Alaska Native Tribal Health Consortium, Liver Disease and Hepatitis Program, Anchorage, Alaska, United States of America.
Centers for Disease Control and Prevention, Anchorage, Alaska, United States of America.
PLoS One. 2021 Dec 2;16(12):e0260970. doi: 10.1371/journal.pone.0260970. eCollection 2021.
Direct-acting antiviral (DAA) drugs have been effective in the treatment of chronic hepatitis C virus (HCV) infection. Limited data are available on safety, tolerability, and efficacy in American Indian or Alaska Native people. We aim to evaluate the treatment outcomes of sofosbuvir- based regimens for treatment of HCV in a real life setting in Alaska Native/American Indian (AN/AI) people.
AN/AI patients within the Alaska Tribal Health System with confirmed positive anti-HCV and HCV RNA, who were 18 years of age and older were included in the study. Pretreatment baseline patient characteristics, treatment efficacy based on sustained virologic response (SVR) 12 weeks after treatment completion, and adverse effects were assessed. The following treatments were given according to the American Association for the Study of Liver Diseases/Infectious Disease Society of America (AASLD/IDSA) HCV Guidance: ledipasvir/sofosbuvir, sofosbuvir plus weight-based ribavirin, and sofosbuvir/velpatasvir.
We included 501 patients with a mean age of 54.3 (range 21.3-78.3) in the study. Overall SVR was achieved in 95.2% of patients who received one of the three DAA regimens. For those with cirrhosis, overall SVR was 92.8% and for those with genotype 3 91.1% achieved SVR. The most common symptom experienced during treatment was headache. Joint pain was found to decrease during treatment. One person discontinued sofosbuvir plus ribavirin due to myocardial infarction and one discontinued sofosbuvir/velpatasvir due to urticaria.
In the real-world setting, sofosbuvir-based treatment is safe, effective, and well tolerated in AN/AI patients. Sustained virologic response was high regardless of HCV genotype or cirrhosis status.
直接作用抗病毒 (DAA) 药物已被证明在治疗慢性丙型肝炎病毒 (HCV) 感染方面非常有效。然而，关于其在美国印第安人或阿拉斯加原住民中的安全性、耐受性和疗效的数据有限。我们旨在评估索非布韦为基础的方案在阿拉斯加原住民/美洲印第安人 (AN/AI) 人群中的真实世界治疗结局。
本研究纳入了在阿拉斯加部落卫生系统中，经确认抗 HCV 和 HCV RNA 阳性、年龄在 18 岁及以上的 AN/AI 患者。评估了治疗前的基线患者特征、治疗结束后 12 周的持续病毒学应答 (SVR) 以及不良反应。根据美国肝病研究协会/传染病学会 (AASLD/IDSA) HCV 指南，给予以下治疗：ledipasvir/索非布韦、索非布韦加体重为基础的利巴韦林以及索非布韦/velpatasvir。
我们纳入了 501 名平均年龄为 54.3 岁（范围 21.3-78.3 岁）的患者。接受三种 DAA 方案之一的患者总体 SVR 率为 95.2%。对于有肝硬化的患者，总体 SVR 率为 92.8%，对于基因型 3 的患者，91.1%达到 SVR。治疗过程中最常见的症状是头痛。关节疼痛在治疗过程中有所减轻。1 名患者因心肌梗死停用索非布韦加利巴韦林，1 名患者因荨麻疹停用索非布韦/velpatasvir。
在真实世界环境中，索非布韦为基础的治疗方案在 AN/AI 患者中安全、有效且耐受性良好。无论 HCV 基因型或肝硬化状态如何，持续病毒学应答率均较高。
