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J Gastroenterol Hepatol. 2016 Nov;31(11):1874-1881. doi: 10.1111/jgh.13378.

Treatment outcomes and validation of the stopping rule for response to peginterferon in chronic hepatitis B: A Thai nationwide cohort study.

Author information

1
Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
2
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
3
Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.
4
Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
5
Phramongkutklao Hospital, Bangkok, Thailand.
6
Faculty of Medicine, Thammasat University, Pathum Thani, Thailand.
7
Buddhachinaraj Hospital, Phitsanulok, Thailand.
8
Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.
9
Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
10
Police General Hospital, Bangkok, Thailand.
11
BMA Medical College and Vajira Hospital, Bangkok, Thailand.
12
Rajavithi Hospital, Bangkok, Thailand.
13
Bhumibol Adulyadej Hospital, Bangkok, Thailand.

Abstract

BACKGROUND AND AIMS:

Peginterferon has demonstrated effectiveness in clinical trials in patients with chronic hepatitis B (CHB). However, its efficacy in real-life settings remains unclear. We investigated the efficacy of peginterferon for CHB and validated the performance of previously identified response predictors in clinical practice.

METHODS:

We analyzed prospectively collected data from a Thai nationwide cohort of CHB patients treated with peginterferon alfa-2a (180 µg/week, 48 weeks).

RESULTS:

Among a total of 233 patients, mostly with genotype B or C, sustained response was observed in 23% of 135 hepatitis B e antigen (HBeAg)-positive patients (HBeAg seroconversion with hepatitis B virus [HBV] DNA < 2000 IU/mL) and 42% of 98 HBeAg-negative patients (HBV DNA < 2000 IU/mL with aminotransferase normalization) at 24 weeks after treatment. Age, sex, presence of cirrhosis, genotype, and pretreatment levels of aminotransferase, HBV DNA, and hepatitis B surface antigen (HBsAg) were not identified as significant predictors of sustained response. In HBeAg-positive patients, HBsAg > 20 000 IU/mL at week 12 provided a good stopping rule, with a negative predictive value of 96%. In HBeAg-negative patients, the performance of 12-week stopping rules of no decline in HBsAg with a < 2log10 decline in HBV DNA and a < 10% log10 decline in HBsAg showed modest negative predictive values of 80% and 66%, respectively, for achieving sustained response.

CONCLUSION:

Outcomes in CHB patients treated with peginterferon in a clinical setting are similar to those demonstrated in clinical trials. Application of the early stopping rule based on HBsAg quantification may allow individualization of therapy, particularly in HBeAg-positive patients.

KEYWORDS:

antiviral therapy; chronic hepatitis B; peginterferon; quantitative HBsAg; stopping rule

PMID:
26997582
DOI:
10.1111/jgh.13378
[Indexed for MEDLINE]

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