Effect on HBs antigen clearance of addition of pegylated interferon alfa-2a to nucleos(t)ide analogue therapy versus nucleos(t)ide analogue therapy alone in patients with HBe antigen-negative chronic hepatitis B and sustained undetectable plasma hepatitis B virus DNA: a randomised, controlled, open-label trial

Bourlière, Marc; Rabiéga, Pascaline; Ganne‐Carrié, Nathalie; Serfaty, Lawrence; Marcellin, Patrick; Barthe, Yoann; Thabut, Dominique; Guyader, Dominique; Hézode, Christophe; Picon, Magali; Causse, Xavier; Leroy, Vincent; Bronowicki, Jean Pierre; Carrieri, Patrizia; Riachi, Ghassan; Rosa, Isabelle; Attali, P; Molina, Jean Michel; Bacq, Yannick; Tran, Albert; Grangé, Jean Didier; Zoulim, Fabien; Fontaine, Hélène; Alric, Laurent; Bertucci, Inga; Bouvier‐Alias, Magali; Carrat, Fabrice

doi:10.1016/s2468-1253(16)30189-3

Cited by 94 publications

(78 citation statements)

References 40 publications

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“…The results also complement those of the large randomized PEGAN study in which peginterferon alfa‐2a was added to ongoing NA therapy in HBeAg‐negative patients . The addition of peginterferon alfa‐2a did not significantly increase HBsAg loss in the ITT population in PEGAN.…”

Section: Discussionsupporting

confidence: 62%

Add‐on peginterferon alfa‐2a to nucleos(t)ide analogue therapy for Caucasian patients with hepatitis B ‘e’ antigen‐negative chronic hepatitis B genotype D

Lampertico

Brunetto

Craxı̀

et al. 2018

Journal of Viral Hepatitis

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Nucleos(t)ide analogues (NAs) and peginterferon have complementary effects in chronic hepatitis B, but it is unclear whether combination therapy improves responses in genotype D-infected patients. We conducted an open-label study of peginterferon alfa-2a 180 μg/week added to ongoing NA therapy in hepatitis B e antigen (HBeAg)-negative, genotype D-infected patients with HBV DNA <20 IU/mL. The primary endpoint was proportion of patients with ≥50% decline in serum HBsAg by the end of the 48-week add-on phase. Seventy patients received treatment, 11 were withdrawn at week 24 for no decrease in HBsAg, and 14 withdrew for other reasons. Response rate (per-protocol population) was 67.4% (29/43) at week 48 (95% confidence interval [CI]: 51, 81) and 50.9% (28/55) at week 96 (95% CI: 38, 66). Median serum HBsAg decreased throughout peginterferon alfa-2a treatment and was significantly lower than baseline at weeks 48, 72 and 96 (P<.001). Decreases in HBsAg of ≥0.5-log and ≥1-log were documented in 19 (44.2%) and 6 (14.0%) patients at week 48 and 6 (10.9%) and 17 (30.9%) patients at week 96. The proportion of patients with HBsAg <1000, <500, <100 and <10 IU/mL at ≥1 timepoint during treatment was 78.6% (n=44), 57.1% (n=32), 21.4% (n=12) and 7.1% (n=4). Interferon gamma-induced protein 10 increased from baseline up to week 48, with week 12 levels significantly associated with response at week 48. Addition of peginterferon alfa-2a to ongoing NA therapy significantly decreased HBsAg levels in HBeAg-negative patients with genotype D infection This article is protected by copyright. All rights reserved.

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Section: Discussionsupporting

confidence: 62%

Add‐on peginterferon alfa‐2a to nucleos(t)ide analogue therapy for Caucasian patients with hepatitis B ‘e’ antigen‐negative chronic hepatitis B genotype D

Lampertico

Brunetto

Craxı̀

et al. 2018

Journal of Viral Hepatitis

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“…The role of Peg‐IFNα in antiviral therapy in patients with CHB has been an interest of investigators for many years. The benefits of Peg‐IFNα monotherapy in combination with NAs, as well as addition to ongoing NAs, have been reported in different studies; however, these studies have primarily evaluated serological changes …”

Section: Discussionmentioning

confidence: 99%

Histological responses of peginterferon alpha add‐on therapy in patients with chronic hepatitis B with advanced liver fibrosis after long‐term nucleos(t)ide analog treatment

Zhang

et al. 2019

Journal of Viral Hepatitis

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Although long‐term antiviral treatment with nucleos(t)ide analogs (NAs) can lead to histological improvement in patients with chronic hepatitis B (CHB), a substantial proportion of patients still fail to achieve regression of fibrosis. Here, we investigated whether peginterferon alpha (Peg‐IFNα） add‐on therapy had benefits on fibrosis regression in patients with sustained severe fibrosis even after long‐term NA treatment. We conducted a retrospective analysis of data from 50 patients with CHB receiving 48 weeks of Peg‐IFNα add‐on therapy. All enrolled patients had advanced fibrosis or cirrhosis (S score ≥ 3) at baseline and underwent NA treatment for at least 1 year before Peg‐IFNα addition. Paired liver biopsies before and after Peg‐IFNα add‐on treatment and laboratory tests at baseline, 24 weeks of treatment, 48 weeks of treatment and long‐term follow‐up were analysed. Of the 50 patients enrolled in this study, 34 patients (68.0%) had significant regression of fibrosis, and 42 (84.0%) showed significant remission of inflammation after Peg‐IFNα add‐on treatment. Compared with nonresponders, patients with significant histological improvement showed faster hepatitis B surface antigen (HBsAg) decline and tended to have higher cumulative hepatitis B e antigen (HBeAg) and HBsAg loss rates during long‐term follow‐up. Peg‐IFNα add‐on therapy led to significant regression of fibrosis and resolution of inflammation in patients with advanced fibrosis after long‐term NA treatment.

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“…In HBeAg-negative CHB patients under NA treatment, two multicentre European studies have assessed the safety and efficacy of a 48-week add-on course of PegIFNa. 139,140 These two studies demonstrated that HBsAg kinetics were fostered by the addition of PegIFNa, but only a few patients cleared HBsAg. HBsAg levels at baseline and week 12 may predict HBsAg decline and/or HBsAg loss.…”

Section: Na Plus Pegifna Recommendationsmentioning

confidence: 99%

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

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Cited by 94 publications

References 40 publications

Add‐on peginterferon alfa‐2a to nucleos(t)ide analogue therapy for Caucasian patients with hepatitis B ‘e’ antigen‐negative chronic hepatitis B genotype D

Add‐on peginterferon alfa‐2a to nucleos(t)ide analogue therapy for Caucasian patients with hepatitis B ‘e’ antigen‐negative chronic hepatitis B genotype D

Histological responses of peginterferon alpha add‐on therapy in patients with chronic hepatitis B with advanced liver fibrosis after long‐term nucleos(t)ide analog treatment

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

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