Real-world effectiveness and safety of direct-acting antivirals in hepatitis C virus patients with mental disorders
Dorota Dybowska, Dorota Zarębska‐Michaluk, Piotr Rzymski, Hanna Berak, Beata Lorenc, Marek Sitko, Michał P. Dybowski, Włodzimierz Mazur, Magdalena Tudrujek‐Zdunek, Justyna Janocha‐Litwin, Ewa Janczewska, Jakub Klapaczyński, Anna Parfieniuk‐Kowerda, Anna Piekarska, Barbara Sobala‐Szczygieł, Krystyna Dobrowolska, Małgorzata Pawłowska, Robert Flisiak
Abstract
BACKGROUND: It is estimated that 58 million people worldwide are infected with the hepatitis C virus (HCV). Patients with severe psychiatric disorders could not be treated with previously available interferon-based therapies due to their unfavorable side effect profile. This has changed with the introduction of direct-acting antivirals (DAA), although their real-life tolerance and effectiveness in patients with different psychiatric disorders remain to be demonstrated. AIM: To evaluate the effectiveness and safety of DAA in patients with various mental illnesses. METHODS: = 13330). Antiviral therapy was considered successful if serum ribonucleic acid (RNA) of HCV was undetectable 12 wk after its completion [sustained virologic response (SVR)]. Safety data, including the incidence of adverse events (AEs), serious AEs (SAEs), and deaths, and the frequency of treatment modification and discontinuation, were collected during therapy and up to 12 wk after treatment completion. The entire study population was included in the intent-to-treat (ITT) analysis. Per-protocol (PP) analysis concerned patients who underwent HCV RNA evaluation 12 wk after completing treatment. RESULTS: 2.5%). CONCLUSION: DAA treatment is safe and effective in HCV-infected patients with mental disorders. No specific psychiatric diagnosis lowered the chance of successful antiviral treatment.