See the published version of this preprint at Hepatology International.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
Original Article
Jia-Horng Kao
National Taiwan University Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-2442-7952
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan.
Methods
Between July 2019 and March 2020, 1,880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100 mg once daily for 12 weeks were included at 15 academic centers in Taiwan. The sustained virologic response at off-treatment week 12 (SVR12) was assessed for evaluable (EP) and per-protocol populations (PP). The tolerance was also reported.
Results
The SVR12 rates by EP and PP analyses were 95.6% (1,798 of 1,880 patients; 95% confidence interval (CI): 94.6%-96.5%) and 99.3% (1,798 of 1,811 patients; 95% CI: 98.8%-99.6%), respectively. Among 82 patients who failed to achieve SVR12, 13 (15.9%) were attributed to virologic failures. The SVR12 rates were comparable regardless of baseline characteristics. A total of 1,859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) patients discontinued treatment due to adverse events (AEs). All patients with serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring in ≥ 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and alanine aminotransferase elevations.
Conclusions
SOF/VEL for 12 weeks is efficacious and well-tolerated chronic HCV-infected patients with compensated liver disease in Taiwan.
Keywords
hepatitis C virus, direct acting antiviral, sofosbuvir, velpatasvir, sustained virologic response, adverse event, East Asian, effectiveness, safety, pangenotypic
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
- COIHepatolInt.pdf
- SupplementaryFigure1.pdf
eGFR changes between baseline and SVR12 according to baseline CKD stage.
Loading...
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Hepatology International.
Version 1
Posted 09 Feb, 2021
No community comments so far
Editorial decision: Accept as is
On 10 Feb, 2021
First submitted
On 23 Jan, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Learn more about our company.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Hepatology International.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Original Article
Jia-Horng Kao
National Taiwan University Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-2442-7952
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Hepatology International.
Version 1
Posted 09 Feb, 2021
No community comments so far
Editorial decision: Accept as is
On 10 Feb, 2021
First submitted
On 23 Jan, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Hepatology International.
Background
Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan.
Methods
Between July 2019 and March 2020, 1,880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100 mg once daily for 12 weeks were included at 15 academic centers in Taiwan. The sustained virologic response at off-treatment week 12 (SVR12) was assessed for evaluable (EP) and per-protocol populations (PP). The tolerance was also reported.
Results
The SVR12 rates by EP and PP analyses were 95.6% (1,798 of 1,880 patients; 95% confidence interval (CI): 94.6%-96.5%) and 99.3% (1,798 of 1,811 patients; 95% CI: 98.8%-99.6%), respectively. Among 82 patients who failed to achieve SVR12, 13 (15.9%) were attributed to virologic failures. The SVR12 rates were comparable regardless of baseline characteristics. A total of 1,859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) patients discontinued treatment due to adverse events (AEs). All patients with serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring in ≥ 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and alanine aminotransferase elevations.
Conclusions
SOF/VEL for 12 weeks is efficacious and well-tolerated chronic HCV-infected patients with compensated liver disease in Taiwan.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
- COIHepatolInt.pdf
- SupplementaryFigure1.pdf
eGFR changes between baseline and SVR12 according to baseline CKD stage.
Loading...