Clinic of Infectious Diseases, University of Bari, University Hospital Policlinico, Piazza Giulio Cesare n. 11, 70124, Bari, Italy.
BMC Infect Dis. 2020 Mar 6;20(1):196. doi: 10.1186/s12879-020-4922-2.
Few data are available regarding the use of direct antiviral agents (DAAs) for chronic hepatitis C in psychiatric patients. The aim of the study is to assess safety and outcome of DAAs in patients with psychiatric comorbidities.
This retrospective, observational, single-centre study enrolled patients treated with psychiatric drugs who initiated DAAs between 2015 and 2018. Patients were classified into two groups: A (on anxiolitycs/antidepressant) and B (on antipsychotics). Week-12 sustained virological response (SVR-12) and adverse events (AEs) were evaluated.
One hundred forty-four patients were included (A:101; B:43). Patients were 49.3% males, mean age 60 years (SD ± 13.5); 31.9% cirrhotic; 125 (86.8%) HCV-monoinfected and 19 (13.2%) HCV /HIV-coinfected. Twenty patients (13.8%) required a change of psychiatric therapy before initiation of DAA. Overall, SVR-12 was achieved in 88.2% of subjects in intention-to-treat(ITT)-analysis. Lower SVR rates were observed in group B vs A (79% vs 92%, p = 0.045) and in those changing psychiatric drugs vs others (8% vs 30%, p = 0.015). According to per-protocol (PP)-analysis, SVR-12 was achieved in 93/95 (97.9%) in group A versus 34/36 (94.4%) in group B (p = 0.30). At least one AE occurred in 60 patients (41.6%), including 10 severe AEs, leading to 3 discontinuations. AEs were more frequently reported in group A (p = 0.015).
The study confirms effectiveness and safety of DAA-based treatment also in this special population, even if a careful evaluation of history and drug-drug interactions is warranted.
关于精神科患者使用直接抗病毒药物(DAA)治疗慢性丙型肝炎的相关数据有限。本研究旨在评估精神科合并症患者使用 DAA 的安全性和结局。
本回顾性、观察性、单中心研究纳入了 2015 年至 2018 年间接受精神科药物治疗且开始使用 DAA 的患者。患者被分为两组:A 组(使用抗焦虑药/抗抑郁药)和 B 组(使用抗精神病药)。评估了第 12 周持续病毒学应答(SVR12)和不良事件(AE)。
共纳入 144 例患者(A 组 101 例,B 组 43 例)。患者中男性占 49.3%,平均年龄 60 岁(标准差 ± 13.5);31.9%为肝硬化;125 例(86.8%)为 HCV 单感染,19 例(13.2%)为 HCV/HIV 共感染。20 例(13.8%)患者在开始 DAA 治疗前需要调整精神科治疗方案。总体而言,意向治疗(ITT)分析中,88.2%的患者达到 SVR12。B 组 SVR12 率低于 A 组(79%比 92%,p=0.045),调整精神科药物治疗的患者低于未调整的患者(8%比 30%,p=0.015)。根据方案(PP)分析,A 组 95 例患者中的 93 例(97.9%)和 B 组 36 例患者中的 34 例(94.4%)达到 SVR12(p=0.30)。60 例患者(41.6%)发生至少 1 例 AE,包括 10 例严重 AE,导致 3 例停药。A 组的 AE 报告更为频繁(p=0.015)。
本研究证实了 DAA 治疗在这一特殊人群中的有效性和安全性,即使需要仔细评估病史和药物相互作用。