Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA.
Department of Clinical Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.
Curr Med Res Opin. 2021 Jul;37(7):1085-1097. doi: 10.1080/03007995.2021.1920900. Epub 2021 May 19.
Favipiravir is a repurposed drug to treat coronavirus 2019 (COVID-19). Due to a lack of available real-world data, we assessed its effectiveness and safety in moderately to critically ill COVID-19 patients.
This retrospective study was conducted in two public/specialty hospitals in Saudi Arabia. We included patients ≥18 years) admitted April-August 2020 with confirmed SARS-CoV-2 diagnosed by real-time polymerase chain reaction (RT-PCR) from nasopharyngeal swab. Patients received either favipiravir (1800 mg or 1600 mg twice daily loading dose, followed by 800 mg or 600 mg twice daily) or supportive-care treatment. Patients were excluded if they were outside the study period, classified as having a mild form of the disease per WHO criteria, or had an incomplete patient file. Kaplan-Meier (KM) models were used to estimate median time to discharge. Discharge ratios, progression to mechanical ventilation, and mortality outcomes were estimated across the severity spectrum using Cox proportional-hazards models. As a sensitivity analysis, we performed propensity score-matching (PSM) analysis.
Overall, median time to discharge was 10 days (95%CI = 9-10) in the favipiravir arm versus 15 days (95%CI = 14-16) in the supportive-care arm. The accelerated discharge benefit was seen across the COVID-19 spectrum of severity. The adjusted discharge ratio was 1.96 (95%CI = 1.56-2.46). Progression to mechanical ventilation was slower with favipiravir (HR = 0.10, 95%CI = 0.04-0.29). There was no significant effect on mortality (HR = 1.56, 95%CI = 0.73-3.36). There was a statistically non-significant trend toward worse outcomes in the critical category (HR = 2.80, 95%CI = 0.99-7.89). Age was an independent risk factor for mortality in mechanically ventilated patients. PSM analyses confirmed these findings.
Favipiravir was associated with clinical benefits, including accelerated discharge rate and less progression to mechanical ventilation; however, no overall mortality benefits were seen across the severity spectrum.
法匹拉韦是一种用于治疗 2019 年冠状病毒病（COVID-19）的药物。由于缺乏可用的真实世界数据，我们评估了其在中重度 COVID-19 患者中的疗效和安全性。
本回顾性研究在沙特阿拉伯的两家公立医院/专科医院进行。我们纳入了 2020 年 4 月至 8 月期间因实时聚合酶链反应（RT-PCR）检测鼻咽拭子中 SARS-CoV-2 阳性而确诊为 COVID-19 的年龄≥18 岁的患者。患者接受法匹拉韦（1800mg 或 1600mg 每日 2 次负荷剂量，随后 800mg 或 600mg 每日 2 次）或支持性治疗。如果患者处于研究期之外、根据世界卫生组织（WHO）标准归类为疾病轻度、或患者病历不完整，则将其排除在外。采用 Kaplan-Meier（KM）模型估计中位出院时间。使用 Cox 比例风险模型估计严重程度谱上的出院比例、进展为机械通气和死亡率结果。作为敏感性分析，我们进行了倾向评分匹配（PSM）分析。
总体而言，在法匹拉韦组，中位出院时间为 10 天（95%CI=9-10），而在支持性治疗组为 15 天（95%CI=14-16）。在 COVID-19 严重程度谱中都观察到了加速出院的益处。调整后的出院比例为 1.96（95%CI=1.56-2.46）。使用法匹拉韦后进展为机械通气的速度较慢（HR=0.10，95%CI=0.04-0.29）。对死亡率没有显著影响（HR=1.56，95%CI=0.73-3.36）。在危重类别中，结局恶化的趋势具有统计学意义但无显著差异（HR=2.80，95%CI=0.99-7.89）。年龄是机械通气患者死亡的独立危险因素。PSM 分析证实了这些发现。
法匹拉韦与临床益处相关，包括加快出院率和减少进展为机械通气；然而，在严重程度谱上未观察到总体死亡率益处。
