1.0 log,

P < 0.001) and varied according to HBV genotype. Viral suppression was

greater in the PEG-IFN group from week 4 throughout the entire treatment period

(P < 0.001). The response rate was 32% for the PEG-IFN group and 11% for the

placebo group (P < 0.001). Among responders, HBV DNA decline was greater for

patients treated with PEG-IFN than with a placebo: the mean difference in HBV

DNA decline was 0.7 log (P = 0.001) at 4 weeks and 2 log (P < 0.001)

at the EOT. ALT flares (>5 times the upper limit) were associated with a greater

HBV DNA decline during PEG-IFN. In conclusion, PEG-IFN therapy resulted in a

greater HBV DNA decline in positive HBeAg patients than a placebo. The decline

of HBV DNA was greater in patients with HBeAg loss or who exhibited an ALT flare

during PEG-IFN than in patients with spontaneous HBeAg loss or flares during

placebo therapy.

J. Med. Virol. 83:1917-1923, 2011. © 2011 Wiley-Liss, Inc.

Copyright © 2011 Wiley-Liss, Inc.

PMID: 21915866 [PubMed - in process]

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