THROMBOTIC EVENTS IN PATIENTS WITH HEPATITIS C VIRUS LIVER CIRRHOSIS TREATED WITH DIRECT ACTING ANTIVIRALS AND SUSTAINED VIROLOGICAL RESPONSE
The advent of direct-acting antivirals (DAAs) is a major breakthrough in hepatology representing the therapeutical standard of care in patients with chronic hepatitis C virus infection over the past few years. Despite high rates of sustained virological response (SVR), DAAs therapy doesn’t eliminate the risk of thrombotic events. Aim: We aimed to assess the incidence and risk factors of thrombotic events in patients with SVR treated with DAAs. Material and methods: We retrospectively analyzed a cohort of patients with HCV-related liver cirrhosis treated with paritaprevir/ritonavir, ombitasvir and dasabuvir (PrOD) ± ribavirin and ledipasvir/sofosbuvir (LED/SOF) ± ribavirin for 12/24 weeks, in a tertiary gastroenterology referral center from North-Eastern Romania, between January 1st 2016 and January 1st 2018. All patients with presumption of thrombosis were evaluated by vascular Doppler, abdominal ultrasound and confirmed by CT scan. Results: The study included 321 HCV-infected cirrhotic patients treated with PrOD or LED/SOF, with documented SVR, mean age 59,7 ± 8,5 years, predominantly female (59%). Of the total number, 307 (95.63%) received PrOD and 14 (4.36%) patients were treated with LED/SOF. Mean period from SVR and the occurrence of thrombotic events was 250±123 days. Thrombotic complications were reported in 14 (4.36%) patients: 4 (28.57%) with deep vein thrombosis, 4 (28.57%) with portal vein thrombosis (PVT), 6 (42.85%) with malignant PVT. All patients had associated cardiovascular (8- 57.14%) and metabolic comorbidities (6- 42.85%). The main clinical manifestations at diagnosis were: swelling, edema, erythema and lower limb pain in 4 patients, upper digestive hemorrhage in 2 patients, ascitic decompensation in 4 patient and 4 patients were asymptomatic. Biologically there was no significant change in prothrombin serum levels (baseline values in patients treated with PrOD was 11.67 ± 0.91 versus 11.70 ± 0.83 at SVR, p=0.993, respectively 11.5 ± 0.84 sec at baseline versus 11.4 ± 0.68 at SVR, p=0.715 in patients treated with LED/SOF+RBV) and platelet count (126 000 (101 500-162 000) vs. 131 000 (101 000-165 000), p= 0.818 in patients treated with PrOD, respectively 94857.14 ± 32 vs. 92428.57 ± 35, p= 0.853, in patients treated with LED/SOF+RBV). Conclusions: We conclude that thrombotic events in patients with HCV-related liver cirrhosis treated with DAAs are not influenced by the variations of coagulation parameters, rather correspond to the hypercoagulability status of the cirrhotic patient.
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