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Douhara et al. DAA therapy for patients with CHC

occurrence of hepatocellular carcinoma (HCC) [2-4] . performed using the Wilcoxon rank-sum test. A P
However, these results were supported by studies with value of < 0.05 was deemed statistically significant. All
only IFN-based regimens. Thus, it is unclear whether statistical analyses were performed using IBM SPSS
DAA therapy reduces the occurrence of HCC. statistics version 22 (IBM Corp., Armonk, NY, USA).

The aim of this study was to evaluate the safety, RESULTS
efficacy and HCC development after DAA therapy in
patients with CHC. Baseline characteristics of patients
Between January 2015 and March 2016, a total of
METHODS 33 patients received DAA therapy. All patients were
followed for 24 weeks after DAA treatment. Table 1
Patients shows the principle baseline characteristics of this
In this retrospective cohort study, we analyzed data study.
from consecutive patients with CHC who were treated
with DAA therapy at our hospital in the middle south Virological response
area of Nara prefecture, Japan, between January 2015 Sustained virological response after 24 weeks (SVR24)
and March 2016 [Figure 1]. All data were obtained from was achieved in all patients (100%), regardless of geno-
individual patient records at our hospital. The eligibility type 1 or 2 [Figure 2].
of each patient for the treatment of HCV with DAA
therapy was assessed following the criteria established Serological response
by the Japan society of hepatology. The criteria for Aspartate aminotransferase (AST) and alanine amino-
treatment included: patients with chronic hepatitis or transferase (ALT) indicated significantly decreased liver
Child-Pugh class A liver cirrhosis with no evidence inflammation after SVR24. The FIB4-index, which is a
of HCC as confirmed by ultrasound sonography (US) calculated hepatic fibrosis marker, was also significantly
and/or contrast-enhanced computed tomography decreased. Moreover, alpha (α)-fetoprotein, which
(CT)/magnetic resonance imaging (MRI). At the end showed both liver inflammation and tumor marker,
of therapy and at 24 weeks off therapy, liver function was significantly decreased. However, total bilirubin
was estimated again. The virological response to (T-bil), albumin and platelet count were not significantly
DAA therapy was assessed by quantitative HCV-RNA changed after SVR24 [Table 2].
detection using real-time polymerase chain reaction.
At 24 weeks off therapy, patients underwent another Adverse events
abdominal ultrasound evaluation. If focal lesions
of the liver were detected by US, patients were re- Liver function disorder was only observed in the
evaluated with CE-CT/MRI to assess the occurrence daclatasvir (DCV) + Asunaprevir (ASV) group. Anemia
or recurrence of HCC. was found only in the sofosbuvir (SOF) + ribavirin
(RBV) group [Table 3]. One patient treated with SOF +
Statistics Table 1: The principle baseline characteristics of the
Bivariate analyses of continuous variables were study, n = 33

Characteristics n (%)
Week 0 12 24 36 48
Mean age, year (range) 68 (41-83)
Male 18 (54.5)
HCV GT1 DCV + ASV SVR 24
n = 13 Japanese 33 (100)
History of IFN therapy 20 (60.6)
HCV GT1 SOF + LDV SVR 24 HCV-RNA, log IU/mL (range) 6.0 (4.5-7.1)
n = 14 HCV GT1 27 (81.8)
GT2 6 (18.2)
HCV GT1 SOF + RBV SVR 24
n = 6 Cirrhosis 8 (24.2)
Platelet (10 mm ) 14.4 ± 4.5
3
4
Figure 1: A total of 33 consecutive patients were treated with Aspartate aminotransferase (IU/L) 43 ± 20
DAA for CHC at our hospital between January 2015 and March
2016. Patients were divided into a DCV + ASV group, an SOF + Alanine aminotransferase (IU/L) 46 ± 29
LDV group and an SOF + RBV group consisting of 13, 14 and 6 T-bil (mg/dL) 0.8 ± 0.3
patients, respectively. The laboratory data were collected at the Albumin (g/dL) 4.1 ± 0.3
start and after 24 weeks of DAA therapy. HCC development was AFP (ng/mL) 11.1±19.0
estimated by ultrasound sonography and/or CE-CT; DAA: direct- FIB4 Index 3.6 ± 2.6
acting antiviral agents; CHC: chronic hepatitis C; DCV: daclatasvir;
ASV: asunaprevir; SOF: sofosbuvir; LDV: ledipasvir; RBV: ribavirin; Data are reported as the mean ± SD. HCV: hepatic C virus; T-bil:
CE-CT: contrast-enhanced computed tomography total bilirubin; AFP: Alpha-fetoprotein； IFN: interferon
216 Hepatoma Research ¦ Volume 3 ¦ October 17, 2017