Reddy Pavan Kumar, Patil Saiprasad, Khobragade Akash, Balki Akash, Raj Aneesh, Kalikar Mrunalini, Reddy Raghavendra, Shinde Ravindra, Cr Jayanthi, Mutha Abhinandan, Boyilla Nagaraju, Rajadhyaksha Girish C, Karnik Niteen, Bhagat Sagar, Pendse Amol, Dhage Priyanka, Wu Wen, Rangwala Shabbir, Barkate Hanmant
Critical Care Medicine, Care Hospital, Hyderabad, Telangana, India.
Global Medical Affairs, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India.
Int J Gen Med. 2022 May 3;15:4551-4563. doi: 10.2147/IJGM.S349241. eCollection 2022.
To evaluate the safety and efficacy of favipiravir, which is prescribed for the treatment of patients with mild-to-moderate coronavirus disease 2019 (COVID-19) in India.
This was a prospective, open-label, multicenter, single-arm postmarketing study conducted in India. Patients with mild-to-moderate COVID-19 received favipiravir (3600 mg [1800 mg orally twice daily] on the first day, followed by 800 mg orally twice daily, up to a maximum of 14 days) as a part of their treatment. The primary endpoints were to evaluate the safety of favipiravir by assessing the number of adverse events (AEs) and treatment-related AEs. The secondary endpoints were to evaluate the efficacy of favipiravir by assessing time to clinical cure, rate of clinical cure, time to pyrexia resolution, rate of oxygen requirement, and all-cause mortality.
A total of 1083 patients were enrolled in this study from December 2020 to June 2021. Adverse events were reported in 129 patients (11.9%), 116 (10.7%) of whom had mild AEs. Dose modification or withdrawal of favipiravir treatment was reported in four patients (0.37%). The median time to clinical cure and pyrexia resolution was 7 and 4 days, respectively. A total of 1036 patients (95.8%) exhibited clinical cure by day 14. Oxygen support was required by 15 patients (1.4%). One death was reported, which was unrelated to favipiravir.
In the real-world setting, favipiravir was well-tolerated, and no new safety signals were detected.
评估法匹拉韦在印度用于治疗轻至中度2019冠状病毒病（COVID-19）患者的安全性和有效性。
这是一项在印度进行的前瞻性、开放标签、多中心、单臂上市后研究。轻至中度COVID-19患者接受法匹拉韦治疗（第1天口服3600毫克[每日两次，每次1800毫克]，随后每日两次，每次口服800毫克，最长14天）作为其治疗的一部分。主要终点是通过评估不良事件（AE）和治疗相关AE的数量来评估法匹拉韦的安全性。次要终点是通过评估临床治愈时间、临床治愈率、发热消退时间、吸氧率和全因死亡率来评估法匹拉韦的有效性。
2020年12月至2021年6月，共有1083例患者纳入本研究。129例患者（11.9%）报告了不良事件，其中116例（10.7%）为轻度AE。4例患者（0.37%）报告了法匹拉韦治疗的剂量调整或停药。临床治愈和发热消退的中位时间分别为7天和4天。共有1036例患者（95.8%）在第14天实现临床治愈。15例患者（1.4%）需要吸氧支持。报告1例死亡，与法匹拉韦无关。
在现实世界中，法匹拉韦耐受性良好，未检测到新的安全信号。
