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, P.; Brunetto, M.; Craxì, A.; Gaeta, G.; Rizzetto, M.; Rozzi, A.; Colombo, M.; Antonio, D.; Andreone, P.; Antonio, D.; Brancaccio, G.; Bruzzone, L.; Caccamo, G.; Caccianotti, B.; Chessa, L.; Ciarallo, M.; Coco, B.; Colombatto, P.; Cursaro, C.; D'Aluisio, D.; Demelia, L.; Dissegna, D.; Invernizzi, F.; Lenisa, I.; Lembo, T.; Levrero, M.; Marchese, V.; Mangia, G.; Picciotto, A.; Pierconti, S.; Antonio, D.; Raimondo, G.; Rastelli, C.

Risultato della ricerca: Article

3 Citazioni (Scopus)

Abstract

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/wk added to ongoing NA therapy in hepatitis B e antigen (HBeAg)-negative, genotype D-infected patients with hepatitis B virus 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 Seventy patients received treatment, 11 were withdrawn at week 24 for no decrease in HBsAg, and 14 withdrew for other reasons.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 < 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 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 (ClinicalTrials. gov NCT01706575).
Lingua originaleEnglish
pagine (da-a)118-125
Numero di pagine8
RivistaJournal of Viral Hepatitis
Volume26
Stato di pubblicazionePublished - 2019

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Virology
  • Infectious Diseases

Cita questo

Lampertico, P.; Brunetto, M.; Craxì, A.; Gaeta, G.; Rizzetto, M.; Rozzi, A.; Colombo, M.; Antonio, D.; Andreone, P.; Antonio, D.; Brancaccio, G.; Bruzzone, L.; Caccamo, G.; Caccianotti, B.; Chessa, L.; Ciarallo, M.; Coco, B.; Colombatto, P.; Cursaro, C.; D'Aluisio, D.; Demelia, L.; Dissegna, D.; Invernizzi, F.; Lenisa, I.; Lembo, T.; Levrero, M.; Marchese, V.; Mangia, G.; Picciotto, A.; Pierconti, S.; Antonio, D.; Raimondo, G.; Rastelli, C. (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. Journal of Viral Hepatitis, 26, 118-125.

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, P.; Brunetto, M.; Craxì, A.; Gaeta, G.; Rizzetto, M.; Rozzi, A.; Colombo, M.; Antonio, D.; Andreone, P.; Antonio, D.; Brancaccio, G.; Bruzzone, L.; Caccamo, G.; Caccianotti, B.; Chessa, L.; Ciarallo, M.; Coco, B.; Colombatto, P.; Cursaro, C.; D'Aluisio, D.; Demelia, L.; Dissegna, D.; Invernizzi, F.; Lenisa, I.; Lembo, T.; Levrero, M.; Marchese, V.; Mangia, G.; Picciotto, A.; Pierconti, S.; Antonio, D.; Raimondo, G.; Rastelli, C.

In: Journal of Viral Hepatitis, Vol. 26, 2019, pag. 118-125.

Risultato della ricerca: Article

Lampertico, P.; Brunetto, M.; Craxì, A.; Gaeta, G.; Rizzetto, M.; Rozzi, A.; Colombo, M.; Antonio, D.; Andreone, P.; Antonio, D.; Brancaccio, G.; Bruzzone, L.; Caccamo, G.; Caccianotti, B.; Chessa, L.; Ciarallo, M.; Coco, B.; Colombatto, P.; Cursaro, C.; D'Aluisio, D.; Demelia, L.; Dissegna, D.; Invernizzi, F.; Lenisa, I.; Lembo, T.; Levrero, M.; Marchese, V.; Mangia, G.; Picciotto, A.; Pierconti, S.; Antonio, D.; Raimondo, G.; Rastelli, C. 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.', Journal of Viral Hepatitis, vol. 26, pagg. 118-125.
Lampertico, P.; Brunetto, M.; Craxì, A.; Gaeta, G.; Rizzetto, M.; Rozzi, A.; Colombo, M.; Antonio, D.; Andreone, P.; Antonio, D.; Brancaccio, G.; Bruzzone, L.; Caccamo, G.; Caccianotti, B.; Chessa, L.; Ciarallo, M.; Coco, B.; Colombatto, P.; Cursaro, C.; D'Aluisio, D.; Demelia, L.; Dissegna, D.; Invernizzi, F.; Lenisa, I.; Lembo, T.; Levrero, M.; Marchese, V.; Mangia, G.; Picciotto, A.; Pierconti, S.; Antonio, D.; Raimondo, G.; Rastelli, C. 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. Journal of Viral Hepatitis. 2019;26:118-125.
Lampertico, P.; Brunetto, M.; Craxì, A.; Gaeta, G.; Rizzetto, M.; Rozzi, A.; Colombo, M.; Antonio, D.; Andreone, P.; Antonio, D.; Brancaccio, G.; Bruzzone, L.; Caccamo, G.; Caccianotti, B.; Chessa, L.; Ciarallo, M.; Coco, B.; Colombatto, P.; Cursaro, C.; D'Aluisio, D.; Demelia, L.; Dissegna, D.; Invernizzi, F.; Lenisa, I.; Lembo, T.; Levrero, M.; Marchese, V.; Mangia, G.; Picciotto, A.; Pierconti, S.; Antonio, D.; Raimondo, G.; Rastelli, C. / 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: Journal of Viral Hepatitis. 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 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/wk added to ongoing NA therapy in hepatitis B e antigen (HBeAg)-negative, genotype D-infected patients with hepatitis B virus 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 < 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 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 (ClinicalTrials. gov NCT01706575).",
author = "{Lampertico, P.; Brunetto, M.; Crax{\`i}, A.; Gaeta, G.; Rizzetto, M.; Rozzi, A.; Colombo, M.; Antonio, D.; Andreone, P.; Antonio, D.; Brancaccio, G.; Bruzzone, L.; Caccamo, G.; Caccianotti, B.; Chessa, L.; Ciarallo, M.; Coco, B.; Colombatto, P.; Cursaro, C.; D'Aluisio, D.; Demelia, L.; Dissegna, D.; Invernizzi, F.; Lenisa, I.; Lembo, T.; Levrero, M.; Marchese, V.; Mangia, G.; Picciotto, A.; Pierconti, S.; Antonio, D.; Raimondo, G.; Rastelli, C.} and Antonio Craxi and {Di Marco}, Vito and Vincenza Calvaruso and Fabrizio Bronte",
year = "2019",
language = "English",
volume = "26",
pages = "118--125",
journal = "Journal of Viral Hepatitis",
issn = "1352-0504",
publisher = "Wiley-Blackwell",

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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 - Lampertico, P.; Brunetto, M.; Craxì, A.; Gaeta, G.; Rizzetto, M.; Rozzi, A.; Colombo, M.; Antonio, D.; Andreone, P.; Antonio, D.; Brancaccio, G.; Bruzzone, L.; Caccamo, G.; Caccianotti, B.; Chessa, L.; Ciarallo, M.; Coco, B

AU - Craxi, Antonio

AU - Di Marco, Vito

AU - Calvaruso, Vincenza

AU - Bronte, Fabrizio

PY - 2019

Y1 - 2019

N2 - 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/wk added to ongoing NA therapy in hepatitis B e antigen (HBeAg)-negative, genotype D-infected patients with hepatitis B virus 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 < 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 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 (ClinicalTrials. gov NCT01706575).

AB - 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/wk added to ongoing NA therapy in hepatitis B e antigen (HBeAg)-negative, genotype D-infected patients with hepatitis B virus 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 < 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 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 (ClinicalTrials. gov NCT01706575).

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

M3 - Article

VL - 26

SP - 118

EP - 125

JO - Journal of Viral Hepatitis

JF - Journal of Viral Hepatitis

SN - 1352-0504

ER -