O112 : HBsAg clearance after addition of 48 weeks of pegifn in HBeAg negative CHB patients on nucleos(T)ide therapy with undetectable hbvdna for at least one year: final results from ANRS-HB06 pegan study: multicenter randomized controlled phase III trial

Bourlière, Marc; Rabiéga, Pascaline; Ganne‐Carrié, Nathalie; Serfaty, Lawrence; Marcellin, Patrick; Pouget, Noelle; Guyader, Dominique; Hézode, Christophe; Picon, Maurice; Causse, Xavier; Leroy, Vincent; Bronowicki, J.-P.; Riachi, Ghassan; Rosa, Isabelle; Attali, P; Molina, Josefina; Bacq, Y.; Tran, Anthony; Grangé, Jean Didier; Zoulim, Fabien; Fontaine, H.; Bertucci, Inga; Bouvier‐Alias, Magali; Carrat, Fabrice; Benhamou, Yves

doi:10.1016/s0168-8278(15)30131-8

Cited by 16 publications

(25 citation statements)

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“…As illustrated in Figure , a total of 24 trials were selected from 2632 potentially eligible studies, all of which were published in English . After removal of duplicates and initial screening, 87 studies were further evaluated for eligibility.…”

Section: Resultsmentioning

confidence: 99%

Systematic review with meta‐analysis: combination treatment of regimens based on pegylated interferon for chronic hepatitis B focusing on hepatitis B surface antigen clearance

Qiu

Liu

et al. 2018

Aliment Pharmacol Ther

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Section: Resultsmentioning

confidence: 99%

Systematic review with meta‐analysis: combination treatment of regimens based on pegylated interferon for chronic hepatitis B focusing on hepatitis B surface antigen clearance

Qiu

Liu

et al. 2018

Aliment Pharmacol Ther

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“…At the 24‐week interim analysis, median quantitative HBsAg declined by 36% ( P < 0.0001 vs baseline) and one patient (1.4%) cleared HBsAg . In a multicenter French study (PEGAN study), 183 HBeAg‐negative chronic hepatitis B patients (40% Caucasian, different viral genotypes) with undetectable HBV DNA for an average of 198 weeks (range 1‐1074) while on NUC were randomized to either continue NUC or add on Peg‐IFN for 48 weeks . At week 48, HBsAg loss rates were significantly higher in the combo than in the NUC group (8% vs 1%, P < 0.0327).…”

Section: To Improve Nuc Therapymentioning

confidence: 99%

The royal wedding in chronic hepatitis B: The haves and the have‐nots for the combination of pegylated interferon and nucleos(t)ide therapy

Lampertico

2015

Hepatology

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C ombination therapy of oral nucleos(t)ide analogues (NUC) and pegylated interferon-alpha 2a (Peg-IFN) is not currently recommended by international guidelines because of unproven superior efficacy. However, this position might be subverted by recent studies, one of which has been published in this issue of HEPATOLOGY 1 including for the first time potent and high genetic barrier NUC, entecavir (ETV), and tenofovir (TDF). There are different ways to combine IFN and NUC, "de novo" meaning simultaneous administration of the two drugs in naive patients versus "add-on" or "switch to" strategies in patients already on therapy. There are also different reasons to combine immunomodulators and antivirals, either to improve response to NUC or to improve response to IFN. To Improve NUC TherapyBoth ETV and TDF halt viral replication in >95% of naive patients over 5-8 years of treatment, preventing progression to cirrhosis, portal hypertension, and clinical decompensation and reducing, in selected patients, the attack rates of hepatocellular carcinoma. Since the only disadvantage of this strategy is the low rate of hepatitis B surface antigen (HBsAg) clearance, the best and safest current stopping rule, 2,3 recent studies have addressed if the combination with Peg-IFN may reduce the duration of NUC therapy. The study by Brouwer et al., published in this issue of HEPATOLOGY, 1 explores the "early add-on" Peg-IFN strategy by comparing a 48-week course of ETV versus 24 weeks of ETV followed by 24 weeks of "add-on" Peg-IFN for naive hepatitis B e antigen (HBeAg)-positive patients. At week 48, the two treatment groups showed similar HBeAg seroconversion (9% vs 17%), HBsAg <1000 IU/mL (18% vs 28%), and hepatitis B virus (HBV) DNA <20 IU/mL rates (50% vs 61%), while alanine aminotransferase (ALT) normalization rates were higher in the ETV monotherapy group (78% vs 49%, P < 0.001). However, when the kinetics of HBV DNA, HBsAg, and HBeAg levels between weeks 24 and 48 were compared, add-on Peg-IFN significantly improved virological and serological declines. At week 72, with all patients on ETV monotherapy in both groups, HBeAg seroconversion rates were indeed lower in patients always treated with ETV versus those who received a 24-month course of Peg-IFN add-on (11% vs 26%, P 5 0.012), but the rates of HBsAg <1000 IU/mL, HBV DNA <20 IU/mL, and normal ALT levels were similar (18% vs 25%, 57% vs 57%, 83% vs 86%, respectively). Someone may argue that a 24-week add-on period was too short to provide strong evidence in favor of this strategy, which remains for the time being difficult to export into clinical practice.Other studies have been designed to improve either on-or off-therapy response for patients already treated for years with NUC. The "early switch to" approach has been explored in 192 Chinese HBeAg-positive patients (OSST trial) who, after 20 months of ETV, were randomized to either continue ETV or "switch to" Peg-IFN for 48 weeks.4 By week 48, while the proportion of patients with HBV DNA <1000 copies/ mL and with normal ALT...

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“…Whilst PegIFN has been associated with increased incidence of AEs compared with NAs, it has a well‐recognized, predictable and, thus, manageable safety profile . PegIFN discontinuation has been reported in up to 20% of NA‐treated patients, with higher rates observed in HBeAg‐negative patients than in HBeAg‐positive patients . In studies of NA‐treated patients, up to 13% required a dose modification, which is lower than historical rates observed in all‐comers in the registration trials (46‐47%) .…”

Section: Safety Of Peginterferon In Nucleos(t)ide‐treated Hbeag‐negatmentioning

confidence: 96%

“…Half of all patients achieved undetectable HBV‐DNA, but decline in HBsAg was modest, particularly in those who did not achieve durable response after treatment discontinuation . Add‐on strategies for HBeAg‐negative patients have since been further investigated in three recent large multicentre trials …”

Section: Peginterferon In Nucleos(t)ide‐treated Hbeag‐negative Chronimentioning

confidence: 99%

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The role of peginterferon in nucleos(t)ide‐analogue‐treated chronic hepatitis B patients: A review of published literature

Zhang

Xie

Ning

et al. 2017

Journal of Viral Hepatitis

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Chronic hepatitis B infection (CHB) causes up to 1.0 million deaths annually. Currently, more than 90% of CHB patients worldwide are receiving indefinite nucleos(t)ide analogue (NA) therapy. New strategies for optimizing hepatitis B surface antigen (HBsAg) loss are required for NA-treated patients as the majority are unable to achieve HBsAg loss and may require lifelong therapy. In hepatitis B e antigen (HBeAg)-positive patients, switching from NAs to finite peginterferon (PegIFN) therapy can double HBeAg seroconversion rates. One in five patients who switch to PegIFN can achieve HBsAg loss, whereas patients who continue NA therapy typically do not. In HBeAg-negative NA-treated patients, add-on PegIFN therapy achieves higher, albeit modest, HBsAg loss rates compared with continued NA monotherapy and offers the opportunity for NA-treated patients to achieve the inactive carrier state. In the absence of curative therapies, PegIFN represents a valuable, finite option for NA-treated patients who would otherwise require potentially lifelong therapy.

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O112 : HBsAg clearance after addition of 48 weeks of pegifn in HBeAg negative CHB patients on nucleos(T)ide therapy with undetectable hbvdna for at least one year: final results from ANRS-HB06 pegan study: multicenter randomized controlled phase III trial

Cited by 16 publications

References 0 publications

Systematic review with meta‐analysis: combination treatment of regimens based on pegylated interferon for chronic hepatitis B focusing on hepatitis B surface antigen clearance

Systematic review with meta‐analysis: combination treatment of regimens based on pegylated interferon for chronic hepatitis B focusing on hepatitis B surface antigen clearance

The royal wedding in chronic hepatitis B: The haves and the have‐nots for the combination of pegylated interferon and nucleos(t)ide therapy

The role of peginterferon in nucleos(t)ide‐analogue‐treated chronic hepatitis B patients: A review of published literature

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