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Page 4 of 11 Nakamura et al. Hepatoma Res 2019;5:16 I http://dx.doi.org/10.20517/2394-5079.2019.06

Table 1. The baseline characteristics of 312 patients at the time of direct-acting antiviral treatment
Final HCC Tx before DAA
Characteristics All patients (n = 312)
Hepatectomy (n = 89) RFA (n = 223)
Age (years) 74 (68-79) 74 (68-78) 74 (68-79)
Gender (male) 182 (58.3%) 50 (56.2%) 132 (59.1%)
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Platelet (× 10 /μL)* 105 (76-140) 113 (98-137) 99 (73-142)
ALB (g/dL)* 3.8 (3.4-4.0) 3.9 (3.6-4.2) 3.7 (3.4-4.0)
T.Bil (mg/dL)** 0.8 (0.6-1.1) 0.73 (0.6-0.9) 0.89 (0.6-1.2)
AST (U/L) 52 (37-67) 51 (39-70) 52 (36-66)
ALT (U/L) 41 (28-60) 42 (31-65) 39 (27-60)
GGTP (U/L) 37 (25-55) 40 (26-62) 36 (24-52)
PT-INR 1.07 (1.0-1.14) 1.07 (0.99-1.11) 1.06 (1.00-1.15)
Child-Pugh grade A** 280 (89.7%) 83 (93.3%) 197 (88.3%)
Fib-4 index 5.64 (3.75-8.04) 5.06 (3.65-6.85) 5.88 (3.75-8.53)
HCV genotype*
Genotype 1 251 (80.5%) 65 (73.0%) 186 (83.4%)
Genotype 2 60 (19.2%) 24 (27.0%) 36 (16.2%)
Genotype 1 + 2 1 (0.3%) 0 (0%) 1 (0.4%)
HCV-RNA (log IU/mL) 6.0 (5.4-6.4) 6.0 (5.4-6.5) 6.0 (5.4-6.4)
SVR at 12 weeks 288 (92.3%) 83 (93.3%) 205 (91.9%)
*P < 0.001; **P < 0.05; The values indicate the median (interquartile range) unless otherwise noted. ALB: albumin; T.Bil: total
bilirubin; AST: aspartate aminotransferase; ALT: alanine aminotransferase; GGTP: gamma-glutamyl transpeptidase; PT-INR:
1/2
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prothrombin time-international normalized ratio; FIB-4 index = Age (years) × AST (U/L)/[PLT(10 /L) × ALT (U/L)]; HCV: hepatitis
C virus; HCC: hepatocellular carcinoma; Tx: treatment; SVR: sustained virological response
RESULTS
Patient characteristics
The clinical characteristics of the patients and the characteristics of HCC before DAA treatment are shown in
[Tables 1 and 2], respectively. The median age was 74 years old, and 182 (58.3%) patients were male. Two hundred
and fifty-one (80.4%) and 60 patients (19.2%) had HCV genotypes 1 and 2, respectively, and 1 patient had both. An
SVR12 was achieved by 288 patients (92.3%). The median tumor size at the initial treatment was 18 mm, and 244
patients (78.2%) had a single tumor. The interval from the final HCC treatment and DAA therapy was 297 days
(median). The median follow-up time from the end of DAA treatment was 855 days.

The recurrence and survival rates
HCC recurred in 135 patients (43.2%), and the 1-, 2- and 3-year cumulative recurrence rates after DAA therapy
were 18.3%, 38.8% and 55.4%, respectively [Figure 1]. The 1-, 2- and 3-year-overall survival rates were 99.4%, 98.6%
and 95.4%, respectively [Figure 2].

Risk factors for recurrence
In the univariate analysis, the factors associated with HCC recurrence included AFP ≥ 10 ng/mL and multiple
tumors at the initial HCC treatment, T.Bil > 0.8 mg/dL, AFP-L3 ≥ 10% at the initiation of DAA therapy, a history of
multiple treatments before DAA therapy, RFA as the final HCC treatments before DAA, period between the final
HCC treatment and DAA therapy < 1 year, AFP ≥ 10 ng/mL, DCP ≥ 28 mAU/mL, AFP-L3 ≥ 10% and non-SVR12
[Table 3].

In the multivariate analysis, the factors associated with HCC recurrence were multiple tumors at the first HCC
treatment [HR = 2.21; 95% confidence interval (CI): 1.41-3.49], a history of multiple treatments for HCC before DAA
therapy (HR = 1.97; 95%CI: 1.28-3.02) and AFP-L3 ≥ 10% at the initiation of DAA therapy (HR = 4.74; 95%CI: 2.10-10.7)
[Table 4].

The relationship between the number of times the patient had received treatment for HCC and recurrence is
shown in [Figure 3]. The recurrence rates increased as the number of previous treatments for HCC increased: the