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

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.

• Authors: 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
• Journal: PloS one (PLoS One) Vol. 15 Issue 4 Pg. e0230893 ( 2020) ISSN: 1932-6203 [Electronic] United States
• PMID: 32275726 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)

Chemical References

• Hepatitis B Surface Antigens
• Hepatitis B e Antigens
• Interferon-alpha
• Recombinant Proteins
• Polyethylene Glycols
• peginterferon alfa-2a

Topics

• Adult
• Female
• Hepatitis B Surface Antigens (metabolism)
• Hepatitis B e Antigens (metabolism)
• Hepatitis B, Chronic (drug therapy, metabolism)
• Humans
• Interferon-alpha (adverse effects, therapeutic use)
• Internationality
• Male
• Polyethylene Glycols (adverse effects, therapeutic use)
• Recombinant Proteins (adverse effects, therapeutic use)
• Safety
• Treatment Outcome