PIN2 EFFECTIVENESS AND SAFETY OF DIRECT-ACTING ANTIVIRALS FOR HEPATITIS C VIRUS INFECTED PATIENTS AFTER LIVER TRANSPLANTATION. RESULTS IN REAL CLINICAL PRACTICE.

Abstract

Recurrent hepatitis C virus (HCV) infection is observed after liver transplantation (LT) among HCV-infected patients. Clinical trials have displayed that direct-acting antivirals (DAAs) have increased response and safety rate across different HCV-infected patient populations, including LT recipients. The objective is to evaluate real-life effectiveness and safety of DAAs therapy in HCV-infected LT recipients. Prospective, observational study in HCV-infected patients undergoing LT, who initiated DAAs treatment from 2015 to 2018. Exclusion criteria: patients from penitentiary centers, pediatrics, hepatic retransplatation. Effectiveness main variable: sustained virological response 12 weeks post-treatment (SVR12). Safety variable: treatment withdrawal secondary to severe adverse events. Covariates: gender, age, HIV coinfection, previous treatment, hepatic transplantation, cirrhosis, fibrosis, viral genotype, baseline viral load and antiviral treatment. Statistical method: intention-to-treat descriptive analysis, comparing LT patients with no-LT patients. Statistical signification calculated with Fisher exact or Mann-Whitney tests. Study authorised by the Health System Investigation Committee. 1313 patients were included, 43 of them LT-recipients: 69.7% males; 61.7 years mean age; 67.1% genotype 1; 11.7% cirrhotics (F4), 11.6% F3 fibrosis grade, 32.6% F2; 41.9% with hepatocellular carcinoma; 44.9% HCV-treatment-experienced; 42.1% null-responders and 21.1% recidivants to previous treatments; 62.8% treated with ledispasvir/sofosbuvir±ribavirin; 48.9% treatment length for 12 weeks and 48.9% for 24 weeks. A high treatment-experienced patients rate was observed in LT-recipients vs no-LT-recipients (44.2% vs 24.5%; p=0.006); similar genotype or fibrosis grade in both cohorts (p>0.05). Effectiveness results in LT-recipients vs no-LT-recipients: 0.00% vs 1.26% recidivants (p=0.97); 0.00% vs 0.31% null-responders (p=0.30); 100.0% vs 96.06% SVR12 (p=0.36). No patient experimented treatment withdrawal in both cohorts (LT-recipient or no-LT-recipient) due to severe adverse events (p>0.99). DAAs are safe and effectives in the treatment of recurrent HCV infection after liver transplantation, even with unfavorable baseline response factors, as previous antiviral treatment. Results are very similar to those observed among no-LT-recipients.