COVID Isolation Department, Almaza Fever Hospital, Cairo, Egypt.
Tropical Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
J Med Life. 2022 Mar;15(3):350-358. doi: 10.25122/jml-2021-0175.
COVID-19 is a pandemic disease caused by SARS-CoV-2, which is an RNA virus similar to the hepatitis C virus (HCV) in the replication process. Sofosbuvir/ledipasvir is an approved drug to treat HCV infection. This study investigates the efficacy of Sofosbuvir/ledipasvir as a treatment for patients with moderate COVID-19 infection. This is a single-blinded parallel-randomized controlled trial. The participants were randomized equally into the intervention group that received Sofosbuvir/ledipasvir (S.L. group), and the control group received Oseltamivir, Hydroxychloroquine, and Azithromycin (OCH group). The primary outcomes were the cure rate over time and the incidence of serious adverse events. The secondary outcomes included the laboratory findings. 250 patients were divided equally into each group. Both groups were similar regarding gender, but age was higher in the S.L. group (p=0.001). In the S.L. group, 89 (71.2%) patients were cured, while only 51 (40.8%) patients were cured in the OCH group. The cure rate was significantly higher in the S.L. group (RR=1.75, p<0.001). Kaplan-Meir plot showed a considerably higher cure over time in the S.L. group (Log-rank test, p=0.032). There were no deaths in the S.L. group, but there were six deaths (4.8%) in the OCH group (RR=0.08, p=0.013). Seven patients (5.6%) in the S.L. group and six patients (4.8%) in the OCH group were admitted to the intensive care unit (ICU) (RR=1.17, P=0.776). There were no significant differences between treatment groups regarding total leukocyte and neutrophils count, lymph, and urea. Sofosbuvir/ledipasvir is suggestive of being effective in treating patients with moderate COVID-19 infection. Further studies are needed to compare Sofosbuvir/ledipasvir with new treatment protocols.
COVID-19 是一种由 SARS-CoV-2 引起的大流行疾病，该病毒在复制过程中类似于丙型肝炎病毒（HCV）。索非布韦/利迪帕韦是一种已批准用于治疗 HCV 感染的药物。本研究旨在探讨索非布韦/利迪帕韦治疗中度 COVID-19 感染患者的疗效。这是一项单盲平行随机对照试验。参与者被平均随机分为接受索非布韦/利迪帕韦（S.L.组）的干预组和接受奥司他韦、羟氯喹和阿奇霉素（OCH 组）的对照组。主要结局是随时间推移的治愈率和严重不良事件的发生率。次要结局包括实验室检查结果。250 名患者平均分为两组。两组在性别方面相似，但 S.L.组的年龄较高（p=0.001）。在 S.L.组中，89（71.2%）名患者治愈，而 OCH 组中只有 51（40.8%）名患者治愈。S.L.组的治愈率明显更高（RR=1.75，p<0.001）。Kaplan-Meier 图显示 S.L.组随时间推移的治愈率明显更高（对数秩检验，p=0.032）。S.L.组无死亡病例，但 OCH 组有 6 例死亡（4.8%）（RR=0.08，p=0.013）。S.L.组有 7 名（5.6%）患者和 OCH 组有 6 名（4.8%）患者需要入住重症监护病房（ICU）（RR=1.17，P=0.776）。两组患者的白细胞和中性粒细胞计数、淋巴细胞和尿素水平无显著差异。索非布韦/利迪帕韦可能对治疗中度 COVID-19 感染患者有效。需要进一步研究比较索非布韦/利迪帕韦与新的治疗方案。
