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Treatment outcomes and validation of the stopping rule for response to peginterferon in chronic hepatitis B: A Thai nationwide cohort study
Author(s) -
Charatcharoenwitthaya Phunchai,
Sukeepaisarnjaroen Wattana,
Piratvisuth Teerha,
Thongsawat Satawat,
Sanpajit Theeranun,
Chonprasertsuk Soonthorn,
Jeamsripong Woramon,
Sripariwuth Ekawee,
Komolmit Piyawat,
Patcharatrakul Tanisa,
Boonsirichan Rattana,
Bunchorntavakul Chalermrat,
Tuntipanichteerakul Supoj,
Tanwandee Tawesak
Publication year - 2016
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.13378
Subject(s) - medicine , hbsag , hbeag , gastroenterology , cohort , chronic hepatitis , hepatitis b virus , seroconversion , hepatitis b , cirrhosis , genotype , immunology , virus , biochemistry , chemistry , gene
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 < 2log 10 decline in HBV DNA and a < 10% log 10 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.