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

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.

• Authors: Phunchai Charatcharoenwitthaya, Wattana Sukeepaisarnjaroen, Teerha Piratvisuth, Satawat Thongsawat, Theeranun Sanpajit, Soonthorn Chonprasertsuk, Woramon Jeamsripong, Ekawee Sripariwuth, Piyawat Komolmit, Tanisa Patcharatrakul, Rattana Boonsirichan, Chalermrat Bunchorntavakul, Supoj Tuntipanichteerakul, Tawesak Tanwandee, Thai Association for the Study of the Liver on Chronic Hepatitis B
• Journal: Journal of gastroenterology and hepatology (J Gastroenterol Hepatol) Vol. 31 Issue 11 Pg. 1874-1881 (Nov 2016) ISSN: 1440-1746 [Electronic] Australia
• PMID: 26997582 (Publication Type: Journal Article, Multicenter Study, Validation Study)
• Copyright: © 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Chemical References

• Antiviral Agents
• Biomarkers
• DNA, Viral
• Hepatitis B e Antigens
• Interferon-alpha
• Recombinant Proteins
• Polyethylene Glycols
• peginterferon alfa-2a

Topics

• Adult
• Antiviral Agents (administration & dosage, therapeutic use)
• Biomarkers (blood)
• Cohort Studies
• DNA, Viral (blood)
• Drug Administration Schedule
• Female
• Hepatitis B e Antigens (blood)
• Hepatitis B virus (genetics, isolation & purification)
• Hepatitis B, Chronic (drug therapy, virology)
• Humans
• Interferon-alpha (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Polyethylene Glycols (administration & dosage, therapeutic use)
• Predictive Value of Tests
• Prognosis
• Prospective Studies
• Recombinant Proteins (administration & dosage, therapeutic use)
• Treatment Outcome