Title: Efficacy of extracorporeal immunoadsorption therapy for removal of HBsAg
Version: 1 Date: 20 Feb 2025
Reviewer:  Heba Shawky
Reviewer's report:
I hereby state my comments regarding the manuscript entitled "Efficacy and safety of
extracorporeal immunoadsorption therapy for removal of HBsAg". In this study, Wang et al.
sought to investigates the efficacy and safety of removal of HBsAg using immunoadsorption.
I found the manuscript addressing a significant clinical question concerning a common disease
affecting a considerable number of people worldwide, not only in China. This study addresses
a critical topic and warrants publication, provided that the following issues are resolved:
1. Considering that the authors approach the biosafety of anti-HBsAg functionalized sepharose
beads; given that it is mentioned in the main title, I have some concerns about the assessment
methodology of biosafety:
# Regardless of the in vitro assessment of cytotoxicity in V79 lung fibroblasts, in page 6, lines
155-157 the authors mention that: To investigate the efficiency and biocompatibility, healthy
rabbits (n=3) were connected to the immunosorbent column and the blood of animals was
circulated through the extracorporeal circuit for 2 h. Rabbits were then monitored for 48 h".
Please clarify whether you investigated the anti-HBsAg functionalized sepharose beads or the
control beads.
# In case that the authors investigated the curative system, i.e., anti-HBsAg functionalized
sepharose beads, two days are far from enough investigating acute toxicity, it should be extended
to 14 days minimum.
# Animal mortality is not the only criterion for biosafety, particularly that the developed system
is investigated in this preclinical study as a step for human use. There are no biochemical,
immunological, or histopathological assessments of biosafety.
2. Regarding the characterization of the developed extracorporeal circulation system, SEM is
merely a method of morphological assessment, more investigations should have been carried
out to determine the molecular interactions between the adsorbed antibody and sepharose beads,
which indicates the system stability.
Title: Efficacy of extracorporeal immunoadsorption therapy for removal of HBsAg
Version: 1 Date: 20 Feb 2025
Reviewer:  Heba Shawky
Reviewer's report:
I hereby state my comments regarding the manuscript entitled "Efficacy and safety of
extracorporeal immunoadsorption therapy for removal of HBsAg". In this study, Wang et al.
sought to investigates the efficacy and safety of removal of HBsAg using immunoadsorption.
I found the manuscript addressing a significant clinical question concerning a common disease
affecting a considerable number of people worldwide, not only in China. This study addresses
a critical topic and warrants publication, provided that the following issues are resolved:
1. Considering that the authors approach the biosafety of anti-HBsAg functionalized sepharose
beads; given that it is mentioned in the main title, I have some concerns about the assessment
methodology of biosafety:
# Regardless of the in vitro assessment of cytotoxicity in V79 lung fibroblasts, in page 6, lines
155-157 the authors mention that: To investigate the efficiency and biocompatibility, healthy
rabbits (n=3) were connected to the immunosorbent column and the blood of animals was
circulated through the extracorporeal circuit for 2 h. Rabbits were then monitored for 48 h".
Please clarify whether you investigated the anti-HBsAg functionalized sepharose beads or the
control beads.
# In case that the authors investigated the curative system, i.e., anti-HBsAg functionalized
sepharose beads, two days are far from enough investigating acute toxicity, it should be extended
to 14 days minimum.
# Animal mortality is not the only criterion for biosafety, particularly that the developed system
is investigated in this preclinical study as a step for human use. There are no biochemical,
immunological, or histopathological assessments of biosafety.
2. Regarding the characterization of the developed extracorporeal circulation system, SEM is
merely a method of morphological assessment, more investigations should have been carried
out to determine the molecular interactions between the adsorbed antibody and sepharose beads,
which indicates the system stability.
Please review this paper.
user
Title: Efficacy of extracorporeal immunoadsorption therapy for removal of HBsAg
Version: 1 Date: 20 Feb 2025
Reviewer:  Heba Shawky
Reviewer's report:
I hereby state my comments regarding the manuscript entitled "Efficacy and safety of
extracorporeal immunoadsorption therapy for removal of HBsAg". In this study, Wang et al.
sought to investigates the efficacy and safety of removal of HBsAg using immunoadsorption.
I found the manuscript addressing a significant clinical question concerning a common disease
affecting a considerable number of people worldwide, not only in China. This study addresses
a critical topic and warrants publication, provided that the following issues are resolved:
1. Considering that the authors approach the biosafety of anti-HBsAg functionalized sepharose
beads; given that it is mentioned in the main title, I have some concerns about the assessment
methodology of biosafety:
# Regardless of the in vitro assessment of cytotoxicity in V79 lung fibroblasts, in page 6, lines
155-157 the authors mention that: To investigate the efficiency and biocompatibility, healthy
rabbits (n=3) were connected to the immunosorbent column and the blood of animals was
circulated through the extracorporeal circuit for 2 h. Rabbits were then monitored for 48 h".
Please clarify whether you investigated the anti-HBsAg functionalized sepharose beads or the
control beads.
# In case that the authors investigated the curative system, i.e., anti-HBsAg functionalized
sepharose beads, two days are far from enough investigating acute toxicity, it should be extended
to 14 days minimum.
# Animal mortality is not the only criterion for biosafety, particularly that the developed system
is investigated in this preclinical study as a step for human use. There are no biochemical,
immunological, or histopathological assessments of biosafety.
2. Regarding the characterization of the developed extracorporeal circulation system, SEM is
merely a method of morphological assessment, more investigations should have been carried
out to determine the molecular interactions between the adsorbed antibody and sepharose beads,
which indicates the system stability.
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