PMID- 37476581 OWN - NLM STAT- MEDLINE DCOM- 20231113 LR - 20231113 IS - 2219-2840 (Electronic) IS - 1007-9327 (Print) IS - 1007-9327 (Linking) VI - 29 IP - 25 DP - 2023 Jul 7 TI - Real-world effectiveness and safety of direct-acting antivirals in hepatitis C virus patients with mental disorders. PG - 4085-4098 LID - 10.3748/wjg.v29.i25.4085 [doi] AB - 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: This was a retrospective observational study encompassing 14272 patients treated with DAA for chronic hepatitis C in 22 Polish hepatology centers, including 942 individuals diagnosed with a mental disorder (anxiety disorder, bipolar affective disorder, depression, anxiety-depressive disorder, personality disorder, schizophrenia, sleep disorder, substance abuse disorder, and mental illness without a specific diagnosis). The safety and effectiveness of DAA in this group were compared to those in a group without psychiatric illness (n = 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: Among patients with mental illness, there was a significantly higher percentage of men, treatment-naive patients, obese, human immunodeficiency virus and hepatitis B virus-coinfected, patients with cirrhosis, and those infected with genotype 3 (GT3) while infection with GT1b was more frequent in the population without psychiatric disorders. The cure rate calculated PP was not significantly different in the two groups analyzed, with a SVR of 96.9% and 97.7%, respectively. Although patients with bipolar disorder achieved a significantly lower SVR, the multivariate analysis excluded it as an independent predictor of treatment non-response. Male sex, GT3 infection, cirrhosis, and failure of previous therapy were identified as independent negative predictors. The percentage of patients who completed the planned therapy did not differ between groups with and without mental disorders. In six patients, symptoms of mental illness (depression, schizophrenia) worsened, of which two discontinued treatments for this reason. New episodes of sleep disorders occurred significantly more often in patients with mental disorders. Patients with mental illness were more frequently lost to follow-up (4.2% vs 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. CI - (c)The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved. FAU - Dybowska, Dorota AU - Dybowska D AD - Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz 85-030, Poland. FAU - Zarebska-Michaluk, Dorota AU - Zarebska-Michaluk D AD - Department of Infectious Diseases and Allergology, Jan Kochanowski University, Kielce 25-317, Poland. AD - Department of Infectious Diseases, Provincial Hospital, Kielce 25-317, Poland. dorota1010@tlen.pl. FAU - Rzymski, Piotr AU - Rzymski P AD - Department of Environmental Medicine, University of Medical Sciences, Poznan 60-806, Poland. AD - Integrated Science Association, Universal Scientific Education and Research Network, Poznan 60-806, Poland. FAU - Berak, Hanna AU - Berak H AD - Outpatient Clinic, Hospital for Infectious Diseases in Warsaw, Warsaw 01-201, Poland. FAU - Lorenc, Beata AU - Lorenc B AD - Pomeranian Center of Infectious Diseases, Medical University, Gdansk 80-214, Poland. FAU - Sitko, Marek AU - Sitko M AD - Department of Infectious and Tropical Diseases, Jagiellonian University, Krakow 31-088, Poland. FAU - Dybowski, Michal AU - Dybowski M AD - Utrecht University School of Economics, Utrecht University, Utrecht 3584 EC, Netherlands. FAU - Mazur, Wlodzimierz AU - Mazur W AD - Clinical Department of Infectious Diseases, Medical University of Silesia, Chorzow 41-500, Poland. FAU - Tudrujek-Zdunek, Magdalena AU - Tudrujek-Zdunek M AD - Department of Infectious Diseases, Medical University of Lublin, Lublin 20-059, Poland. FAU - Janocha-Litwin, Justyna AU - Janocha-Litwin J AD - Department of Infectious Diseases and Hepatology, Medical University of Wroclaw, Wroclaw 50-367, Poland. FAU - Janczewska, Ewa AU - Janczewska E AD - Department of Basic Medical Sciences, Faculty of Public Health in Bytom, Medical University of Silesia, Katowice 40-007, Poland. FAU - Klapaczynski, Jakub AU - Klapaczynski J AD - Department of Internal Medicine and Hepatology, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw 00-241, Poland. FAU - Parfieniuk-Kowerda, Anna AU - Parfieniuk-Kowerda A AD - Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok 15-089, Poland. FAU - Piekarska, Anna AU - Piekarska A AD - Department of Infectious Diseases and Hepatology, Medical University of Lodz, Lodz 91-347, Poland. FAU - Sobala-Szczygiel, Barbara AU - Sobala-Szczygiel B AD - Department of Infectious Diseases and Hepatology, Medical University of Silesia, Bytom 41-902, Poland. FAU - Dobrowolska, Krystyna AU - Dobrowolska K AD - Collegium Medicum, Jan Kochanowski University, Kielce 25-317, Poland. FAU - Pawlowska, Malgorzata AU - Pawlowska M AD - Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz 85-030, Poland. FAU - Flisiak, Robert AU - Flisiak R AD - Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok 15-089, Poland. LA - eng PT - Journal Article PT - Observational Study PL - United States TA - World J Gastroenterol JT - World journal of gastroenterology JID - 100883448 RN - 0 (Antiviral Agents) RN - 63231-63-0 (RNA) SB - IM MH - Humans MH - Male MH - Antiviral Agents/adverse effects MH - Drug Therapy, Combination MH - Hepacivirus/genetics MH - *Hepatitis C/drug therapy MH - *Hepatitis C, Chronic/complications/diagnosis/drug therapy MH - Liver Cirrhosis MH - RNA MH - *Substance-Related Disorders/drug therapy MH - Sustained Virologic Response MH - Treatment Outcome MH - Female PMC - PMC10354581 OTO - NOTNLM OT - Direct-acting antivirals OT - Hepatitis C OT - Mental disorders COIS- Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article. EDAT- 2023/07/21 06:44 MHDA- 2023/10/23 00:43 PMCR- 2023/07/07 CRDT- 2023/07/21 04:08 PHST- 2023/03/23 00:00 [received] PHST- 2023/04/01 00:00 [revised] PHST- 2023/04/28 00:00 [accepted] PHST- 2023/10/23 00:43 [medline] PHST- 2023/07/21 06:44 [pubmed] PHST- 2023/07/21 04:08 [entrez] PHST- 2023/07/07 00:00 [pmc-release] AID - 10.3748/wjg.v29.i25.4085 [doi] PST - ppublish SO - World J Gastroenterol. 2023 Jul 7;29(25):4085-4098. doi: 10.3748/wjg.v29.i25.4085.