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Abstract Details
Final Analysis of the International Observational S-Collate Study of Peginterferon alfa-2a in Patients With Chronic Hepatitis B
3Gastroenterology and Hepatology, Sungkyunkwan University School of Medicine, Seoul, South Korea.
4Infectious Disease and Hepatology, Medical University of Bialystok, Bialystok, Poland.
5Gastroenterology and Hepatology, Prince of Songkla University, Songkhla, Thailand.
6Liver Unit, Asklepios Klinik St. Georg, Hamburg, Germany.
7Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
8Service d'Hepatologie, Institut Arnault Tzanck, Saint-Laurent-du-Var, France.
9Liver Unit, Queen Mary University of London, London, United Kingdom.
10Gastroenterology, Laiko General Hospital, Athens, Greece.
11PROMETRIS GmbH, Mannheim, Germany.
12Roche s.r.o., Prague, Czech Republic.
13F. Hoffmann-La Roche Ltd, Basel, Switzerland.
14Roche Pharma AG, Grenzach-Wyhlen, Germany.
15Gastroenterology and Hepatology, University of Milan, Milan, Italy.
Abstract
Background and aims: Sustained off-treatment immune control is achievable in a proportion of patients with chronic hepatitis B treated with peginterferon alfa-2a. We evaluated on-treatment predictors of hepatitis B surface antigen (HBsAg) clearance 3 years after peginterferon alfa-2a treatment and determined the incidence of hepatocellular carcinoma.
Methods: A prospective, international, multicenter, observational study in patients with chronic hepatitis B who have been prescribed peginterferon alfa-2a (40KD) in a real-world setting. The primary endpoint was HBsAg clearance after 3 years' follow-up.
Results: The modified intention-to-treat population comprised 844 hepatitis B e antigen (HBeAg)-positive patients (540 [64%] completed 3 years' follow-up), and 872 HBeAg-negative patients (614 [70%] completed 3 years' follow-up). At 3 years' follow-up, HBsAg clearance rates in HBeAg-positive and HBeAg-negative populations, respectively, were 2% (16/844) and 5% (41/872) in the modified intention-to-treat population and 5% [16/328] and 10% [41/394] in those with available data. In HBeAg-positive patients with data, Week 12 HBsAg levels <1500, 1500-20,000, and >20,000 IU/mL were associated with HBsAg clearance rates at 3 years' follow-up of 11%, 1%, and 5%, respectively (Week 24 predictability was similar). In HBeAg-negative patients with available data, a ≥10% decline vs a <10% decline in HBsAg at Week 12 was associated with HBsAg clearance rates of 16% vs 4%. Hepatocellular carcinoma incidence was lower than REACH-B (Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B) model predictions.
Conclusions: Sustained off-treatment immune control is achieved with peginterferon alfa-2a in a real-world setting. HBsAg clearance 3 years after completion of peginterferon alfa-2a can be predicted on the basis of on-treatment HBsAg kinetics.