Eficacy and safety of pegylated interferon-α2a in patients with lamivudine-resistant HBeAg-positive chronic hepatitis B

Dong Jin Suh, Han Chu Lee, Kwan Soo Byun, Mong Cho, Young Oh Kweon, Won Young Tak, Chae Yoon Chon, Kwang Cheol Koh, Young Sok Lee

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Lamivudine resistance develops in up to 80% of patients with chronic hepatitis B (CHB) after 5 years of treatment. Cross-resistance between nucleoside/ nucleotide analogues limits management options in these patients. To investigate the role of pegylated interferon-α2a as rescue therapy in these patients, the efficacy and safety of pegylated interferon-α2a between treatment-naive patients and lamivudine-resistant patients with hepatitis B e antigen (HBeAg)-positive CHB were compared. Methods: A total of 150 HBeAg-positive CHB patients were stratified according to prior treatment. Lamivudineresistant patients (n=64) and treatment-naive patients (n=86) received pegylated interferon-α2a once-weekly for 48 weeks and were followed-up for an additional 24 weeks. Primary end points were HBeAg loss and HBV DNA <100,000 copies/ml at end of follow-up. Results: A total of 65 (76%) treatment-naive patients and 49 (77%) lamivudine-resistant patients completed treatment and 24 weeks of follow-up. Rates of HBeAg loss were comparable at end of follow-up between treatment- naive patients and lamivudine-resistant patients (20.9% and 23.4%, respectively; P=0.8423). Similarly, rates of HBV DNA<100,000 copies/ml were comparable at end of follow-up between treatment-naive patients and lamivudine-resistant patients (20.9% and 21.9%, respectively; P=1.000). There was no statistically signiicant difference in alanine aminotransferase normalization rates between treatment-naive patients and lamivudine-resistant patients (36.0% and 29.7%, respectively; P=0.4848). A total of one patient in each group achieved hepatitis B surface antigen (HBsAg) loss and seroconversion. The most common adverse events were those known to occur with pegylated interferon-α2a therapy, and safety profiles were similar between both patient populations. Conclusions: Pegylated interferon-α2a may be effective as a rescue therapy in patients with lamivudine-resistant HBeAg-positive CHB.

Original languageEnglish
Pages (from-to)765-773
Number of pages9
JournalAntiviral Therapy
Volume18
Issue number6
DOIs
Publication statusPublished - 2013 Dec 1

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Lamivudine
Hepatitis B e Antigens
Chronic Hepatitis B
Interferons
Safety
Therapeutics
DNA

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

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Eficacy and safety of pegylated interferon-α2a in patients with lamivudine-resistant HBeAg-positive chronic hepatitis B. / Suh, Dong Jin; Lee, Han Chu; Byun, Kwan Soo; Cho, Mong; Kweon, Young Oh; Tak, Won Young; Chon, Chae Yoon; Koh, Kwang Cheol; Lee, Young Sok.

In: Antiviral Therapy, Vol. 18, No. 6, 01.12.2013, p. 765-773.

Research output: Contribution to journalArticle

Suh, Dong Jin ; Lee, Han Chu ; Byun, Kwan Soo ; Cho, Mong ; Kweon, Young Oh ; Tak, Won Young ; Chon, Chae Yoon ; Koh, Kwang Cheol ; Lee, Young Sok. / Eficacy and safety of pegylated interferon-α2a in patients with lamivudine-resistant HBeAg-positive chronic hepatitis B. In: Antiviral Therapy. 2013 ; Vol. 18, No. 6. pp. 765-773.
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abstract = "Background: Lamivudine resistance develops in up to 80{\%} of patients with chronic hepatitis B (CHB) after 5 years of treatment. Cross-resistance between nucleoside/ nucleotide analogues limits management options in these patients. To investigate the role of pegylated interferon-α2a as rescue therapy in these patients, the efficacy and safety of pegylated interferon-α2a between treatment-naive patients and lamivudine-resistant patients with hepatitis B e antigen (HBeAg)-positive CHB were compared. Methods: A total of 150 HBeAg-positive CHB patients were stratified according to prior treatment. Lamivudineresistant patients (n=64) and treatment-naive patients (n=86) received pegylated interferon-α2a once-weekly for 48 weeks and were followed-up for an additional 24 weeks. Primary end points were HBeAg loss and HBV DNA <100,000 copies/ml at end of follow-up. Results: A total of 65 (76{\%}) treatment-naive patients and 49 (77{\%}) lamivudine-resistant patients completed treatment and 24 weeks of follow-up. Rates of HBeAg loss were comparable at end of follow-up between treatment- naive patients and lamivudine-resistant patients (20.9{\%} and 23.4{\%}, respectively; P=0.8423). Similarly, rates of HBV DNA<100,000 copies/ml were comparable at end of follow-up between treatment-naive patients and lamivudine-resistant patients (20.9{\%} and 21.9{\%}, respectively; P=1.000). There was no statistically signiicant difference in alanine aminotransferase normalization rates between treatment-naive patients and lamivudine-resistant patients (36.0{\%} and 29.7{\%}, respectively; P=0.4848). A total of one patient in each group achieved hepatitis B surface antigen (HBsAg) loss and seroconversion. The most common adverse events were those known to occur with pegylated interferon-α2a therapy, and safety profiles were similar between both patient populations. Conclusions: Pegylated interferon-α2a may be effective as a rescue therapy in patients with lamivudine-resistant HBeAg-positive CHB.",
author = "Suh, {Dong Jin} and Lee, {Han Chu} and Byun, {Kwan Soo} and Mong Cho and Kweon, {Young Oh} and Tak, {Won Young} and Chon, {Chae Yoon} and Koh, {Kwang Cheol} and Lee, {Young Sok}",
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T1 - Eficacy and safety of pegylated interferon-α2a in patients with lamivudine-resistant HBeAg-positive chronic hepatitis B

AU - Suh, Dong Jin

AU - Lee, Han Chu

AU - Byun, Kwan Soo

AU - Cho, Mong

AU - Kweon, Young Oh

AU - Tak, Won Young

AU - Chon, Chae Yoon

AU - Koh, Kwang Cheol

AU - Lee, Young Sok

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N2 - Background: Lamivudine resistance develops in up to 80% of patients with chronic hepatitis B (CHB) after 5 years of treatment. Cross-resistance between nucleoside/ nucleotide analogues limits management options in these patients. To investigate the role of pegylated interferon-α2a as rescue therapy in these patients, the efficacy and safety of pegylated interferon-α2a between treatment-naive patients and lamivudine-resistant patients with hepatitis B e antigen (HBeAg)-positive CHB were compared. Methods: A total of 150 HBeAg-positive CHB patients were stratified according to prior treatment. Lamivudineresistant patients (n=64) and treatment-naive patients (n=86) received pegylated interferon-α2a once-weekly for 48 weeks and were followed-up for an additional 24 weeks. Primary end points were HBeAg loss and HBV DNA <100,000 copies/ml at end of follow-up. Results: A total of 65 (76%) treatment-naive patients and 49 (77%) lamivudine-resistant patients completed treatment and 24 weeks of follow-up. Rates of HBeAg loss were comparable at end of follow-up between treatment- naive patients and lamivudine-resistant patients (20.9% and 23.4%, respectively; P=0.8423). Similarly, rates of HBV DNA<100,000 copies/ml were comparable at end of follow-up between treatment-naive patients and lamivudine-resistant patients (20.9% and 21.9%, respectively; P=1.000). There was no statistically signiicant difference in alanine aminotransferase normalization rates between treatment-naive patients and lamivudine-resistant patients (36.0% and 29.7%, respectively; P=0.4848). A total of one patient in each group achieved hepatitis B surface antigen (HBsAg) loss and seroconversion. The most common adverse events were those known to occur with pegylated interferon-α2a therapy, and safety profiles were similar between both patient populations. Conclusions: Pegylated interferon-α2a may be effective as a rescue therapy in patients with lamivudine-resistant HBeAg-positive CHB.

AB - Background: Lamivudine resistance develops in up to 80% of patients with chronic hepatitis B (CHB) after 5 years of treatment. Cross-resistance between nucleoside/ nucleotide analogues limits management options in these patients. To investigate the role of pegylated interferon-α2a as rescue therapy in these patients, the efficacy and safety of pegylated interferon-α2a between treatment-naive patients and lamivudine-resistant patients with hepatitis B e antigen (HBeAg)-positive CHB were compared. Methods: A total of 150 HBeAg-positive CHB patients were stratified according to prior treatment. Lamivudineresistant patients (n=64) and treatment-naive patients (n=86) received pegylated interferon-α2a once-weekly for 48 weeks and were followed-up for an additional 24 weeks. Primary end points were HBeAg loss and HBV DNA <100,000 copies/ml at end of follow-up. Results: A total of 65 (76%) treatment-naive patients and 49 (77%) lamivudine-resistant patients completed treatment and 24 weeks of follow-up. Rates of HBeAg loss were comparable at end of follow-up between treatment- naive patients and lamivudine-resistant patients (20.9% and 23.4%, respectively; P=0.8423). Similarly, rates of HBV DNA<100,000 copies/ml were comparable at end of follow-up between treatment-naive patients and lamivudine-resistant patients (20.9% and 21.9%, respectively; P=1.000). There was no statistically signiicant difference in alanine aminotransferase normalization rates between treatment-naive patients and lamivudine-resistant patients (36.0% and 29.7%, respectively; P=0.4848). A total of one patient in each group achieved hepatitis B surface antigen (HBsAg) loss and seroconversion. The most common adverse events were those known to occur with pegylated interferon-α2a therapy, and safety profiles were similar between both patient populations. Conclusions: Pegylated interferon-α2a may be effective as a rescue therapy in patients with lamivudine-resistant HBeAg-positive CHB.

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