直接作用抗病毒药物在韩国慢性丙型肝炎和血友病初治或经治患者中的应用。
Direct Acting Antiviral Agents in Korean Patients with Chronic Hepatitis C and Hemophilia Who Are Treatment-Naïve or Treatment-Experienced.
机构信息
Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Department of Pediatrics, Korea Hemophilia Foundation Hospital, Seoul, Korea.
出版信息
Gut Liver. 2017 Sep 15;11(5):721-727. doi: 10.5009/gnl17209.
BACKGROUND/AIMS: Chronic hepatitis C (CHC) is a major comorbidity in patients with hemophilia.
METHODS
Patients (n=30) were enrolled between September 2015 and April 2016. Twenty-six patients were genotype 1 (1b, n=21; 1a, n=5) and four patients were genotype 2a/2b. Among 21 patients with genotype 1b, Y93H resistance-associated variants (RAVs) were detected in three patients (14.3%). We evaluated sustained virologic response (SVRs) at 12 weeks, as well as relapse and safety.
RESULTS
Five patients with genotype 1a and three patients with genotype 1b (RAV positive) received ledipasvir/sofosbuvir for 12 weeks. SVR12 rate was 100% (8/8). Eleven patients with genotype 1b were treatment-naïve and received daclatasvir plus asunaprevir for 24 weeks. SVR12 rate was 91% (10/11). One patient experienced viral breakthrough without RAV at 12 weeks. Seven treatment-experienced patients with genotype 1b received daclatasvir plus asunaprevir for 24 weeks. SVR12 rate was 85.7% (6/7). One patient experienced viral breakthrough with RAV (L31M, Y93H) at 12 weeks. Four patients with genotype 2a/2b received sofosbuvir plus ribavirin for 12 weeks. SVR12 rate was 100% (4/4). No serious adverse event-related discontinuations were noted.
CONCLUSIONS
New direct acting antiviral treatment achieved high SVRs rates at 12 weeks in CHC patients with hemophilia without serious adverse events.
背景/目的：慢性丙型肝炎（CHC）是血友病患者的主要合并症。
方法
患者（n=30）于 2015 年 9 月至 2016 年 4 月期间入组。26 例患者为基因型 1（1b，n=21；1a，n=5），4 例患者为基因型 2a/2b。在 21 例基因型 1b 患者中，有 3 例（14.3%）检测到 Y93H 耐药相关变异（RAV）。我们评估了 12 周时的持续病毒学应答（SVR）以及复发和安全性。
结果
5 例基因型 1a 和 3 例基因型 1b（RAV 阳性）患者接受了 ledipasvir/sofosbuvir 治疗 12 周。SVR12 率为 100%（8/8）。11 例基因型 1b 患者为初治患者，接受达卡他韦联合asunaprevir 治疗 24 周。SVR12 率为 91%（10/11）。1 例患者在 12 周时发生无 RAV 的病毒突破。7 例基因型 1b 的治疗经验患者接受达卡他韦联合asunaprevir 治疗 24 周。SVR12 率为 85.7%（6/7）。1 例患者在 12 周时发生 RAV（L31M，Y93H）相关的病毒突破。4 例基因型 2a/2b 患者接受 sofosbuvir 联合利巴韦林治疗 12 周。SVR12 率为 100%（4/4）。未观察到与严重不良事件相关的停药。
结论
新型直接作用抗病毒治疗在无严重不良事件的情况下，在血友病合并 CHC 患者中实现了 12 周时的高 SVR 率。
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