Department of Pharmacy, Shizuoka General Hospital, Shizuoka City, Shizuoka, Japan.
Department of Pharmacy, Shizuoka City Shimizu Hospital, Shizuoka City, Shizuoka, Japan.
J Clin Pharm Ther. 2022 Jul;47(7):940-947. doi: 10.1111/jcpt.13624. Epub 2022 Feb 28.
In Japan, ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir are recommended as first-line treatments for patients with untreated hepatitis C virus genotype 1. Although they have demonstrated a high efficacy in clinical trials, there are no direct comparative studies. Clarification of their effectiveness and safety in real-world clinical practice is required. Therefore, we conducted a retrospective multicentre study on the effectiveness of these direct-acting antivirals in real-world clinical practice.
We retrospectively evaluated the clinical data of untreated patients with persistent HCV genotype 1 infection who started first-line treatment with ledipasvir/sofosbuvir, elbasvir/grazoprevir or glecaprevir/pibrentasvir between September 2015 and January 2019 at 11 medical institutions in Japan. The primary efficacy endpoint was a sustained virologic response after 12 weeks of treatment. The secondary endpoints included sustained virologic response after 24 weeks of treatment and end of treatment response. The safety endpoint was treatment completion rate.
During the study, 420 patients (median age, 70 years; 181 males) received ledipasvir/sofosbuvir, 48 (median age 72, years; 29 males) received elbasvir/grazoprevir and 63 (median age 66, years; 35 males) received glecaprevir/pibrentasvir. For ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir, the sustained virologic response after 12 weeks of treatment was 98.6%, 97.9% and 100%; the sustained virologic response after 24 weeks of treatment was 99.0%, 97.7% and 100%; the end of treatment response was 99.8%, 97.9% and 98.4%; and the treatment completion rate was 98.3%, 91.7% and 100% respectively.
In real-world clinical practice, hepatitis C virus treatment with ledipasvir/sofosbuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir was effective with safety.
在日本，利迪帕韦/索磷布韦、艾尔巴韦/格拉瑞韦和格卡瑞韦/哌仑他韦被推荐作为初治丙型肝炎病毒基因型 1 患者的一线治疗药物。虽然这些药物在临床试验中显示出了很高的疗效，但目前尚无直接的比较研究。因此，我们在日本的 11 家医疗机构进行了一项关于这些直接作用抗病毒药物在真实临床实践中的疗效的回顾性多中心研究。
我们回顾性评估了 2015 年 9 月至 2019 年 1 月期间，11 家日本医疗机构的未经治疗的持续 HCV 基因型 1 感染患者使用 ledipasvir/sofosbuvir、elbasvir/grazoprevir 或 glecaprevir/pibrentasvir 进行一线治疗的临床数据。主要疗效终点是治疗 12 周后的持续病毒学应答。次要终点包括治疗 24 周后的持续病毒学应答和治疗结束时的应答。安全性终点是治疗完成率。
在研究期间，420 例患者（中位年龄 70 岁；181 例男性）接受了 ledipasvir/sofosbuvir 治疗，48 例（中位年龄 72 岁；29 例男性）接受了 elbasvir/grazoprevir 治疗，63 例（中位年龄 66 岁；35 例男性）接受了 glecaprevir/pibrentasvir 治疗。对于 ledipasvir/sofosbuvir、elbasvir/grazoprevir 和 glecaprevir/pibrentasvir，治疗 12 周后的持续病毒学应答率分别为 98.6%、97.9%和 100%；治疗 24 周后的持续病毒学应答率分别为 99.0%、97.7%和 100%；治疗结束时的应答率分别为 99.8%、97.9%和 98.4%；治疗完成率分别为 98.3%、91.7%和 100%。
在真实的临床实践中，使用 ledipasvir/sofosbuvir、elbasvir/grazoprevir 和 glecaprevir/pibrentasvir 治疗丙型肝炎病毒是有效的，且安全性良好。
