Internal Medicine Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt.
Sci Rep. 2021 Feb 25;11(1):4623. doi: 10.1038/s41598-021-84066-3.
The new anti-hepatitis C virus (HCV) molecules improve treatment regimens and outcomes, but there are drawbacks. New combinations should target the HCV infectious cycle and be effective against all HCV genotypes. We developed the novel formulation Catvira, composed of epigallocatechingallate (EGCG) + sofosbuvir + ribavirin. Here, we compared Catvira to sofosbuvir + ribavirin tablets in patients with CHC genotype 4 in a randomized open-label efficacy and safety study. Treatment-naïve and treatment-experienced patients (n = 80) were randomly assigned to receive a single daily fixed dose of Catvira or sofosbuvir + ribavirin for 12 or 24 weeks. Both Catvira and sofosbuvir + ribavirin yielded similar outcomes of viral load (p < 0.001). Patients receiving Catvira had a significantly more rapid rate of viral load decline with sustained virologic response (SVR12) achieved by 90% of patients receiving 12 weeks of treatment. Catvira did not impact hemoglobin levels while sofosbuvir + ribavirin showed significant decline in hemoglobin levels after 24 weeks (p < 0.05). In this clinical trial (ClinicalTrials.gov Identifier NCT02483156), we found that Catvira administered daily for 12 or 24 weeks is safe, effective, and well-tolerated in both naïve and treatment-experienced patients with HCV genotype 4.
新型抗丙型肝炎病毒 (HCV) 分子改善了治疗方案和结果，但也存在一些缺点。新的组合应该针对 HCV 感染周期，并对所有 HCV 基因型有效。我们开发了新型制剂 Catvira，由表没食子儿茶素没食子酸酯 (EGCG) + 索非布韦 + 利巴韦林组成。在此，我们在一项随机、开放标签的疗效和安全性研究中比较了 Catvira 与索非布韦 + 利巴韦林片剂在 HCV 基因型 4 患者中的疗效。初治和经治患者（n = 80）随机接受每日一次固定剂量的 Catvira 或索非布韦 + 利巴韦林治疗 12 或 24 周。Catvira 和索非布韦 + 利巴韦林均产生了相似的病毒载量结果（p < 0.001）。接受 Catvira 治疗的患者病毒载量下降更快，12 周治疗后 90%的患者达到持续病毒学应答 (SVR12)。Catvira 对血红蛋白水平没有影响，而索非布韦 + 利巴韦林在 24 周后血红蛋白水平显著下降（p < 0.05）。在这项临床试验（ClinicalTrials.gov 标识符 NCT02483156）中，我们发现每日接受 12 或 24 周 Catvira 治疗的初治和经治 HCV 基因型 4 患者安全、有效且耐受良好。
