Page 41 - Read Online

Page 4 of 9 Dai et al. Hepatoma Res 2020;6:16 I http://dx.doi.org/10.20517/2394-5079.2019.40

RESULTS
Patient characteristics
As shown in Table 1, 1237 patients were enrolled in the current study, with their patient and viral
characteristics and treatment regimens also shown. The mean age was 61.8 years with 43.8% being males;
the most common viral genotype was HCV genotype-1 (HCV-1, 74.6%); and the proportion of patients with
liver cirrhosis was 48.3% (n = 597), whereas 28 patients (4.7%) had decompensated liver cirrhosis. Three
hundred and thirty-five patients (27.1%) failed previous interferon-based regimens, and 83 patients (6.7%)
were dually infected with the hepatitis B virus. The most commonly used DAA regimen was Paritaprevir/
ritonavir plus Ombitasvir and Dasabuvir (PrOD) (34.2%), followed by SOF plus Ledipasvir (LDV).

One hundred and twenty-four patients (10.0%) had previous history of HCC before treatment. Of them, 101
patients (8.2%) had inactive HCC whereas the remaining 23 patients (1.9%) had active HCC at the time of
DAA initiation.

Compared to patients without HCC, those with pre-existing HCC were older, had higher pretreatment
aspartate aminotransferase, FIB-4 and bilirubin levels, lower body weight, albumin and platelet counts, and
a higher proportion were males, had liver cirrhosis, and interferon-experienced history. Treatment regimens
differed among patients with or without HCC; HCC patients had a higher proportion of PrOD usage than
those without.

Treatment responses
The SVR12 rate was 98.9%, and was 99.3%, 98.7%, 97.9%, 100%, 99% and 100% in patients who received
PrOD, Elbasvir (EBR)/Grazoprevir (GZR), SOF/LDV, SOF/DCV, Glecaprevir (GLE)/Pibrentasvir (PIB) and
SOF/Velpatasvir (VEL) respectively. The SVR12 was similar between patients with and without pre-existing
HCC (98.4% vs. 98.9%, P = 0.64) [Table1]. While HCC patients were classified as those with active or inactive
HCC, the SVR12 was also similar between patients with and without active HCC (95.7% vs. 99.0%, P = 0.34).

Among the 101 patients without viable HCC at the time of DAA initiation, eighty-four patients were with
curative therapy and the other 17 patients experienced HCC recurrence before DAAs. Among the 23 patients
with viable HCC at the time of DAA treatment, ten patients with HCC had ever received curative therapy
whereas the remaining 13 patients with HCC had never received this. Patient and viral characteristics as well
as treatment regimens are shown in Table 2. The SVR12 rates were similar among the four populations, being
98.8% (83/84), 100% (17/17), 90% (9/10) and 100% (13/13) respectively. None of the clinical factor including
the HCC status was associated with SVR to the DAA treatment [Table 3].

DISCUSSION
In the present study in Taiwanese patients with HCC, in addition to the similar effectiveness compared to
patients without HCC by high potency DAAs, we demonstrate equivalent effectiveness also in both patients
with and without HCC. With a relatively high SVR rate by interferon-based therapy in Taiwan compared
to Western countries [20,21] , the Taiwanese National Health Insurance Scheme has reimbursed the cost of the
[22]
PegIFN/RBV therapy since 2013 . Due to the adverse effects of the IFN-based regimen, the treatment of
patients with HCC is quite limited, even though the SVR rate is equivalent in patients with and without
HCC when patients achieved good adherence, particularly in CHC patients after successful eradication of
[23]
HCC . Since 2017, DAAs have been reimbursed by TNHI (free of charge for DAA medication) in patients
with limited to advanced fibrosis and cirrhosis. The DAA treatment then became the standard treatment of
CHC in Taiwan for patients fulfilling the reimbursement criteria, instead of interferon-based therapy. The
high SVR rate has been reported as more than 97% in patients who completed the duration of therapy by
ASV plus DCV if the patients had no NS5A mutants, PrOD with/without RBV and GZR/EBR with/without