BLEEDING EVENTS IN PATIENTS WITH HCV- RELATED LIVER CIRRHOSIS TREATED WITH DIRECT ACTING ANTIVIRALS - FACT OR NATURAL COURSE ?
Abstract
Aim: We aimed to assess the incidence and risk factors of bleeding events in cirrhotic patients with sustained virological response (SVR) treated with direct-acting antivirals (DAAs) therapy. 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 1st2016 and January 1st, 2019. All patients with presumption of digestive bleeding (hematemesis or melena) were evaluated and confirmed by upper digestive endoscopy. Patients known with thrombophilia were not included in the study group. Results: The study included 874HCV-infected cirrhotic patients treated with PrOD or LED/SOF ± RBV, with documented SVR, mean age 58,7±6,2years, predominantly female (58%). Of the total number, 443 (50.68%) received PrOD and 431 (49.31%) patients were treated with LED/SOF ± RBV. From all, 572 (65.34%) patients had Child-Pugh class A, 226 (25.96%) class B and 76 (8.7%) class C cirrhosis. Mean period from SVR and the occurrence of bleeding events was 230±121 days. Bleeding complications after SVR were reported in 16(1.83%) patients: 9 (56.25%) with variceal hemorrhage and7 (43.75%) with non-variceal hemorrhage. 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: Bleeding events in patients with HCV-related liver cirrhosis treated with DAAs are not influenced by the variations of coagulation parameters, rather correspond to the hemodynamic changes induced by the status of advanced liver disease. It should be underlined that the bleeding events were mostly variceal bleeding, due to persistent portal hypertension despite viral eradication.
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