Effectiveness and safety of direct-acting antivirals in hepatitis C infected patients with mental disorders: Results in real clinical practice.

Abstract

The aim of this study is to analyze the effectiveness and safety of direct-acting antivirals (DAAs) in psychiatric patients with chronic hepatitis C (CHC). Secondary objectives included adherence and drug-drug interaction (DDIs) evaluations. Prospective observational comparative study carried out during 3 years. Psychiatric patients were included and mental illness classified by a psychiatric team based on clinical records. Main effectiveness and safety variables were sustained virologic response (SVR) at posttreatment week 12 (SVR12) and rate of on-treatment serious drug-related adverse events (AEs), respectively. A total of 242 psychiatric and 900 nonpsychiatric patients were included. SVR12 by intention-to-treat (ITT) analysis of psychiatric vs nonpsychiatric patients was 92.6% (95% confidence interval [CI], 89.1-96.1) vs 96.2% (95% CI, 94.9-97.5) (P = .02). SVR12 by modified-ITT analysis was 97.8% (95% CI, 95.0-99.3) vs 98.4% (95% CI, 97.5-99.3) (P = .74). 92.2% of psychiatric patients with mental disorders secondary to multiple drug use (MDSDU) and 93.0% of psychiatric patients without MDSDU vs 96.2% of nonpsychiatric patients reached SVR12 (P = .05 and P = .20, respectively). The percentage of adherent patients to DAAs did not show differences between cohorts (P = .08). 30.2% of psychiatric patients and 27.6% of nonpsychiatric patients presented clinically relevant DDIs (P = .47). 1.7% vs 0.8% of psychiatric vs nonpsychiatric patients developed serious AEs (P = .39); no serious psychiatric AEs were present. DAAs have shown a slightly lower effectiveness in psychiatric patients with CHC, as a result of loss of follow up, which justifies the need for integrated and multidisciplinary health care teams. DAAs safety, adherence, and DDIs, however, are similar to that of nonpsychiatric patients.