Title: Analysis of Antiviral Efficacy after Switching from Brand to Generic Entecavir in patients
with treatment-naïve chronic hepatitis B
Version: 2 Date: 25 Jan 2022
Reviewer's report:
In this Paper, the Authors aimed to evaluate the antiviral activity and safety of entecavir generic
drugs (ETV-Generic) in comparison to entecavir-brand-name drugs (ETV-Brand) in chronic
hepatitis B (CHB) patients. The Authors found that, in clinical real-life setting, the efficacy and
safety profiles of switching from ETV- Brand to ETV-Generic had no difference in treatment-
naïve CHB patients.
There are few real-world data regarding the clinical efficacy of switching from ETV-Brand
to ETV-Generic, therefore the topic is of interest. The paper is well written. Despite several
limitations regarding the small sample size, the retrospective nature of a single center study, I
feel that the Paper can be considered for publication after minor revisions.
Minor comments:
In the Abstract, please change to: Entecavir (ETV) can suppress hepatitis B virus replication
as a…
In the Abstract, please change to: For the treatment of chronic hepatitis B (CHB), affordable…
In the Abstract, Conclusion, please change to: In treatment-naïve CHB-patients, the efficacy
and…
In the Results, Baseline characteristics: please add the range to the mean treatment period
From text and Table 1, I understand that at baseline all 175 patients had normal ALT levels, but
no patients had undetectable HBV DNA levels despite more than 48 weeks of ETV treatment…
could the Authors explain this?
Throughout the text, please change from “patients with CHB” to “CHB-patients”
Title: Analysis of Antiviral Efficacy after Switching from Brand to Generic Entecavir in patients
with treatment-naïve chronic hepatitis B
Version: 2 Date: 25 Jan 2022
Reviewer's report:
In this Paper, the Authors aimed to evaluate the antiviral activity and safety of entecavir generic
drugs (ETV-Generic) in comparison to entecavir-brand-name drugs (ETV-Brand) in chronic
hepatitis B (CHB) patients. The Authors found that, in clinical real-life setting, the efficacy and
safety profiles of switching from ETV- Brand to ETV-Generic had no difference in treatment-
naïve CHB patients.
There are few real-world data regarding the clinical efficacy of switching from ETV-Brand
to ETV-Generic, therefore the topic is of interest. The paper is well written. Despite several
limitations regarding the small sample size, the retrospective nature of a single center study, I
feel that the Paper can be considered for publication after minor revisions.
Minor comments:
In the Abstract, please change to: Entecavir (ETV) can suppress hepatitis B virus replication
as a…
In the Abstract, please change to: For the treatment of chronic hepatitis B (CHB), affordable…
In the Abstract, Conclusion, please change to: In treatment-naïve CHB-patients, the efficacy
and…
In the Results, Baseline characteristics: please add the range to the mean treatment period
From text and Table 1, I understand that at baseline all 175 patients had normal ALT levels, but
no patients had undetectable HBV DNA levels despite more than 48 weeks of ETV treatment…
could the Authors explain this?
Throughout the text, please change from “patients with CHB” to “CHB-patients”
Please review this paper.
user
Title: Analysis of Antiviral Efficacy after Switching from Brand to Generic Entecavir in patients
with treatment-naïve chronic hepatitis B
Version: 2 Date: 25 Jan 2022
Reviewer's report:
In this Paper, the Authors aimed to evaluate the antiviral activity and safety of entecavir generic
drugs (ETV-Generic) in comparison to entecavir-brand-name drugs (ETV-Brand) in chronic
hepatitis B (CHB) patients. The Authors found that, in clinical real-life setting, the efficacy and
safety profiles of switching from ETV- Brand to ETV-Generic had no difference in treatment-
naïve CHB patients.
There are few real-world data regarding the clinical efficacy of switching from ETV-Brand
to ETV-Generic, therefore the topic is of interest. The paper is well written. Despite several
limitations regarding the small sample size, the retrospective nature of a single center study, I
feel that the Paper can be considered for publication after minor revisions.
Minor comments:
In the Abstract, please change to: Entecavir (ETV) can suppress hepatitis B virus replication
as a…
In the Abstract, please change to: For the treatment of chronic hepatitis B (CHB), affordable…
In the Abstract, Conclusion, please change to: In treatment-naïve CHB-patients, the efficacy
and…
In the Results, Baseline characteristics: please add the range to the mean treatment period
From text and Table 1, I understand that at baseline all 175 patients had normal ALT levels, but
no patients had undetectable HBV DNA levels despite more than 48 weeks of ETV treatment…
could the Authors explain this?
Throughout the text, please change from “patients with CHB” to “CHB-patients”
assistant