Louie Vincent, Latt Nyan L, Gharibian Derenik, Sahota Amandeep, Yanny Beshoy T, Mittal Rasham, Bider-Canfield Zoe, Cheetham T Craig
Ambulatory Care Pharmacist at the Los Angeles Medical Center in CA.
Gastroenterology Fellow at the Los Angeles Medical Center in CA.
Perm J. 2017;21:16-096. doi: 10.7812/TPP/16-096.
Traditional hepatitis C virus treatment was limited by low cure rates, side effects, and stringent monitoring requirements. Sofosbuvir, a direct-acting antiviral agent with a cure rate of 96%, was introduced in 2013. However, trials frequently excluded patients with advanced liver disease and prior treatment experience. This study aims to elucidate the real-world cure rates and sofosbuvir safety profile.
A retrospective cohort study was conducted at Kaiser Permanente Southern California involving patients with hepatitis C virus who received sofosbuvir treatment. Patients age 18 years and older were included, and pregnant patients were excluded. The primary end point was sustained virologic response at 12 weeks posttreatment. Secondary end points were safety and medication adherence. Multiple logistic regression analysis was used to compare patients with genotypes 1 and 2 infections.
Of the 213 study patients, 42.3% had cirrhosis, and 38% were treatment-experienced. Most patients (69.5%) received dual therapy (sofosbuvir + ribavirin), whereas the remainder (30.5%) received triple therapy (sofosbuvir + ribavirin + interferon). The overall rate of sustained virologic response at 12 weeks posttreatment rate was 72.9% for genotype 1 infection, 64.7% in the treatment-experienced subgroup, and 66.7% in the cirrhosis subgroup. Rates of sustained virologic response at 12 weeks posttreatment for genotypes 2 and 3 were 90.8% and 55%, respectively. Most patients experienced anemia and fatigue. Women and patients with a lower baseline viral load were statistically more likely to be cured.
Real-world cure rates were similar to rates seen in clinical trials for genotype 2 infection and lower for genotype 1 infection. Patients with genotype 1 and 3 infection did better with triple therapy compared with dual therapy. Patients tolerated therapy well with side effects, serious adverse events, and discontinuation rates similar to clinical trials. Women and patients with lower baseline hepatitis C viral load were more likely to achieve sustained virological response at 12 weeks posttreatment.
传统的丙型肝炎病毒治疗受到治愈率低、副作用以及严格监测要求的限制。索磷布韦是一种直接抗病毒药物，治愈率为96%，于2013年推出。然而，试验经常排除患有晚期肝病和有过治疗经历的患者。本研究旨在阐明真实世界中的治愈率以及索磷布韦的安全性概况。
在南加州永久医疗集团进行了一项回顾性队列研究，纳入接受索磷布韦治疗的丙型肝炎病毒患者。纳入年龄18岁及以上的患者，排除孕妇。主要终点是治疗后12周的持续病毒学应答。次要终点是安全性和药物依从性。采用多重逻辑回归分析比较基因型1和2感染的患者。
在213例研究患者中，42.3%患有肝硬化，38%有过治疗经历。大多数患者（69.5%）接受了联合治疗（索磷布韦+利巴韦林），其余患者（30.5%）接受了三联治疗（索磷布韦+利巴韦林+干扰素）。治疗后12周，基因型1感染的总体持续病毒学应答率为72.9%，有过治疗经历的亚组为64.7%，肝硬化亚组为66.7%。基因型2和3在治疗后12周的持续病毒学应答率分别为90.8%和55%。大多数患者出现贫血和疲劳。女性和基线病毒载量较低的患者在统计学上更有可能治愈。
真实世界中的治愈率与基因型2感染在临床试验中的治愈率相似，而基因型1感染的治愈率较低。与联合治疗相比，基因型1和3感染的患者采用三联治疗效果更好。患者对治疗耐受性良好，副作用、严重不良事件和停药率与临床试验相似。女性和基线丙型肝炎病毒载量较低的患者在治疗后12周更有可能实现持续病毒学应答。
