Favipiravir for Lassa fever: an open-label, randomized controlled phase 2 trial.

Preclinical evidence suggests high-dose favipiravir is a promising antiviral treatment alternative.

临床前证据表明，高剂量法匹拉韦是一种有前景的抗病毒治疗替代方案。

We conducted a randomized controlled open-label phase 2 clinical trial at two reference hospitals in Nigeria to evaluate favipiravir in the treatment of LF.

我们在尼日利亚的两家参考医院开展了一项随机对照开放标签的2期临床试验，以评估法匹拉韦治疗利什曼病的效果。

Primary endpoints were the description of classic pharmacokinetic parameters (maximum plasma concentration, time to reach maximum plasma concentration, area under the curve (AUC), half-life and volume of distribution) as well as the safety and tolerability of favipiravir compared with ribavirin in the treatment of acute LF.

主要终点是描述经典药代动力学参数（最大血浆浓度、达到最大血浆浓度的时间、曲线下面积（AUC）、半衰期和分布容积）以及法匹拉韦与利巴韦林治疗急性利什曼病的安全性和耐受性比较。

Hospitalized adult patients with mild-to-moderate RT-PCR-confirmed LF were eligible to participate.

符合入组条件的为成年住院患者，其症状为轻度至中度，且经RT-PCR确认为利福平耐药性结核病（LF）。

In total, 41 patients were randomized (ribavirin n = 21; favipiravir n = 20), and 36 completed the 10-day follow-up period.

共有41名患者被随机分配（利巴韦林组n=21；法匹拉韦组n=20），其中36名完成了10天的随访期。

A total of 19 (46.3%) participants were female, and the median age was 37 years.

共有19名（46.3%）参与者为女性，中位年龄为37岁。

The primary endpoints were met.

主要终点已达到。

Pharmacokinetic analysis of favipiravir in a one-compartment model indicated reliable exposure with maximum plasma concentration of 50.9 (IQR 42.1 to 75.1) mg l-1 in steady state, half-life of 10.9 (IQR 8.2 to 17.1) h and AUC (0-240 h) of 9,275 (IQR 7,139.4 to 15,794.8) mg l-1 h-1.

在单室模型中对法匹拉韦的药代动力学分析表明，在稳态时，最大血浆浓度为50.9 (四分位数间距 42.1 至 75.1) mg l-1，半衰期为10.9 (四分位数间距 8.2 至 17.1) 小时，AUC (0-240 h) 为9,275 (四分位数间距 7,139.4 至 15,794.8) mg l-1 h-1。

The 30 drug-related treatment-emergent adverse events were evenly distributed between the treatment arms; 16 (53.5%) events occurred in the favipiravir group, and none of these were classified as severe or serious.

30个与药物相关的治疗后不良事件在治疗组之间均匀分布；16个（53.5%）事件发生在法匹拉韦组，且这些均未被分类为严重或危及生命。

Anemia was the most frequently observed adverse eventin the ribavirin arm and vomiting in the favipiravir arm.

在利巴韦林组中，观察到的最常见不良事件是贫血，在法匹拉韦组中则是呕吐。

All study participants survived and were successfully discharged from the isolation ward.

所有研究参与者均存活，并成功从隔离病房出院。

This trial indicates favipiravir's potential as a safe and well-tolerated alternative treatment regimen for LF and pharmacokinetic data suggest an optimized favipiravir regimen for future clinical evaluation.

这项试验表明法匹拉韦作为利福平耐药性结核病的安全且耐受性良好的替代治疗方案的潜力，药代动力学数据表明了未来临床评估中优化的法匹拉韦方案。

Clinicaltrials.gov: NCT04907682 .

Clinicaltrials.gov: NCT04907682 .