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RESEARCH PRODUCT

Disease outcomes after DAA-induced SVR: Data from the resist-HCV cohort

Giovanni MazzolaAntonio CraxìAnna LicataM. CannizzaroV. PortelliVincenza CalvarusoGiuseppe MaliziaI. ScalisiV. Di MarcoL. La RoccaSalvatore PettaA. Di RosoliniLuigi MondelloGiovanni SquadritoS. MadoniaM. RusselloM. DistefanoGiuseppe CabibboF. CartabellottaGaetano BertinoCarmelo IacobelloGiuseppe AlaimoBruno CacopardoA. AvernaG. RaimondoCalogero CammàM.r. CannavòF. Di LorenzoIrene CacciolaL. GuarneriG. FiduliA. DavìTullio PrestileoA. MontineriA. DigiacomoG. Scifo

subject

Oncologymedicine.medical_specialtyDAA disease outcome hepatitis CHepatologybusiness.industryDisease outcomeGastroenterology02 engineering and technology021001 nanoscience & nanotechnology03 medical and health sciences0302 clinical medicine030220 oncology & carcinogenesisInternal medicineCohortMedicine030211 gastroenterology & hepatology0210 nano-technologybusiness

description

Background and aims: Large scale, real life data on the long term course of liver disease after HCV clearance obtained with DAAs are still scanty, and the separate effects on hepatic and non-hepatic causes of death still unclear. Method: We evaluated 4147 patients (mean age: 65.7 ± 11.5 years, 57.6% males) included in the prospective RESIST-HCV cohort who started DAAs treatment in 22 centres between March 2015 and April 2017. All patients were follow after SVR to register liver-related and unrelated outcomes. The primary endpoint was the evaluation of survival since starting DAAs. Cox regression analysis was used to assess the predictors of liver-related and unrelated death. Results: Patients were observed for a median of 50 weeks (range: 1–199), 934 (22.5%) had diagnosis of chronic hepatitis (F3 in >90%), 2851 (68.7%) had Child A cirrhosis and 362 (8.7%) had Child B cirrhosis. Overall, 3766 patients (90.8%) achieved SVR while 381 patients (9.2%) were HCV-RNA positive at the last control. Fifty-five patients (1.3%) died during the observation: 25 of them died for liver related causes and 30 for unrelated causes (16: cardiovascular disease, 6: sepsis, 8: other). The lack of SVR was associated with an increased incidence of overall mortality in comparison to patients with SVR (hazard ratio [HR]; 28.9; 95% confidence interval [CI]: 16.5–50.8; p < 0.001) and death from liver-related and unrelated causes (HR: 18.5, 95%CI: 8.2–41.3; p < 0.001 and HR: 45.5; 95%CI: 19.3–107.4; p < 0.001 respectively). By multivariate Cox regression analysis lack of SVR (HR: 14.9, 95%CI: 6.3–35.1; p < 0.001) and Child B cirrhosis (HR: 29.4, 95%CI: 3.8–223.9; p < 0.001) were independently related with liver mortality. Independent predictors of liver-unrelated mortality were no SVR (HR: 41.77, 95%CI: 17.30–100.87; p < 0.001), Child B cirrhosis (HR: 3.00, 95%CI: 1.36–6.22; p = 0.006), BMI (HR: 0.89, 95%CI: 0.81–0.98, p = 0.023) and diabetes (HR: 2.38, 95%CI: 1.13–5.00, p = 0.022). Conclusion: In this real world setting using a variety of DAA regimens SVR reduced overall mortality and risk of liver-related and unrelated deaths at all stages of disease, nut mostly in Child A cirrhosis. The effect on cardiovascular deaths, which is evident also in the pre-cirrhotic stages deserves further follow up and investigation.

10.1016/j.dld.2018.01.005http://hdl.handle.net/20.500.11769/328482