Final analysis of the international observational S-Collate study of peginterferon alfa-2a in patients with chronic hepatitis B

Patrick Marcellin, Qing Xie, Seung Woon Paik, Robert Flisiak, Teerha Piratvisuth, Jörg Petersen, Tarik Asselah, Markus Cornberg, Denis Ouzan, Graham R Foster, Georgios Papatheodoridis, Diethelm Messinger, Loredana Regep, Georgios Bakalos, Ulrich Alshuth, Pietro Lampertico and Heiner Wedemeyer

PLOS ONE, 2020, vol. 15, issue 4, 1-16

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 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

Date: 2020
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0230893

DOI: 10.1371/journal.pone.0230893

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