Abstract

The combination paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD), which achieves a high sustained virologic response (SVR) rate and few side effects, has dramatically changed the outcome of hepatitis C virus (HCV) infection. The risk of hepatocellular carcinoma (HCC) and variceal bleeding in patients treated with interferon (IFN)-free direct-acting antivirals (DAAs) is unknown. The aim of this prospective study was to evaluate the rate of HCC and variceal bleeding and identify prognostic factors for decompensation/complications in HCV-1b-infected patients with compensated liver cirrhosis following treatment with PrOD with or without ribavirin. Material and methods: A total of 483 HCV patients received PrOD treatment. Patients with a history of HCC were excluded from the study. Prior antiviral therapy was identified in 59% of patients. Patient data were collected at baseline, at the end of treatment (EoT), at 3 months after EOT (SVR) and during an 18-month surveillance period. Patients were divided into two age groups: <60 years (233 patients) and ≥60 years (250 patients). Results: The median observation period was 540 days. During this period, HCC developed in 18 patients (3.7%) and variceal bleeding developed in 9 patients (1.9%). A Propensity score matching analysis found no significant difference in the incidence of HCC (p= 0.078) or variceal bleeding (p=0.426) between the two groups. The mean serum AFP levels decreased in the young group (baseline=19.44 ng/dL, SVR=4.57 ng/dL) and the elderly group (baseline=4.52 ng/dL, SVR=10.69 ng/dL). Edge of decompensation and previous esophageal varices were significantly associated with the risk of variceal bleeding. Conclusions: The risk of HCC (5.3%) and variceal bleeding (2%) development in elderly patients (≥60years) following viral eradication by IFN-free DAA therapy may follow a specific pattern.

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