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.

Vito Di Marco, Fabrizio Bronte, Antonio Craxi, Vincenza Calvaruso, 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, Alessandra Scuteri, Barbara Coco, Piero Colombatto, Demelia, Cursaro, Toniutto, Invernizzi, Vito Di Marco, Pietro Lampertico, Antonino Picciotto, Giovanni Squadrito, Gaia Caccamo, Sorbello

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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 Seventy patients receivedtreatment, 11 were withdrawn at week 24 for no decrease in HBsAg, and 14 withdrewfor other reasons.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).
Original languageEnglish
Pages (from-to)118-125
Number of pages8
JournalJournal of Viral Hepatitis
Volume26
Publication statusPublished - 2019

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Infectious Diseases
  • Virology

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    Di Marco, V., Bronte, F., Craxi, A., Calvaruso, V., Colombo, M., Levrero, M., Andreone, Scuteri, Vukotic, R., Bronte, Calvaruso, V., Rastelli, Rizzetto, M., Brunetto, M. R., Gaeta, G. B., Lenisa, Mangia, Dissegna, Chessa, L., ... 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. Journal of Viral Hepatitis, 26, 118-125.