Michael Garron Hospital, Toronto East Health Network, Toronto, Ontario, Canada.
Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
PLoS One. 2023 Oct 19;18(10):e0293302. doi: 10.1371/journal.pone.0293302. eCollection 2023.
Large observational studies have demonstrated the real-world effectiveness of nirmatrelvir-ritonavir in preventing severe COVID-19 in higher risk individuals, but have provided limited information on other aspects of nirmatrelvir-ritonavir use. Our objective was to evaluate prescribing outcomes such as the prevalence of drug-drug interactions (DDI), adverse drug events (ADE) and treatment adherence in an outpatient community clinic setting.
We conducted a single-centre retrospective cohort study of adult outpatients prescribed nirmatrelvir-ritonavir in our community COVID-19 assessment clinic in Toronto, Ontario between March 3 and September 20, 2022. We performed a descriptive analysis of the patient population, DDIs, DDI interventions, treatment adherence, ADEs and clinical outcomes of patients prescribed nirmatrelvir-ritonavir.
There were 637 individuals prescribed nirmatrelvir-ritonavir during the study period. The median age was 70, the median number of risk factors for severe disease were 2, 45% were immunocompromised and 82% had received 3 or more COVID-19 vaccine doses. 95% (542/572) completed the 5-day course of therapy with 68% (388/572) having complete symptom resolution by 28-day. Eleven percent (60/572) experienced recurrent symptoms following the completion of nirmatrelvir-ritonavir. Over 70% had one or more clinically significant DDIs requiring mitigation and 62% of patients experienced at least one ADE, which was most commonly dysgeusia or gastrointestinal-related. Ninety-five percent (542/572) of patients completed therapy as prescribed. Overall, hospitalization within 28 days was 3.3% with 1.2% attributed to COVID-19 and there were no deaths.
Nirmatrelvir-ritonavir was associated with a high prevalence of clinically significant DDIs, which required mitigation strategies and a high frequency of mild ADEs. Collaborative assessment to address medication alterations resulted in high treatment adherence.
大型观察性研究表明,尼马曲韦/利托那韦在高风险人群中预防严重 COVID-19 的真实世界疗效,但对尼马曲韦/利托那韦使用的其他方面提供的信息有限。我们的目的是评估处方结果,如药物-药物相互作用(DDI)的发生率、药物不良反应(ADE)和治疗依从性,在一个门诊社区诊所环境中。
我们对 2022 年 3 月 3 日至 9 月 20 日在安大略省多伦多市我们的社区 COVID-19 评估诊所开具尼马曲韦/利托那韦的成年门诊患者进行了一项单中心回顾性队列研究。我们对患者人群、DDI、DDI 干预、治疗依从性、ADE 和服用尼马曲韦/利托那韦患者的临床结局进行了描述性分析。
研究期间共有 637 人开具了尼马曲韦/利托那韦。中位年龄为 70 岁,中位严重疾病风险因素数为 2,45%为免疫功能低下,82%接受了 3 剂或更多 COVID-19 疫苗。95%(542/572)完成了 5 天疗程,68%(388/572)在 28 天时有完全症状缓解。11%(60/572)在尼马曲韦/利托那韦完成后出现症状复发。超过 70%的患者有一个或多个需要减轻的临床显著 DDI,62%的患者出现至少一种 ADE,最常见的是味觉障碍或胃肠道相关。95%(542/572)的患者按规定完成了治疗。总体而言,28 天内住院率为 3.3%,其中 1.2%归因于 COVID-19,无死亡病例。
尼马曲韦/利托那韦与临床显著 DDI 的高发生率相关,需要采取缓解策略,并且 ADE 的发生率很高。通过协作评估来解决药物改变的问题,从而提高了治疗依从性。