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Berge et al. Clinical outcomes of direct-acting antivirals

In terms of treatment, the most frequent combination carcinoma [Figure 1]. In one case, a suspicious lesion
was sofosbuvir/ledipasvir (35.5%) and 66.7% of was detected before treatment and, during the follow-
patients also received ribavirin. Most participants up, 2 nodules were confirmed with a triple-phase
(78.9%) were treated for 12 weeks. Six patients computerized scan, one of 4.8 cm and one of 1.5 cm,
(6.7%) had relevant adverse effects: 3 patients treated compatible with hepatocellular carcinoma. Another
with ribavirin developed moderate anaemia, which patient had a post-transplant recurrence in the form
improved after lowering the dose; 1 patient referred of lymphatic metastasis 15 months after initiation of
severe asthenia; 1 patient developed a purpura which therapy (without hepatocellular carcinoma in the liver
required corticosteroids and 1 patient suffered an acute graft). One patient developed a 4-cm nodule with portal
on chronic liver failure which required discontinuation vein thrombosis, one patient had a 3.3-cm nodule and
of therapy during the third week of treatment. Eighty- the last patient developed multiple hepatic nodules
six out of 90 patients (94.6%) achieved SVR12. One and bone metastasis. Thus, 3 patients out of 84 (3.6%)
patient died during the follow-up due to a metastatic developed de novo hepatocellular carcinoma. The
hepatocellular carcinoma. There were no deaths due median time between initiation of treatment and the
to unrelated liver causes. diagnosis of liver cancer was 12 months.
Clinical decompensations
Five patients had a history of hepatocellular carcinoma:
2 patients had one nodule smaller than 5 cm, 2 patients Four patients (4.4%) suffered an episode of hepatic
had 3 nodules smaller than 3 cm, and 1 patient had 2 decompensation during the year of follow-up [Figure 2]:
nodules smaller than 2 cm. Three of them underwent 1 patient with non-malignant portal thrombosis
liver transplantation between 2004 and 2013 and developed ascites, 1 patient with a history of ascites
developed graft cirrhosis. The other 2 patients were developed an acute on chronic liver failure during the
treatment, and 2 patients developed ascites coinciding
treated first with direct-acting antivirals and underwent with the diagnosis of hepatocellular carcinoma.
liver transplantation during the follow-up period.
Evolution of liver function
Hepatocellular carcinoma
Five patients (5.5%) developed hepatocellular Seven patients (7.8%) improved MELD score more than
one point, 63 patients (70%) showed no differences
or ± one point and in 11 patients (12.2%) MELD score
Table 1: Baseline characteristics of the study population worsened more than one point. Two patients (2.2%)
Characteristic Data, n (%) underwent liver transplantation during the follow-up
Follow-up (months), median (range) 16 (12-21) and there was insufficient data to calculate MELD
Age (years), mean ± SD 58 ± 8.57 score in 7 patients (7.8%).
Gender: male 66 (73.3)
Treatment Hepatocellular carcinoma
Naive 34 (37.8)
Experienced 56 (62.2) 1.0
Liver graft cirrhosis 10 (11.1)
Genotype
1a 27 (30)
1b 47 (52.2) 0.8
2 1 (1.1)
3 11 (12.2)
4 4 (4.5)
Treatment 0.6
Sofosbuvir/ledipasvir 32 (35.5)
Sofosbuvir/daclatasvir 24 (26.7) Free from Hepatocellular carcinoma
Sofosbuvir/simeprevir 16 (17.8)
Paritaprevir/ritonavir/ombitasvir/dasabuvir 11 (12.2) 0.4
Simeprevir/interferon 4 (4.4)
Sofosbuvir/interferon 1 (1.1)
Rivabirin: yes 60 (66.7)
Weeks of treatment 0.2
2 1 (1.1)
12 71 (78.9)
24 18 (20) 0.0
MELD score, median (range) 7 (6-16)
History of previous hepatocellular carcinoma 5 (5.6) 0 5 10 15 20 25
Albumin (mg/dL), mean ± SD 4,140 ± 424 Follow-up time (months)
3
Platelets (mm ), mean ± SD 117,788 ± 50,546 Figure 1: Kaplan Meier estimates of staying free of hepatocellular
Bilirrubin (mg/dL), mean ± SD 1.06 ± 0.27 carcinoma after direct-acting antiviral treatment
Hepatoma Research ¦ Volume 3 ¦ September 27, 2017 211