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.

Vincenza Calvaruso, Vito Di Marco, Fabrizio Bronte, Antonio Craxi, Massimo Colombo, Massimo Levrero, Andreone, Scuteri, Ranka Vukotic, Bronte, Vincenza Calvaruso, Rastelli, Mario Rizzetto, Maurizia R. Brunetto, Giovanni B. Gaeta, Lenisa, Mangia, Dissegna, Luchino Chessa, LemboGiovanni Raimondo, Rizzo, Teresa Santantonio, Subic, Giuseppina Brancaccio, Antonio, Antonio, Antonio, Caccianotti, Marchese, Pierconti, Antonella Rozzi, Ciarallo, Bruzzone, D'Aluisio, Barbara Coco, Piero Colombatto, Demelia, Cursaro, Toniutto, Invernizzi, Vito Di Marco, Pietro Lampertico, Antonino Picciotto, Giovanni Squadrito, Gaia Caccamo, Sorbello

Risultato della ricerca: Article

3 Citazioni (Scopus)

Abstract

Nucleos(t)ide analogues (NAs) and peginterferon have complementary effects inchronic hepatitis B, but it is unclear whether combination therapy improvesresponses in genotype D-infected patients. We conducted an open-label study ofpeginterferon alfa-2a 180 μg/wk added to ongoing NA therapy in hepatitis Be antigen (HBeAg)-negative, genotype D-infected patients with hepatitis B virusDNA <20 IU/mL. The primary endpoint was proportion of patients with ≥50% declinein serum HBsAg by the end of the 48-week add-on phase. Seventy patients receivedtreatment, 11 were withdrawn at week 24 for no decrease in HBsAg, and 14 withdrewfor other reasons. Response rate (per-protocol population) was 67.4% (29/43) atweek 48 (95% confidence interval [CI]: 51, 81) and 50.9% (28/55) at week 96 (95% CI:38, 66). Median serum HBsAg decreased throughout peginterferonalfa-2a treatment and was significantly lower than baseline at weeks 48, 72 and 96(P < 0.001). Decreases in HBsAg of ≥0.5-log10 and ≥1-log10 were documented in 19(44.2%) and 6 (14.0%) patients at week 48 and 6 (10.9%) and 17 (30.9%) patients atweek 96. The proportion of patients with HBsAg <1000, <500, <100 and <10 IU/mLat ≥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 toweek 48, with week 12 levels significantly associated with response at week 48.Addition of peginterferon alfa-2a to ongoing NA therapy significantly decreasedHBsAg levels in HBeAg-negative patients with genotype D infection (ClinicalTrials.gov NCT01706575).
Lingua originaleEnglish
pagine (da-a)118-125
Numero di pagine8
RivistaDefault journal
Volume26
Stato di pubblicazionePublished - 2019

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Infectious Diseases
  • Virology

Cita questo

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. / Calvaruso, Vincenza; Di Marco, Vito; Bronte, Fabrizio; Craxi, Antonio; Colombo, Massimo; Levrero, Massimo; Andreone; Scuteri; Vukotic, Ranka; Bronte; Calvaruso, Vincenza; Rastelli; Rizzetto, Mario; Brunetto, Maurizia R.; Gaeta, Giovanni B.; Lenisa; Mangia; Dissegna; Chessa, Luchino; Lembo; Raimondo, Giovanni; Rizzo; Santantonio, Teresa; Subic; Brancaccio, Giuseppina; Antonio; Antonio; Antonio; Caccianotti; Marchese; Pierconti; Rozzi, Antonella; Ciarallo; Bruzzone; D'Aluisio; Coco, Barbara; Colombatto, Piero; Demelia; Cursaro; Toniutto; Invernizzi; Di Marco, Vito; Lampertico, Pietro; Picciotto, Antonino; Squadrito, Giovanni; Caccamo, Gaia; Sorbello.

In: Default journal, Vol. 26, 2019, pag. 118-125.

Risultato della ricerca: Article

Calvaruso, V, Di Marco, V, Bronte, F, Craxi, A, Colombo, M, Levrero, M, Andreone, Scuteri, Vukotic, R, Bronte, Calvaruso, V, Rastelli, Rizzetto, M, Brunetto, MR, Gaeta, GB, Lenisa, Mangia, Dissegna, Chessa, L, Lembo, Raimondo, G, Rizzo, Santantonio, T, Subic, Brancaccio, G, Antonio, Antonio, Antonio, Caccianotti, Marchese, Pierconti, Rozzi, A, Ciarallo, Bruzzone, D'Aluisio, Coco, B, Colombatto, P, Demelia, Cursaro, Toniutto, Invernizzi, Di Marco, V, Lampertico, P, Picciotto, A, Squadrito, G, Caccamo, G & Sorbello 2019, '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.', Default journal, vol. 26, pagg. 118-125.
Calvaruso, Vincenza ; Di Marco, Vito ; Bronte, Fabrizio ; Craxi, Antonio ; Colombo, Massimo ; Levrero, Massimo ; Andreone ; Scuteri ; Vukotic, Ranka ; Bronte ; Calvaruso, Vincenza ; Rastelli ; Rizzetto, Mario ; Brunetto, Maurizia R. ; Gaeta, Giovanni B. ; Lenisa ; Mangia ; Dissegna ; Chessa, Luchino ; Lembo ; Raimondo, Giovanni ; Rizzo ; Santantonio, Teresa ; Subic ; Brancaccio, Giuseppina ; Antonio ; Antonio ; Antonio ; Caccianotti ; Marchese ; Pierconti ; Rozzi, Antonella ; Ciarallo ; Bruzzone ; D'Aluisio ; Coco, Barbara ; Colombatto, Piero ; Demelia ; Cursaro ; Toniutto ; Invernizzi ; Di Marco, Vito ; Lampertico, Pietro ; Picciotto, Antonino ; Squadrito, Giovanni ; Caccamo, Gaia ; Sorbello. / 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. In: Default journal. 2019 ; Vol. 26. pagg. 118-125.
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title = "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.",
abstract = "Nucleos(t)ide analogues (NAs) and peginterferon have complementary effects inchronic hepatitis B, but it is unclear whether combination therapy improvesresponses in genotype D-infected patients. We conducted an open-label study ofpeginterferon alfa-2a 180 μg/wk added to ongoing NA therapy in hepatitis Be antigen (HBeAg)-negative, genotype D-infected patients with hepatitis B virusDNA <20 IU/mL. The primary endpoint was proportion of patients with ≥50{\%} declinein serum HBsAg by the end of the 48-week add-on phase. Seventy patients receivedtreatment, 11 were withdrawn at week 24 for no decrease in HBsAg, and 14 withdrewfor other reasons. Response rate (per-protocol population) was 67.4{\%} (29/43) atweek 48 (95{\%} confidence interval [CI]: 51, 81) and 50.9{\%} (28/55) at week 96 (95{\%} CI:38, 66). Median serum HBsAg decreased throughout peginterferonalfa-2a treatment and was significantly lower than baseline at weeks 48, 72 and 96(P < 0.001). Decreases in HBsAg of ≥0.5-log10 and ≥1-log10 were documented in 19(44.2{\%}) and 6 (14.0{\%}) patients at week 48 and 6 (10.9{\%}) and 17 (30.9{\%}) patients atweek 96. The proportion of patients with HBsAg <1000, <500, <100 and <10 IU/mLat ≥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 toweek 48, with week 12 levels significantly associated with response at week 48.Addition of peginterferon alfa-2a to ongoing NA therapy significantly decreasedHBsAg levels in HBeAg-negative patients with genotype D infection (ClinicalTrials.gov NCT01706575).",
author = "Vincenza Calvaruso and {Di Marco}, Vito and Fabrizio Bronte and Antonio Craxi and Massimo Colombo and Massimo Levrero and Andreone and Scuteri and Ranka Vukotic and Bronte and Vincenza Calvaruso and Rastelli and Mario Rizzetto and Brunetto, {Maurizia R.} and Gaeta, {Giovanni B.} and Lenisa and Mangia and Dissegna and Luchino Chessa and Lembo and Giovanni Raimondo and Rizzo and Teresa Santantonio and Subic and Giuseppina Brancaccio and Antonio and Antonio and Antonio and Caccianotti and Marchese and Pierconti and Antonella Rozzi and Ciarallo and Bruzzone and D'Aluisio and Barbara Coco and Piero Colombatto and Demelia and Cursaro and Toniutto and Invernizzi and {Di Marco}, Vito and Pietro Lampertico and Antonino Picciotto and Giovanni Squadrito and Gaia Caccamo and Sorbello",
year = "2019",
language = "English",
volume = "26",
pages = "118--125",
journal = "Default journal",

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TY - JOUR

T1 - 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.

AU - Calvaruso, Vincenza

AU - Di Marco, Vito

AU - Bronte, Fabrizio

AU - Craxi, Antonio

AU - Colombo, Massimo

AU - Levrero, Massimo

AU - Andreone, null

AU - Scuteri, null

AU - Vukotic, Ranka

AU - Bronte, null

AU - Calvaruso, Vincenza

AU - Rastelli, null

AU - Rizzetto, Mario

AU - Brunetto, Maurizia R.

AU - Gaeta, Giovanni B.

AU - Lenisa, null

AU - Mangia, null

AU - Dissegna, null

AU - Chessa, Luchino

AU - Lembo, null

AU - Raimondo, Giovanni

AU - Rizzo, null

AU - Santantonio, Teresa

AU - Subic, null

AU - Brancaccio, Giuseppina

AU - Antonio, null

AU - Antonio, null

AU - Antonio, null

AU - Caccianotti, null

AU - Marchese, null

AU - Pierconti, null

AU - Rozzi, Antonella

AU - Ciarallo, null

AU - Bruzzone, null

AU - D'Aluisio, null

AU - Coco, Barbara

AU - Colombatto, Piero

AU - Demelia, null

AU - Cursaro, null

AU - Toniutto, null

AU - Invernizzi, null

AU - Di Marco, Vito

AU - Lampertico, Pietro

AU - Picciotto, Antonino

AU - Squadrito, Giovanni

AU - Caccamo, Gaia

AU - Sorbello, null

PY - 2019

Y1 - 2019

N2 - Nucleos(t)ide analogues (NAs) and peginterferon have complementary effects inchronic hepatitis B, but it is unclear whether combination therapy improvesresponses in genotype D-infected patients. We conducted an open-label study ofpeginterferon alfa-2a 180 μg/wk added to ongoing NA therapy in hepatitis Be antigen (HBeAg)-negative, genotype D-infected patients with hepatitis B virusDNA <20 IU/mL. The primary endpoint was proportion of patients with ≥50% declinein serum HBsAg by the end of the 48-week add-on phase. Seventy patients receivedtreatment, 11 were withdrawn at week 24 for no decrease in HBsAg, and 14 withdrewfor other reasons. Response rate (per-protocol population) was 67.4% (29/43) atweek 48 (95% confidence interval [CI]: 51, 81) and 50.9% (28/55) at week 96 (95% CI:38, 66). Median serum HBsAg decreased throughout peginterferonalfa-2a treatment and was significantly lower than baseline at weeks 48, 72 and 96(P < 0.001). Decreases in HBsAg of ≥0.5-log10 and ≥1-log10 were documented in 19(44.2%) and 6 (14.0%) patients at week 48 and 6 (10.9%) and 17 (30.9%) patients atweek 96. The proportion of patients with HBsAg <1000, <500, <100 and <10 IU/mLat ≥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 toweek 48, with week 12 levels significantly associated with response at week 48.Addition of peginterferon alfa-2a to ongoing NA therapy significantly decreasedHBsAg levels in HBeAg-negative patients with genotype D infection (ClinicalTrials.gov NCT01706575).

AB - Nucleos(t)ide analogues (NAs) and peginterferon have complementary effects inchronic hepatitis B, but it is unclear whether combination therapy improvesresponses in genotype D-infected patients. We conducted an open-label study ofpeginterferon alfa-2a 180 μg/wk added to ongoing NA therapy in hepatitis Be antigen (HBeAg)-negative, genotype D-infected patients with hepatitis B virusDNA <20 IU/mL. The primary endpoint was proportion of patients with ≥50% declinein serum HBsAg by the end of the 48-week add-on phase. Seventy patients receivedtreatment, 11 were withdrawn at week 24 for no decrease in HBsAg, and 14 withdrewfor other reasons. Response rate (per-protocol population) was 67.4% (29/43) atweek 48 (95% confidence interval [CI]: 51, 81) and 50.9% (28/55) at week 96 (95% CI:38, 66). Median serum HBsAg decreased throughout peginterferonalfa-2a treatment and was significantly lower than baseline at weeks 48, 72 and 96(P < 0.001). Decreases in HBsAg of ≥0.5-log10 and ≥1-log10 were documented in 19(44.2%) and 6 (14.0%) patients at week 48 and 6 (10.9%) and 17 (30.9%) patients atweek 96. The proportion of patients with HBsAg <1000, <500, <100 and <10 IU/mLat ≥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 toweek 48, with week 12 levels significantly associated with response at week 48.Addition of peginterferon alfa-2a to ongoing NA therapy significantly decreasedHBsAg levels in HBeAg-negative patients with genotype D infection (ClinicalTrials.gov NCT01706575).

UR - http://hdl.handle.net/10447/345359

M3 - Article

VL - 26

SP - 118

EP - 125

JO - Default journal

JF - Default journal

ER -