PLoS ONE (Jan 2020)

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,
  • Heiner Wedemeyer

DOI
https://doi.org/10.1371/journal.pone.0230893
Journal volume & issue
Vol. 15, no. 4
p. e0230893

Abstract

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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 <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.