Options
Four weeks of off‐treatment follow‐up is sufficient to determine virologic responses at off‐treatment week 12 in patients with hepatitis C virus infection receiving fixed‐dose pangenotypic direct‐acting antivirals
Journal
Journal of Medical Virology
Journal Volume
96
Journal Issue
5
ISSN
0146-6615
1096-9071
Date Issued
2024-05
Author(s)
Chen‐Hua Liu
Yu‐Ping Chang
Ji‐Yuh Lee
Chi‐Yi Chen
Wei‐Yu Kao
Chih‐Lin Lin
Yu‐Lueng Shih
Cheng‐Yuan Peng
Fu‐Jen Lee
Shang‐Chin Huang
Tung‐Hung Su
Tai‐Chung Tseng
Chun‐Jen Liu
Pei‐Jer Chen
Jia‐Horng Kao
Abstract
<jats:title>Abstract</jats:title>
<jats:p>
Early confirmation of sustained virologic response (SVR) or viral relapse after direct‐acting antivirals (DAAs) for hepatitis C virus (HCV) infection is essential based on public health perspectives, particularly for patients with high risk of nonadherence to posttreatment follow‐ups. A total of 1011 patients who achieved end‐of‐treatment virologic response, including 526 receiving fixed‐dose pangenotypic DAAs, and 485 receiving other types of DAAs, who had available off‐treatment weeks 4 and 12 serum HCV RNA data to confirm SVR at off‐treatment week 12 (SVR
<jats:sub>12</jats:sub>
) or viral relapse were included. The positive predictive value (PPV) and negative predictive value (NPV) of SVR
<jats:sub>4</jats:sub>
to predict patients with SVR
<jats:sub>12</jats:sub>
or viral relapse were reported. Furthermore, we analyzed the proportion of concordance between SVR
<jats:sub>12</jats:sub>
and SVR
<jats:sub>24</jats:sub>
in 943 patients with available SVR
<jats:sub>24</jats:sub>
data. The PPV and NPV of SVR
<jats:sub>4</jats:sub>
to predict SVR
<jats:sub>12</jats:sub>
were 98.5% (95% confidence interval [CI]: 98.0–98.9) and 100% (95% CI: 66.4–100) in the entire population. The PPV of SVR
<jats:sub>4</jats:sub>
to predict SVR
<jats:sub>12</jats:sub>
in patients receiving fixed‐dose pangenotypic DAAs was higher than those receiving other types of DAAs (99.8% [95% CI: 98.9–100] vs. 97.1% [95% CI: 96.2–97.8],
<jats:italic>p</jats:italic>
< 0.001). The NPVs of SVR
<jats:sub>4</jats:sub>
to predict viral relapse were 100%, regardless of the type of DAAs. Moreover, the concordance between SVR
<jats:sub>12</jats:sub>
and SVR
<jats:sub>24</jats:sub>
was 100%. In conclusion, an off‐treatment week 4 serum HCV RNA testing is sufficient to provide an excellent prediction power of SVR or viral relapse at off‐treatment week 12 among patients with HCV who are treated with fixed‐dose pangenotypic DAAs.
</jats:p>
<jats:p>
Early confirmation of sustained virologic response (SVR) or viral relapse after direct‐acting antivirals (DAAs) for hepatitis C virus (HCV) infection is essential based on public health perspectives, particularly for patients with high risk of nonadherence to posttreatment follow‐ups. A total of 1011 patients who achieved end‐of‐treatment virologic response, including 526 receiving fixed‐dose pangenotypic DAAs, and 485 receiving other types of DAAs, who had available off‐treatment weeks 4 and 12 serum HCV RNA data to confirm SVR at off‐treatment week 12 (SVR
<jats:sub>12</jats:sub>
) or viral relapse were included. The positive predictive value (PPV) and negative predictive value (NPV) of SVR
<jats:sub>4</jats:sub>
to predict patients with SVR
<jats:sub>12</jats:sub>
or viral relapse were reported. Furthermore, we analyzed the proportion of concordance between SVR
<jats:sub>12</jats:sub>
and SVR
<jats:sub>24</jats:sub>
in 943 patients with available SVR
<jats:sub>24</jats:sub>
data. The PPV and NPV of SVR
<jats:sub>4</jats:sub>
to predict SVR
<jats:sub>12</jats:sub>
were 98.5% (95% confidence interval [CI]: 98.0–98.9) and 100% (95% CI: 66.4–100) in the entire population. The PPV of SVR
<jats:sub>4</jats:sub>
to predict SVR
<jats:sub>12</jats:sub>
in patients receiving fixed‐dose pangenotypic DAAs was higher than those receiving other types of DAAs (99.8% [95% CI: 98.9–100] vs. 97.1% [95% CI: 96.2–97.8],
<jats:italic>p</jats:italic>
< 0.001). The NPVs of SVR
<jats:sub>4</jats:sub>
to predict viral relapse were 100%, regardless of the type of DAAs. Moreover, the concordance between SVR
<jats:sub>12</jats:sub>
and SVR
<jats:sub>24</jats:sub>
was 100%. In conclusion, an off‐treatment week 4 serum HCV RNA testing is sufficient to provide an excellent prediction power of SVR or viral relapse at off‐treatment week 12 among patients with HCV who are treated with fixed‐dose pangenotypic DAAs.
</jats:p>
SDGs
Publisher
Wiley
Type
journal-article