Alotaibi Musim, Ali Ahmed, Bakhshwin Duaa, Alatawi Yasser, Alotaibi Sultan, Alhifany Abdullah, Alharthi Badr, Alharthi Nasser, Alyazidi Awatef, Alharthi Yasmeen, Alrafiah Aziza
Department of Pharmacology, King Abdulaziz University, Jeddah City, Kingdom of Saudi Arabia.
Department of Pharmacy, King Faisal Medical Complex, Taif City, Kingdom of Saudi Arabia.
Int J Gen Med. 2021 Sep 14;14:5597-5606. doi: 10.2147/IJGM.S329881. eCollection 2021.
Coronavirus disease (COVID-19) is an infectious disease due to SARS-COV-2. Patients with risk factors are vulnerable to severe morbidity and mortality. Favipiravir (FPV) and hydroxychloroquine (HCQ) are considered possible COVID-19 treatments.
To investigate the effectiveness and safety of FPV compared to HCQ in patients with COVID-19 as the standard of care approved by the national protocol there.
This is a retrospective cohort study on patients with COVID-19 who were administered either FPV or HCQ at King Faisal Medical Complex, Taif, Saudi Arabia, from June 2020 to August 2020.
In total, 508 patients were included in the analysis. Patients were categorized into three groups by medication. Patients enrolled in this study were 244 (55.8%) on FPV, 193 (44.2%) on HCQ and 71 (13.81%) on neither medication. Patients who received FPV had higher age and greater comorbidity. Most of the patients were discharged on day 14 (n = 303, 59.6%), 26 (36.6%) in neither med, 154 (63.1%) in FPV and 123 (63.7%) in HCQ groups with significant difference between groups ( < 0.0001). Mortality rate was 8.2% (n = 20) in FPV and 7.3% (n = 14) in HCQ groups with significant difference between groups (P = 0.048). Regarding drug safety, 19.7% of patients treated with FPV vs 7.8% HCQ have adverse effects with significant difference between groups ( < 0.0001). Most of the side effects were increase ALT and AST. Meanwhile, prolonged Q-T interval was reported only in the HCQ group (2.6%). From Cox regression modeling, only mechanical ventilation due to Covid 19 was predictive for mortality (HR: 16.598, 95% CI: 7.095-38.828, P < 0.0001). Meanwhile, there was no significant difference in the prediction of discharge of FPV (vs HCQ) (HR: 0.933, 95% CI: 0.729-1.195, = 0.5843), predictors of mortality were HCQ (vs FPV) (HR: 2.3, 95% CI: 0.994-5.487, = 0.0518). Kaplan-Meier survival curves showed improved survival time and discharged time among patients in the HCQ versus FPV group with an insignificant difference between them ( = 0.85, = 0.06, respectively).
The present study concluded that FPV and HCQ showed comparable efficacy in decrease mortality and oxygen requirements. FPV likely has a more favorable safety profile regarding cardiac toxicity. A randomized clinical trial with large patient numbers is recommended to confirm the effectiveness of these drugs in COVID-19 patients.
冠状病毒病（COVID-19）是由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的一种传染病。有风险因素的患者易发生严重发病和死亡。法匹拉韦（FPV）和羟氯喹（HCQ）被认为是可能治疗COVID-19的药物。
以该国方案批准的标准治疗方法为对照，研究FPV与HCQ相比治疗COVID-19患者的有效性和安全性。
这是一项回顾性队列研究，研究对象为2020年6月至2020年8月在沙特阿拉伯塔伊夫的法赫德国王医疗中心接受FPV或HCQ治疗的COVID-19患者。
总计508例患者纳入分析。患者按用药情况分为三组。本研究纳入的患者中，244例（55.8%）接受FPV治疗，193例（44.2%）接受HCQ治疗，71例（13.81%）未接受任何药物治疗。接受FPV治疗的患者年龄更大且合并症更多。大多数患者在第14天出院（n = 303，59.6%），未接受任何药物治疗组为26例（36.6%），FPV组为154例（63.1%），HCQ组为123例（63.7%），组间差异有统计学意义（P < 0.0001）。FPV组死亡率为8.2%（n = 20），HCQ组为7.3%（n = 14），组间差异有统计学意义（P = 0.048）。关于药物安全性，接受FPV治疗的患者中有19.7%出现不良反应，而接受HCQ治疗的患者中这一比例为7.8%，组间差异有统计学意义（P < 0.0001）。大多数副作用是谷丙转氨酶（ALT）和谷草转氨酶（AST）升高。同时，仅在HCQ组报告有Q-T间期延长（2.6%）。根据Cox回归模型，仅因COVID-19进行机械通气可预测死亡率（风险比：16.598，95%置信区间：7.
