Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
J Gastroenterol. 2017 Aug;52(8):986-991. doi: 10.1007/s00535-017-1310-9. Epub 2017 Jan 30.
The optimal therapy for recurrent hepatitis C virus (HCV) infection after liver transplantation has not yet been established. This study aimed to clarify the efficacy and safety of interferon-free therapy with sofosbuvir and ledipasvir without ribavirin for 12 weeks in Japanese patients with HCV genotype 1b infection after living donor liver transplantation.
A cohort study of living donor liver transplant recipients with recurrent HCV genotype 1b infection treated with sofosbuvir (400 mg/day) and ledipasvir (90 mg/day) was performed at six liver transplant centers in Japan.
Fifty-four patients were treated with sofosbuvir and ledipasvir. Thirty-eight patients (70%) were treatment experienced, including 17 patients who had undergone prior direct-acting-antiviral-based triple therapy. Ten patients had resistance-associated substitutions at L31 or Y93 in the NS5A region of the HCV genome. Fifty-three patients completed the 12-week treatment protocol; treatment was discontinued in one patient who developed pneumonia at 4 weeks and died thereafter. All 53 patients who completed the treatment regimen achieved a sustained virological response 12 weeks after completion of treatment. Treatment was well tolerated in most patients, but seven patients developed serious adverse events, including hemorrhagic duodenal ulcers (n = 3), infection (n = 2), pleural effusion (n = 1), and alveolar hemorrhage (n = 1).
Sofosbuvir and ledipasvir treatment without ribavirin for 12 weeks was highly effective in achieving a sustained virological response in Japanese patients who developed recurrent HCV genotype 1b infection after living donor liver transplantation.
肝移植后复发丙型肝炎病毒（HCV）感染的最佳治疗方法尚未确定。本研究旨在明确无利巴韦林的索磷布韦和来迪派韦联合治疗方案在日本丙型肝炎病毒 1b 基因型肝移植后复发患者中的疗效和安全性。
在日本的 6 家肝移植中心进行了一项索磷布韦（400mg/天）和来迪派韦（90mg/天）治疗丙型肝炎病毒 1b 基因型肝移植后复发的肝移植受者的队列研究。
54 例患者接受了索磷布韦和来迪派韦治疗。38 例（70%）患者有治疗史，其中 17 例患者曾接受过直接作用抗病毒药物三联治疗。10 例患者在 HCV 基因组的 NS5A 区有 L31 或 Y93 耐药相关替代。53 例患者完成了 12 周的治疗方案；1 例患者在 4 周时发生肺炎并随后死亡，因此停止治疗。所有完成治疗方案的 53 例患者在完成治疗后 12 周均达到持续病毒学应答。大多数患者对治疗耐受良好，但 7 例患者发生严重不良事件，包括出血性十二指肠溃疡（n=3）、感染（n=2）、胸腔积液（n=1）和肺泡出血（n=1）。
无利巴韦林的索磷布韦和来迪派韦治疗方案在日本肝移植后复发丙型肝炎病毒 1b 基因型感染患者中，12 周的治疗方案能高度有效地实现持续病毒学应答。
