Abstract
Background
Few studies have investigated the long-term effects of interferon (IFN) therapy for chronic hepatitis B (CHB). In this retrospective study, we investigated the efficacy of and predictors of response to IFN therapy in CHB patients.
Methods
We analyzed data for 615 Japanese CHB patients (hepatitis B e antigen [HBeAg]-positive 414, HBeAg-negative 201) treated with IFN, and conducted follow up for a median duration of 8.1 years (range 0.5–23.2). Responders were defined as patients who showed continuously normalized alanine transaminase (ALT) levels, HBeAg clearance, and low hepatitis B virus (HBV) DNA levels at 6 months post-treatment or for a span of more than 6 months until each test point at 1, 3, 5, and 10 years.
Results
The IFN response rates of all patients were 21, 18, 21, 23, and 25% at 6 months and 1, 3, 5, and 10 years, respectively. On multivariate analysis, significant determinants of the outcome of IFN therapy were as follows: at 6 months and 1 year, young age, low HBV DNA levels, and long duration of treatment; at 3 years, long duration of treatment, young age, and high level of albumin; at 5 years, high level of albumin, female, and pretreated with IFN; and at 10 years, HBeAg-negative. Sixty-nine of the 615 patients (11%) achieved seroclearance of hepatitis B surface antigen (HBsAg). On multivariate analysis, age ≥30 years, HBV genotype A, and male were all independent factors predicting the achievement of HBsAg seroclearance.
Conclusion
HBeAg, HBV DNA level, age, sex, albumin, duration of treatment, pretreatment with IFN, and HBV genotype were important factors in determining long-term response to IFN therapy.
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Abbreviations
- CHB:
-
Chronic hepatitis B
- HBV:
-
Hepatitis B virus
- IFN:
-
Interferon
- HBeAg:
-
Hepatitis B e antigen
- ALT:
-
Alanine transaminase
- MU:
-
Million units
- HBsAg:
-
Hepatitis B surface antigen
- CLEIA:
-
Chemiluminescent enzyme immunoassay
- bDNA:
-
Branched-chain DNA probe assay
- TMA-HPA:
-
Transcription-mediated amplification and hybridization protection assay
- PCR:
-
Polymerase chain reaction
- ELISA:
-
Enzyme-linked immunosorbent assay
- AST:
-
Aspartate transaminase
- AFP:
-
α Fetoprotein
- OR:
-
Odds ratio
- CI:
-
Confidence interval
- HCC:
-
Hepatocellular carcinoma
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Acknowledgments
This study was supported in part by a Grant-in-aid from the Ministry of Health, Labor and Welfare of Japan. These authors disclose the following: Dr. Kumada reports having received investigator, lecture, and consulting fees from Dainippon Sumitomo Pharma Co., MSD KK, and Toray Co. Dr. Ikeda reports having received investigator, lecture, and consulting fees from Dainippon Sumitomo Pharma Co. No other potential conflicts of interest relevant to this article were reported.
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Suzuki, F., Arase, Y., Suzuki, Y. et al. Long-term efficacy of interferon therapy in patients with chronic hepatitis B virus infection in Japan. J Gastroenterol 47, 814–822 (2012). https://doi.org/10.1007/s00535-012-0548-5
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DOI: https://doi.org/10.1007/s00535-012-0548-5