Combination of Tenofovir Disoproxil Fumarate and Peginterferon α-2a Increases Loss of Hepatitis B Surface Antigen in Patients with Chronic Hepatitis B

Patrick Marcellin, Sang Hoon Ahn, Xiaoli Ma, Florin A. Caruntu, Won Young Tak, Magdy Elkashab, Wan Long Chuang, Seng Gee Lim, Fehmi Tabak, Rajiv Mehta, Joerg Petersen, Graham R. Foster, Lillian Lou, Eduardo B. Martins, Phillip Dinh, Lanjia Lin, Amoreena Corsa, Prista Charuworn, G. Mani Subramanian, Hans ReiserHendrick W. Reesink, Scott Fung, Simone I. Strasser, Huy Trinh, Maria Buti, Giovanni B. Gaeta, Aric J. Hui, George Papatheodoridis, Robert Flisiak, Henry L Y Chan

Research output: Contribution to journalArticle

Abstract

Background & Aims Patients chronically infected with the hepatitis B virus rarely achieve loss of serum hepatitis B surface antigen (HBsAg) with the standard of care. We evaluated HBsAg loss in patients receiving the combination of tenofovir disoproxil fumarate (TDF) and peginterferon α-2a (peginterferon) for a finite duration in a randomized trial. Methods In an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus peginterferon for 48 weeks (group A), TDF plus peginterferon for 16 weeks followed by TDF for 32 weeks (group B), TDF for 120 weeks (group C), or peginterferon for 48 weeks (group D). The primary end point was the proportion of patients with serum HBsAg loss at week 72. Results At week seventy-two, 9.1% of subjects in group A had HBsAg loss compared with 2.8% of subjects in group B, none of the subjects in group C, and 2.8% of subjects in group D. A significantly higher proportion of subjects in group A had HBsAg loss than in group C (P

Original languageEnglish (US)
Pages (from-to)134-144.e10
JournalGastroenterology
Volume150
Issue number1
DOIs
StatePublished - Jan 1 2016
Externally publishedYes

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Tenofovir
Chronic Hepatitis B
Hepatitis B Surface Antigens
Standard of Care
Serum
Hepatitis B virus

Keywords

  • Clinical Trial
  • HBeAg Seroconversion
  • HBV
  • Virologic Response

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Combination of Tenofovir Disoproxil Fumarate and Peginterferon α-2a Increases Loss of Hepatitis B Surface Antigen in Patients with Chronic Hepatitis B. / Marcellin, Patrick; Ahn, Sang Hoon; Ma, Xiaoli; Caruntu, Florin A.; Tak, Won Young; Elkashab, Magdy; Chuang, Wan Long; Lim, Seng Gee; Tabak, Fehmi; Mehta, Rajiv; Petersen, Joerg; Foster, Graham R.; Lou, Lillian; Martins, Eduardo B.; Dinh, Phillip; Lin, Lanjia; Corsa, Amoreena; Charuworn, Prista; Subramanian, G. Mani; Reiser, Hans; Reesink, Hendrick W.; Fung, Scott; Strasser, Simone I.; Trinh, Huy; Buti, Maria; Gaeta, Giovanni B.; Hui, Aric J.; Papatheodoridis, George; Flisiak, Robert; Chan, Henry L Y.

In: Gastroenterology, Vol. 150, No. 1, 01.01.2016, p. 134-144.e10.

Research output: Contribution to journalArticle

Marcellin, P, Ahn, SH, Ma, X, Caruntu, FA, Tak, WY, Elkashab, M, Chuang, WL, Lim, SG, Tabak, F, Mehta, R, Petersen, J, Foster, GR, Lou, L, Martins, EB, Dinh, P, Lin, L, Corsa, A, Charuworn, P, Subramanian, GM, Reiser, H, Reesink, HW, Fung, S, Strasser, SI, Trinh, H, Buti, M, Gaeta, GB, Hui, AJ, Papatheodoridis, G, Flisiak, R & Chan, HLY 2016, 'Combination of Tenofovir Disoproxil Fumarate and Peginterferon α-2a Increases Loss of Hepatitis B Surface Antigen in Patients with Chronic Hepatitis B', Gastroenterology, vol. 150, no. 1, pp. 134-144.e10. https://doi.org/10.1053/j.gastro.2015.09.043
Marcellin, Patrick ; Ahn, Sang Hoon ; Ma, Xiaoli ; Caruntu, Florin A. ; Tak, Won Young ; Elkashab, Magdy ; Chuang, Wan Long ; Lim, Seng Gee ; Tabak, Fehmi ; Mehta, Rajiv ; Petersen, Joerg ; Foster, Graham R. ; Lou, Lillian ; Martins, Eduardo B. ; Dinh, Phillip ; Lin, Lanjia ; Corsa, Amoreena ; Charuworn, Prista ; Subramanian, G. Mani ; Reiser, Hans ; Reesink, Hendrick W. ; Fung, Scott ; Strasser, Simone I. ; Trinh, Huy ; Buti, Maria ; Gaeta, Giovanni B. ; Hui, Aric J. ; Papatheodoridis, George ; Flisiak, Robert ; Chan, Henry L Y. / Combination of Tenofovir Disoproxil Fumarate and Peginterferon α-2a Increases Loss of Hepatitis B Surface Antigen in Patients with Chronic Hepatitis B. In: Gastroenterology. 2016 ; Vol. 150, No. 1. pp. 134-144.e10.
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T1 - Combination of Tenofovir Disoproxil Fumarate and Peginterferon α-2a Increases Loss of Hepatitis B Surface Antigen in Patients with Chronic Hepatitis B

AU - Marcellin, Patrick

AU - Ahn, Sang Hoon

AU - Ma, Xiaoli

AU - Caruntu, Florin A.

AU - Tak, Won Young

AU - Elkashab, Magdy

AU - Chuang, Wan Long

AU - Lim, Seng Gee

AU - Tabak, Fehmi

AU - Mehta, Rajiv

AU - Petersen, Joerg

AU - Foster, Graham R.

AU - Lou, Lillian

AU - Martins, Eduardo B.

AU - Dinh, Phillip

AU - Lin, Lanjia

AU - Corsa, Amoreena

AU - Charuworn, Prista

AU - Subramanian, G. Mani

AU - Reiser, Hans

AU - Reesink, Hendrick W.

AU - Fung, Scott

AU - Strasser, Simone I.

AU - Trinh, Huy

AU - Buti, Maria

AU - Gaeta, Giovanni B.

AU - Hui, Aric J.

AU - Papatheodoridis, George

AU - Flisiak, Robert

AU - Chan, Henry L Y

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Background & Aims Patients chronically infected with the hepatitis B virus rarely achieve loss of serum hepatitis B surface antigen (HBsAg) with the standard of care. We evaluated HBsAg loss in patients receiving the combination of tenofovir disoproxil fumarate (TDF) and peginterferon α-2a (peginterferon) for a finite duration in a randomized trial. Methods In an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus peginterferon for 48 weeks (group A), TDF plus peginterferon for 16 weeks followed by TDF for 32 weeks (group B), TDF for 120 weeks (group C), or peginterferon for 48 weeks (group D). The primary end point was the proportion of patients with serum HBsAg loss at week 72. Results At week seventy-two, 9.1% of subjects in group A had HBsAg loss compared with 2.8% of subjects in group B, none of the subjects in group C, and 2.8% of subjects in group D. A significantly higher proportion of subjects in group A had HBsAg loss than in group C (P

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