Objective:
The development of hepatocellular carcinoma (HCC) is not uncommon
in patients who achieve eradication of the hepatitis C virus through direct-acting
antiviral (DAA) treatment. The aim of this study was to identify the patients at high risk
for novel HCC development after a sustained virologic response (SVR) by DAA treatment.
Patients and Methods:
A total of 518 patients with no history of HCC
treatment and who achieved SVR by DAA treatment were evaluated retrospectively. The
correlations between HCC development and the patients’ characteristics were evaluated. For
patients who underwent gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid
(Gd-EOB-DTPA)-enhanced magnetic resonance imaging (MRI) or dynamic contrast-enhanced
computed tomography, the relationship between the imaging findings and subsequent HCC
development was also assessed.
Results:
HCC developed newly in 22 patients, and the 1-year and 3-year
cumulative HCC rates were 2.0% and 8.5%, respectively. In multivariate analysis, a FIB-4
index >4.0 and a post-treatment α-fetoprotein >4.0 ng/ml were significant risk
factors for HCC. In 26 of 118 patients who underwent an MRI before DAA treatment, a
non-hypervascular hypo-intense nodule was seen in the hepatobiliary phase, and in 6 of 182
patients who underwent a CT, a non-hypervascular hypo-enhanced nodule was seen in the
delayed phase. The sensitivity and specificity of the MRI-positive findings for the
subsequent development of HCC were 0.92 and 0.87, respectively, and those of the CT were
0.40 and 0.99, respectively. In multivariate analysis of patients who underwent an MRI, a
non-hypervascular hypo-intense nodule was the only factor that was significantly related
to HCC development (HR 32.4, p = 0.001).
Conclusion:
Gd-EOB-DTPA-enhanced MRI was found to be reliable for risk
evaluation of subsequent HCC development in patients after SVR by DAA treatment. Patients
with a non-hypervascular hypo-intense nodule need more careful observation for incident
HCC.
Objective: Combination therapy with glecaprevir and pibrentasvir (G/P) has been shown to provide a sustained virologic response (SVR) rate of >97% in patients with chronic hepatitis C virus (HCV) infection in the first published real-world Japanese data. However, a recently published study showed that the treatment was often discontinued in patients ≥75 years old, resulting in low SVR in intention-to-treat (ITT) analysis. Thus, our aim was to evaluate real-world data for G/P therapy in patients ≥75 years of age, the population density of which is high in "rural" regions. Patients and Methods: We conducted a multicenter study to assess the efficacy and safety of G/P therapy for chronic HCV infection, in the North Kanto area in Japan. Results: Of the 308 patients enrolled, 294 (95.5%) completed the treatment according to the protocol. In ITT and per-protocol analyses, the overall SVR12 rate was 97.1% and 99.7%, respectively. The old-aged patients group consisted of 59 participants, 56 of whom (94.9%) completed the scheduled protocol. Although old-aged patients tended to have non-SVR factors such as liver cirrhosis, history of HCC, and prior DAA therapies, the SVR12 rates in old-aged patients were 98.3% and 100% in the ITT and PP analyses, respectively. Of 308 patients enrolled, adverse events were observed in 74 patients (24.0%), with grade ≥3 events in 8 patients (2.6%). There was no significant difference in any grade and grade ≥3 adverse events between the old-aged group and the rest of the study participants. Only one patient discontinued the treatment because of adverse events. Conclusion: G/P therapy is effective and safe for old-aged patients.
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